OITA (Kyodo) A 61-year-old man filed a suit Friday seeking state relief and damages for being infected with hepatitis C from tainted blood products, which are not covered under a 2008 law on blanket relief for people with the infectious disease.
The plaintiff lodged the suit with the Oita District Court seeking the law to be applied to him and ¥2 million in damages.
In Tokyo, the Health, Labor and Welfare Ministry said this was the first lawsuit filed by a patient with hepatitis C who was given tainted blood products not covered by the relief law.
According to the suit, the man underwent heart surgery at Kurume University Hospital in Kurume, Fukuoka Prefecture, in 1976, and was administered the blood products globulin and albumin.
He developed symptoms of acute hepatitis, including jaundice, two weeks later. He was confirmed to be infected with hepatitis C, according to the legal document.
The plaintiff was found suffering from cirrhosis of the liver in 2007 and was confirmed in 2010 to have developed liver cancer, the document says.
The plaintiff's counsel said there were no other chances for the plaintiff to have contracted hepatitis C except when he was administered the blood products.
The relief law, which was enacted in January 2008, offers blanket relief to people with hepatitis C caused by tainted blood products such as fibrinogen. Globulin and albumin are not covered by the law.
Under the law, people who contracted hepatitis C from contaminated blood products such as fibrinogen will receive compensation ranging from ¥12 to ¥40 million per person depending on the severity of the case.
Hepatitis C is a liver disease mainly transmitted by blood.
Saturday, July 31, 2010
CryoLife Q2 Edited -Biofoam rollout on-track, Medafor sold Hemostase with improper packaging and IFU
Ashley Lee
Product revenues which consist primarily of BioGlue and HemoStase increased 2% and 5% in the second quarter and first half of 2010 compared to the corresponding periods in 2009. The increases year-over-year primarily reflects the growing usage of HemoStase in cardiac and vascular surgical indications in the US and cardiac, vascular and general surgery indications in many markets outside of the US.
Total preservation services and product gross margins were 61% for the second quarter of 2010 compared to 63% for the second quarter of 2009, and 60% in the first half of 2010, compared to 64% in the first half of 2009. Preservation services gross margins for the second quarter of 2010 were 40% compared to 43% in the
second quarter of ’09, and 40% in the first half of 2010, compared to 44% in the first half of 2009.
Product gross margins for the second quarter of 2010 were 82% compared to 84% in the corresponding period in 2009, and 82% in the first half of 2010, compared to 84% in the first half of 2009.
General, administrative and marketing expenses for the second quarter of 2010 were $11.7 million compared to $12.3 million for the second quarter of 2009. These expenses for the second quarter of 2010 included approximately $420,000 in cost related to our litigation to our litigation with Medafor.
General, administrative and marketing expenses for the first half of 2010 were $25.5 million compared to $25.1 million in the first half of 2009. The first half of 2010 included a charge of $729,000 related to the write-off of capitalized legal
expenses associated with our BioGlue intellectual property rights in Germany, and approximately $834,000 in cost related to our litigation with Medafor.
Steve Anderson
In late June, Medafor filled most of an approximately $2.5 million order for HemoStase, the hemostatic agents that we distribute for them. We were surprised that this order was filled since they had refused to fill three previous orders, totaling approximately $1.8 million that we had placed in March and April of this year.
As a result of Medafor not shipping the March and April orders, we were enable to fill some requests for the 1 gram size product. We believe this adversely affected our quarter two HemoStase revenues over what we believe they would have been along with the confusion in the marketplace caused by Medafor’s announcement that it was terminating the agreement and what we believe are continued sales by Medafor into our exclusive field. We expect to pursue reimbursement of our damages from those lost sales in our lawsuit against Medafor.
Another thing that we found disturbing about Medafor’s order filling process is that we believe a portion of the product they delivered to us in late June did not meet our incoming acceptance standard. We do not believe this portion of their shipment had the proper instructions for use in the baggage or the correct information on the printed boxes. These discrepancies affected the 5 gram product. This is the second instance of this type of issue.
We placed another order for approximately $1.3 million of HemoStase with Medafor on July 9th. They have begun to fill this order, but have informed us that they will not fill all of it on a timely basis. They have also informed us that they will not fill all of our June purchase order on a timely basis.
These issues with Medafor make working with them increasingly difficult and working with these folks is increasingly becoming similar to trying to work with Larry, Moe and Curly. Despite the difficulty of dealing with Medafor’s management, however, we continue to have faith in the HemoStase product.
During the second quarter, our European perspective multicenter single arm study for BioFoam was completed. A total of 55 patients from three countries were enrolled in this study. There were 15 enrolled in the UK, 15 in France, and 25 in Germany. The focus of the study was to determine the effectiveness of BioFoam in sealing liver resections.
Data analysis of the primary endpoint show the achievement of hemostasis within three minutes in 92% of the application sites. BioFoam’s mean hemostatic time compares favorably to those reported for comparative products. The final report should be completed in the third quarter and will be used to supplement in application for approval in Canada. Since product launch, there have been approximately a 130 cases of BioFoam in the clinical setting.
We continue to move forward on our approval IDE for BioFoam used in the sealing of liver parenchyma. Upon receipt of final approval from the United States Department of Defense, we expect to start patient enrollment into the study mid third quarter of this year.
The approved IDE is for a prospective multicenter randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
Upon successful completion of the feasibility study, a follow on prospective multicenter randomized controlled pivotal study will be conducted. It is currently projected that the pivotal investigation will enroll a total of a 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites.
We expect tissue processing revenues to increase between mid-single and low-double digits on a percentage basis in 2010 compared to 2009, BioGlue revenues to increase by low single digits on a percentage basis, and HemoStase revenues to increase more than tissue or BioGlue revenues on a percentage basis.
Matt Dolan – Roth Capital Partners
Maybe a couple of question on the guidance, and the changes we saw there, just to be clear. So on the revenue line, Ashley, can you just walk us through why the top end is coming down? Is that specifically related to HemoStase or something more in the base CryoLife book of business?
