The XXIII Congress of the International Society on Thrombosis and Haemostasis and 57th SSC Meeting will be held in Kyoto for 2011.
Wednesday, December 29, 2010
Saturday, December 25, 2010
Wednesday, December 22, 2010
Stanford's ideas generate $65.1 million in revenues
A new report card for one of the nation's most powerful innovation engines shows that Stanford-based inventions generated $65.1 million in income for the university in 2009 despite the recession -- up from $62.5 million the previous year.
Stanford's total earnings from inventions were $1.1 billion during the past four decades, with more than half coming from just two inventions: the hypertext searching used by Google and groundbreaking DNA-splicing technology, according to an annual survey by the Association of University Technology Managers.
No longer isolated "ivory towers," schools like Stanford harvest great ideas and then try to send them out in the world. There they can be turned into commercial products -- and reward the campus with royalty income from licensing rights.
The two most lucrative inventions are decades old and are no longer producing revenue. Recombinant DNA, a 1974 invention, creates artificial DNA through gene splicing and brought in $225 million; Google's "PageRank" tool, patented in 1996, brought in $336 million.
Every school dreams of the next Gatorade -- a simple mixture of water, sugar, lemon juice, sodium, potassium, and phosphate that has yielded the University of Florida more than $80 million since 1973.
But instead of bringing home the bacon, many universities throw money into the void with little hope of return.
There's a chasm between a good idea and a product, termed "the valley of death."
Patents are expensive, with fees and legal costs involved in obtaining a single patent range from $20,000 to $25,000. Because it takes so long to bring a product to market, the royalties are based on license deals done 10 to 15 years ago.
Stanford ranks 10th in annual earnings among the nation's campuses, according to the new survey. By comparison, the University of California system had 47 startup companies and $103 million in royalties.
Nationally, scientific research from about 150 universities created 555 startup companies and resulted in more than 4,500 patent optioning and licensing deals last year, earning $1.8 billion in payouts.
Stanford's royalty revenue in 2009 came from 517 different technologies, generating from $3 million to $38 million. Its current big money-maker is an antibody invention, which led to the development of many valuable drugs.
But the statistics are sobering: After Google's PageRank and recombinant DNA inventions, "the rest of it is a bunch of technologies that generated much less income," said Katharine Ku, Stanford's Director for Technology Licensing, in a rare public presentation to the school's faculty senate last year. Only 19 inventions brought in more than $5 million. About 58 earned about $1 million, she said.
Fewer than half of the 300 research universities actively seeking patents have managed to break even from technology transfer efforts. Instead, two-thirds of the revenue tracked by the association has gone to only 13 institutions, including Stanford and UC.
Stanford's other best ideas, among the 7,400 inventions total, are FM Sound Synthesis, which led to the ringing of cell phones; recombinant DNA, used to make vast amounts of proteins like insulin, among other products; MINOS, an optimization software program; functional antibodies and DSL, which provides digital data transmission over the phone wires.
Ku recalled when Stanford engineering students Larry Page and Sergey Brin took their research project, based on a new search technology, to her office in hopes of finding a company interested in licensing their invention. Stanford marketed it to every potential licensee it could think of -- without success. So Page and Brin created their own company, and licensed the PageRank tool from Stanford. In exchange, Stanford was given Google stock.
Further reading
Stanford's total earnings from inventions were $1.1 billion during the past four decades, with more than half coming from just two inventions: the hypertext searching used by Google and groundbreaking DNA-splicing technology, according to an annual survey by the Association of University Technology Managers.
No longer isolated "ivory towers," schools like Stanford harvest great ideas and then try to send them out in the world. There they can be turned into commercial products -- and reward the campus with royalty income from licensing rights.
The two most lucrative inventions are decades old and are no longer producing revenue. Recombinant DNA, a 1974 invention, creates artificial DNA through gene splicing and brought in $225 million; Google's "PageRank" tool, patented in 1996, brought in $336 million.
Every school dreams of the next Gatorade -- a simple mixture of water, sugar, lemon juice, sodium, potassium, and phosphate that has yielded the University of Florida more than $80 million since 1973.
But instead of bringing home the bacon, many universities throw money into the void with little hope of return.
There's a chasm between a good idea and a product, termed "the valley of death."
Patents are expensive, with fees and legal costs involved in obtaining a single patent range from $20,000 to $25,000. Because it takes so long to bring a product to market, the royalties are based on license deals done 10 to 15 years ago.
Stanford ranks 10th in annual earnings among the nation's campuses, according to the new survey. By comparison, the University of California system had 47 startup companies and $103 million in royalties.
Nationally, scientific research from about 150 universities created 555 startup companies and resulted in more than 4,500 patent optioning and licensing deals last year, earning $1.8 billion in payouts.
Stanford's royalty revenue in 2009 came from 517 different technologies, generating from $3 million to $38 million. Its current big money-maker is an antibody invention, which led to the development of many valuable drugs.
But the statistics are sobering: After Google's PageRank and recombinant DNA inventions, "the rest of it is a bunch of technologies that generated much less income," said Katharine Ku, Stanford's Director for Technology Licensing, in a rare public presentation to the school's faculty senate last year. Only 19 inventions brought in more than $5 million. About 58 earned about $1 million, she said.
Fewer than half of the 300 research universities actively seeking patents have managed to break even from technology transfer efforts. Instead, two-thirds of the revenue tracked by the association has gone to only 13 institutions, including Stanford and UC.
Stanford's other best ideas, among the 7,400 inventions total, are FM Sound Synthesis, which led to the ringing of cell phones; recombinant DNA, used to make vast amounts of proteins like insulin, among other products; MINOS, an optimization software program; functional antibodies and DSL, which provides digital data transmission over the phone wires.
Ku recalled when Stanford engineering students Larry Page and Sergey Brin took their research project, based on a new search technology, to her office in hopes of finding a company interested in licensing their invention. Stanford marketed it to every potential licensee it could think of -- without success. So Page and Brin created their own company, and licensed the PageRank tool from Stanford. In exchange, Stanford was given Google stock.
Further reading
Thursday, December 16, 2010
German Plant-based Hemostatic Innovation HaemoCer Receives CE Approval
BAYREUTH;Germany, December 16, 2010 /PRNewswire/ -- BioCer Entwicklungs GmbH, a Bayreuth, Germany-based medical device manufacturer, are pleased to announce the CE approval of HaemoCer(TM), an Absorbable Polysaccharide Hemostat (APH). Introduction of HaemoCer(TM) APH will commence this month in the European Union and other selected international markets.
HaemoCer(TM) is an absorbable, surgical hemostatic technology created via a Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) process. PURE processing utilizes sophisticated, plant-based polymer crosslinking that creates ultra-hydrophilic, biocompatible, polysaccharide compounds. The PURE technology format of HaemoCer(TM) is a powder; alternate novel product formats are planned for release Q2 2011. A family of customized, single-use application instruments will enhance the delivery of HaemoCer(TM) particles to the wound site for the control of capillary, venous and arteriolar bleeding in both open and minimally invasive surgical procedures. There is no thrombin, collagen, or other human or animal components in HaemoCer(TM) particles.
Heinz-Josef Schmies, Managing Director of BioCer Entwicklungs Gmbh commented, "In conjunction with clinical trial results due Q1 2011, the introduction of HaemoCer(TM) APH and its proprietary, integrated PURE technology represents the next generation of polysaccharide hemostatic agents. Complete production of HaemoCer(TM) is conducted in Germany and has been warmly received by multi-disciplinary surgical specialists. Our technology has been favorably received in multiple international markets and fields."
BioCer Entwicklungs GmbH is a privately held medical device company and develops novel materials and uses them to create new or modified medical devices and manufacturing technologies. BioCer Entwicklungs current solutions incorporate ceramic, polysaccharide, polymer and other composite materials developed with leading Bavarian scientific expertise in collaboration the University of Bayreuth. The proprietary, patent-pending technology platform for HaemoCer(TM) and PURE processing will focus on the worldwide, hemostasis, wound care, hernia repair and orthopedic marketplaces. For information, distribution inquiries, and licensing options, visit http://www.biocer-gmbh.de/en/ Contact:info@biocer-gmbh.de
Wednesday, December 15, 2010
Blood disease attacks body’s ability to stop bleeding
A 16-year-old Paducah boy and a 72-year-old Hickory woman share a condition that could leave them unable to stop bleeding from a major wound.
Dr. Danny Butler of Paducah said Derek Willett and Phyllis Dublin suffer from idiopathic thrombocytopenic purpora. He described the disease as an assault by the body’s own immune system on blood platelets. Platelets are the component of the blood that gather at wound sites and form blood clots, stopping the body from bleeding to death. Different from hemophilia, the body suffers only from sudden acute drops in platelet levels, not in clotting factor.
“Common side effects are bruising, nosebleeds, a black spot in the mouth and bleeding into the gums,” Butler said. “We usually diagnose with a platelet count.”
Butler said the cause of the disease is unknown. Some patients, like Dublin, experience severe bleeding. Dublin bled into her lungs, which could have caused her to drown. The condition is treated by suppressing the entire immune system through anti-inflammatory steroids such as prednisone. Once treated, Dublin’s lungs re-absorbed the blood.
“We don’t know why some people choose to bleed from a certain location.” Butler said. “It could be life-threatening. We have to always look at the platelet levels. If it’s low, we would not like to operate and have to treat.”
If blood platelet levels are low or a patient has suffered severe bleeding, a blood transfusion remains an option. Butler warned that even with a transfusion, the body’s immune system could attack blood platelets. In severe cases, surgeons could remove a patient’s spleen. The spleen removes blood platelets attacked by antibodies.
“It’s a little more common in women than men and people 65 or older,” Butler said. “A lot can trigger the immune system. For every organ, we’re finding auto-immune disorders. We have a lot of work to do.”
Willett said his physician discovered the disease in a routine blood screening in 2009. The junior at St. Mary High School in Paducah said he was undergoing a physical for cross-country running when doctors noted his low platelet count. He’s reported no major episodes of bleeding, but monitors his platelet count closely.
“Doctors say I should avoid head and other serious trauma, but I’m not on steroids at this point,” Willett said. “They won’t do that unless my platelet count falls below 20,000 because steroids affect other organs in a bad way.”
Willett said he has conducted several fundraisers for Vanderbilt University Medical Center to research ITP. He’s raised $600 with a bake sale, selling bracelets and with a donation jar. For now, he is mindful of potential risks and hopes he grows out of his condition.
Dublin said she’s had no major episodes since August, but blames ITP for periods of weakness and fatigue earlier in the year.
“It was difficult to breathe, no worse than that,” Dublin said. She said the difficulty hit her one day about 11 a.m. “By 12:30, I was in the ER fighting for my life,” Dublin said.
Dublin said she stopped at the Mayfield Fire Department for oxygen. An ambulance took her to Western Baptist Hospital for treatment.
“I haven’t had any problems since, and the doctor started me on 90 mg of prednisone,” Dublin said. “He moved me from 90 to 60 to 40 and 10. Now I take 5 mg every other day. The thing is, this can affect anyone at any age, and comes on with no warning.”
Willett told teens and people of all ages to have complete blood count exam to determine if platelet levels are low.
