Omrix, a Johnson & Johnson unit, obtains FDA approval for fibrin sealant

Johnson & Johnson (NYSE: JNJ) unit Omrix Biopharmaceuticals Ltd. has obtained US Food and Drug Administration (FDA) approval for its fibrin human sealant patch, one of Omrix's most interest products and the reason why Johnson and Johnson acquired it for $438 million in 2007.

The product, now called Evarrest, is based on Omrix's biological sealant for stopping problematic bleeding during surgery. "Unexpected and uncontrollable bleeding during surgery poses a significant challenge to surgeons, and in some surgical procedures can raise the patient's mortality rate to 20%," says Ethicon Biosurgery (the J&J division which includes Omrix) in its press release.

Omrix's biological sealant is currently used to stop bleeding during surgery or from wounds, but the Evarrest patch Evarrest is easier to use. To stop bleeding, the surgeon places the sealant over the wound and manually compresses it in place for three minutes. The sealant becomes part of the body, gradually degrading over several days or weeks.

The sealant is based on the production of clotting substances in human blood plasma. Ethicon Biosurgery says, "Clinical studies demonstrate that Evarrest is 98% effective in stopping bleeding and maintaining hemostasis compared to the current standard of care at 53%, potentially minimizing disruption to the surgical procedure."

The FDA approval is good news for Johnson & Johnson and for Israel's life sciences industry, and the company will produce Evarrest in Israel, at least over the next few years.

Johnson & Johnson unit Ethicon Inc., which is responsible for hemostasis and sealing solutions to which Omrix belongs, is also considering other options for producing Evarrest and other products later on. It is in talks with Swiss's Octapharma AG, founded by Omrix founder Robert Taub, for this purpose. Omrix was a spin-off of Octapharma, a producer of human plasma products.

In 2009, the State of Israel sued Omrix's founders and Johnson & Johnson for not paying royalties on the acquisition of the intellectual property of the inventor of Omrix's products, a doctor at Sheba Medical Center Tel Hashomer. Omrix and Johnson & Johnson say Omrix was responsible for most of the invention, or that which it received it from Octapharma. The case is still pending, and while it has not yet affected Ormix's thriving operations in Israel to date, it may affect them in the future.

The incredible value of blood saving....

Click to enlarge.... Bloodless surgery in US Jehovah's Witnesses results in Heart benefits.

Recombinant Human Albumin for Use in Unique Sealant Technology

Novozymes Biopharma is pleased to announce that its recombinant human albumin, albucult®, is being used by Neomend in its ProGEL® PLATINUM surgical sealant.
This product will be commercially available in Europe beginning in the second quarter of 2011. Neomend is an innovator in sealant and adhesion prevention products for the surgical marketplace. The company utilises albucult as a key component in ProGEL PLATINUM, the only sealant of its kind developed to treat pleural air leaks following lung resection surgery. Neomend’s ProGEL is a hydrogel polymer consisting of Novozymes’ albucult and a cross-linking component of polyethylene glycol (PEG). When they are combined, a rapid cross-linking reaction creates a hydrogel matrix that results in the formation of a strong, adherent and flexible seal. The technology, which has received a European CE Mark, enables surgeons to more effectively treat lung air leaks during surgery and has already been used in more than 8,000 procedures in the US since April of last year.
David Renzi, Neomend’s President and CEO, commented: “Novozymes’ extensive experience in manufacturing, regulatory and global supply, combined with its commitment to innovation, makes the company the ideal partner for Neomend to work with on its unique sealant technology. We will launch ProGEL PLATINUM in Europe in the second quarter of this year, while also continuing the development of this platform technology into other clinical areas such as spine, general surgery and gynecology.”
“Novozymes is delighted that Neomend has selected albucult for use in its unique sealant technology”, said Dermot Pearson, Marketing Director, Novozymes Biopharma. “The partnership demonstrates Novozymes’ commitment to providing quality materials for use in the healthcare, pharmaceutical and biotechnology industries and allows the company to position itself as a reliable partner in the wound sealant and medical device markets.” The use of albucult in ProGEL PLATINUM and other medical devices confers a range of unique advantages not possible with animal-derived ingredients such as sustainability of supply, GMP compliance and improved biocompatibility. Albucult also delivers unprecedented performance and quality benefits to medical applications including sealants, device coating and cell therapy applications while ensuring batch-to-batch consistency, which can significantly reduce lot testing burdens for customers.