Ashley Lee
There are a couple of things of note there. A good portion of the top line – at least the top end of the range coming down relates to grant revenue associated with the BioFoam IDE a little delayed in getting that started. And it looks like that we will in fact begin enrollment in that trial during the third quarter. So, again, as you recall too, those revenue – any revenues that we record there, there are some corresponding expenses. So any reduction in revenue for BioFoam is really neutral to the bottom line of the guidance there.
The other thing is as we mentioned a little bit earlier, the HemoStase revenues were adversely affected in the second quarter of this year, due to the variety of issues that we previously mentioned. As we moved into the third quarter, it looks like things are starting to normalize, again for the HemoStase revenue. So there’s a little bit of an effect there. And, BioGlue, saw a trialing of a new product in the Northeast called ProGel. We don't think the product works as well as BioGlue. However, we did see some trial and errors, so we’re bringing it down a little bit for that.
Matt Dolan – Roth Capital Partners
So you're talking about close to $1 million in litigation in the second half of the year?
Ashley Lee
Yes, and that’s roughly what we spent in the first half of the year.
Matt Dolan – Roth Capital Partners
Okay. And then just two more. So, on the Medafor situation, I mean, what sort of timeframe do you feel like you can find some type of appropriate substitute or replacement for HemoStase? At this point, obviously the relationship doesn't sound like it's overly healthy.
Ashley Lee
We’ve stated in the past that we would prefer to remain in the agreement and continue to distribute HemoStase. We just want to move forward with the agreement. With that being said, we continued to look at a business development opportunities in a wide variety of areas and we are not going to get specific on any of our business development activities. And then when if there is an announcement to make in that area, then we’ll announce it.
Raymond Myers – The Benchmark Company
Okay, great. And my next area of questions is regarding the HemoStase. Given though the lack of cooperation from Medafor that you received to date and particularly recently with them not sending the correct product and packaging, do you think that under the current circumstances you will be able to grow your HemoStase sales in the second half of this year or is it permanently impaired?
Steve Anderson
I don’t think it’s permanently impaired. I think it has a lot to do with their ability to get their product packaged on a routine basis, they do that with contract packaging firms, they don’t do it themselves. And I think it’s a matter of their coordinating those processes better in their company.
I know that they have enough powder in storage to significantly increase their production. But I – from a far, I guess it has to do more with getting that raw material to the people that package their product for them and get the throughput coming out on a more regular basis.
Raymond Myers – The Benchmark Company
Do you have the supply currently to supply all the different sizes that you require?
Ashley Lee
We do.
Raymond Myers – The Benchmark Company
Okay. So there's no impediment in that regard currently?
Ashley Lee
Currently, there is not.
Tuesday, July 27, 2010
FDA Approves Orthovita's New Collagen Facility
Orthovita, Inc. (NASDAQ: VITA | PowerRating), an orthobiologics and biosurgery company, reported today that the U.S. Food and Drug Administration (FDA) approved Orthovita's PMA supplement for a new collagen processing facility in Malvern, Pennsylvania. Orthovita will use the new facility to process the highly purified form of collagen used in its VITAGEL(TM) Surgical Hemostat product. VITAGEL is a composite liquid hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. VITAGEL is combined with the patient's own plasma immediately prior to application to a bleeding site. A fibrin/collagen clot forms quickly to control bleeding and provide a three-dimensional matrix to facilitate healing.
The approval of the new facility not only gives Orthovita enhanced control over the supply and quality of a key raw material for its VITAGEL product, but also provides the Company with an opportunity to develop, manufacture and market additional collagen-based products. This technology processes collagen to retain crucial aspects of its natural molecular structure and the potent biological characteristics found in the collagen of living tissues. As a result, the collagen processed at the facility will be among the purest available on the market.
Orthovita's President and Chief Executive Officer Antony Koblish stated, "We are very pleased to have further solidified our supply control over our VITAGEL product. The regulatory approval of our collagen facility also gives us another resource for executing on our goal to broaden our product offerings and increase sales force leverage. We are actively engaged in research and development work for products based on the versatile properties of the ultra pure collagen that can be made at our FDA-approved facility. We are also pursuing outside partnering and co-development arrangements to utilize our collagen facility and technical know-how."
The approval of the new facility not only gives Orthovita enhanced control over the supply and quality of a key raw material for its VITAGEL product, but also provides the Company with an opportunity to develop, manufacture and market additional collagen-based products. This technology processes collagen to retain crucial aspects of its natural molecular structure and the potent biological characteristics found in the collagen of living tissues. As a result, the collagen processed at the facility will be among the purest available on the market.
Orthovita's President and Chief Executive Officer Antony Koblish stated, "We are very pleased to have further solidified our supply control over our VITAGEL product. The regulatory approval of our collagen facility also gives us another resource for executing on our goal to broaden our product offerings and increase sales force leverage. We are actively engaged in research and development work for products based on the versatile properties of the ultra pure collagen that can be made at our FDA-approved facility. We are also pursuing outside partnering and co-development arrangements to utilize our collagen facility and technical know-how."
Cardiva Medical, Inc. Announces U.S. Distribution for Hemostasis Products
SUNNYVALE, Calif., July 26 — /PRNewswire/ -- Cardiva Medical, Inc. announced today that it has signed an agreement with Advanced Vascular Dynamics to distribute several products used for postcatheterization femoral and radial artery hemostasis in the U.S. These products include i) RadAR™, an innovative radial artery compression device, ii) ComfortPress™, an ergonomic hand-held manual compression assist device, iii) ExpressAR™, an external mobile compression device and iv) Celox Vascular™, a chitosan based hemostatic patch.
"We are delighted to offer these unique products to our customers in the US," said John McCurdy, Vice President of Sales. McCurdy continued, "The products complement our Catalyst femoral artery closure system and will enable our customers to take advantage of economical alternatives for femoral and radial artery closure." RadAR, ComfortPress, ExpressAR and Celox Vascular are used in cardiac catheterization labs, interventional radiology departments and intensive care units. "This helps us extend our product lines to more customers and enhance our level of onsite customer service. We are very pleased to work with Cardiva," said Matthew Semler, President of Advanced Vascular Dynamics.