Tuesday, December 7, 2010
Novo Nordisk presents positive clinical data on two investigational compounds within bleeding disorders
Orlando, US – (7 December 2010) – Novo Nordisk presented data from a phase 2 trial evaluating the safety, pharmacokinetics and efficacy of a recombinant factor VIIa (rFVIIa) analogue, designed to have a faster action profile than NovoSeven® (rFVIIa) in haemophilia patients with inhibitors (antibody formation against factor preparations). The company also presented data from a phase 3 trial investigating a recombinant compound in patients with congenital factor XIII deficiency, a rare, inherited bleeding disorder. The data were presented at the 52nd American Society of Hematology (ASH) Annual Meeting and Exposition.
rFVIIa analogue (NN1731)[1]: phase 2 results
Results were presented from a phase 2 trial, adept™1, in which haemophilia patients aged 12 years or older experiencing a joint bleed were randomised to receive up to three doses of NN1731 or NovoSeven®. The trial showed that NN1731 was safe and no antibody formation against NN1731 was seen in the trial. Evaluation of patients who received NN1731at the two highest dose levels showed that 96% of the joint bleeds were well-controlled with the product; the efficacy of NovoSeven® was similar to that observed in previous clinical studies (efficacy in approximately 90% of bleeds).
In addition, the number of adverse events (AEs), including serious adverse events (SAEs), was lower in patients being treated with NN1731 compared to those in the control group. A total of 12 SAEs were reported and all occurred 16 days or longer after exposure to NN1731.
“There were no safety concerns observed in patients at any dose level of NN1731,” said Dr Erich de Paula, of the State University of Campinas in São Paulo, Brazil, who presented the trial during the meeting. “Additionally, the phase 2 trial results demonstrated the potential of the rFVIIa analogue to stop joint bleeds quickly and effectively. These results further support the distinct fast action profile of the rFVIIa analogue in treating bleeds in haemophilia patients with inhibitors.”
NovoSeven® was used as a control in the trial due to its proven efficacy and safety profile. NovoSeven®was specifically developed to treat people with haemophilia A or B with inhibitors to factor VIII or IX replacement.
rFXIII compound: phase 3 results
Results were presented from mentor™1[2], a phase 3 trial examining the efficacy and safety of a recombinant factor XIII (rFXIII) compound for the prevention of bleeds associated with congenital FXIII deficiency, a rare bleeding disorder with about 600–1,000 diagnosed patients worldwide.
In the trial, 41 patients were treated for one year, with rFXIII administered as a preventative, once-monthly replacement therapy for congenital FXIII deficiency. FXIII-deficient patients with no previous history of FXIII treatment were used as a control. Currently, the only treatment available is derived from human blood plasma, which carries an inherent risk of infections.[3]
The trial results demonstrated that treatment with monthly recombinant FXIII injections significantly decreased the number of bleeding episodes requiring treatment compared to the historic control group. Over the course of the treatment period, a total of five bleeding episodes were observed in four patients. All five events were associated with trauma, and were not related to low FXIII activity levels in patients. Additionally, no thromboembolic events or fatal adverse events were reported.
“These data show the potential for rFXIII to become a safe and effective treatment option for patients who would otherwise use treatments at risk for contamination,” said Prof Aida Inbal of the Hemostasis Unit and Hematology Clinic in the Institute of Hematology at Rabin Medical Center in Tel Aviv, Israel. “We think this is an extremely important milestone in the development of a treatment that is not sourced from human plasma for patients suffering from congenital FXIII deficiency.”
Novo Nordisk plans to file for US Food and Drug Administration approval of the rFXIII in the first half of 2011.
Saturday, November 20, 2010
Appeals Court Stays Judgment in HemCon's Patent Infringement Case
PORTLAND, Ore.--(BUSINESS WIRE)--HemCon Medical Technologies, Inc., announced today that the U.S. Court of Appeals for the Federal Circuit granted HemCon's motion to stay the injunction and final judgment (including the damages award) obtained against it in a patent infringement case brought by Marine Polymer Technologies, Inc. The stay halts any enforcement of the lower court’s injunction and damages award while HemCon attempts to have both overturned on appeal, a process expected to take on the order of 12 to 18 months to complete. As a result, HemCon can continue selling its chitosan-based wound care products and will not be required to pay financial damages during this appeal process.
"HemCon is extremely pleased that the appellate court agreed that HemCon could continue selling its product line during the pendency of the appeal. We will urge on appeal that the lower court decision finding infringement was incorrect, in part because the Marine Polymer patent is invalid when properly interpreted," said John W. Morgan, HemCon's President and Chief Executive Officer. "The stay is a victory for HemCon's customers, including military personnel whose lives are being saved by HemCon products, and hospital patients who benefit from reduced infection risk and better hemostasis."
The stay is the most recent decision in the patent infringement action instituted by Marine Polymer Technologies, Inc. "In imposing the stay, the Court of Appeals concluded that HemCon had shown a strong likelihood of succeeding on appeal, or at least a substantial case on the merits and that any potential harm weighed in HemCon’s favor," Morgan explained. "We believe the appeals court will ultimately agree with our conclusion that our products do not infringe the Marine Polymer patent. We look forward to further presenting our case to the Court.”
HemCon Medical Technologies, Inc. (www.hemcon.com) founded in 2001, develops, manufactures, and markets innovative technologies to control bleeding and infection resulting from trauma or surgery. HemCon products are designed for use by military and civilian first responders as well as medical professionals in hospital, dental and clinical settings where rapid control of bleeding is of critical importance. HemCon is headquartered in Portland, Ore., with additional commercial operations in Ireland and the Czech Republic.
"HemCon is extremely pleased that the appellate court agreed that HemCon could continue selling its product line during the pendency of the appeal. We will urge on appeal that the lower court decision finding infringement was incorrect, in part because the Marine Polymer patent is invalid when properly interpreted," said John W. Morgan, HemCon's President and Chief Executive Officer. "The stay is a victory for HemCon's customers, including military personnel whose lives are being saved by HemCon products, and hospital patients who benefit from reduced infection risk and better hemostasis."
The stay is the most recent decision in the patent infringement action instituted by Marine Polymer Technologies, Inc. "In imposing the stay, the Court of Appeals concluded that HemCon had shown a strong likelihood of succeeding on appeal, or at least a substantial case on the merits and that any potential harm weighed in HemCon’s favor," Morgan explained. "We believe the appeals court will ultimately agree with our conclusion that our products do not infringe the Marine Polymer patent. We look forward to further presenting our case to the Court.”
HemCon Medical Technologies, Inc. (www.hemcon.com) founded in 2001, develops, manufactures, and markets innovative technologies to control bleeding and infection resulting from trauma or surgery. HemCon products are designed for use by military and civilian first responders as well as medical professionals in hospital, dental and clinical settings where rapid control of bleeding is of critical importance. HemCon is headquartered in Portland, Ore., with additional commercial operations in Ireland and the Czech Republic.
Baxter buying hemophilia business for up to $285M
Baxter International Inc. said Friday that it will pay as much as $285 million to buy a hemophilia drug candidate and other assets from privately held biotechnology company Archemix.Baxter currently sells the hemophilia drug Advate. The new deal gives the company all of Archemix's hemophilia assets, including an early-stage drug candidate called ARC19499. ARC19499 is a subcutaneous hemophilia therapy that is intended to improve blood clotting. An early clinical trial is being performed in the U.K.Baxter said the value of the deal could rise to $285 million including milestone payments. The drug and medical device maker said it will take a $30 million charge in the fourth quarter for the value of the hemophilia unit's research and development activities. Baxter expects the purchase to close by the end of 2010.
Friday, November 19, 2010
Ethicon Inc announces submission of BLA for Fibrin Pad
Ethicon Inc, a Johnson & Johnson (NYSE: JNJ) company, reported on Thursday the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for the Fibrin Pad to aid in stopping soft tissue bleeding during surgery.
The company's BLA submission includes efficacy and safety data from a randomised, controlled clinical study in which the Fibrin Pad was used as an adjunct to hemostasis in soft tissue bleeding. According to Ethicon the Fibrin Pad is a novel product candidate that combines two methods of action: biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin).The Fibrin Pad is intended for use by surgeons as an adjunct to hemostasis when surgical methods are ineffective or impractical to control bleeding.
ArterX™ Clinical Trial Results Announced at Veith Meeting
MOUNTAIN VIEW, Calif., Nov. 18, 2010 /PRNewswire/ -- US clinical trial results for Tenaxis' investigational vascular surgical sealant, ArterX, were presented today at the Veith Meeting in New York. William M. Stone, MD of the Mayo Clinic, Scottsdale AZ reported a more than 20% margin of improvement for ArterX Surgical Sealant in the sealing of vascular suture lines compared with a control group featuring a commercially available gelatin foam/thrombin combination.
In a presentation titled "A Novel More Effective Glue-Sealant (ArterX) for Hemostasis at Vascular Suture Lines and Other Sites," Dr. Stone reported that ArterX Surgical Sealant achieved immediate hemostasis more than 60% of the time in a 217 patient clinical trial conducted at 11 different hospitals in the US.
President and CEO, David Smith, commented, "We are delighted with the preliminary results of our US clinical trial. We were also able to show a statistically significant reduction in operating time of 36 minutes in the ArterX group, and ArterX patients were discharged from hospital after 4.1 days, an improvement of 1.3 days over the control group. If approved, we believe that ArterX Surgical Sealant will yield economic benefits for surgeons and hospitals that adopt it."
ArterX Surgical Sealant is currently under review by the FDA and is not available for sale in the USA.
ArterX is CE marked for the EU.
In a presentation titled "A Novel More Effective Glue-Sealant (ArterX) for Hemostasis at Vascular Suture Lines and Other Sites," Dr. Stone reported that ArterX Surgical Sealant achieved immediate hemostasis more than 60% of the time in a 217 patient clinical trial conducted at 11 different hospitals in the US.
President and CEO, David Smith, commented, "We are delighted with the preliminary results of our US clinical trial. We were also able to show a statistically significant reduction in operating time of 36 minutes in the ArterX group, and ArterX patients were discharged from hospital after 4.1 days, an improvement of 1.3 days over the control group. If approved, we believe that ArterX Surgical Sealant will yield economic benefits for surgeons and hospitals that adopt it."
ArterX Surgical Sealant is currently under review by the FDA and is not available for sale in the USA.
ArterX is CE marked for the EU.
Tuesday, November 16, 2010
Blood-clotting drug given to wounded soldiers can cause heart attacks
A drug given to wounded soldiers in Iraq and Afghanistan may be putting their lives in further danger by causing heart attacks and strokes.
The treatment is used to stop serious bleeding in injured troops, but trials show the drug increases the risk of blood clots forming in arteries, which can kill or cause complications that result in amputation.
The dangerous side effects are all the more concerning because years of trials have yet to prove the drug is any better at saving the lives of injured soldiers than a placebo.
The drug, called NovoSeven, was licensed more than a decade ago to stop bleeding in haemophiliacs, but is used by military doctors and in civilian hospitals on an "off-label" basis to treat patients suffering from major blood loss due to trauma or surgery. The drug, also known as recombinant factor seven, costs several thousand pounds per patient but an effective alternative called tranexamic acid costs just £5 per patient.
A spokesman for the Ministry of Defence confirmed that NovoSeven was used by UK forces as "a medicine of last resort", when all other attempts to stem bleeding had failed. The US military also uses the drug.
Prof Ian Roberts, an expert in trauma care at the London School of Hygiene and Tropical Medicine, warned in 2006 that NovoSeven was being used off-label before trials had clarified whether or not it helped save lives.
