DALLAS – June 4, 2010 – A minimally invasive technique used to destroy kidney tumors with an electrically controlled heating probe showed similar effectiveness as surgical removal of tumors in curbing cancer recurrence rates for up to five years after treatment.
In an article available online in the journal Cancer, Dr. Jeffrey Cadeddu, professor of urology and radiology at UT Southwestern Medical Center, reported the outcomes of more than 200 patients who were treated with radiofrequency ablation (RFA).
Once the diagnosis of tumor is confirmed and the RFA technique is agreed upon, a needle-like probe is placed inside the tumor. The radiofrequency electricity waves passing through the probe heat up tumor tissue and destroy it. Surgeons view the RFA procedure with the aid of imaging devices such as computed tomography (CT scan).
Of the 208 patients who underwent the RFA procedure, 160 were diagnosed with renal cell carcinoma, a type of kidney cancer that is slow-growing but malignant and able to spread easily to other organs. Those patients had three- and five-year survival rates of more than 95 percent.
"These types of cancers aren't typically fast-growing, but there are between 40,000 and 50,000 cases of kidney cancers diagnosed each year in the United States," Dr. Cadeddu said. "The fact that cancer survival rates were comparable to surgical interventions is very encouraging."
Currently, many patients who are diagnosed with primary tumors that originate inside the kidney are treated surgically.
"The standard treatment is usually a partial nephrectomy, where the surgeon removes the tumor and some surrounding tissue via open or laparascopic surgery," said Dr. Cadeddu. "With surgery, there is a 5 percent to 10 percent risk of bleeding and an associated need for transfusion, as well as an increased chance of readmission for the patient. Of course, the recovery time is longer as well."
With open surgery, surgeons go in through a patient's abdomen or flank to remove the kidney tumor. A laparascopic partial nephrectomy involves doctors accessing the organ through several small incisions in a patient's abdomen. The recovery time for open surgery is about six to eight weeks and three to four weeks for laparascopic procedures.
With RFA, 90 percent of the patients are able to go home the same day, said Dr. Cadeddu, but the real advantage to RFA is its superior preservation of kidney tissue.
"Preserving kidney function has been clearly demonstrated to maximize quality of life and length of life for patients with kidney tumors," Dr. Cadeddu said. "Whenever possible, we try to save as much of the kidney as we can."
Wednesday, June 2, 2010
Devices, Drug Cut Bleeding Risk in PCI
Combining the direct thrombin inhibitor bivalirudin (Angiomax) with vascular closure devices was associated with the lowest rate of bleeding complications in patients undergoing percutaneous coronary intervention (PCI), a large database analysis showed.
Among more than 1.5 million PCI patients in the National Cardiovascular Data Registry (NCDR), 0.9% suffered bleeding complications when both bivalirudin and vascular closure devices were used, according to Steven P. Marso, MD, of the University of Missouri in Kansas City, and colleagues.
The highest rate, 2.8%, was seen in patients for whom manual compression was the sole means of bleeding control, the researchers reported in the June 2 issue of the Journal of the American Medical Association.
Rates associated with vascular closure devices and bivalirudin alone were 2.1% and 1.6%, respectively (P<0.001>for differences):
6.1%, manual compression
4.6%, vascular closure devices
3.8%, bivalirudin
2.3%, vascular closure devices plus bivalirudin
But Marso and colleagues also found that the combination approach was used more often in low-risk patients. Only 14.4% of high-risk patients had both bivalirudin and closure devices for bleeding control, compared with 21.0% of low-risk patients.
By the same token, 40.3% of high-risk patients had manual compression versus 30.8% of low-risk patients.
"This apparent risk-treatment paradox highlights an opportunity for routine preprocedural risk stratification as a means to identify patients ideally suited for individualized bleeding avoidance strategies with the goal of increasing the safety of PCI," Marso and colleagues wrote.
"Targeting bleeding complications as a quality-improvement goal holds great potential for improving the safety and cost-effectiveness of PCI," they added.
The study examined outcomes in 1,522,935 patients undergoing PCI at 935 hospitals participating in the data registry from 2004 to 2008.