"We are delighted to offer these unique products to our customers in the US," said John McCurdy, Vice President of Sales. McCurdy continued, "The products complement our Catalyst femoral artery closure system and will enable our customers to take advantage of economical alternatives for femoral and radial artery closure." RadAR, ComfortPress, ExpressAR and Celox Vascular are used in cardiac catheterization labs, interventional radiology departments and intensive care units. "This helps us extend our product lines to more customers and enhance our level of onsite customer service. We are very pleased to work with Cardiva," said Matthew Semler, President of Advanced Vascular Dynamics.
Thursday, July 22, 2010
EU Pricing Pressure Sure To Impact Hemostasis Market
"European governments grappling to reduce large budget deficits are focusing their cost-cutting on a large spending item - pharmaceuticals," The Wall Street Journal reports. "Several countries in recent weeks, including Spain, Germany and Italy, have proposed or enacted reductions in what they will pay or taken other cost-control measures for various drugs. ... In Europe, state healthcare systems pay for the bulk of drug purchases. European governments have long been known for their frugality when negotiating prices with drug companies, but the latest cuts are more severe than usual. Europe is the second largest market after the U.S. for many drug companies."The European Federation of Pharmaceutical Industries and Associations, the industry's main lobbying body in Europe, is warning of the economic consequences. In a statement, the group said the cuts would "sharply diminish revenues to manufacturers...with an impact on their R&D investments. This in turn will impact European economic recovery and employment"
The dollar's climbing value threatens to pressure sales in coming quarters for U.S. medical-device and drug makers that are big exporters to Europe.
The greenback's rise--it's up about 15% against the euro this year--compounds worries already brewing that cash-strapped European governments, pressured by a debt crisis on the continent, will cut back on health-care spending.
The greenback's rise--it's up about 15% against the euro this year--compounds worries already brewing that cash-strapped European governments, pressured by a debt crisis on the continent, will cut back on health-care spending.
For device companies, Piper Jaffray analyst Matt Miksic called the currency impact "manageable for most" because of hedging plans. He sees a 1% to 2% earnings impact this year.
The currency effects can be very complex. Many companies routinely give sales estimates that exclude the currency impact so that the business' performance isn't shrouded. Also, they typically employ a mix of natural and financial hedges to protect earnings, even if sales take a big hit.
Natural hedges can include overseas manufacturing capacity, which can put the cost of production in the same currency as sales. For big multinational companies doing business around the globe, currency values in different countries can sometimes have an offsetting effect. Then there are foreign- exchange contracts companies can enter to manage risk.
But the dollar's strength still adds strain. JPMorgan noted a trend over the past decade of device stocks performing better than the broader market when currency rates add to sales, but worse when currency is a negative factor. "In short, MedTech stocks seldom outperform in the face of an FX headwind," analyst Michael Weinstein said.
Some of the dollar's gains have come since companies reported first-quarter results in April; however, device-maker Medtronic's recent report offered some fresh perspective. The company, which posted sales of $15.8 billion for its year ended April 30, said exchange rates at Monday's level would dent sales by $400 million to $500 million in the new fiscal year.
But the company also said its hedging strategy should mostly shield earnings.
The backdrop to currency concerns is the threat European sales also will decline because of government spending cuts. But some big companies have downplayed this risk.
This is "spooking investors," Abbott Laboratories (ABT) Chief Executive Miles White said at a recent conference. He explained that Abbott factored pressure in Europe into its 2010 financial forecasts and that he doesn't plan to change them directly due to European woes.
The currency effects can be very complex. Many companies routinely give sales estimates that exclude the currency impact so that the business' performance isn't shrouded. Also, they typically employ a mix of natural and financial hedges to protect earnings, even if sales take a big hit.
Natural hedges can include overseas manufacturing capacity, which can put the cost of production in the same currency as sales. For big multinational companies doing business around the globe, currency values in different countries can sometimes have an offsetting effect. Then there are foreign- exchange contracts companies can enter to manage risk.
But the dollar's strength still adds strain. JPMorgan noted a trend over the past decade of device stocks performing better than the broader market when currency rates add to sales, but worse when currency is a negative factor. "In short, MedTech stocks seldom outperform in the face of an FX headwind," analyst Michael Weinstein said.
Some of the dollar's gains have come since companies reported first-quarter results in April; however, device-maker Medtronic's recent report offered some fresh perspective. The company, which posted sales of $15.8 billion for its year ended April 30, said exchange rates at Monday's level would dent sales by $400 million to $500 million in the new fiscal year.
But the company also said its hedging strategy should mostly shield earnings.
The backdrop to currency concerns is the threat European sales also will decline because of government spending cuts. But some big companies have downplayed this risk.
This is "spooking investors," Abbott Laboratories (ABT) Chief Executive Miles White said at a recent conference. He explained that Abbott factored pressure in Europe into its 2010 financial forecasts and that he doesn't plan to change them directly due to European woes.
Baxter's Profit Drops 8.9%
Baxter International Inc.'s second-quarter earnings fell 8.9%, including a charge, as it faced macroeconomic headwinds and individual product issues. The Deerfield, Ill., based maker of products for conditions such as hemophilia and kidney failure, tightened its 2010 earnings guidance and backed sales expectations, but warned that issues in key markets will continue. "Clearly 2010 has been a challenging year," said Robert Parkinson, Baxter's chairman and chief executive, noting pressure from U.S. health-care reform, economic pressures, and softness in its plasma protein-based business.
Notably, Mr. Parkinson said the company continues to operate "through a transition period in the plasma proteins environment."
The slowdown in the plasma-based business has been a source of uncertainty for investors, as it is a key component in Baxter's largest business unit. For the remainder of the year, Mr. Parkinson projected plasma protein sales to decline in the mid-single digits, and antibody therapy sales to decline about 10%.
