MILAN, Italy, Apr 12, 2010 (BUSINESS WIRE) -- Sorin Group, (MIL:SRN), a global company and a leader in the treatment of cardiovascular diseases, announced today that it has completed the sale, for $7 million (EUR5.25 million) in cash paid in installments over two and a half years, of the Angel(R) Whole Blood Separation System ("Angel(TM)") and activAT(R) Autologous Thrombin Processing Kit ("activAT(R)") product lines to Cytomedix, Inc. (GTF 0.90, -0.05, -5.26%), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis. Together these products had sales of approximately $5 million (EUR3.75 million) in 2009.
Angel(TM) consists of a blood processing device and disposable products used for separation of whole blood into red cells, platelet poor plasma and platelet rich plasma ("PRP"); activAT(R) is designed to produce autologous thrombin serum from platelet poor plasma, providing a completely autologous, safe alternative to bovine-derived products.
"We are pleased to enter into an agreement to sell these non-core assets to Cytomedix, and we count on Cytomedix to maintain the same high level of customer service, support and product excellence that our customers have come to expect from Sorin", said Michel Darnaud, President, Cardiopulmonary Business Unit.
Thursday, April 22, 2010
Baxter International Inc. Q1 2010
Sales in the regenerative medicine business which includes our bio surgery products totaled $119 million and increased 20%. Sales excluding foreign currency grew 14% and continue to reflect robust growth of Floseal, Coseal and Tisseel....... we expect the regenerative medicine to have sales growth exceeding 25% reflecting the ApaTech acquisition and continued double digit growth in the base business.........
Besides the existing growth vehicles of hemophilia and bio surgery and the various product categories of medication delivery like [hemostasia] and nutritionals, if you just look at kind of near-term new product launches in the various businesses, not to get off of IVIG. Let’s start with that. We have a 30 gram IVIG product we hope to get approved this year and hopefully launch in the U.S. by the end of this year. We have a 10% sub-q product without Enhance, without the Hylenex technology that we will be submitting shortly and hope to have on the market in 2011. Then of course HYQ which incorporates the Hylenex technology we are very excited about. Then new indications like MMN and the whole Alzheimer’s thing which we don’t need to get into.
So even within the antibody therapy area we have a very nice lineup of near-term and longer term things that can really I think change the game. The rest of bio science of course we just got approval for TachoSil in our bio surgery business which we will be launching. We continue to make good progress with our seasonal influenza vaccine targeting EU approval this year and hopefully approval and launch in the U.S. before too long.
I guess where we are completing a trial right now for a broader hemostasis claim which could be very helpful for the growth of that product. I mentioned in renal but Enterprise which is the next generation PD cycler we will be launching hopefully by sometime in early 2011. Our hemo next generation infusion pump platform. Then in the short-term a number of market expansion opportunities with existing products. ADVATE launches in big markets this year like Brazil and then next year Russia. Following year China. Supreme launch in Japan. I will stop there. I am getting pretty granular. We have a fairly nice array and continuous array in all of our businesses of new product launches both near-term and obviously some bigger things longer term. In addition to the existing growth platforms whether it is hemophilia or recombinant and bio surgery and so on. I covered a lot.
St. Jude Medical Inc. Q1 2010
..........Total sales of cardiovascular products for the first quarter of 2010 were $256 million, up 7% over the first quarter of 2009, including $10 million of favorable foreign currency translation. On a constant currency basis, first quarter cardiovascular products sales increased 3% versus last year. Within this category of products, sales of vascular closure products in the first quarter of 2010 were $98 million consistent with the first quarter of 2009.........
Sunday, April 18, 2010
Medafor Abandons Efforts to Deny Shareholder Status to CryoLife CEO
In November 2009, Medafor, Inc. filed a lawsuit against Mr. Anderson and Mr. Richard Zerban, the former CEO of Medafor, regarding Mr. Zerban's sale to Mr. Anderson of 1,000 shares of Medafor stock (the "Transaction"). Mr. Anderson asserted a counterclaim against Medafor and third party claims against Mr. Gary Shope, Medafor's CEO, and Mr. Gavin Thomson, Medafor's CFO, in the lawsuit regarding the Transaction.