"There are both civilian patients and wounded soldiers who will have been given this drug and the best evidence shows they would not have benefited, but would have experienced heart attacks, strokes and possible amputations," Roberts said.
By continuing to use the drug, the military and hospital surgeons were leaving themselves vulnerable to legal action, he added. "You cannot defend giving this treatment outside of a randomised controlled trial," he said.
He added that the US military, which has used NovoSeven for years, should explain why it embraced the drug. "What advice were they acting on? Was the advice they received truly independent, or were people compromised in any way? It is important to know," he said.
Dr Mads Krogsgaard Thomsen, chief science officer at Novo Nordisk, the Danish company that makes NovoSeven, said the drug posed very low risk when used under licence to stop bleeding in haemophiliacs and for certain rare blood clotting disorders. "We cannot encourage as a company, by any means, the off-label use of NovoSeven. This is not something we are promoting and it is not something we are responsible for."
Thomsen estimates that between 10% and 20% of NovoSeven is used off-label. "Every now and then, physicians do use it as a last resort in patients that are otherwise likely to die," he said.
Roberts believes the case for using NovoSeven is weakened further by the availability of a much cheaper alternative drug, tranexamic acid, which is known to save lives in bleeding patients without dangerous side effects. A trial of tranexamic acid, called Crash-2, was published in the Lancet in June.
Marcel Levi, professor of internal medicine at Amsterdam Medical Centre, published a review of NovoSeven trials in the New England Journal of Medicine last week that was funded by NovoNordisk. "If you look at whether the drug stops bleeding, or whether fewer transfusions are needed, then many studies are positive. If the only thing that matters is mortality, then it is much harder to prove that this is a useful drug," he said.
Beverley Hunt, a consultant haematologist who worked on the Crash 2 trial at Guy's and St Thomas's Hospital in London, said: "The issue around the use of factor seven in patients with massive blood loss is that there is a lack of evidence to show us how clinically efficacious it really is, what dose to use and when to use it. The problem with using an agent that alters blood clotting is that it is a tightrope walk in reducing the risk of bleeding without increasing the risk of blood clots.
"The recent data showing that its use is associated with a 5% risk of arterial thrombosis means we should not be using it early in the management of massive blood loss. If however despite normal good practice, somebody is bleeding to death and you have nothing left, are you willing to take a 5% risk of arterial thrombosis, and the answer is yes you are."
The treatment is used to stop serious bleeding in injured troops, but trials show the drug increases the risk of blood clots forming in arteries, which can kill or cause complications that result in amputation.
The dangerous side effects are all the more concerning because years of trials have yet to prove the drug is any better at saving the lives of injured soldiers than a placebo.
The drug, called NovoSeven, was licensed more than a decade ago to stop bleeding in haemophiliacs, but is used by military doctors and in civilian hospitals on an "off-label" basis to treat patients suffering from major blood loss due to trauma or surgery. The drug, also known as recombinant factor seven, costs several thousand pounds per patient but an effective alternative called tranexamic acid costs just £5 per patient.
A spokesman for the Ministry of Defence confirmed that NovoSeven was used by UK forces as "a medicine of last resort", when all other attempts to stem bleeding had failed. The US military also uses the drug.
Prof Ian Roberts, an expert in trauma care at the London School of Hygiene and Tropical Medicine, warned in 2006 that NovoSeven was being used off-label before trials had clarified whether or not it helped save lives.
"There are both civilian patients and wounded soldiers who will have been given this drug and the best evidence shows they would not have benefited, but would have experienced heart attacks, strokes and possible amputations," Roberts said.
By continuing to use the drug, the military and hospital surgeons were leaving themselves vulnerable to legal action, he added. "You cannot defend giving this treatment outside of a randomised controlled trial," he said.
He added that the US military, which has used NovoSeven for years, should explain why it embraced the drug. "What advice were they acting on? Was the advice they received truly independent, or were people compromised in any way? It is important to know," he said.
Dr Mads Krogsgaard Thomsen, chief science officer at Novo Nordisk, the Danish company that makes NovoSeven, said the drug posed very low risk when used under licence to stop bleeding in haemophiliacs and for certain rare blood clotting disorders. "We cannot encourage as a company, by any means, the off-label use of NovoSeven. This is not something we are promoting and it is not something we are responsible for."
Thomsen estimates that between 10% and 20% of NovoSeven is used off-label. "Every now and then, physicians do use it as a last resort in patients that are otherwise likely to die," he said.
Roberts believes the case for using NovoSeven is weakened further by the availability of a much cheaper alternative drug, tranexamic acid, which is known to save lives in bleeding patients without dangerous side effects. A trial of tranexamic acid, called Crash-2, was published in the Lancet in June.
Marcel Levi, professor of internal medicine at Amsterdam Medical Centre, published a review of NovoSeven trials in the New England Journal of Medicine last week that was funded by NovoNordisk. "If you look at whether the drug stops bleeding, or whether fewer transfusions are needed, then many studies are positive. If the only thing that matters is mortality, then it is much harder to prove that this is a useful drug," he said.
Beverley Hunt, a consultant haematologist who worked on the Crash 2 trial at Guy's and St Thomas's Hospital in London, said: "The issue around the use of factor seven in patients with massive blood loss is that there is a lack of evidence to show us how clinically efficacious it really is, what dose to use and when to use it. The problem with using an agent that alters blood clotting is that it is a tightrope walk in reducing the risk of bleeding without increasing the risk of blood clots.
"The recent data showing that its use is associated with a 5% risk of arterial thrombosis means we should not be using it early in the management of massive blood loss. If however despite normal good practice, somebody is bleeding to death and you have nothing left, are you willing to take a 5% risk of arterial thrombosis, and the answer is yes you are."
Tuesday, November 9, 2010
X-ray crystallography reveals structure of precursor to blood-clotting protein
ST. LOUIS — Using state-of-the-art robotic and x-ray crystallographic equipment, researchers at Saint Louis University have revealed for the first time the molecular structure of the zymogen, or inactive, form of a blood-clotting enzyme.
In an article published in Proceedings of the National Academy of Sciences, Enrico Di Cera, M.D., chair of the department of biochemistry and molecular biology at Saint Louis University School of Medicine and lead researcher of the study, said the NIH-funded research offers important information about the protein.
“This research is very basic and very important,” said Di Cera. “It provides a missing link between the inactive zymogen form of thrombin and the mature enzyme generated upon vascular injury.”
Before thrombin becomes active, it circulates throughout the blood in the inactive zymogen form. When the active enzyme is needed, for example after a vascular injury, the coagulation cascade is initiated and the zymogen is converted into an active enzyme that causes blood to clot.
Blood clotting performs the important function of stopping blood loss after an injury. However, when triggered in the wrong conditions, clotting can lead to debilitating or fatal conditions like heart attack, stroke and deep vein thrombosis.
In previous laboratory research, Di Cera re-engineered thrombin to act as an anticoagulant, stopping blood from clotting and opening the door to the development of new therapeutic strategies for the treatment of thrombosis, the presence of blood clots in blood vessels, which is responsible for nearly a third of all deaths in the U.S.
While researchers have an understanding of the structure of active thrombin, very little was known about its zymogen form. In order to learn more, researchers used x-ray crystallography to gather data about the molecular structure of the protein.
The process involves growing a crystal of the protein, shooting x-ray beams through the crystal and analyzing the diffraction patterngenerated on a detector plate in order to detail the three-dimensional structure of the protein.
The structure of the zymogen form of thrombin provides crucial details about the activation mechanism that sheds light on the way the mature enzyme works. Future research can capitalize on these new findings to define better strategies for therapeutic intervention.
“Until now, we’ve known nothing about the zymogen form of thrombin or any blood-clotting enzyme,” said Di Cera. “All the structural information has been limited to the active form.
“We now know that the zymogen form of thrombin is very different from the mature enzyme, in ways that open new opportunities for therapeutic intervention.”
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.
In an article published in Proceedings of the National Academy of Sciences, Enrico Di Cera, M.D., chair of the department of biochemistry and molecular biology at Saint Louis University School of Medicine and lead researcher of the study, said the NIH-funded research offers important information about the protein.
“This research is very basic and very important,” said Di Cera. “It provides a missing link between the inactive zymogen form of thrombin and the mature enzyme generated upon vascular injury.”
Before thrombin becomes active, it circulates throughout the blood in the inactive zymogen form. When the active enzyme is needed, for example after a vascular injury, the coagulation cascade is initiated and the zymogen is converted into an active enzyme that causes blood to clot.
Blood clotting performs the important function of stopping blood loss after an injury. However, when triggered in the wrong conditions, clotting can lead to debilitating or fatal conditions like heart attack, stroke and deep vein thrombosis.
In previous laboratory research, Di Cera re-engineered thrombin to act as an anticoagulant, stopping blood from clotting and opening the door to the development of new therapeutic strategies for the treatment of thrombosis, the presence of blood clots in blood vessels, which is responsible for nearly a third of all deaths in the U.S.
While researchers have an understanding of the structure of active thrombin, very little was known about its zymogen form. In order to learn more, researchers used x-ray crystallography to gather data about the molecular structure of the protein.
The process involves growing a crystal of the protein, shooting x-ray beams through the crystal and analyzing the diffraction patterngenerated on a detector plate in order to detail the three-dimensional structure of the protein.
The structure of the zymogen form of thrombin provides crucial details about the activation mechanism that sheds light on the way the mature enzyme works. Future research can capitalize on these new findings to define better strategies for therapeutic intervention.
“Until now, we’ve known nothing about the zymogen form of thrombin or any blood-clotting enzyme,” said Di Cera. “All the structural information has been limited to the active form.
“We now know that the zymogen form of thrombin is very different from the mature enzyme, in ways that open new opportunities for therapeutic intervention.”
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.
Monday, November 8, 2010
Baxter International raises outlook after third-quarter earnings beat expectations
Baxter International Inc.’s third-quarter earnings beat Wall Street expectations Thursday, propelled by a jump in sales in the company’s IV solutions business. After the company’s earnings release, Baxter’s stock price rose by more than 3 percent.
The Deerfield-based medical supply and pharmaceutical company posted earnings of $594 million, or $1.01 per diluted share, in the quarter ended Sept. 30, besting Wall Street’s consensus projections of 97 cents. Net income rose 12 percent from the same quarter in 2009, when the company earned $532 million, or 87 cents per diluted share.
In the 2009 quarter, the company incurred a one-time charge of $27 million for the retirement of a syringe pump. Without that cost, 2010 third-quarter earnings would have been 1 percent lower than 2009.
Still, the company raised the floor of its 2010 annual forecast from $3.93 to $3.96 per diluted share, and now expects 2 percent to 3 percent annual sales growth. Its previous forecast called for growth in the range of 1 percent to 3 percent. The top forecast figure remained at $3.98.
“We continue to aggressively manage general administrative and discretionary spending across the company,” Robert Parkinson, Baxter’s chairman and chief financial officer, said in a Thursday morning conference call. “We’re selectively investing in several key promotional activities aimed at demand creation, new product launches and driving future growth of our higher margin products.”
Baxter’s third-quarter revenue grew by 3 percent to $3.2 billion from last year’s $3.1 billion. The medical delivery sector, which manufactures intravenous solutions and sets, intravenous nutritional products, medical pumps and drug manufacturing products, spurred much of the company’s third-quarter momentum by racking up $1.2 billion dollars in sales, up 2 percent globally and 12 percent domestically.