Among them, 30,654 had inhospital bleeding complications. These were defined in three ways: serious enough to warrant transfusion or a prolonged hospital stay for management, or leading to a decrease of more than 3 g/dL in blood hemoglobin content.
Bleeding risks were predicted on the basis of age, gender, peripheral vascular disease, renal function, previous congestive heart failure, previous PCI, and whether patients had myocardial infarction with ST-segment elevation. The risk prediction model had been developed previously from NCDR data.
Marso and colleagues suggested several potential explanations for the lower use of the drug-plus-device strategy in high-risk patients.
One is that assessing patients for bleeding risk is neither easy nor common, they indicated. Another is that familiarity with bivalirudin and/or closure devices outside the elective PCI setting may be limited.
"The results of this study suggest the need for additional research to better understand why higher-risk patients are least likely to receive bleeding avoidance strategies," Marso and colleagues wrote, adding that interventions to encourage pre-PCI risk assessment should be tested.
In a statement, Ralph Brindis, MD, MPH, president of the American College of Cardiology, said the study's findings would themselves help reverse the paradox.
"Assessing a patient's risk of bleeding prior to PCI can help improve its safety by utilizing proven bleeding avoidance strategies for patients most likely to benefit from the procedure," he said. "This study identifies how we can adapt our practices to focus on individual comorbidities and provide even greater high-quality, patient-centered care."
Kirk Garratt, MD, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, commented in a statement that the data do suggest "a synergy between drug and device."
"My only concern is that we don't know how many patients were considered for a closure device but didn't get one," he said.
"We always take a picture of the artery after we put the sheath in, to see if a closure device will work. Sometimes we learn that the artery has been punctured in a way that increases bleeding and prevents use of closure devices," he observed.
The authors noted several limitations of the study. "First, this was not a randomized trial; thus, a causal relationship between bleeding avoidance and evaluated strategies cannot be concluded. Second, potential unmeasured confounding is a limitation of all observational studies."
Among more than 1.5 million PCI patients in the National Cardiovascular Data Registry (NCDR), 0.9% suffered bleeding complications when both bivalirudin and vascular closure devices were used, according to Steven P. Marso, MD, of the University of Missouri in Kansas City, and colleagues.
The highest rate, 2.8%, was seen in patients for whom manual compression was the sole means of bleeding control, the researchers reported in the June 2 issue of the Journal of the American Medical Association.
Rates associated with vascular closure devices and bivalirudin alone were 2.1% and 1.6%, respectively (P<0.001>for differences):
6.1%, manual compression
4.6%, vascular closure devices
3.8%, bivalirudin
2.3%, vascular closure devices plus bivalirudin
But Marso and colleagues also found that the combination approach was used more often in low-risk patients. Only 14.4% of high-risk patients had both bivalirudin and closure devices for bleeding control, compared with 21.0% of low-risk patients.
By the same token, 40.3% of high-risk patients had manual compression versus 30.8% of low-risk patients.
"This apparent risk-treatment paradox highlights an opportunity for routine preprocedural risk stratification as a means to identify patients ideally suited for individualized bleeding avoidance strategies with the goal of increasing the safety of PCI," Marso and colleagues wrote.
"Targeting bleeding complications as a quality-improvement goal holds great potential for improving the safety and cost-effectiveness of PCI," they added.
The study examined outcomes in 1,522,935 patients undergoing PCI at 935 hospitals participating in the data registry from 2004 to 2008.
Among them, 30,654 had inhospital bleeding complications. These were defined in three ways: serious enough to warrant transfusion or a prolonged hospital stay for management, or leading to a decrease of more than 3 g/dL in blood hemoglobin content.
Bleeding risks were predicted on the basis of age, gender, peripheral vascular disease, renal function, previous congestive heart failure, previous PCI, and whether patients had myocardial infarction with ST-segment elevation. The risk prediction model had been developed previously from NCDR data.
Marso and colleagues suggested several potential explanations for the lower use of the drug-plus-device strategy in high-risk patients.
One is that assessing patients for bleeding risk is neither easy nor common, they indicated. Another is that familiarity with bivalirudin and/or closure devices outside the elective PCI setting may be limited.