Medafor has agreed to dismiss with prejudice all of its claims against Mr. Anderson and Mr. Zerban in the Lawsuit and has agreed to register the 1,000 shares in Mr. Anderson's name effective as of May 13, 2009. Medafor also retracts the allegations it has made on its website and elsewhere that the Transaction was wrongful.
Mr. Anderson, in turn, has agreed to dismiss with prejudice all of his counterclaims against Medafor and all of his third-party claims against Mr. Shope and Mr. Thomson.
As part of the dismissal, both parties withdraw the allegations they have made against one another in the Lawsuit. No party admits or acknowledges liability or wrongdoing in this matter. The Lawsuit was settled to the Parties' mutual satisfaction.
CryoLife was not a party to the lawsuit.
Medafor has agreed to dismiss with prejudice all of its claims against Mr. Anderson and Mr. Zerban in the Lawsuit and has agreed to register the 1,000 shares in Mr. Anderson's name effective as of May 13, 2009. Medafor also retracts the allegations it has made on its website and elsewhere that the Transaction was wrongful.
Mr. Anderson, in turn, has agreed to dismiss with prejudice all of his counterclaims against Medafor and all of his third-party claims against Mr. Shope and Mr. Thomson.
As part of the dismissal, both parties withdraw the allegations they have made against one another in the Lawsuit. No party admits or acknowledges liability or wrongdoing in this matter. The Lawsuit was settled to the Parties' mutual satisfaction.
CryoLife was not a party to the lawsuit.
Comparison between TachoComb and TachoSil
TachoComb has frequently been used for the treatment of both venous and arterial bleeding. However, anaphylactic reactions have been reported after repeated use of hemostatic agents containing aprotinin such as TachoComb. Because aprotinin is also associated with risk of renal failure, manufacturing of a new product--TachoSil--which lacks aprotinin seems a logic evolvement. Furthermore, thrombin on the TachoSil material has been changed from bovine in TachoComb to human origin. These changes in the biochemical composition could lead to changes in the hemostatic performance. Therefore, we aimed to disclose any difference in hemostatic efficacy of the two products. METHODS: Twelve 70-kg pigs had controlled insults to the thoracic aorta with and without heparin administration. The iatrogenic lesion was randomly covered with either TachoComb or TachoSil and the time to hemostasis was measured. RESULTS: Time to hemostasis when using TachoSil compared with TachoComb was increased 14% (-13% to 48%) with heparin and 10% (-26% to 66%) without heparin (mean +/- 95% confidence interval; p > 0.05 in both). Time to hemostasis with heparin administration increased significantly in both treatments: TachoComb 80% (26%-156%) (p = 0.001) and TachoSil 75% (18%-158%) (p = 0.005). CONCLUSION: We found neither statistical nor clinical evidence that TachoComb should have better hemostatic properties than does TachoSil in arterial bleeding. Both TachoSil and TachoComb can be used with heparin administration, but significant prolongation of the time to hemostasis is to be expected for both products. TachoSil should be preferred to TachoComb due to the potential lower risk of side effects when using the former.
World Hemophilia Day
On World Hemophilia Day 2010, April 17, meet the many faces of bleeding disorders - united to achieve Treatment for All. Each year hemophilia organizations around the world celebrate World Hemophilia Day, increasing awareness of hemophilia and other bleeding disorders.
The World Federation of Hemophilia (WFH) will launch “The Many Faces of Bleeding Disorders” video podcast on World Hemophilia Day. This video podcast celebrates the whole bleeding disorders community – people with hemophilia and symptomatic carriers, males and females with von Willebrand disease, as well as rarer factor deficiencies, and inherited platelet disorders. It features the impact of these conditions through global patient perspectives and includes a call-to-action for access and improved patient standard of care.
“The goal of the World Federation of Hemophilia is that, one day, treatment will be available for all those with inherited bleeding disorders, regardless of where they live,” said Mark Skinner, WFH president. “Our vision of Treatment for All means expanding services beyond hemophilia.”
Visit www.wfh.org/whd :
for more information about World Hemophilia Day. The World Hemophilia Day website is supported by Bayer, Baxter, and Novo Nordisk. View “The Many Faces of Bleeding Disorders” video podcast, made possible with funding from Baxter Healthcare Corporation, at www.wfh.org/whd : .