The company’s bioscience division also is outperforming analysts’ expectations, led by developments in critical-care blood plasma replacement therapeutics. Sales at the division did not grow significantly during the quarter but have grown 3 percent so far this year, totaling $3.4 billion.
“We view this commentary, quarterly results, and outlook as all positives for the company and encourage investors to revisit what should be a core holding in the healthcare space,” said Daniel Owczarski, a financial analyst with Avondale Partners LLC.
In the first nine months, Baxter has earned $1.1 billion, or $1.79 per diluted share, down 35 percent from the same period last year, when the company earned $1.7 billion, or $2.66 per diluted share. Revenue, rose 3 percent to $9.3 billion, compared with last year’s $9.1 billion.
The Deerfield-based medical supply and pharmaceutical company posted earnings of $594 million, or $1.01 per diluted share, in the quarter ended Sept. 30, besting Wall Street’s consensus projections of 97 cents. Net income rose 12 percent from the same quarter in 2009, when the company earned $532 million, or 87 cents per diluted share.
In the 2009 quarter, the company incurred a one-time charge of $27 million for the retirement of a syringe pump. Without that cost, 2010 third-quarter earnings would have been 1 percent lower than 2009.
Still, the company raised the floor of its 2010 annual forecast from $3.93 to $3.96 per diluted share, and now expects 2 percent to 3 percent annual sales growth. Its previous forecast called for growth in the range of 1 percent to 3 percent. The top forecast figure remained at $3.98.
“We continue to aggressively manage general administrative and discretionary spending across the company,” Robert Parkinson, Baxter’s chairman and chief financial officer, said in a Thursday morning conference call. “We’re selectively investing in several key promotional activities aimed at demand creation, new product launches and driving future growth of our higher margin products.”
Baxter’s third-quarter revenue grew by 3 percent to $3.2 billion from last year’s $3.1 billion. The medical delivery sector, which manufactures intravenous solutions and sets, intravenous nutritional products, medical pumps and drug manufacturing products, spurred much of the company’s third-quarter momentum by racking up $1.2 billion dollars in sales, up 2 percent globally and 12 percent domestically.
The company’s bioscience division also is outperforming analysts’ expectations, led by developments in critical-care blood plasma replacement therapeutics. Sales at the division did not grow significantly during the quarter but have grown 3 percent so far this year, totaling $3.4 billion.
“We view this commentary, quarterly results, and outlook as all positives for the company and encourage investors to revisit what should be a core holding in the healthcare space,” said Daniel Owczarski, a financial analyst with Avondale Partners LLC.
In the first nine months, Baxter has earned $1.1 billion, or $1.79 per diluted share, down 35 percent from the same period last year, when the company earned $1.7 billion, or $2.66 per diluted share. Revenue, rose 3 percent to $9.3 billion, compared with last year’s $9.1 billion.
King Pharma Disappoints
King Pharma's branded Pharmaceuticals segment declined 43.3% with revenues coming in at $160.8 million. Revenues of almost all key products declined from the year-ago period.
Thrombin-JMI sales declined 25.9% to $32.2 million. We expect Thrombin-JMI sales to continue declining due to tough competition in the form of Bristol-Myers Squibbs’ Recothrom and Johnson & Johnson’s Evithrom.
Thrombin-JMI sales declined 25.9% to $32.2 million. We expect Thrombin-JMI sales to continue declining due to tough competition in the form of Bristol-Myers Squibbs’ Recothrom and Johnson & Johnson’s Evithrom.
Seven U.S. Medical Centers Commence Study to Change Femoral Artery Cath Lab Access
REDWOOD CITY, Calif., Nov. 8, 2010 /PRNewswire/ -- Arstasis is pleased to announce that patient enrollment has begun in the RECITAL (A Patient Registry Evaluating Closure Following Access with the Arstasis One Access System) Study. The non-randomized, prospective, post-approval study is anticipated to enroll up to 500 patients in at least seven U.S. hospitals. The goal of the study is to observe the clinical safety and effectiveness of the Arstasis One Access System in patients undergoing diagnostic angiography procedures through the femoral artery.
The first patient was enrolled at La Paz Regional Medical Center inParker, Arizona. "We've begun performing Arstaotomy procedures routinely in our cath lab because they make femoral artery access safer for our patients, easier for me and my staff, and less expensive for our hospital compared with closure devices or manual compression," said Dr. Frank Kresock, chief of interventional cardiology at La Paz Regional Medical Center, the physician who performed the procedure.
Since 1959, physicians have been using the Modified Seldinger Technique (or "Seldinger Technique" for short) to insert flexible catheters into the femoral artery of patients for the purpose of performing procedures in the patient's arterial-vascular system. The most prevalent such procedure, angiography, is thought to be performed more than half a million times per month worldwide. At the end of every such case, each patient is left with a substantial hole in his/her femoral artery (upper inner thigh) which typically takes significant effort and cath lab resources to get to stop bleeding. With the Arstasis One Access System, however, physicians may create a shallow-angle needle pathway through the wall of the femoral artery. At the end of the procedure, when the sheath is withdrawn, the shallow-angle pathway collapses from the normal pressure of the patient's femoral artery blood flow from below and approximately 3-4 minutes of mild, non-occlusive finger-pressure from above, resulting in a quickly sealing access site.
"The Arstasis One femoral artery access system marks the beginning of a new approach to heart catheterization," commented Zoltan G. Turi, MD, the Director of the Vascular Center at Cooper University Hospital and Professor of Medicine at Robert Wood Johnson Medical School in Camden, New Jersey, and the national principal investigator of the RECITAL study. "We hope to show that patients who participate in this study benefit from femoral artery closure that has advantages over regular manual compression", Dr. Turi continued. "We are also interested in this technology because Arstasis facilitated closure, unlike vascular closure devices, does not result in any foreign materials being implanted."
The study will also assess patient satisfaction due to reduction of pain and discomfort as well as early mobility. In non-U.S. clinical trials the resulting closed access site was typically so secure that a patient could get up from his/her bed and begin walking hours sooner than would be the case with a standard femoral arteriotomy, sometimes as soon as those patients receiving Vessel Closure Devices.
"This procedure over the Angioseal, in my opinion, was 100% better because of the recovery time, less swelling and bruising. This is much better, I'm glad I got the Arstaotomy," said Russell McKenzie, Dr. Kresock's 75-year old patient at La Paz Regional Medical Center who was the first to enroll in the RECITAL study.
Detailed information about the Arstasis One, and the Arstaotomy procedure, is available at www.arstasis.com.
ABOUT ARSTASIS, INC.
Arstasis, Inc., headquartered in Redwood City, California, is a medical device manufacturer dedicated to bringing innovative access devices to cardiologists, interventional radiologists, their staffs, and patients. The company's first product, the Arstasis One, was cleared for U.S. commercialization by the FDA in 2010. The device is used in the Arstaotomy? procedure, a new way to gain access to the femoral artery that improves upon the Seldinger Technique and that some physicians believe results in a more pleasant and efficient cath lab and post-procedure experience for clinician and patient alike.
The first patient was enrolled at La Paz Regional Medical Center inParker, Arizona. "We've begun performing Arstaotomy procedures routinely in our cath lab because they make femoral artery access safer for our patients, easier for me and my staff, and less expensive for our hospital compared with closure devices or manual compression," said Dr. Frank Kresock, chief of interventional cardiology at La Paz Regional Medical Center, the physician who performed the procedure.
Since 1959, physicians have been using the Modified Seldinger Technique (or "Seldinger Technique" for short) to insert flexible catheters into the femoral artery of patients for the purpose of performing procedures in the patient's arterial-vascular system. The most prevalent such procedure, angiography, is thought to be performed more than half a million times per month worldwide. At the end of every such case, each patient is left with a substantial hole in his/her femoral artery (upper inner thigh) which typically takes significant effort and cath lab resources to get to stop bleeding. With the Arstasis One Access System, however, physicians may create a shallow-angle needle pathway through the wall of the femoral artery. At the end of the procedure, when the sheath is withdrawn, the shallow-angle pathway collapses from the normal pressure of the patient's femoral artery blood flow from below and approximately 3-4 minutes of mild, non-occlusive finger-pressure from above, resulting in a quickly sealing access site.
"The Arstasis One femoral artery access system marks the beginning of a new approach to heart catheterization," commented Zoltan G. Turi, MD, the Director of the Vascular Center at Cooper University Hospital and Professor of Medicine at Robert Wood Johnson Medical School in Camden, New Jersey, and the national principal investigator of the RECITAL study. "We hope to show that patients who participate in this study benefit from femoral artery closure that has advantages over regular manual compression", Dr. Turi continued. "We are also interested in this technology because Arstasis facilitated closure, unlike vascular closure devices, does not result in any foreign materials being implanted."
The study will also assess patient satisfaction due to reduction of pain and discomfort as well as early mobility. In non-U.S. clinical trials the resulting closed access site was typically so secure that a patient could get up from his/her bed and begin walking hours sooner than would be the case with a standard femoral arteriotomy, sometimes as soon as those patients receiving Vessel Closure Devices.
"This procedure over the Angioseal, in my opinion, was 100% better because of the recovery time, less swelling and bruising. This is much better, I'm glad I got the Arstaotomy," said Russell McKenzie, Dr. Kresock's 75-year old patient at La Paz Regional Medical Center who was the first to enroll in the RECITAL study.
Detailed information about the Arstasis One, and the Arstaotomy procedure, is available at www.arstasis.com.
ABOUT ARSTASIS, INC.
Arstasis, Inc., headquartered in Redwood City, California, is a medical device manufacturer dedicated to bringing innovative access devices to cardiologists, interventional radiologists, their staffs, and patients. The company's first product, the Arstasis One, was cleared for U.S. commercialization by the FDA in 2010. The device is used in the Arstaotomy? procedure, a new way to gain access to the femoral artery that improves upon the Seldinger Technique and that some physicians believe results in a more pleasant and efficient cath lab and post-procedure experience for clinician and patient alike.
Sunday, November 7, 2010
Researchers invent inkjet that prints out living skin
This is no horror movie, this is part of a recent presentation at the American College of Surgeons Clinical Congress, where Wake Forest Institute for Regenerative Medicine researchers had a super fun time showing off their results from a printer that uses living cells instead of ink. Fluid based inkjet technology used in the very printers you’ve got in your home or office is used to lay down cells, printing large sections of living tissue down on cut up or damaged areas of the body. These fine folks from the Institute note that “any loss of full-thickness skin of more than 4 cm in diameter will not heal by itself,” and that with this device, (refined and tested extensively, of course,) skin that might have been otherwise damaged horrifically can now be patched up to a much higher level of healthiness. Testing has occurred on mice revealing advanced healing by the second and third week of recovery and complete closure of the skin by the end of week three on wounds that would otherwise still be open to infection.
The printer works with two heads, one that dispenses skin cells mixed with fibrinogen (a blood coagulant) and type I collagen (connective tissue’s main component in scars), the other which sends out thrombin (another coagulant.) Together these create a chemical reaction and form fibrin, another protein that works on the clotting of blood. On top of this is one more layer printed by the printer: keratinocytes – the outer layer of skin we’ve all got right this moment.
Future research will be done on the pigs who, if you know your Gangs of New York lore, are great to practice stabbing on because they’ve got skin that very closely resembles human skin. Will this device ever hit your local wartime hospital or town hospital? Who can tell?