In its last earnings call in April, Baxter cut its 2010 outlook and said there was a surprising slowdown for plasma-based medical products.
Mr. Parkinson said that Baxter has implemented some new commercial strategies to counteract market share loss in sales of a plasma-based drug called Gammagard. He said that there are "some early positive signs" that the company's share position, and the U.S. market as a whole, are stabilizing.
Looking ahead, the company narrowed its 2010 adjusted earnings guidance to $3.93 to $3.98 a share, from a previous view of $3.92 to $4.00 a share. It projects sales growth of 1% to 3%, which amounts to $12.7 billion to $12.9 billion.
Baxter also forecast third-quarter earnings of 96 cents to 99 cents a share on revenue growth of 1% to 3%.
Earnings for the three months ended June 30 dropped 9% to $535 million, or 90 cents a share. The company recorded a $22 million write-down related to an expected settlement with the Greek government. Excluding items, the company earned 93 cents a share.
Sales in the period rose 2.3% to $3.2 billion, with the change primarily coming from the effects of currency exchange.
The company's biggest business unit, bioscience, reported a 4% revenue drop to $1.4 billion, mostly because of increased Medicaid rebates required by the U.S. health-care overhaul in the spring, as well as lower revenue derived from antibody therapies, vaccines, and some international hemophilia products.
Sales in the medication delivery unit rose 9% to $1.2 billion, helped by its intravenous and injectable therapies, along with sales of the Sigma Spectrum infusion pump.
The company is in the process of recalling about 200,000 Colleague brand drug-infusion pumps in the U.S. while offering customers either refunds or replacement devices over the next two years.
Problems with the pumps, typically found bedside at hospitals where they deliver intravenous fluid and drugs, have been a long-running issue for Baxter amid problems linked to reports of patient injuries and deaths.
Baxter is offering Spectrum brand pumps from a private company called Sigma International, in which Baxter has a 40% ownership stake. On Thursday, it said it continues to work with Sigma to increase manufacturing capacity to meet expected demand.
The ability to meet demand is key, as the company faces competition from rival pump makers CareFusion Corp. and Hospira Inc.
Mr. Parkinson said it is too early to tell how the company's market share for the products will change, but it will have a better view by the end of the year.
Baxter's renal unit, which includes products for managing advanced kidney failure, saw sales rise 6% to $585 million.
In the quarter, the company repurchased 15.2 million shares for about $677 million.
The slowdown in the plasma-based business has been a source of uncertainty for investors, as it is a key component in Baxter's largest business unit. For the remainder of the year, Mr. Parkinson projected plasma protein sales to decline in the mid-single digits, and antibody therapy sales to decline about 10%.
In its last earnings call in April, Baxter cut its 2010 outlook and said there was a surprising slowdown for plasma-based medical products.
Mr. Parkinson said that Baxter has implemented some new commercial strategies to counteract market share loss in sales of a plasma-based drug called Gammagard. He said that there are "some early positive signs" that the company's share position, and the U.S. market as a whole, are stabilizing.
Looking ahead, the company narrowed its 2010 adjusted earnings guidance to $3.93 to $3.98 a share, from a previous view of $3.92 to $4.00 a share. It projects sales growth of 1% to 3%, which amounts to $12.7 billion to $12.9 billion.
Baxter also forecast third-quarter earnings of 96 cents to 99 cents a share on revenue growth of 1% to 3%.
Earnings for the three months ended June 30 dropped 9% to $535 million, or 90 cents a share. The company recorded a $22 million write-down related to an expected settlement with the Greek government. Excluding items, the company earned 93 cents a share.
Sales in the period rose 2.3% to $3.2 billion, with the change primarily coming from the effects of currency exchange.
The company's biggest business unit, bioscience, reported a 4% revenue drop to $1.4 billion, mostly because of increased Medicaid rebates required by the U.S. health-care overhaul in the spring, as well as lower revenue derived from antibody therapies, vaccines, and some international hemophilia products.
Sales in the medication delivery unit rose 9% to $1.2 billion, helped by its intravenous and injectable therapies, along with sales of the Sigma Spectrum infusion pump.
The company is in the process of recalling about 200,000 Colleague brand drug-infusion pumps in the U.S. while offering customers either refunds or replacement devices over the next two years.
Problems with the pumps, typically found bedside at hospitals where they deliver intravenous fluid and drugs, have been a long-running issue for Baxter amid problems linked to reports of patient injuries and deaths.
Baxter is offering Spectrum brand pumps from a private company called Sigma International, in which Baxter has a 40% ownership stake. On Thursday, it said it continues to work with Sigma to increase manufacturing capacity to meet expected demand.
The ability to meet demand is key, as the company faces competition from rival pump makers CareFusion Corp. and Hospira Inc.
Mr. Parkinson said it is too early to tell how the company's market share for the products will change, but it will have a better view by the end of the year.
Baxter's renal unit, which includes products for managing advanced kidney failure, saw sales rise 6% to $585 million.
In the quarter, the company repurchased 15.2 million shares for about $677 million.
Use Your Own Blood In Transfusions During Emergency Operations
A new report in the July issue of Archives of Surgery, now provide information that a person using their own blood during transfusions is possibly now cost effective.
Trauma injuries is the leading cause of death in persons between the ages of one and forty four, a major player in this cause is major blood loss this is obtained from the background facts in the report. This seems to hold especially accurate in deaths which happen in the operating room or twenty four hours after the trauma had occurred. Patients that go into shock due to hemorrhaging need a transfusion, usually with packed red blood cells and plasma. Any transfusion of blood from another person (allogeneic) is linked to an array of problems which include having a reaction to the transfusion, infectious diseases being transmitted and being susceptible to antigens according to researchers. Additionally, transfusions of allogeneic blood products in trauma patients have solely been linked to heightened morbidity and mortality, specifically when using blood that has been stored awhile.