The World Federation of Hemophilia (WFH) will launch “The Many Faces of Bleeding Disorders” video podcast on World Hemophilia Day. This video podcast celebrates the whole bleeding disorders community – people with hemophilia and symptomatic carriers, males and females with von Willebrand disease, as well as rarer factor deficiencies, and inherited platelet disorders. It features the impact of these conditions through global patient perspectives and includes a call-to-action for access and improved patient standard of care.
“The goal of the World Federation of Hemophilia is that, one day, treatment will be available for all those with inherited bleeding disorders, regardless of where they live,” said Mark Skinner, WFH president. “Our vision of Treatment for All means expanding services beyond hemophilia.”
Visit www.wfh.org/whd :
for more information about World Hemophilia Day. The World Hemophilia Day website is supported by Bayer, Baxter, and Novo Nordisk. View “The Many Faces of Bleeding Disorders” video podcast, made possible with funding from Baxter Healthcare Corporation, at www.wfh.org/whd : .Sunday, April 11, 2010
Concerns Raised About Synthetic Glue for Hernia Repair
Boston—A study showing adverse effects from a synthetic cyanoacrylate tissue sealant used in an animal hernia model won the award for best paper in general surgery at the 2006 annual meeting of the Society of Laparoendoscopic Surgeons. Although the brand of synthetic surgical glue tested in the study is approved for use only in Europe, at least one other manufacturer of cyanoacrylate sealant is seeking approval from the FDA for its use in vascular surgery.
The study, in 16 rats, found that in all cases, the glue prevented tissue from adhering to or integrating with the mesh, impaired tissue flexibility and resulted in a severe inflammatory response marked by large seroma formations.
The cyanoacrylate examined in the study was Glubran 2, made by the Italian firm GEM S.r.l. (Viareggio, Italy) and approved for use in Europe in both traditional and laparoscopic surgery.
“It seems not very appropriate for hernia repair in an experimental model, to say the least,” said the lead author of the study, Alexander H. Petter-Puchner, MD, a surgical resident at the Ludwig Boltzmann Institute for Experimental and Clinical Traumatology in Vienna, Austria.
Surgeons who heard the report said it comes amid a welcomed stream of studies into novel means for fixing mesh during hernia repair.
“There are a bunch of these cyanoacrylates that have been used clinically or investigationally as tissue adhesives,” said Raymond J. Lanzafame, MD, the immediate past president of the Society of Laparoendoscopic Surgeons. “The good news is that some of the the cyanoacrylate compounds are hydrophilic. But they, like the currently available cyanoacrylates, do generate a pretty intense inflammatory response. If it’s a version that isn’t broken down by the body in some way, it can turn out as bad as, if not worse than, a suture granuloma in terms of producing pain and irritation.”
Phillip Shadduck, MD, of Regional Surgical Associates in Durham, N.C., said in an interview after Dr. Petter-Puchner’s presentation that while a strong inflammatory response was seen in the study, newer cyanoacrylates might not evoke the same reaction. “We’ve learned in the abdomen, and now in the abdominal wall, that the chemistry of the cyanoacrylates makes a big difference in the inflammatory response it activates,” he said. “There are newer cyanoacrylates coming out in an effort to elicit less of an inflammatory response.”
One such cyanoacrylate, designed to be biodegradable, was approved for use in Europe in February 2005 as an adjunct to sutures during peripheral vascular reconstructions. The product, Omnex, is made by Closure Medical Corporation in Raleigh, N.C., which was recently acquired by Johnson & Johnson. (Dr. Shadduck reported that he has done consulting on the Omnex product.)
In March at the annual meeting of the Society for Clinical Vascular Surgery, results from a trial of 150 patients at 15 centers in the United States and Europe showed significant benefits for Omnex as an adjunctive sealant for vascular anastomoses compared with Surgicel Nu-Knit Absorbable Hemostat (Johnson & Johnson). The study found a statistically significant difference in time to hemostasis between the sealant, with a mean of 119.3 seconds, compared with Surgicel, with a mean of 403.8 seconds (P<0.001). Among patients in the Omnex group, 54.5% had immediate hemostasis, compared with only 10% in the Surgicel group (P<0.001). No significant difference in incidence of adverse events occurred between the two groups (P=0.60).