The printer works with two heads, one that dispenses skin cells mixed with fibrinogen (a blood coagulant) and type I collagen (connective tissue’s main component in scars), the other which sends out thrombin (another coagulant.) Together these create a chemical reaction and form fibrin, another protein that works on the clotting of blood. On top of this is one more layer printed by the printer: keratinocytes – the outer layer of skin we’ve all got right this moment.
Future research will be done on the pigs who, if you know your Gangs of New York lore, are great to practice stabbing on because they’ve got skin that very closely resembles human skin. Will this device ever hit your local wartime hospital or town hospital? Who can tell?
CryoLife Slips To Loss In Q3
(RTTNews) - CryoLife Inc. (CRY: News), an implantable biological medical device and cardiovascular tissue processing company, Thursday reported a loss for the third quarter, compared to a profit last year, mainly reflecting higher expenses.
CryoLife's net loss for the quarter was $3.03 million or $0.11 per share compared to a net income of $1.86 million or $0.07 per share last year.
For the recent third quarter, the company recorded charges of $3.7 million for acquired in-process research and development related to the Starch Medical transaction, $3.6 million related to the impairment of its investment in Medafor common stock and $1.6 million related to HemoStase inventory that the company does not believe that it will be able to distribute.
Excluding these charges, adjusted net income for the quarter was $2.6 million or $0.09 per share. On average, three analysts polled by Thomson Reuters expected the company to earn $0.09 per share in the quarter. Analysts' estimates typically excludes special items.
The Kennesaw, Georgia-based company's total revenues improved slightly to $28.44 million from $28.22 million in the comparable quarter last year. Three analysts were looking for a revenue of $29.30 million.
Total gross margins decreased to 54% from 60% last year, mainly due to the charge related to the write-off of the HemoStase inventory.
CryoLife's net loss for the quarter was $3.03 million or $0.11 per share compared to a net income of $1.86 million or $0.07 per share last year.
For the recent third quarter, the company recorded charges of $3.7 million for acquired in-process research and development related to the Starch Medical transaction, $3.6 million related to the impairment of its investment in Medafor common stock and $1.6 million related to HemoStase inventory that the company does not believe that it will be able to distribute.
Excluding these charges, adjusted net income for the quarter was $2.6 million or $0.09 per share. On average, three analysts polled by Thomson Reuters expected the company to earn $0.09 per share in the quarter. Analysts' estimates typically excludes special items.
The Kennesaw, Georgia-based company's total revenues improved slightly to $28.44 million from $28.22 million in the comparable quarter last year. Three analysts were looking for a revenue of $29.30 million.
Total gross margins decreased to 54% from 60% last year, mainly due to the charge related to the write-off of the HemoStase inventory.
Effects of an absorbable polysaccharide hemostat PerClot(r) on fracture healing of the cranial bone
Tuesday, October 26, 2010
EU Protocol for the use of CryoLife BioFoam
CryoLife protocol for EU rollout of BioFoam, Click Thumbnail to view.
ARCHIVE
On 10/27/09, CryoLife (NYSE: CRY) announced that the FDA has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam Surgical Matrix protein hydro-gel technology. BioFoam will be used to help seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemo-static agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial. CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. Upon successful completion of the feasibility study, and subsequent FDA and DoD approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study will be conducted. It is currently anticipated that the pivotal investigation will enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites.
ARCHIVE
On 10/27/09, CryoLife (NYSE: CRY) announced that the FDA has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam Surgical Matrix protein hydro-gel technology. BioFoam will be used to help seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemo-static agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial. CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. Upon successful completion of the feasibility study, and subsequent FDA and DoD approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study will be conducted. It is currently anticipated that the pivotal investigation will enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites.
Tenaxis Medical, Inc. Announces 'Fileable' Status of PMA
MOUNTAIN VIEW, Calif., Oct. 25 /PRNewswire/ -- Tenaxis Medical submitted its PMA to the FDA on July 27, 2010 and has now received confirmation from the FDA that "we have made a threshold determination that the PMA is sufficiently complete to permit a substantive review and is, therefore, suitable for filing."In the pivotal study designed to demonstrate superiority, the ArterX Surgical Sealant was compared to a thrombin soaked gelatin-sponge hemostat to reduce or eliminate suture line bleeding. President & Chief Executive Officer, David Smithcommented, "We are delighted that the FDA has made the determination to substantively review the PMA. We are continuing to prepare for our US launch and this was an important milestone."
About Tenaxis Medical, Inc.
Incorporated in 2004 and located in Mountain View, CA, Tenaxis Medical, Inc. is a privately held company. It develops novel, high performance sealants for use in vascular and general surgery. In addition to the ArterX Surgical Sealant, the company is developing a second high performance sealant for use throughout the gastrointestinal tract, and an anti-adhesion agent that can be delivered laparoscopically to help prevent or reduce pelvic and abdominal adhesions.
CONTACT: Ronald Dieck, +1-650-691-9016, ext. 110, for Tenaxis Medical, Inc.
Monday, October 25, 2010
Study shows use of superglue in chest surgery cuts recovery time in half
Victor Haddad used Krazy Glue in his woodworking shop for years to mend his accidental wounds. Then last year, as he awaited a heart operation, he discovered on the Internet that a Calgary doctor was using a superglue to fuse bones together after chest surgeries.The minute he read about the experimental procedure, he says, “I wanted it.”
He became a patient of Paul Fedak, a cardiac surgeon who pioneered the technique in 2009 at Calgary’s Foothills Hospital Medical Centre. In June of this year, Dr. Fedak replaced Mr. Haddad’s aortic valve and joined his sternum using steel wire, and then sealed the bones with a sticky paste called Kryptonite.
Mr. Haddad was out of the hospital in seven days. Within six weeks, the 59-year-old resident of Milk River, Alta., was back to work as a real-estate broker. Mr. Haddad didn’t bother to fill his prescription for pain meds, he says. “I’ve been pain free since before I left hospital.”
His surgery was standard except that Dr. Fedak took a few minutes to apply adhesive to the ends of the chest bones before stitching up the soft tissue. According to Dr. Fedak, breastbones heal much faster when secured with wire as well as Kryptonite glue.
Instead of it taking six to eight weeks for the bone to fuse back together, “we do it in 24 hours.” The glue makes it rock solid within a day.
A study released Sunday suggests the use of adhesive in chest surgery reduces the normal recovery time by half. Patients have less physical disability in the first six weeks after surgery and can breathe deeply sooner, Dr. Fedak reports. He adds that patients are able to cough with less discomfort and require significantly less medication such as narcotics to manage pain.
No complications or side effects from the glue were reported among the 55 patients in the randomized controlled trial.
The procedure has the potential to improve post-operative care for an estimated 1.4 million open-chest surgeries performed worldwide each year, according to the Heart and Stroke Foundation of Canada.
Dr. Fedak has applied to the Canadian Institutes of Health Research to fund a larger clinical trial involving 2,000 patients throughout North America, which should start in six months, he says.
Although medical adhesives are widely used in hip replacements and other procedures, most bone cements contain toxic ingredients that are dangerous for use in the chest, notes Dr. Fedak. In contrast, Kryptonite is an adhesive polymer composed of calcium carbonate and fatty acids derived from castor bean oil. It is “bio-compatible” and turns into a porous bonelike substance as it cures, he says.
Dr. Fedak doesn’t recommend the adhesive for patients at high risk for internal bleeding and other complications after surgery, because doctors might need to re-enter the breastbone and the procedure would take longer if the breastbone is well-bonded. Otherwise, he says, “you could use this on almost any patient.”
Regulators in Canada and the United States have approved the use of Kryptonite, which is made by the Doctors Research Group in the United States.
The glue is expensive, adding $700 to $1,000 to the cost of performing surgery. The need for public funding is a barrier to routine use, Dr. Fedak says. But he suggests that using Kryptonite could result in net savings to the health-care system by reducing recovery time and major post-op complications, including breastbones that separate after surgery.
“If a patient leaves the hospital a day early, that would be thousands of dollars of savings,” he points out.
Patients from around the world have contacted him, seeking repairs to sternums that didn’t heal properly after surgery, Dr. Fedak says. Although he is cautious about expanding the use of Kryptonite prematurely, he adds, reconstructions to damaged sternums “work very well.”
Mr. Haddad says he’s been the envy of his friends since he was glued back together with Kryptonite. He mentions a neighbour who took more than six months to bounce back after recent heart surgery.
“He is absolutely annoyed that he wasn’t in the [Kryptonite] study.”
Thursday, October 21, 2010
Vascular Solutions Announces Record Third Quarter Results. Edited
Vascular Solutions, Inc. (Nasdaq: VASC) today reported financial results for the third quarter ended September 30, 2010. Highlights of the third quarter include:
Achieved record net revenue of $19.9 million, an increase of 15% from the third quarter of 2009.
Highlighted the clinical success of the GuideLiner® catheter at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington D.C. in September, with GuideLiner catheter sales increasing by 37% sequentially from the second quarter of 2010.
Achieved net income of $1,464,000, or $0.09 per diluted share.
Issued guidance for 14% to 16% revenue growth to between $20.8 million and $21.2 million in the fourth quarter of 2010 and net income of between $0.94 and $1.00 per share (including $14.3 to $15.0 million, or $0.83 to $0.87 per share, of income tax benefit as the result of the Company's potential recognition of its remaining net operating loss carryforwards as a deferred asset in the fourth quarter).
Commenting on the results, Vascular Solutions' Chief Executive Officer Howard Root said: "Contrary to what many companies in our sector are reporting, we are pleased to report 15% revenue growth in the third quarter to a new record quarterly level, resulting from substantial new product launches and continued sales expansion of our existing products. Of special note, our GuideLiner catheter has generated unprecedented interest in a Vascular Solutions' product since its U.S. launch less than a year ago, and that interest is translating into broader sales opportunities and increased visibility at major medical meetings. With a full pipeline of internally-developed new products in development, along with acquisition and product distribution candidates in evaluation, we are very optimistic about our ability to continue with our consistent sales growth and success.".....
Net sales of hemostat products (primarily consisting of the D-Stat® Dry, D-Stat Flowable and D-Stat Radial products) were $6.1 million in the third quarter, a decrease of 5% from the third quarter of 2009. "During the third quarter one of our primary competitors in the patch market was subjected to an injunction preventing their sales in the U.S. as the result of a patent infringement verdict initiated by another competitor, but that injunction was quickly subjected to an administrative stay while the case is presented to the Federal Circuit. We expect that administrative stay to be subject to a substantive decision by the Federal Circuit very soon, which, if the injunction or judgment is allowed to stand, would open up approximately 15% of the patch market to our sales force," commented Mr. Root.....
Achieved record net revenue of $19.9 million, an increase of 15% from the third quarter of 2009.
Highlighted the clinical success of the GuideLiner® catheter at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington D.C. in September, with GuideLiner catheter sales increasing by 37% sequentially from the second quarter of 2010.
Achieved net income of $1,464,000, or $0.09 per diluted share.
Issued guidance for 14% to 16% revenue growth to between $20.8 million and $21.2 million in the fourth quarter of 2010 and net income of between $0.94 and $1.00 per share (including $14.3 to $15.0 million, or $0.83 to $0.87 per share, of income tax benefit as the result of the Company's potential recognition of its remaining net operating loss carryforwards as a deferred asset in the fourth quarter).