"The results of this study suggest the need for additional research to better understand why higher-risk patients are least likely to receive bleeding avoidance strategies," Marso and colleagues wrote, adding that interventions to encourage pre-PCI risk assessment should be tested.
In a statement, Ralph Brindis, MD, MPH, president of the American College of Cardiology, said the study's findings would themselves help reverse the paradox.
"Assessing a patient's risk of bleeding prior to PCI can help improve its safety by utilizing proven bleeding avoidance strategies for patients most likely to benefit from the procedure," he said. "This study identifies how we can adapt our practices to focus on individual comorbidities and provide even greater high-quality, patient-centered care."
Kirk Garratt, MD, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, commented in a statement that the data do suggest "a synergy between drug and device."
"My only concern is that we don't know how many patients were considered for a closure device but didn't get one," he said.
"We always take a picture of the artery after we put the sheath in, to see if a closure device will work. Sometimes we learn that the artery has been punctured in a way that increases bleeding and prevents use of closure devices," he observed.
The authors noted several limitations of the study. "First, this was not a randomized trial; thus, a causal relationship between bleeding avoidance and evaluated strategies cannot be concluded. Second, potential unmeasured confounding is a limitation of all observational studies."
Kuros Completes Patient Recruitment
Zurich, Switzerland, 2nd June 2010 - Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced today that it has completed recruitment in a 200 patient Phase IIb clinical trial designed to assess the efficacy and safety of KUR-113 (Viz.I-040202) in open tibial shaft fractures.
This study is a randomized, controlled, open-label (dose-blinded) dose finding study of the safety and efficacy of KUR-113 in the treatment of patients with acute open tibial shaft fractures. The aim of the trial is to assess the safety and efficacy of KUR-113 in combination with standard of care (SOC) vs SOC alone. The use of KUR-113 is designed to improve bone healing by reducing the time needed to achieve bone healing as well as the incidence of secondary interventions.
KUR-113 utilizes Kuros’ “TG-hook” technology for binding proprietary biologics into a fibrin sealant. The product candidate is composed of a variant of parathyroid hormone (vPTH) and fibrin sealant and is applied directly to the fracture site in the form of a paste. KUR-113 has been designed to deliver vPTH locally at the fracture site and to maintain this via the slow controlled release of vPTH over time from the fibrin matrix. The fibrin matrix also plays a further important role in the bone healing process by providing a physical scaffold for cell ingrowth. The trial will assess whether this approach is safe and efficacious.
A total of 200 patients have been randomized and treated in over 31 centers across Europe. The primary endpoint of this study is the proportion of patients healed at 6 months after surgery when compared to SOC alone. Kuros is expecting to report the outcome of this study in the first half of 2011.
Dr. Virginia Jamieson, Chief Medical Officer of Kuros, commented: “We are very pleased to have completed recruitment for this study with KUR-113 and we look forward to reporting the results of this novel approach to the treatment of open tibial shaft fractures in the first half of 2011.”
KUR-113 is licensed to Baxter International Inc. under a collaboration and license agreement which was signed in 2005. Following the successful completion of this study, Baxter will take over responsibility for the further development of KUR-113.
Didier Cowling, Chief Executive Officer of Kuros, commented: “Completion of patient recruitment in this large Phase IIb study is another significant step for Kuros. We look forward to broadening the application of this technology to additional orthopedic settings”
This study is a randomized, controlled, open-label (dose-blinded) dose finding study of the safety and efficacy of KUR-113 in the treatment of patients with acute open tibial shaft fractures. The aim of the trial is to assess the safety and efficacy of KUR-113 in combination with standard of care (SOC) vs SOC alone. The use of KUR-113 is designed to improve bone healing by reducing the time needed to achieve bone healing as well as the incidence of secondary interventions.
KUR-113 utilizes Kuros’ “TG-hook” technology for binding proprietary biologics into a fibrin sealant. The product candidate is composed of a variant of parathyroid hormone (vPTH) and fibrin sealant and is applied directly to the fracture site in the form of a paste. KUR-113 has been designed to deliver vPTH locally at the fracture site and to maintain this via the slow controlled release of vPTH over time from the fibrin matrix. The fibrin matrix also plays a further important role in the bone healing process by providing a physical scaffold for cell ingrowth. The trial will assess whether this approach is safe and efficacious.