Using a compound similar to the one approved for external use in the United States under the trade name Dermabond, Omnex is under consideration by the FDA for internal use during vascular surgery.
Whether Omnex would have the kind of detrimental effects in hernia repair that were seen in Dr. Petter-Puchner’s study of Glubran 2 is unclear, but the chief of minimally invasive surgery at the department of surgery, Keck School of Medicine of USC, Los Angeles, said he would be “wary” of such a use.
“The artificial glues, or glues that have any artificial nature, stay around in the body and create a foreign body reaction,” said Namir Katkhouda, MD, who published the first study using a fibrin sealant, Tisseel, for mesh fixation in hernia repair (Ann Surg2001;233:18-25). “Some people have spun around the concept of using sealants in mesh fixation to these other adhesives [with artificial components]. I am absolutely wary of them. The important difference between the fibrin sealants and any artificial sealant is that the fibrin is naturally removed by the body at 10 days. That’s what you want.”
Tisseel, made by Baxter (Irvine, Calif.), is widely used in Europe for mesh fixation, but is currently approved in the United States only for cardiopulmonary bypass surgery, splenic repair and colostomy closure. A spokesman for Baxter said the company has a “strong desire” to broaden the indications for Tisseel in the United States.
In his award-winning paper, Dr. Petter-Puchner presented data on 20 Sprague Dawley rats, in which two defects per animal were created in the abdominal wall left and right of the linea alba (1.5 cm in diameter), with the peritoneum was spared. The lesions were left untreated for 10 days to achieve a chronic condition and then were covered with 2 cm×2 cm of mesh sealed with Glubran 2. Four of the animals were sacrificed after 17 days, eight after four weeks and another eight after 12 weeks. The meshes were then biomechanically tested and histology was performed.
At the 12-week mark, the hook-pull test revealed a loss of mesh adhesion wherever the sealant had been used. “There was no tissue integration through the mesh and histology revealed strong inflammation,” Dr. Petter-Puchner said during his presentation. “We also saw a huge seroma formation.”
Using a suction cone to test the elasticity of the tissue, his group found 4.2 mm of deformation in untreated areas, but just one-tenth that much in areas where Glubran had been applied, demonstrating a loss of flexibility.
The study, in 16 rats, found that in all cases, the glue prevented tissue from adhering to or integrating with the mesh, impaired tissue flexibility and resulted in a severe inflammatory response marked by large seroma formations.
The cyanoacrylate examined in the study was Glubran 2, made by the Italian firm GEM S.r.l. (Viareggio, Italy) and approved for use in Europe in both traditional and laparoscopic surgery.
“It seems not very appropriate for hernia repair in an experimental model, to say the least,” said the lead author of the study, Alexander H. Petter-Puchner, MD, a surgical resident at the Ludwig Boltzmann Institute for Experimental and Clinical Traumatology in Vienna, Austria.
Surgeons who heard the report said it comes amid a welcomed stream of studies into novel means for fixing mesh during hernia repair.
“There are a bunch of these cyanoacrylates that have been used clinically or investigationally as tissue adhesives,” said Raymond J. Lanzafame, MD, the immediate past president of the Society of Laparoendoscopic Surgeons. “The good news is that some of the the cyanoacrylate compounds are hydrophilic. But they, like the currently available cyanoacrylates, do generate a pretty intense inflammatory response. If it’s a version that isn’t broken down by the body in some way, it can turn out as bad as, if not worse than, a suture granuloma in terms of producing pain and irritation.”
Phillip Shadduck, MD, of Regional Surgical Associates in Durham, N.C., said in an interview after Dr. Petter-Puchner’s presentation that while a strong inflammatory response was seen in the study, newer cyanoacrylates might not evoke the same reaction. “We’ve learned in the abdomen, and now in the abdominal wall, that the chemistry of the cyanoacrylates makes a big difference in the inflammatory response it activates,” he said. “There are newer cyanoacrylates coming out in an effort to elicit less of an inflammatory response.”
One such cyanoacrylate, designed to be biodegradable, was approved for use in Europe in February 2005 as an adjunct to sutures during peripheral vascular reconstructions. The product, Omnex, is made by Closure Medical Corporation in Raleigh, N.C., which was recently acquired by Johnson & Johnson. (Dr. Shadduck reported that he has done consulting on the Omnex product.)