Dr. Carlos V. R. Brown, of the University Medical Center Brackenridge, Austin, Texas, and associates had examined forty seven adult trauma patients that had undergone an emergency operation and had been given intraoperative cell salvage, a method in which shed blood is gathered and prepared in order for red blood cells to be transfused back into the patient in 2006 or 2007. In everyone of these patients the researchers had chosen a corresponding patient who was the same age, sex, same system and identical severity of injury and had the same operation but did not have savage cells.
Patients that were in the savage cell group displayed an average intraoperative blood loss of 1,795 milliliters, and averaged a return of 819 milliliters of their own blood. They also had been given less intraoperative and total units of allogeneic packed red blood cells the associated group (two vs four units in surgery and four vs 8 in total units) and also had received less total units of plasma.
The amount from blood product transfusion which includes the complete cost of cell salvage, was lower in the group who had receive this particular procedure ($1,1616 vs. $2,584). The groups had alike of duration of stay in the intensive care unit (eight days for both) and in the hospital (18 for salvage group and 20 in comparison group), there was no dissimilarity in death ratios (6 in the salvage group and 10 in comparison group).
In closing, this current cohort study adjoins with the already present literature in reference concerning the benefit of outcomes in intraoperative cell salvage andautolgous transfusion in patients of trauma who undergo emergency surgical mediation according to the researchers writings in this study. They furthermore state that further studies are warranted to positively substantiate the safety of transfusing contaminated blood to per-operative determined patients that would get the greater advantages from autologous transfusion and also to maximize cost effectiveness. Meanwhile the centers that have avenues to a cell salvage program should frequently use autologous transfusion as a role in their intraoperative resuscitation. Most critically, centers that do not use intraoperative cell salvage and autotransfusion should establish and take away blockades to putting in use this life saving technique.
Trauma injuries is the leading cause of death in persons between the ages of one and forty four, a major player in this cause is major blood loss this is obtained from the background facts in the report. This seems to hold especially accurate in deaths which happen in the operating room or twenty four hours after the trauma had occurred. Patients that go into shock due to hemorrhaging need a transfusion, usually with packed red blood cells and plasma. Any transfusion of blood from another person (allogeneic) is linked to an array of problems which include having a reaction to the transfusion, infectious diseases being transmitted and being susceptible to antigens according to researchers. Additionally, transfusions of allogeneic blood products in trauma patients have solely been linked to heightened morbidity and mortality, specifically when using blood that has been stored awhile.
Dr. Carlos V. R. Brown, of the University Medical Center Brackenridge, Austin, Texas, and associates had examined forty seven adult trauma patients that had undergone an emergency operation and had been given intraoperative cell salvage, a method in which shed blood is gathered and prepared in order for red blood cells to be transfused back into the patient in 2006 or 2007. In everyone of these patients the researchers had chosen a corresponding patient who was the same age, sex, same system and identical severity of injury and had the same operation but did not have savage cells.
Patients that were in the savage cell group displayed an average intraoperative blood loss of 1,795 milliliters, and averaged a return of 819 milliliters of their own blood. They also had been given less intraoperative and total units of allogeneic packed red blood cells the associated group (two vs four units in surgery and four vs 8 in total units) and also had received less total units of plasma.
The amount from blood product transfusion which includes the complete cost of cell salvage, was lower in the group who had receive this particular procedure ($1,1616 vs. $2,584). The groups had alike of duration of stay in the intensive care unit (eight days for both) and in the hospital (18 for salvage group and 20 in comparison group), there was no dissimilarity in death ratios (6 in the salvage group and 10 in comparison group).
In closing, this current cohort study adjoins with the already present literature in reference concerning the benefit of outcomes in intraoperative cell salvage andautolgous transfusion in patients of trauma who undergo emergency surgical mediation according to the researchers writings in this study. They furthermore state that further studies are warranted to positively substantiate the safety of transfusing contaminated blood to per-operative determined patients that would get the greater advantages from autologous transfusion and also to maximize cost effectiveness. Meanwhile the centers that have avenues to a cell salvage program should frequently use autologous transfusion as a role in their intraoperative resuscitation. Most critically, centers that do not use intraoperative cell salvage and autotransfusion should establish and take away blockades to putting in use this life saving technique.
Wednesday, July 21, 2010
Johnson & Johnson Q2 2010 with commentary on EU Pricing Impact
Ethicon worldwide sales grew operationally by 8.2% with the U.S. up over 12.65%, and sales outside the U.S. up 5% operationally. Growth was driven by sutures, biosurgicals and Mentor products. Additionally, the acquisitions of Acclarent this year, contributed to the growth in the quarter. Ethicon Endo-Surgery achieved operational growth of 6.6% in the second quarter of 2010, with the U.S. sales growing 3.7% and sales outside the U.S. up with an operational basis by 8.8%. Growth was driven by of the Advanced Sterilization, Endo and HARMONIC products.
Frederick Wise – Leerink Swann LLC
OK, thank you. Next, Dominic, obviously, you're talking about the increased EU price pressures. Maybe I missed it, but during the Medical Device Day in early June, it seemed like you all hadn't seen it yet. Can you give us a little more color on what you're seeing, how you're seeing it? And obviously you're talking about the sort of an accelerating impact for the rest of this year, is this something we should be concerned about accelerating further into 2011 and beyond?
Dominic Caruso
Right, Rick. That's a great question. So, let me just be clear on the EU pricing pressure that we're seeing. They're much more significant in the Pharmaceutical business than they are in the Medical Device business. If you've been – I'm sure you've been following the various governmental austerity programs that include price reduction; those price reductions are specifically directed towards Pharmaceutical products where those governments have much more of an active role in pricing in those types of products.
With respect to the Medical Device business, that business is characterized quite differently than the Pharmaceutical business. It's characterized by largely a DRG system and largely a tender system. So, we have not yet seen much of an impact at all on pricing and medical devices. We do expect that it may begin to show up later in the year or into next year. But of the estimates that I gave you earlier of approximately $200 million from increased acceleration of pricing pressures in Europe, that is largely in the Pharmaceutical business, not in the Medical Device space.