Commenting on the results, Vascular Solutions' Chief Executive Officer Howard Root said: "Contrary to what many companies in our sector are reporting, we are pleased to report 15% revenue growth in the third quarter to a new record quarterly level, resulting from substantial new product launches and continued sales expansion of our existing products. Of special note, our GuideLiner catheter has generated unprecedented interest in a Vascular Solutions' product since its U.S. launch less than a year ago, and that interest is translating into broader sales opportunities and increased visibility at major medical meetings. With a full pipeline of internally-developed new products in development, along with acquisition and product distribution candidates in evaluation, we are very optimistic about our ability to continue with our consistent sales growth and success.".....
Net sales of hemostat products (primarily consisting of the D-Stat® Dry, D-Stat Flowable and D-Stat Radial products) were $6.1 million in the third quarter, a decrease of 5% from the third quarter of 2009. "During the third quarter one of our primary competitors in the patch market was subjected to an injunction preventing their sales in the U.S. as the result of a patent infringement verdict initiated by another competitor, but that injunction was quickly subjected to an administrative stay while the case is presented to the Federal Circuit. We expect that administrative stay to be subject to a substantive decision by the Federal Circuit very soon, which, if the injunction or judgment is allowed to stand, would open up approximately 15% of the patch market to our sales force," commented Mr. Root.....
Sunday, October 17, 2010
Robotic technology speeds recovery and improves outcomes
■ Robotic surgery reduces blood loss, decreases length of hospital stay, decreases postoperative pain, and improves recovery time.
■ Robotic surgery is particularly useful in gynecologic surgery because of the limited space within the pelvic cavity.
■ The versatility of robotic instruments has expanded the range of gynecologic conditions amenable to minimally invasive surgery.
■ The cost of setting up and maintaining robotic surgical systems can be prohibitive.
■ Studies that evaluate long-term outcomes of robotic surgery are needed to further validate the place of robots in the OR.
Over the past two decades, minimally invasive surgery has progressed beyond all expectations. Many operations that used to require laparotomy are now routinely performed using laparoscopic techniques. Appendectomies, cholecystectomies, and even hysterectomies are done through keyhole-size incisions that are aesthetically pleasing to the patient and less costly in terms of postoperative pain, length of hospital stay, and blood loss. Conventional laparoscopic surgery, however, is not without its limitations. Difficulties such as tremor amplification, reverse fulcrum, and loss of dexterity create problems for the surgeon, limiting the potential of the laparoscope.1 Fortunately, with the help of robotic technology, many of these problems can be overcome. With names that conjure up images of the great works of Italian masters, robots are challenging surgeons to learn the art and the science of a new type of surgery. Robotic technology is revolutionizing minimally invasive surgery.
HISTORY OF ROBOTIC SURGERY
Robotic surgery was first conceived as a way to facilitate surgery performed on military personnel injured in the field. The intent was to enable surgeons to operate remotely, reducing the risk to the surgeon and increasing the speed of delivery of potentially lifesaving treatment to the patient. With the development of a remote console (surgeon control center), a patient side cart (engages robotic arms), and a vision cart (camera display), surgery that did not require the surgeon to lay hands on the patient became possible. As robotic capabilities became more sophisticated, robotic surgery moved away from the battlefield and directly into the OR. Although many robotic models have been developed over the years, currently the only FDA-approved robotic platform is the da Vinci Surgical System. The da Vinci platform was approved for use in urology in 2000 and then for gynecology in 2005.2 This article focuses primarily on the application of robotic technology to gynecology, given the tremendous potential of robot-assisted laparoscopic surgery in this field.
INCREASED FLEXIBILITY AND PRECISION IN GYNECOLOGIC SURGERY
Robotic surgery is particularly useful in gynecologic surgery because of its flexibility within the limited space of the pelvic cavity. Traditional laparoscopic instruments are awkward to maneuver in the tight confines of the pelvis. This difficulty is compounded by other problems associated with conventional laparoscopy including the following: reverse fulcrum (counterintuitive movements), tremor amplification, ergonomic challenges, and tissue visualization that is only two- dimensional (2D). Robotic platforms overcome many of these problems. The surgeon moves the robotic arms and cameras using hand controls and foot pedals. Movements of robotic instruments mimic those of the surgeon's hands, eliminating the reverse fulcrum effect. Previously, operators needed to move their hands in the opposite direction of the one they desired, but robotics allow surgeons to move their hands in the direction they want the instruments to move. This feature improves precision and control, facilitating procedures on very delicate tissues.3
The EndoWrist instrument tip of the da Vinci robotic system moves in multiple directions, offering the operator 7 degrees of freedom, greater articulation, and a degree of dexterity comparable to that of the human hand. This improves the surgeon's ability to grasp, cut, dissect, cauterize, and suture fragile tissues within the tight confines of the pelvic cavity. Tremor is eliminated as well.
IMPROVED VISUALIZATION AND COMFORT
The da Vinci Surgical System has cameras that provide the surgeon with 3D, high-definition images of the operative field, improving visualization of blood vessels, tissues, and nerves. The surgeon can magnify images and zoom in on targets while looking through the vision screen. This improved clarity increases accuracy and compensates somewhat for the loss of haptic (tactile) feedback that is inherent in robotic surgery.
Robotic technology also reduces the ergonomic challenges of classic laparoscopy. The surgeon is seated at the remote console, obviating the need to be a contortionist to manipulate the instruments into the desired position. This increases surgeon comfort and decreases fatigue, helping the surgeon focus attention on the work at hand and providing for complex gynecologic surgeries that require longer OR time. As a result of these developments, the range of gynecologic conditions amenable to minimally invasive surgery has increased along with the number of patients who benefit from this technique. Surgeries such as sacrocolpopexy, myomectomy, and cancer staging can now be done without laparotomy.4
RISKS AND BENEFITS
As the scope of robotic gynecologic surgery continues to expand, increasing numbers of patients will ask PAs about the risks and benefits of this surgery. Already, radio and television commercials promote robotics as a reason to select a particular hospital. Tuned-in patients will no doubt start to question PAs about the efficacy of robotic hysterectomy, tubal reversal, and myomectomy: Is my uterus really safe in the hands of a "droid"? Consequently, knowing some of the published data relating to this surgery is both useful and necessary.
Multiple research studies have shown that minimally in vasive surgery significantly reduces blood loss, decreases post operative pain, shortens hospital stay, and decreases morbidity. Patients need less analgesia, recover faster, and benefit from a quicker return to their usual activities. These benefits hold true for a wide range of gynecologic surgeries and apply to both robot-assisted and conventional laparoscopic surgery. Recent studies, however, demonstrate that the advantages for patients may be even greater using robotics.3-5
Several studies have shown that robotic surgery is superior to conventional laparoscopic surgery for suturing, knot tying, and lysis of adhesions. These findings support the premise that robot-assisted surgery is a cut above conventional laparoscopic surgery, especially for those patients who have scarring or adhesions.2Payne and Dauterive compared surgical outcomes for 200 total laparoscopic hysterectomies to robot-assisted hysterectomies. They concluded that robotic surgery halved blood loss, shortened hospital stay, and reduced conversions to laparotomy. Laparotomy remains the primary method of performing myomectomy, as conventional laparoscopy is difficult due to problems with enucleation, removal, and multi-layer suturing. Robotic surgery overcomes many of these problems, offering patients an effective treatment for their fibroids plus the advantages of minimally invasive surgery.4
Robot-assisted gynecologic surgery for cancer staging has many benefits. Boggess and colleagues compared robot-assisted staging with laparoscopic staging for endometrial cancer. The robotic approach was associated with decreased length of hospital stay, an increase in the number of nodes retrieved, and less blood loss. Robotics had the added benefit of allowing staging on obese women who otherwise would have needed laparotomy.6
As the United States population ages, PAs are likely to encounter increasing numbers of patients with pelvic organ prolapse. Repair of prolapse is not usually conducive to conventional laparoscopic techniques, as surgeons encounter technical difficulties with mesh placement, knot tying, tissue dissection, and suturing. The robotic approach alleviates many of these difficulties, making minimally invasive surgery a more viable option.7
OTHER FACTORS TO CONSIDER
Several other important factors need to be considered by PAs when discussing robotics with patients. Robotic surgery is more expensive than conventional laparoscopic surgery and laparotomy. Learning curves are steep for surgeons, initially resulting in longer operating times for patients as new skills are learned. Robotic surgery precludes haptic feedback, as it denies the surgeon the ability to palpate the tissues. The lack of direct physical and visual contact between the patient and operator may raise ethical concerns, particularly in situations where the surgeon is situated at a considerable distance from the patient. Information may not be secure and communication may break down. Finally, studies that evaluate long-term outcomes of robot-assisted gynecologic surgery are needed to assess survival, effects on quality of life, postoperative function, and durability.8 Nonetheless, a growing body of evidence supports the premise that robots represent a significant advance in the field of gynecologic surgery, reaping considerable benefits for patients and clinicians. Source: JAAPA
■ Robotic surgery is particularly useful in gynecologic surgery because of the limited space within the pelvic cavity.
■ The versatility of robotic instruments has expanded the range of gynecologic conditions amenable to minimally invasive surgery.
■ The cost of setting up and maintaining robotic surgical systems can be prohibitive.
■ Studies that evaluate long-term outcomes of robotic surgery are needed to further validate the place of robots in the OR.
Over the past two decades, minimally invasive surgery has progressed beyond all expectations. Many operations that used to require laparotomy are now routinely performed using laparoscopic techniques. Appendectomies, cholecystectomies, and even hysterectomies are done through keyhole-size incisions that are aesthetically pleasing to the patient and less costly in terms of postoperative pain, length of hospital stay, and blood loss. Conventional laparoscopic surgery, however, is not without its limitations. Difficulties such as tremor amplification, reverse fulcrum, and loss of dexterity create problems for the surgeon, limiting the potential of the laparoscope.1 Fortunately, with the help of robotic technology, many of these problems can be overcome. With names that conjure up images of the great works of Italian masters, robots are challenging surgeons to learn the art and the science of a new type of surgery. Robotic technology is revolutionizing minimally invasive surgery.
HISTORY OF ROBOTIC SURGERY
Robotic surgery was first conceived as a way to facilitate surgery performed on military personnel injured in the field. The intent was to enable surgeons to operate remotely, reducing the risk to the surgeon and increasing the speed of delivery of potentially lifesaving treatment to the patient. With the development of a remote console (surgeon control center), a patient side cart (engages robotic arms), and a vision cart (camera display), surgery that did not require the surgeon to lay hands on the patient became possible. As robotic capabilities became more sophisticated, robotic surgery moved away from the battlefield and directly into the OR. Although many robotic models have been developed over the years, currently the only FDA-approved robotic platform is the da Vinci Surgical System. The da Vinci platform was approved for use in urology in 2000 and then for gynecology in 2005.2 This article focuses primarily on the application of robotic technology to gynecology, given the tremendous potential of robot-assisted laparoscopic surgery in this field.