In March at the annual meeting of the Society for Clinical Vascular Surgery, results from a trial of 150 patients at 15 centers in the United States and Europe showed significant benefits for Omnex as an adjunctive sealant for vascular anastomoses compared with Surgicel Nu-Knit Absorbable Hemostat (Johnson & Johnson). The study found a statistically significant difference in time to hemostasis between the sealant, with a mean of 119.3 seconds, compared with Surgicel, with a mean of 403.8 seconds (P<0.001). Among patients in the Omnex group, 54.5% had immediate hemostasis, compared with only 10% in the Surgicel group (P<0.001). No significant difference in incidence of adverse events occurred between the two groups (P=0.60).
Using a compound similar to the one approved for external use in the United States under the trade name Dermabond, Omnex is under consideration by the FDA for internal use during vascular surgery.
Whether Omnex would have the kind of detrimental effects in hernia repair that were seen in Dr. Petter-Puchner’s study of Glubran 2 is unclear, but the chief of minimally invasive surgery at the department of surgery, Keck School of Medicine of USC, Los Angeles, said he would be “wary” of such a use.
“The artificial glues, or glues that have any artificial nature, stay around in the body and create a foreign body reaction,” said Namir Katkhouda, MD, who published the first study using a fibrin sealant, Tisseel, for mesh fixation in hernia repair (Ann Surg2001;233:18-25). “Some people have spun around the concept of using sealants in mesh fixation to these other adhesives [with artificial components]. I am absolutely wary of them. The important difference between the fibrin sealants and any artificial sealant is that the fibrin is naturally removed by the body at 10 days. That’s what you want.”
Tisseel, made by Baxter (Irvine, Calif.), is widely used in Europe for mesh fixation, but is currently approved in the United States only for cardiopulmonary bypass surgery, splenic repair and colostomy closure. A spokesman for Baxter said the company has a “strong desire” to broaden the indications for Tisseel in the United States.
In his award-winning paper, Dr. Petter-Puchner presented data on 20 Sprague Dawley rats, in which two defects per animal were created in the abdominal wall left and right of the linea alba (1.5 cm in diameter), with the peritoneum was spared. The lesions were left untreated for 10 days to achieve a chronic condition and then were covered with 2 cm×2 cm of mesh sealed with Glubran 2. Four of the animals were sacrificed after 17 days, eight after four weeks and another eight after 12 weeks. The meshes were then biomechanically tested and histology was performed.
At the 12-week mark, the hook-pull test revealed a loss of mesh adhesion wherever the sealant had been used. “There was no tissue integration through the mesh and histology revealed strong inflammation,” Dr. Petter-Puchner said during his presentation. “We also saw a huge seroma formation.”
Using a suction cone to test the elasticity of the tissue, his group found 4.2 mm of deformation in untreated areas, but just one-tenth that much in areas where Glubran had been applied, demonstrating a loss of flexibility.
New Published Study Finds the Cost of Blood Transfusions is Significantly Under-Estimated, Establishes True Cost at $522 to $1,183 Per Unit
IRVINE, Calif., April 5 /PRNewswire-FirstCall/ -- A new blood transfusion cost analysis study published in the April 2010issue of Transfusion, a peer-reviewed academic journal, shows that when all of the complex cost factors leading up to and after a red blood cell (RBC) transfusion are considered, the actual cost of blood is substantially higher than previously estimated. With actual blood transfusion costs ranging between $522 and $1,183 per-unit—37% higher than estimated by prior studies, which did not include all associated costs—the new study calculates that the true cost of blood is 3.2 to 4.8-fold higher than reported blood product acquisition costs.(1)
"Representing the most detailed and rigorous method utilized to date to account for the cost of blood transfusions," studyfindings confirm that annual expenditures on blood and transfusion-related activities for surgical patients are significant resource drains—costing between $1.6 to $6.0 million per hospital surveyed.