Frederick Wise – Leerink Swann LLC
OK, thank you. Next, Dominic, obviously, you're talking about the increased EU price pressures. Maybe I missed it, but during the Medical Device Day in early June, it seemed like you all hadn't seen it yet. Can you give us a little more color on what you're seeing, how you're seeing it? And obviously you're talking about the sort of an accelerating impact for the rest of this year, is this something we should be concerned about accelerating further into 2011 and beyond?
Dominic Caruso
Right, Rick. That's a great question. So, let me just be clear on the EU pricing pressure that we're seeing. They're much more significant in the Pharmaceutical business than they are in the Medical Device business. If you've been – I'm sure you've been following the various governmental austerity programs that include price reduction; those price reductions are specifically directed towards Pharmaceutical products where those governments have much more of an active role in pricing in those types of products.
With respect to the Medical Device business, that business is characterized quite differently than the Pharmaceutical business. It's characterized by largely a DRG system and largely a tender system. So, we have not yet seen much of an impact at all on pricing and medical devices. We do expect that it may begin to show up later in the year or into next year. But of the estimates that I gave you earlier of approximately $200 million from increased acceleration of pricing pressures in Europe, that is largely in the Pharmaceutical business, not in the Medical Device space.
Tuesday, July 20, 2010
Warm Ischemia Worsens Partial Nephrectomy Outcomes, Study Finds
Warm ischemia during partial nephrectomy (PN) on a solitary kidney is associated with an increased risk of acute renal failure (ARF) and CKD, according to researchers.
Consequently, they concluded, “PN with no ischemia should be used when technically feasible in patients with solitary kidney.”
R. Houston Thompson, MD, of Mayo Clinic in Rochester, Minn., and collaborators studied 458 patients who underwent open PN (411 patients) or laparoscopic PN (47 patients) for a renal mass in a solitary kidney. The researchers excluded patients treated with cold ischemia. They explained that no ischemia was used if a tumor was sufficiently exophytic or in a position where regional compression could provide sufficient hemostasis during tumor enucleation.
No ischemia was used in 96 patients (21%), whereas 362 patients (79%) had a median of 21 minutes of warm ischemia (achieved with hilar clamping). Compared with the no-ischemia patients, warm ischemia patients had a significant twofold increased risk of ARF and a fourfold increased risk of having a glomerular filtration rate (GFR) below 15 mL/min/1.73 m2 in the post-operative period, the investigators reported in European Urology (published online ahead of print).
In addition, of 297 patients with a preoperative GFR of 30 or higher, those treated with warm ischemia had a significant 2.3 times increased risk of new-onset stage IV CKD during a mean follow-up of 3.3 years.
“We do not submit that clamping should be avoided at all costs but rather support the use of no clamping in select patients with a tumor that is amenable to manual compression,” the researchers noted.
Dr. Thompson's group noted that their study is limited by its retrospective design. In addition, they pointed out that their study had a significant selection bias. Patients managed with no ischemia were likely to have more exophytic and smaller tumors that presented a lower risk of complications.
Consequently, they concluded, “PN with no ischemia should be used when technically feasible in patients with solitary kidney.”
R. Houston Thompson, MD, of Mayo Clinic in Rochester, Minn., and collaborators studied 458 patients who underwent open PN (411 patients) or laparoscopic PN (47 patients) for a renal mass in a solitary kidney. The researchers excluded patients treated with cold ischemia. They explained that no ischemia was used if a tumor was sufficiently exophytic or in a position where regional compression could provide sufficient hemostasis during tumor enucleation.
No ischemia was used in 96 patients (21%), whereas 362 patients (79%) had a median of 21 minutes of warm ischemia (achieved with hilar clamping). Compared with the no-ischemia patients, warm ischemia patients had a significant twofold increased risk of ARF and a fourfold increased risk of having a glomerular filtration rate (GFR) below 15 mL/min/1.73 m2 in the post-operative period, the investigators reported in European Urology (published online ahead of print).
In addition, of 297 patients with a preoperative GFR of 30 or higher, those treated with warm ischemia had a significant 2.3 times increased risk of new-onset stage IV CKD during a mean follow-up of 3.3 years.
“We do not submit that clamping should be avoided at all costs but rather support the use of no clamping in select patients with a tumor that is amenable to manual compression,” the researchers noted.
Dr. Thompson's group noted that their study is limited by its retrospective design. In addition, they pointed out that their study had a significant selection bias. Patients managed with no ischemia were likely to have more exophytic and smaller tumors that presented a lower risk of complications.
Tuesday, July 13, 2010
FDA Warns on Fibrin Sealant Problem
Air embolisms can occur with some gas- or air-pressurized spray devices used for applying fibrin-based bleeding control products when used improperly during surgery, the FDA warned.
At least seven types of fibrin sealant sprayers were associated with air or gas embolisms, which appear to have occurred when pressure settings were too high or the sprayer tip was too close to the bleeding site.
The FDA emphasized that clinicians should follow manufacturers’ recommendations for pressure control settings and the minimum distance for applying the sealants.
“Although rare, the reports describe air embolisms that are life threatening and include one fatality,” the FDA said.
The bureau listed seven product series that have been affected:
EasySpray and spray set used with Duploject system (Baxter Healthcare)Tissomat and spray set used with Duploject system (Baxter Healthcare)Evicel application device (Omrix Medical)FibriJet Aerosol Applicator (MicroMedics)HemaMyst Surgical Applicator System (Haemacure)MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical)Vitagel Hemostat Spray Set (Orthovita)
Label instructions for all fibrin sealants have been rewritten to note the risk of air embolismsassociated with improper sprayer use.
In addition to following the listed recommendations for pressure settings and proper distances for application, clinicians should be sure to monitor patients’ blood pressure, pulse, oxygen saturation, and end-tidal CO2 levels for signs of embolism, the FDA noted.
The sprayers should also be maintained and tested regularly, the bureau said.
At least seven types of fibrin sealant sprayers were associated with air or gas embolisms, which appear to have occurred when pressure settings were too high or the sprayer tip was too close to the bleeding site.