A total of 200 patients have been randomized and treated in over 31 centers across Europe. The primary endpoint of this study is the proportion of patients healed at 6 months after surgery when compared to SOC alone. Kuros is expecting to report the outcome of this study in the first half of 2011.
Dr. Virginia Jamieson, Chief Medical Officer of Kuros, commented: “We are very pleased to have completed recruitment for this study with KUR-113 and we look forward to reporting the results of this novel approach to the treatment of open tibial shaft fractures in the first half of 2011.”
KUR-113 is licensed to Baxter International Inc. under a collaboration and license agreement which was signed in 2005. Following the successful completion of this study, Baxter will take over responsibility for the further development of KUR-113.
Didier Cowling, Chief Executive Officer of Kuros, commented: “Completion of patient recruitment in this large Phase IIb study is another significant step for Kuros. We look forward to broadening the application of this technology to additional orthopedic settings”
Monday, May 31, 2010
A compound found in sunless tanning spray may help to heal wounds following surgery
Results published today in the Proceedings of the National Academy of Sciences show that a sticky gel composed of polyethylene glycol and a polycarbonate of dihydroxyacetone (MPEG-pDHA) may help to seal wounds created by surgery.
Procedures to remove cancerous breast tissue, for example, often leave a hollow space that fills with seroma fluid that must typically be drained by a temporary implanted drain. "This is an unpleasant side effect of surgery that is oftenunavoidable," explains Dr. Jason Spector, co-author of the study and plastic surgeon at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
The gel could potentially be used in all different reconstructive surgeries to prevent seroma formation. "The new substance would act to glue together the hole left behind to prevent seroma buildup," says Dr. Spector.
DHA is a compound that sticks to compounds in biological tissues, called amines. The sticky properties of DHA are what allows sunless tanner to adhere to the skin without being wiped off. However, it is biodegradable and water soluble as well, which means that the compound does not stay tacked onto the body's tissues forever. Currently used "bio-glues" are made from animal products and take a long time to degrade in the body -- both factors that raise the risk of infection.
"DHA is a compound that is naturally produced in the body," explains Dr. David Putnam, the study's senior author and a biomedical engineer from Cornell University's Department of Biomedical Engineering and School of Chemical and Biomolecular Engineering. "The glue is broken down, or metabolized, and then safely removed by the body."
Dr. Putnam's lab and his collaborators work to create safe, synthetic compounds from chemicals found in nature. DHA is an intermediary compound produced during the metabolism of glucose, a sugar used by the body for fuel.
To create the new compound, MPEG-pDHA, Dr. Putnam and his lab first bound the single molecule monomer of DHA, which is highly reactive, to a protecting group molecule, making it stable enough to manipulate. This allowed the engineers to bind the monomers together to form a polymer, or chain of molecules, along with MPEG. Doing so allows the polymer gel to be injected through a syringe.
"Making a polymer from DHA has eluded chemical engineers for about 20 years," says Dr. Putnam.
Now in gel form, the compound has the ability to stick tissues together, preventing the pocket from filling with seroma fluid, like an internal Band-Aid, explains Dr. Putnam. The researchers found that the gel prevented or significantly lowered seroma formation or fluid buildup in rats that had breast tissue removed.
"The next step would be to test the gel on larger animals and then in clinical trials in human surgical cases," says Dr. Spector.
Previous results, published by Drs. Putnam and Spector, in the August 2009 issue of the Journal of Biomedical Materials Research, showed that the gel also prevented bleeding in a rat liver.
"This is another aspect of the compound that would be greatly beneficial if proven to be applicable in humans," says Dr. Spector. "The gel could speed the healing and decrease bleeding within the body."
Talecris Biotherapeutics to Present at the 2010 Citi Investment Research Global Health Care Conference
RESEARCH TRIANGLE PARK, N.C., May 20 /PRNewswire-FirstCall/ -- Talecris Biotherapeutics Holdings Corp. (Nasdaq:TLCR) today announced that Lawrence D. Stern, chairman and chief executive officer of Talecris, will present at the 2010 Citi Investment Research Global Health Care Conference at 11:30 a.m., Thursday, May 27, 2010, at the Hilton New York Hotel inNew York, N.Y.