In the study, researchers from the Society for the Advancement of Blood Management (SABM) and the Medical Society for Blood Management (MSBM) prospectively analyzed 20,104 surgical patients who had their blood typed and screened in preparation for a blood transfusion at two U.S. and two European hospitals. After precisely mapping all diagnostic, therapeutic, technical, laboratory, logistic, administrative, informational, educational, and quality activities involved in the transfusion of blood in real-world surgical settings, researchers constructed an activity-based cost model capturing all the actual direct and indirect costs of acquiring, delivering, administering, and monitoring RBC transfusions from the hospital perspective—yielding "for the first time a dollar amount for the cost per unit of blood that reflects the complexities of real-world blood utilization."
Study findings also showed that "total annual blood costs are largely driven by transfusion rate," which includes factors such as the proportion of surgical patients transfused and the number of RBC units per patient transfused, and provide a unique understanding of both cost drivers and the opportunities for cost containment. According to researchers, "reducing either or both factors has the potential to reduce costs dramatically."
Most importantly, the study's activity-based cost model provides a "roadmap for institutional administrators worldwide to evaluate hospital processes and the impetus to initiate programs to reduce and optimize blood usage," says lead researcher and the President-elect of SABM, Aryeh Shander, M.D., who is also the Executive Medical Director for The Institute for Patient Blood Management & Bloodless Medicine and Surgery at Englewood Hospital and Medical Center inEnglewood, New Jersey. Dr. Shander believes that this study spotlights the incredibly complex resource and cost drains associated with real-world blood transfusions, offering hospitals and healthcare providers an important cost saving insight that "improved blood testing techniques and blood conservation strategies provide unique opportunities to significantly reduce the number of unnecessary blood transfusions and the quantity of units administered—delivering better cost containment and patient benefits."
While multiple studies have shown that blood transfusions increase morbidity and mortality, the present study did not attempt to evaluate the morbidity-associated costs of blood transfusions. Thus, the cost estimate presented in this study may still underestimate the cost of giving blood transfusions.
Masimo Rainbow SET Pulse CO-Oximetry—a breakthrough noninvasive blood constituent monitoring platform measuring multiple blood constituents that previously required invasive procedures, including: total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, acoustic respiration rate (RRa™), oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI). Masimo SpHb, PVI, and SpO2 have been shown in multiple clinical studies to provide accurate, reliable, real-time measurements that help clinicians to proactively monitor and manage hemoglobin, fluid, and oxygen saturation levels more appropriately and conservatively.
Insurance Company offers screened blood
ALC Health has signed an agreement with the Blood Care Foundation (BCF) to provide clients with screened blood, in the event of a medical emergency, from a network of blood banks around the world.
The service will be added as a new free benefit to all of the company's policies, including travel insurance, from 1 June 2010. ALC Health will be the only international medical provider offering the service across all of its policy products.
Andrew Apps, director at ALC Health commented:"The increase in incidences of people being given infected blood meant that many of our members were requesting a service of this type. We are delighted to be working with the BCF and now, at no extra cost to our customers, they can be assured that in the event of requiring a blood transfusion the blood will be available within a short space of time and will have been fully screened."
The BCF is a Sussex based charity that has been established since 1991 to provide a solution to the problems of sourcing and supplying screened blood in the case of emergencies. The BCF has built up a network of blood banks to overcome the demand where blood is in short supply, or the local blood does not meet US, UK and EU standards. All blood supplied by BCF is drawn from internationally recognised blood centres, which meet the highest international standard. BCF also supplies immunoglobulin and vaccine for the treatment of rabies.
The service will be added as a new free benefit to all of the company's policies, including travel insurance, from 1 June 2010. ALC Health will be the only international medical provider offering the service across all of its policy products.
Andrew Apps, director at ALC Health commented:"The increase in incidences of people being given infected blood meant that many of our members were requesting a service of this type. We are delighted to be working with the BCF and now, at no extra cost to our customers, they can be assured that in the event of requiring a blood transfusion the blood will be available within a short space of time and will have been fully screened."
The BCF is a Sussex based charity that has been established since 1991 to provide a solution to the problems of sourcing and supplying screened blood in the case of emergencies. The BCF has built up a network of blood banks to overcome the demand where blood is in short supply, or the local blood does not meet US, UK and EU standards. All blood supplied by BCF is drawn from internationally recognised blood centres, which meet the highest international standard. BCF also supplies immunoglobulin and vaccine for the treatment of rabies.
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