The FDA emphasized that clinicians should follow manufacturers’ recommendations for pressure control settings and the minimum distance for applying the sealants.
“Although rare, the reports describe air embolisms that are life threatening and include one fatality,” the FDA said.
The bureau listed seven product series that have been affected:
EasySpray and spray set used with Duploject system (Baxter Healthcare)Tissomat and spray set used with Duploject system (Baxter Healthcare)Evicel application device (Omrix Medical)FibriJet Aerosol Applicator (MicroMedics)HemaMyst Surgical Applicator System (Haemacure)MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical)Vitagel Hemostat Spray Set (Orthovita)
Label instructions for all fibrin sealants have been rewritten to note the risk of air embolismsassociated with improper sprayer use.
In addition to following the listed recommendations for pressure settings and proper distances for application, clinicians should be sure to monitor patients’ blood pressure, pulse, oxygen saturation, and end-tidal CO2 levels for signs of embolism, the FDA noted.
The sprayers should also be maintained and tested regularly, the bureau said.
Wednesday, July 7, 2010
Department of Defense Funding Shows Continued and Bi-Partisan Support for STB® Lifesaving Technologies' Products
ROCKVILLE, Md., July 7 /PRNewswire/ -- For the third consecutive year the Department of Defense demonstrated its commitment to help save the lives of our troops by providing STB Lifesaving Technologies® with $2.85 million of funding.
The award is to further advance the development of STB®'s Fibrin Adhesive STat (FAST®) dressing, designed to be effective against the full spectrum of blood loss, including severe arterial and venous bleeding. Fifty percent or more combat-related deaths are attributable to uncontrolled hemorrhaging, and with products such as this, thousands of military and civilian lives could be saved.
"We are most appreciative of the support we have continued to receive from the Department of Defense and members of both the Senate and House. This funding is not only invaluable; it serves as a strong statement of their belief in our Fibrin Adhesive STat (FAST®) dressing and their commitment to help us bring our products to the battlefield, emergency responders and operating rooms," said STB® CEO, Richard Moscarello.
Funding for the grant was included in the FY2009 U.S. Department of Defense appropriations bill and received bipartisan support from Senators Richard Burr (R-NC), Ben Cardin (D-MD), Barbara Mikulski (D-MD), Charles Schumer (D-NY) and former Senator Elizabeth Dole (R-NC) and Representatives Bob Etheridge (D-NC), David Price (D-NC) and Chris Van Hollen (D-MD).
"We've all been encouraged by the pre-clinical studies, but it's particularly gratifying that support for our science is backed with significant monetary commitments as well," said STB®'s Moscarello.
About STB®
Founded in 2005, STB Lifesaving Technologies® (STB®) is a privately held, pre-clinical stage, biotechnology development company located in Rockville, Maryland. STB® which stands for "stop the bleeding", is focused on developing a comprehensive suite of products to stop serious and life threatening bleeding in trauma and surgical settings. With a strong proprietary position using its all-natural protein technology with five patents and one provisional patent pending, STB®'s products will be indispensable to both the military and civilian medical markets.
The award is to further advance the development of STB®'s Fibrin Adhesive STat (FAST®) dressing, designed to be effective against the full spectrum of blood loss, including severe arterial and venous bleeding. Fifty percent or more combat-related deaths are attributable to uncontrolled hemorrhaging, and with products such as this, thousands of military and civilian lives could be saved.
"We are most appreciative of the support we have continued to receive from the Department of Defense and members of both the Senate and House. This funding is not only invaluable; it serves as a strong statement of their belief in our Fibrin Adhesive STat (FAST®) dressing and their commitment to help us bring our products to the battlefield, emergency responders and operating rooms," said STB® CEO, Richard Moscarello.
Funding for the grant was included in the FY2009 U.S. Department of Defense appropriations bill and received bipartisan support from Senators Richard Burr (R-NC), Ben Cardin (D-MD), Barbara Mikulski (D-MD), Charles Schumer (D-NY) and former Senator Elizabeth Dole (R-NC) and Representatives Bob Etheridge (D-NC), David Price (D-NC) and Chris Van Hollen (D-MD).
"We've all been encouraged by the pre-clinical studies, but it's particularly gratifying that support for our science is backed with significant monetary commitments as well," said STB®'s Moscarello.
About STB®
Founded in 2005, STB Lifesaving Technologies® (STB®) is a privately held, pre-clinical stage, biotechnology development company located in Rockville, Maryland. STB® which stands for "stop the bleeding", is focused on developing a comprehensive suite of products to stop serious and life threatening bleeding in trauma and surgical settings. With a strong proprietary position using its all-natural protein technology with five patents and one provisional patent pending, STB®'s products will be indispensable to both the military and civilian medical markets.
Ethicon, Inc. Expands Hemostasis Product Portfolio with Approval of the Company's First Synthetic Internal Use Sealant
SOMERVILLE, N.J., July 7, 2010 /PRNewswire via COMTEX/ -- Ethicon, Inc., a worldwide leader in surgical care, announced today the introduction of ETHICON(TM) OMNEX(TM) Surgical Sealant, ETHICON(TM) Biosurgery's first synthetic sealant designed to achieve adjunctive hemostasis (stoppage of bleeding) in vascular reconstructions by mechanically sealing areas of leakage. The US Food and Drug Administration (FDA) recently granted approval of the Premarket Approval Application (PMA) for ETHICON(TM) OMNEX(TM) Surgical Sealant.