INCREASED FLEXIBILITY AND PRECISION IN GYNECOLOGIC SURGERY
Robotic surgery is particularly useful in gynecologic surgery because of its flexibility within the limited space of the pelvic cavity. Traditional laparoscopic instruments are awkward to maneuver in the tight confines of the pelvis. This difficulty is compounded by other problems associated with conventional laparoscopy including the following: reverse fulcrum (counterintuitive movements), tremor amplification, ergonomic challenges, and tissue visualization that is only two- dimensional (2D). Robotic platforms overcome many of these problems. The surgeon moves the robotic arms and cameras using hand controls and foot pedals. Movements of robotic instruments mimic those of the surgeon's hands, eliminating the reverse fulcrum effect. Previously, operators needed to move their hands in the opposite direction of the one they desired, but robotics allow surgeons to move their hands in the direction they want the instruments to move. This feature improves precision and control, facilitating procedures on very delicate tissues.3
The EndoWrist instrument tip of the da Vinci robotic system moves in multiple directions, offering the operator 7 degrees of freedom, greater articulation, and a degree of dexterity comparable to that of the human hand. This improves the surgeon's ability to grasp, cut, dissect, cauterize, and suture fragile tissues within the tight confines of the pelvic cavity. Tremor is eliminated as well.
IMPROVED VISUALIZATION AND COMFORT
The da Vinci Surgical System has cameras that provide the surgeon with 3D, high-definition images of the operative field, improving visualization of blood vessels, tissues, and nerves. The surgeon can magnify images and zoom in on targets while looking through the vision screen. This improved clarity increases accuracy and compensates somewhat for the loss of haptic (tactile) feedback that is inherent in robotic surgery.
Robotic technology also reduces the ergonomic challenges of classic laparoscopy. The surgeon is seated at the remote console, obviating the need to be a contortionist to manipulate the instruments into the desired position. This increases surgeon comfort and decreases fatigue, helping the surgeon focus attention on the work at hand and providing for complex gynecologic surgeries that require longer OR time. As a result of these developments, the range of gynecologic conditions amenable to minimally invasive surgery has increased along with the number of patients who benefit from this technique. Surgeries such as sacrocolpopexy, myomectomy, and cancer staging can now be done without laparotomy.4
RISKS AND BENEFITS
As the scope of robotic gynecologic surgery continues to expand, increasing numbers of patients will ask PAs about the risks and benefits of this surgery. Already, radio and television commercials promote robotics as a reason to select a particular hospital. Tuned-in patients will no doubt start to question PAs about the efficacy of robotic hysterectomy, tubal reversal, and myomectomy: Is my uterus really safe in the hands of a "droid"? Consequently, knowing some of the published data relating to this surgery is both useful and necessary.
Multiple research studies have shown that minimally in vasive surgery significantly reduces blood loss, decreases post operative pain, shortens hospital stay, and decreases morbidity. Patients need less analgesia, recover faster, and benefit from a quicker return to their usual activities. These benefits hold true for a wide range of gynecologic surgeries and apply to both robot-assisted and conventional laparoscopic surgery. Recent studies, however, demonstrate that the advantages for patients may be even greater using robotics.3-5
Several studies have shown that robotic surgery is superior to conventional laparoscopic surgery for suturing, knot tying, and lysis of adhesions. These findings support the premise that robot-assisted surgery is a cut above conventional laparoscopic surgery, especially for those patients who have scarring or adhesions.2Payne and Dauterive compared surgical outcomes for 200 total laparoscopic hysterectomies to robot-assisted hysterectomies. They concluded that robotic surgery halved blood loss, shortened hospital stay, and reduced conversions to laparotomy. Laparotomy remains the primary method of performing myomectomy, as conventional laparoscopy is difficult due to problems with enucleation, removal, and multi-layer suturing. Robotic surgery overcomes many of these problems, offering patients an effective treatment for their fibroids plus the advantages of minimally invasive surgery.4
Robot-assisted gynecologic surgery for cancer staging has many benefits. Boggess and colleagues compared robot-assisted staging with laparoscopic staging for endometrial cancer. The robotic approach was associated with decreased length of hospital stay, an increase in the number of nodes retrieved, and less blood loss. Robotics had the added benefit of allowing staging on obese women who otherwise would have needed laparotomy.6
As the United States population ages, PAs are likely to encounter increasing numbers of patients with pelvic organ prolapse. Repair of prolapse is not usually conducive to conventional laparoscopic techniques, as surgeons encounter technical difficulties with mesh placement, knot tying, tissue dissection, and suturing. The robotic approach alleviates many of these difficulties, making minimally invasive surgery a more viable option.7
OTHER FACTORS TO CONSIDER
Several other important factors need to be considered by PAs when discussing robotics with patients. Robotic surgery is more expensive than conventional laparoscopic surgery and laparotomy. Learning curves are steep for surgeons, initially resulting in longer operating times for patients as new skills are learned. Robotic surgery precludes haptic feedback, as it denies the surgeon the ability to palpate the tissues. The lack of direct physical and visual contact between the patient and operator may raise ethical concerns, particularly in situations where the surgeon is situated at a considerable distance from the patient. Information may not be secure and communication may break down. Finally, studies that evaluate long-term outcomes of robot-assisted gynecologic surgery are needed to assess survival, effects on quality of life, postoperative function, and durability.8 Nonetheless, a growing body of evidence supports the premise that robots represent a significant advance in the field of gynecologic surgery, reaping considerable benefits for patients and clinicians. Source: JAAPA
Thursday, October 14, 2010
Stöpler to Distribute Z-Medica QuikClot Products for the First Time to Hospitals in The Netherlands
WALLINGFORD, Conn.--(Healthcare Sales & Marketing Network)-- Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced that it has signed an exclusive distribution agreement with Stöpler, a supplier of medical instruments, equipment and disposables to hospitals in the Netherlands, Belgium and Luxembourg. Stöpler will have the exclusive rights to sell and distribute Z-Medica’s full line of QuikClot® hemostatic agents to hospitals and healthcare professionals in The Netherlands.
QuikClot products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Stöpler in European markets since then.
“Bleeding is a problem across the globe, and Z-Medica is aiming to reach beyond the U.S. borders with revolutionary gauze products that are proven effective in some of the most traumatic of circumstances,” said Brian Herrman, Chief Executive Officer, Z-Medica. “We are proud to work with partners like Stöpler, who see the need to have QuikClot in every hospital and carried by all healthcare professionals.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“Our focus is on providing healthcare professionals throughout The Netherlands access to premium brands such as QuikClot, and we are thrilled with the opportunity to provide our partners with this line of life saving devices,” said Eric Knuiman, General Manager of Stöpler. “We foresee great demand for this product as it is not only safe and effective, but also diverse in its applications.”
QuikClot products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Stöpler in European markets since then.
“Bleeding is a problem across the globe, and Z-Medica is aiming to reach beyond the U.S. borders with revolutionary gauze products that are proven effective in some of the most traumatic of circumstances,” said Brian Herrman, Chief Executive Officer, Z-Medica. “We are proud to work with partners like Stöpler, who see the need to have QuikClot in every hospital and carried by all healthcare professionals.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“Our focus is on providing healthcare professionals throughout The Netherlands access to premium brands such as QuikClot, and we are thrilled with the opportunity to provide our partners with this line of life saving devices,” said Eric Knuiman, General Manager of Stöpler. “We foresee great demand for this product as it is not only safe and effective, but also diverse in its applications.”
Wednesday, October 13, 2010
Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients
Danny Bluestein, Ph.D., Professor of Biomedical Engineering at Stony Brook University, has been awarded a five-year, $7.5 million grant by the National Institutes of Health. The award marks the first time a Stony Brook professor has received a Phase II Quantum Grant, given by The National Institute of Biomedical Imaging and Bioengineering (NIBIB), a division of the NIH, to make a profound improvement—or quantum leap forward—in health care.
Dr. Bluestein’s project involves testing and optimizing the designs of various cardiovascular devices with the goal to eliminate the need for anticoagulation therapy for patients with these devices.
Millions of cardiovascular disease patients worldwide are implanted with prosthetic devices. While these devices save lives, they promote blood clot formation and patients are required to take anticoagulants, which may slow the rate at which the patient’s blood clots. There are numerous conditions for which cardiovascular patients take anticoagulants. Most patients with prosthetic heart valves, left ventricular assist devices (LVADs), and biventricular assist devices (BiVADs), need to take anticoagulants. The downsides to this class of drugs are that blood clot formation is not eliminated and there is a risk for dangerous and potentially deadly bleeds if therapy is not properly monitored.
“Dr. Bluestein’s work is certain to contribute to our understanding of cardiovascular disease and pave new ways of treating heart dysfunction,” says Clinton T. Rubin, Ph.D., Director of the Center for Biotechnology, Distinguished SUNY Professor, and Chair of the Department of Biomedical Engineering at SBU.
“The Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients,” says Kenneth Kaushansky, M.D., Senior Vice President, Health Sciences, and Dean, SBU School of Medicine. “Dr. Bluestein’s work stands out as the kind of translational research that is necessary to advance cardiovascular care even more than it has already progressed within the past decade.”
“We developed a Device Thrombogenicity Emulator (DTE) that measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device, as extracted from sophisticated numerical simulations,” says Dr. Bluestein. “The DTE measures the formation of blood clots in an emulated device environment, facilitating the optimization of these devices without the need to build expensive prototypes and test them before optimization is achieved.
“This has a tremendous potential to significantly reduce the ensuing healthcare costs while improving the quality of life for patients with implanted devices,” he explains, likening the concept to wind tunnels used for aeronautic and automotive testing.
During Phase I of the project, Dr. Bluestein and his colleagues developed and tested the DTE, which reduced the need for anticoagulation in laboratory models. During Phase II, he expects to use the DTE to identify ‘hot spot’ trajectories in the flow fields of cardiovascular devices, where clots can form.
“Within the DTE, we can tweak the geometry of the device’s design to optimize it and minimize or eliminate these hot spots,” he notes.
According to Dr. Bluestein, the researchers recently demonstrated in numerical simulations and in the DTE (where clot formation is also measured) that an optimized design of the HeartAssist5, the modern DeBekay LVAD, clot formation was reduced by an order of magnitude. Concurrent animal experiments using the optimized device were conducted by Micromed Inc.—the company that manufactures the device—and the results indicates that its recipients may not require anticoagulation.
Dr. Bluestein is working with various institutions and companies to use the DTE to test and optimize the designs of various prosthetic heart valves, LVADs, BiVADs and the only Food and Drug Administration (FDA)-approved total artificial heart. He envisions the methodology as becoming an FDA standard for testing such medical devices.
“The work of Dr. Bluestein and colleagues contributes enormously to the bridging of our College of Engineering and Applied Sciences to the School of Medicine,” states Yacov Shamash, Ph.D., Vice President for Economic Development, and Dean of the College of Engineering and Applied Science at SBU. “We are excited to see this marriage of engineering and medicine that should lead to great advances in health care.”
The Quantum Grants Program of NIBIB challenges the research community to propose projects that have an innovative, highly focused, collaborative, and interdisciplinary approach targeted to solve a major medical problem or to resolve a highly prevalent technology-based medical challenge. The mission of NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies.
Collaborators on Dr. Bluestein’s project include the Sarver Heart Center at the University of Arizona in Tucson, along with a consortium of four industrial partners: SynCardia Systems, Inc.; MicroMed Cardiovascular, Inc.; Medtronic-ATS Medical Inc., and Innovia LLC. Co-investigators at Stony Brook include Department of Medicine Professor Jolyon Jesty, and Professor Shmuel Einav of the College of Engineering and Applied Science.