A live webcast of Talecris' presentation will be accessible through the investor relations section of the Talecris Web site,www.talecris.com/investor-relations.htm. A replay of the webcast will be available until June 10, 2010, and can be accessed at the same Web address.
A live webcast of Talecris' presentation will be accessible through the investor relations section of the Talecris Web site,www.talecris.com/investor-relations.htm. A replay of the webcast will be available until June 10, 2010, and can be accessed at the same Web address.
Sunday, May 30, 2010
Coils for Nosebleeds
(Reuters Health) - A small study suggests that a surgical treatment generally used on patients with tumors and certain brain disorders may put a stop to nosebleeds that won't stop any other way.
The surgery - which involves injecting coils into the arteries of the nose through arteries in the leg - isn't for everyone. For most people, home remedies such as pressure and tissues work just fine. If they're not enough, doctors may pack the nasal passages with gauze, or sear the bleeding shut using cauterization.
But the author of the study told Reuters Health that about one percent of the population - generally older adults taking blood thinners - suffers from uncontrollable nosebleeds severe enough that surgery may be considered.
The study, published today in the Journal of NeuroInterventional Surgery, tracked 20 such patients who had received the coil treatment. Dr. Walter Lesley, lead author of the study and director of neuroradiology at the Scott & White Clinic in Temple, Texas, and colleagues monitored patients for 30 days, after which 18 of the 20 needed no further surgery.
One patient had another procedure to control bleeding, while another died of unrelated causes.
The study, say the authors, is an important step in figuring out which kind of surgery is safest and most effective.
"There really isn't a lot of good numerical data on using coils at all for nosebleeds," Lesley told Reuters Health. "Our results were encouraging and certainly warrant a larger study comparing (the procedure) head to head with other methods."
Doctors use a few other surgeries to treat severe uncontrollable nosebleeds, including a catheter to plug an artery with sponge-like particles, rather than coils, and tying off an artery in the back of the nose with a staple-like clip.
The current study did not directly compare different treatment methods, but the coil method had a lower failure rate and fewer serious complications than other methods have in other studies. Those complications - which can include stroke and blindness - affected none of the study's participants.
The risks may be different, said Dr. Peter Willems, a neurosurgeon at Leiden University Medical Center in the Netherlands, because the coils don't penetrate as far into the nasal artery as smaller particles. While this could reduce the possibility of some complications, it may make it more difficult to repeat the surgery on those who need it.
Dr. Richard Orlandi, an ear, nose and throat specialist at the University of Utah, believes that each of the procedures is relatively safe, and that the question comes down to cost and availability. Orlandi and his colleagues published a study in 2005 which found that the cost of a procedure similar, but not identical, to the one tested here was $14,088 per patient, compared to $7,561 for a procedure that clipped the nasal artery.
"Performing this procedure really does require a fair amount of skill by a radiologist," which could be a problem in rural settings, he told Reuters Health.
Lesley said the platinum-coil based procedure takes about an hour to complete, and patients either go home that day or the next morning - similar to the recovery time for other treatments.
The researcher said the need for such procedures could grow "because of the benefits of new drugs that thin the blood and can cause more bleeding problems."
SOURCE: here Journal of NeuroInterventional Surgery, May 27, 2010.
CryoLife to present at the Jefferies 2010 Global Life Sciences Conference
CryoLife, Inc. , an implantable biological medical device and cardiovascular tissue processing company, announced today that it will participate in the Jefferies 2010 Global Life Sciences Conference at The Grand Hyatt Hotel in New York City.
Steven G. Anderson, president and chief executive officer of CryoLife, Inc., will present a corporate overview on Tuesday, June 8, 2010 at 9:30 a.m., Eastern Time.
CryoLife's live presentation may be accessed through its Web site, www.cryolife.com, on the Investor Relations page. An archived copy of the presentation will be available for 90 days on the same Web site.