ETHICON(TM) OMNEX(TM) creates a strong, flexible physical seal independent of the body's clotting mechanisms. It is proven in an ex-vivo model to be two-to-four times as strong as other surgical sealants, is ready for use in less than 30 seconds, and proven to seal to ePTFE grafts and bond securely to friable vessels.(1)
"A basic rule of patient safety and excellent outcomes is to prevent unnecessary bleeding during and immediately after surgery," said Alan B. Lumsden MD, Medical Director of the Methodist DeBakey Heart & Vascular Center and the Chairman of the Department of Cardiovascular Surgery at The Methodist Hospital in Houston.* "The availability of an effective surgical sealant such as ETHICON(TM) OMNEX(TM) provides surgeons with a valuable new tool that is clinically proven to decrease the time it takes to seal the surgical site, including ePTFE grafts, and prevent leakage from occurring."ETHICON(TM) OMNEX(TM) is clinically proven to significantly decrease time to hemostasis based on clinical trials conducted to support its safety and effectiveness. Specifically, results from a pivotal, randomized, controlled, open-label, multi-center trial of 151 patients at 13 centers in the United States and European Union demonstrated that ETHICON(TM) OMNEX(TM) provided hemostasis three times faster than oxidized regenerated cellulose at a rate of 1.99 minutes vs 6.73 minutes, with 54 percent of the ETHICON(TM) OMNEX(TM) patients receiving immediate hemostasis.(2) There were no significant differences in adverse events compared to oxidized regenerated cellulose during the study time period and 4+ year follow-up analysis.(2)
ETHICON(TM) OMNEX(TM) Surgical Sealant has proven efficacy in a broad spectrum of vascular reconstructive procedures including arteriovenous access, aortobifemoral bypass, femoral popliteal bypass, endarterectomy, abdominal aortic aneurysm and aortotomies.(1)
ETHICON(TM) OMNEX(TM) Surgical Sealant is contraindicated in patients with known hypersensitivity to cyanoacrylate or formaldehyde. The device is not for intravascular use. ETHICON(TM) OMNEX(TM) Surgical Sealant is intended for use as an adjunctive sealant and is not to be used in place of sutures, staples, or mechanical closure.
ETHICON(TM) OMNEX(TM) creates a strong, flexible physical seal independent of the body's clotting mechanisms. It is proven in an ex-vivo model to be two-to-four times as strong as other surgical sealants, is ready for use in less than 30 seconds, and proven to seal to ePTFE grafts and bond securely to friable vessels.(1)
"A basic rule of patient safety and excellent outcomes is to prevent unnecessary bleeding during and immediately after surgery," said Alan B. Lumsden MD, Medical Director of the Methodist DeBakey Heart & Vascular Center and the Chairman of the Department of Cardiovascular Surgery at The Methodist Hospital in Houston.* "The availability of an effective surgical sealant such as ETHICON(TM) OMNEX(TM) provides surgeons with a valuable new tool that is clinically proven to decrease the time it takes to seal the surgical site, including ePTFE grafts, and prevent leakage from occurring."ETHICON(TM) OMNEX(TM) is clinically proven to significantly decrease time to hemostasis based on clinical trials conducted to support its safety and effectiveness. Specifically, results from a pivotal, randomized, controlled, open-label, multi-center trial of 151 patients at 13 centers in the United States and European Union demonstrated that ETHICON(TM) OMNEX(TM) provided hemostasis three times faster than oxidized regenerated cellulose at a rate of 1.99 minutes vs 6.73 minutes, with 54 percent of the ETHICON(TM) OMNEX(TM) patients receiving immediate hemostasis.(2) There were no significant differences in adverse events compared to oxidized regenerated cellulose during the study time period and 4+ year follow-up analysis.(2)
ETHICON(TM) OMNEX(TM) Surgical Sealant has proven efficacy in a broad spectrum of vascular reconstructive procedures including arteriovenous access, aortobifemoral bypass, femoral popliteal bypass, endarterectomy, abdominal aortic aneurysm and aortotomies.(1)
ETHICON(TM) OMNEX(TM) Surgical Sealant is contraindicated in patients with known hypersensitivity to cyanoacrylate or formaldehyde. The device is not for intravascular use. ETHICON(TM) OMNEX(TM) Surgical Sealant is intended for use as an adjunctive sealant and is not to be used in place of sutures, staples, or mechanical closure.
Sunday, July 4, 2010
Hemostase - Medafor states CryoLife Press Release is Misleading and False
Please click the thumbnail to read.PS - Happy Independence Day!
Thursday, July 1, 2010
Hemostase: Medafor says its off...CryoLife its on.......
.jpg)
NOT SO FAST, MY FRIEND!
The continued quagmire that is the CryoLife/Medafor relationship appears set to continue according to This latest Press Release from CryoLife.
Background
After a failed takeover bid by CryoLife they encouraged Medafor shareholder's to withhold their votes at a recent Medafor shareholder meeting. This was rejected by 95% of the 70% of attendee's and one disappointed shareholder will no doubt be Jim Karerchersuch who commented "I say get rid of CryoLife and let investors make some money,".
Expenses in the tussle continue to escalate for both companies with Medafor CEO Shope stating... "The real problem for Medafor is the distraction and expense stemming from CryoLife's takeover bid and continuing litigation, Shope said. Had it not been for the $1.2 million the company shelled out for legal expenses last year, Medafor would have been profitable, ."
and another online source stating ...."Anderson, who launched the hostile takeover attempt of Medafor in 2009 and chose several public venues to prosecute his case, spent approximately $6 million in the effort."
Conclusions
For those on the sidelines this extremely public battle has been an intriguing insight. Lately barely concealed personal attacks are now appearing in certain news articles relating to CryoLife CEO Steven Andersons, age and absence from the shareholder meeting despite his residence in MN. Meanwhile Medafor management were brought under the spotlight with the CryoLife claim "that Medafor's CEO and chief financial officer earned a combined $700,000 last year." Medafor management also denied any issues related to the fact that Medafor senior executives, and Pennsylvania residents Shope and Pasquale don't live in Minnesota, where the company's 21 employees are based. With Pasquale claiming it isn't necessary to live locally.
Investors and Distributors must be feeling unsettled by the lack of clarity in terms of supply, and without any public statement from Medafor or the courts (where both companies appear more comfortable communicating) the status quo appears confusing.
One positive indication from this mess is that plant-based hemostatic technology is certainly worth fighting for. Medafor partner Orthovita must have an eye on these occurences, as will other key China manufacturer Starch Medical.
Subscribe to:
Posts (Atom)