Dr. Bluestein, Director of the Biofluids Laboratory in the SBU Biomedical Engineering Department, has been with the department since 1996. In 1992, he received his Ph.D. in Mechanical and Biomedical Engineering from Tel Aviv University in Tel Aviv, Israel, where he also earned an M.S. in Mechanical Engineering in 1985. He received a B.S. in Aeronautical Engineering from the Technion-Israel Institute of Technology in 1981.
In 2010, Professor Bluestein was elected into the American Institute for Medical and Biological Engineering’s (AIMBE) College of Fellows, in recognition of his exceptional leadership and achievements in medical and biological engineering.
The Department of Biomedical Engineering at Stony Brook University is one of 25 departments within the School of Medicine and is part of the College of Engineering and Applied Sciences. Established in 2000, the department includes more than 60 faculty training students in undergraduate, MS and PhD programs. Areas of research emphasis include Biomechanics & Biomaterials, Bioelectricity & Bioimaging, Tissue Engineering, Bioinstrumentation and Biosignal Processing, and Cell & Molecular Bioengineering
Dr. Bluestein’s project involves testing and optimizing the designs of various cardiovascular devices with the goal to eliminate the need for anticoagulation therapy for patients with these devices.
Millions of cardiovascular disease patients worldwide are implanted with prosthetic devices. While these devices save lives, they promote blood clot formation and patients are required to take anticoagulants, which may slow the rate at which the patient’s blood clots. There are numerous conditions for which cardiovascular patients take anticoagulants. Most patients with prosthetic heart valves, left ventricular assist devices (LVADs), and biventricular assist devices (BiVADs), need to take anticoagulants. The downsides to this class of drugs are that blood clot formation is not eliminated and there is a risk for dangerous and potentially deadly bleeds if therapy is not properly monitored.
“Dr. Bluestein’s work is certain to contribute to our understanding of cardiovascular disease and pave new ways of treating heart dysfunction,” says Clinton T. Rubin, Ph.D., Director of the Center for Biotechnology, Distinguished SUNY Professor, and Chair of the Department of Biomedical Engineering at SBU.
“The Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients,” says Kenneth Kaushansky, M.D., Senior Vice President, Health Sciences, and Dean, SBU School of Medicine. “Dr. Bluestein’s work stands out as the kind of translational research that is necessary to advance cardiovascular care even more than it has already progressed within the past decade.”
“We developed a Device Thrombogenicity Emulator (DTE) that measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device, as extracted from sophisticated numerical simulations,” says Dr. Bluestein. “The DTE measures the formation of blood clots in an emulated device environment, facilitating the optimization of these devices without the need to build expensive prototypes and test them before optimization is achieved.
“This has a tremendous potential to significantly reduce the ensuing healthcare costs while improving the quality of life for patients with implanted devices,” he explains, likening the concept to wind tunnels used for aeronautic and automotive testing.
During Phase I of the project, Dr. Bluestein and his colleagues developed and tested the DTE, which reduced the need for anticoagulation in laboratory models. During Phase II, he expects to use the DTE to identify ‘hot spot’ trajectories in the flow fields of cardiovascular devices, where clots can form.
“Within the DTE, we can tweak the geometry of the device’s design to optimize it and minimize or eliminate these hot spots,” he notes.
According to Dr. Bluestein, the researchers recently demonstrated in numerical simulations and in the DTE (where clot formation is also measured) that an optimized design of the HeartAssist5, the modern DeBekay LVAD, clot formation was reduced by an order of magnitude. Concurrent animal experiments using the optimized device were conducted by Micromed Inc.—the company that manufactures the device—and the results indicates that its recipients may not require anticoagulation.
Dr. Bluestein is working with various institutions and companies to use the DTE to test and optimize the designs of various prosthetic heart valves, LVADs, BiVADs and the only Food and Drug Administration (FDA)-approved total artificial heart. He envisions the methodology as becoming an FDA standard for testing such medical devices.
“The work of Dr. Bluestein and colleagues contributes enormously to the bridging of our College of Engineering and Applied Sciences to the School of Medicine,” states Yacov Shamash, Ph.D., Vice President for Economic Development, and Dean of the College of Engineering and Applied Science at SBU. “We are excited to see this marriage of engineering and medicine that should lead to great advances in health care.”
The Quantum Grants Program of NIBIB challenges the research community to propose projects that have an innovative, highly focused, collaborative, and interdisciplinary approach targeted to solve a major medical problem or to resolve a highly prevalent technology-based medical challenge. The mission of NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies.
Collaborators on Dr. Bluestein’s project include the Sarver Heart Center at the University of Arizona in Tucson, along with a consortium of four industrial partners: SynCardia Systems, Inc.; MicroMed Cardiovascular, Inc.; Medtronic-ATS Medical Inc., and Innovia LLC. Co-investigators at Stony Brook include Department of Medicine Professor Jolyon Jesty, and Professor Shmuel Einav of the College of Engineering and Applied Science.
Dr. Bluestein, Director of the Biofluids Laboratory in the SBU Biomedical Engineering Department, has been with the department since 1996. In 1992, he received his Ph.D. in Mechanical and Biomedical Engineering from Tel Aviv University in Tel Aviv, Israel, where he also earned an M.S. in Mechanical Engineering in 1985. He received a B.S. in Aeronautical Engineering from the Technion-Israel Institute of Technology in 1981.
In 2010, Professor Bluestein was elected into the American Institute for Medical and Biological Engineering’s (AIMBE) College of Fellows, in recognition of his exceptional leadership and achievements in medical and biological engineering.
The Department of Biomedical Engineering at Stony Brook University is one of 25 departments within the School of Medicine and is part of the College of Engineering and Applied Sciences. Established in 2000, the department includes more than 60 faculty training students in undergraduate, MS and PhD programs. Areas of research emphasis include Biomechanics & Biomaterials, Bioelectricity & Bioimaging, Tissue Engineering, Bioinstrumentation and Biosignal Processing, and Cell & Molecular Bioengineering
Hemostatic Powder Market - Cook Rollout of Endoscopic Application
Novel application of powder could eventually replace endoscopic surgical procedure
TORONTO, Ont., October 13, 2010 — A new material similar to that used by the U.S. Military to treat traumatic injuries is showing promise as the next novel treatment for bleeding ulcers, a condition that commonly affects up to 15 per cent of adults, according to Hong Kong physician Dr. James Lau. Dr. Lau is presenting his findings today on this world-first research at the 23rd International Course on Therapeutic Endoscopy. The course is a world-renowned international conference on the latest innovations in endoscopy organized and hosted by St. Michael's Hospital.
"Nearly 5 to 10 per cent of patients who have a bleeding ulcer experience additional bleeding despite our best treatment efforts," said Dr. Lau, a physician at the Prince of Wales Hospital and professor at the Chinese University of Hong Kong. "However, our findings suggest a new approach with a powder that could ultimately prove to be more effective for patients and result in fewer complications."
A preliminary study on the safety of using a proprietary powder from Cook Medical, by Lau and colleagues, found it was beneficial in treating 95 per cent of patients with bleeding peptic ulcers. A peptic ulcer is an oval sore that develops when the lining of the stomach or duodenum is eaten away by stomach acid and digestive juices. First-line treatment involves the use of an endoscope, or a flexible tube, inserted through the mouth into the small intestine and stomach, to treat and repair bleeding ulcers. This is often done by injecting drugs into a blood vessel at the ulcer base or clipping or sealing the ulcer with a probe that generates heat.
In the study, researchers administered the powder through the channel of an endoscope. The powder was applied to the ulcer in one to two short bursts until bleeding stopped. They found the bleeding was successfully stopped in 95 per cent of cases and there was no recurrent bleeding or complications 30 days after treatment. The preliminary findings suggest the powder has high success rates and, most importantly, the technique of applying the powder is simple.
The findings signal future potential uses of the hemostatic powder to treat bleeding ulcers. Dr. Lau's findings is one of many innovative research studies being shared with colleagues around the world through an international conference at the Four Season Hotel in Toronto hosted by endoscopy experts at St. Michael's Hospital.
The Advanced Diagnostic and Therapeutic Endoscopy unit at St. Michael's is a center of excellence in therapeutic interventional and palliative endoscopy. Known worldwide as leaders in the field of endoscopy, physicians on the team have made groundbreaking discoveries and are performing some of the country's only and most innovative endoscopy techniques that allow for the early diagnosis and treatment of cancer.
St. Michael's Hospital provides compassionate care to all who walk through its doors. The Hospital also provides outstanding medical education to future health care professionals in more than 23 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, and care of the homeless are among the Hospital's recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing Knowledge Institute, research at St. Michael's Hospital is recognized and put into practice around the world. Founded in 1892, the Hospital is fully affiliated with the University of Toronto.
TORONTO, Ont., October 13, 2010 — A new material similar to that used by the U.S. Military to treat traumatic injuries is showing promise as the next novel treatment for bleeding ulcers, a condition that commonly affects up to 15 per cent of adults, according to Hong Kong physician Dr. James Lau. Dr. Lau is presenting his findings today on this world-first research at the 23rd International Course on Therapeutic Endoscopy. The course is a world-renowned international conference on the latest innovations in endoscopy organized and hosted by St. Michael's Hospital.
"Nearly 5 to 10 per cent of patients who have a bleeding ulcer experience additional bleeding despite our best treatment efforts," said Dr. Lau, a physician at the Prince of Wales Hospital and professor at the Chinese University of Hong Kong. "However, our findings suggest a new approach with a powder that could ultimately prove to be more effective for patients and result in fewer complications."
A preliminary study on the safety of using a proprietary powder from Cook Medical, by Lau and colleagues, found it was beneficial in treating 95 per cent of patients with bleeding peptic ulcers. A peptic ulcer is an oval sore that develops when the lining of the stomach or duodenum is eaten away by stomach acid and digestive juices. First-line treatment involves the use of an endoscope, or a flexible tube, inserted through the mouth into the small intestine and stomach, to treat and repair bleeding ulcers. This is often done by injecting drugs into a blood vessel at the ulcer base or clipping or sealing the ulcer with a probe that generates heat.
In the study, researchers administered the powder through the channel of an endoscope. The powder was applied to the ulcer in one to two short bursts until bleeding stopped. They found the bleeding was successfully stopped in 95 per cent of cases and there was no recurrent bleeding or complications 30 days after treatment. The preliminary findings suggest the powder has high success rates and, most importantly, the technique of applying the powder is simple.
The findings signal future potential uses of the hemostatic powder to treat bleeding ulcers. Dr. Lau's findings is one of many innovative research studies being shared with colleagues around the world through an international conference at the Four Season Hotel in Toronto hosted by endoscopy experts at St. Michael's Hospital.
The Advanced Diagnostic and Therapeutic Endoscopy unit at St. Michael's is a center of excellence in therapeutic interventional and palliative endoscopy. Known worldwide as leaders in the field of endoscopy, physicians on the team have made groundbreaking discoveries and are performing some of the country's only and most innovative endoscopy techniques that allow for the early diagnosis and treatment of cancer.
St. Michael's Hospital provides compassionate care to all who walk through its doors. The Hospital also provides outstanding medical education to future health care professionals in more than 23 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, and care of the homeless are among the Hospital's recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing Knowledge Institute, research at St. Michael's Hospital is recognized and put into practice around the world. Founded in 1892, the Hospital is fully affiliated with the University of Toronto.
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