Saturday, May 29, 2010
Friday, May 28, 2010
CORDIS Launches ExoSeal(TM) Vascular Closure Device
New Trial Results on ExoSeal(TM) Vascular Closure Device Support its Clinical Safety* and Efficacy
PARIS, May 27, 2010 /PRNewswire/ -- Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced the launch of the ExoSeal(TM) Vascular Closure Device. ExoSeal(TM) incorporates a number of new advances in technology and simplicity of design to provide precise and secure extravascular arterial closure. Cordis Corporation received CE-Marking approval for ExoSeal(TM) Vascular Closure Device in May 2010. This new product was launched during EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.
ExoSeal(TM) was shown in a recent clinical trial to have an excellent clinical safety* profile during vascular procedures. The 'ECLIPSE Trial' recorded no adverse clinical events and achieved a level of safety comparable to manual compression while significantly reducing time to ambulation. The device has achieved this level of clinical safety by combining easy-to-use functionality with trusted bioabsorbable technology and precise extravascular closure.
"We are very pleased to announce the launch of our first Vascular Closure Device" said Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation. "The ExoSeal(TM) Vascular Closure Device incorporates key advancements including the use of the Polyglycolic Acid Plug, two visual indicators to moderate control of the device and lockout features to reduce the risk of complications. The device is designed for ease of use, reducing the number of components and deployment steps."
"From our experience in the ECLIPSE trial, we were impressed with the safety and the effectiveness of this new closure device. It is very easy to use and nothing is left inside the vessel to threaten arterial blood flow. An advantage compared to other devices is the procedural sheath does not need to be changed which helps promote patient comfort. The two visual indicators are important for positioning the bioabsorbable plug ," explains Marcus Wiemer, M.D., Primary Investigator, Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, in Bad Oeynhausen, Germany**.
ExoSeal(TM) in detail
The ExoSeal(TM) Vascular Closure Device makes use of key technological developments to support the clinical safety of the closure procedure. In the ECLIPSE Trial, the extravascular plug placement was associated with no embolization, infection or other major adverse events, comparable to manual compression [despite the significantly shorter time to ambulation for ExoSeal(TM)]. The bioabsorbable PGA-plug, which is designed to close the femoral artery puncture site with minimal or no inflammation, is fully reabsorbed in 60-90 days. PGA (Polyglycolic Acid) is a trusted non-collagen plug material that is metabolized to carbon dioxide and water. A system of deployment through the existing procedural sheath makes ExoSeal(TM) quicker and easier to use and increases physician convenience by minimizing or eliminating the need for sheath exchange during the procedure. The device uses visual indicators to help the clinician deploy the device correctly. This "visual feedback" also promotes patient comfort during deployment and the 'lock-out' system of ExoSeal(TM) helps ensure that only extra-vascular plug placement can take place.
Flush with VC, Cohera Medical Raises $12.2M of $20M
PITTSBURGH, Pa. -- According to an SEC filing, Cohera Medical has raised $12.2 millionagainst a targeted $20 million from Bradford Capital Partners and Kern Whelan Capital.
The company has now amassed more than $60 million in venture backing. As reported by citybizlist, in May 2008 Cohera collected more than $7.6 million from Kern Whelan and in October of the same year secured $16.1 Million in Series B Financing from Whelan and Bradford. In January of 2010 the company received Series C funding totaling $25 million.
Cohera is a Pittsburgh based company that develops a line of surgical adhesives that are synthetic, biocompatible and resorbable. It is planning to enter clinical trials with its product starting with a target application in plastic surgery.
Named in the filing are Patrick Daly, co-founder president and chief executive officer, Richard Wonsettler, vice president of finance and chief financial officer, Dottie Clower, vice president of research and development and operations, and Eric Beckmanco, co-founder and chief scientific officer; and directors Albert Dombrowski, James Liken, John Kern (Kern Whelan Capital),Doros Platika and Martin Calihan (Bradford Capital Partners).
Bradford Capital Partners is a Pittsburgh-based private investment company that participates in venture capital investments and engages in the acquisition and development of entrepreneurial businesses.
Based in San Francisco, Calif., Kern Whelan Capital manages investment portfolio stretching from new ventures to established and profitable businesses across many industry sectors. The company invests only in few companies and has long term approach towards it liquidity horizon.
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