U.S. FDA advisory meeting - TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE

On Oct. 28, the committee will discuss FDA's risk assessment for potential exposure to the variant Creutzfeldt-Jakob disease(vCJD) agent in U.S.-licensed plasma-derived Factor VIII and labeling of blood and blood components and plasma-derived products, including plasma-derived albumin and products containing plasma-derived albumin, to address the possible risk of transmission of vCJD.
On Oct. 29, the committee will hear informational presentations related to FDA's geographic donor deferral policy to reduce the possible risk of transmission of CJD and vCJD by blood and blood products and human cells, and tissue and cellular and tissue based products. The committee also will hear updates on the development of devices to remove transmissible spongiform encephalopathy agents from blood components and chronic wasting disease.

DATE: Oct 28-29, 0830/1230

LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: Bryan Emery or Rosanna Harvey, 301-827-0314

"There was...crap in that stuff. This stuff was manky, it was filthy, it was dirty ... but they still stuck it in the arms of children"

Patients have called for the inquiry into how people were given infected blood by the Scottish NHS to have a wider remit, as hundreds of pages of evidence were published.
Campaigners hailed the release yesterday of the preliminary report by Lord Penrose, who is chairing the probe, as a milestone.
It included a list of issues that he will investigate during the next year, among them the use of commercial blood products after it was realised internationally that they carried a risk of Aids and the acceptance of blood donations from prisoners.
Hundreds of people in Scotland were given contaminated blood in the 1970s and 1980s either as treatment for blood clotting disorders or through blood transfusions.
The plight of those who caught HIV or hepatitis C as a result is acknowledged in the opening of the preliminary report.
It says: “It would have been impossible for any person involved in this inquiry to have been unaware of and to have remained untouched by the physical, mental and emotional suffering of the individuals and families affected by these serious and potentially fatal diseases.”
Campaign groups including Haemophilia Scotland said that after years of frustration they were pleased to have such a substantial document.
However, they expressed concern that many of the victims and their families who want to be core participants with legal representation when the inquiry progresses to oral hearings will be disappointed.
About 70 patients and their relatives applied to Lord Penrose to be core participants, but so far it is understood about 14 have been accepted.
In addition, Bruce Norval, who has hepatitis C after receiving contaminated blood, complained the inquiry would not explore other infections – in addition to hepatitis C and HIV – to which haemophiliacs given clotting agents may have been exposed.
He said: “One thing that needs to be highlighted is that haemophiliacs are due a public, truthful account of the full toxic potential of the clotting agents we were treated with from childhood. At the moment, the remit would not fully allow for that.
“What we are trying to get is an understanding why this small group of people, which was 500 strong, are now down to half that number, with more dying on a monthly basis.
“There was all kinds of crap in that stuff. This stuff was manky, it was filthy, it was dirty and they knew it, but they still stuck it in the arms of children.”
The inquiry will examine how patients affected were tested for infections and informed about the results. According to the report, almost two-thirds of patient witnesses said they did not know they were being tested for hepatitis C or HIV and a number describe finding out they had hepatitis C years after tests were carried out.
Lord Penrose has been given accounts of doctors dismissing the illness as “nothing to worry about”, while one witness with HIV said the doctor who told his family was “quite blase”.
The report was released after the inquiry team analysed more than 80,000 documents and took more than 100 statements from patients and relatives.
Solicitor Advocate Patrick McGuire, of Thompsons solicitors, the recognised legal representative of families and sufferers, welcomed the report.
He said: “The document … is clearly very well reasoned and therefore a clear measure of the amount of work that has been put in by Lord Penrose and his team and for that I would personally like to thank him.”
He added that it was subject to consultation and he would be discussing some issues with Lord Penrose.
Lord Penrose said: “It is important to emphasise that I have not reached any conclusions on matters of fact or provided any recommendations at this stage and the list of topics that I have included for further investigation at the public hearings is not definitive.
“I am now inviting comments on these topics from interested individuals and organisations by the end of October.”

Minnesotans Help Produce As Well As Benefit from Lifesaving Therapies

ANNAPOLIS, Md., Sept. 1 /PRNewswire/ -- This month, Minnesotans are recognized for their outstanding contributions to lifesaving therapies that treat critically ill individuals and for their donations of the blood component, plasma, that makes the creation of these unique therapies possible. Throughout September, Minnesota Gov. Tim Pawlenty is recognizing "Plasma Protein Therapies Month" in the North Star State, helping to raise awareness for the rare, genetic diseases treated with the therapies and valuing the contributions of voluntary plasma donors in the state.

Plasma protein therapies, which include plasma-derived therapies and recombinant blood clotting factors (a biotechnology product), are used every day to treat people with hemophilia, a blood clotting disorder that causes painful internal bleeding and debilitating joint damage; primary immunodeficiency diseases, which rob a person's ability to fight even common infections; and alpha-1 antitrypsin deficiency, also known as genetic chronic obstructive pulmonary disease (COPD). In addition, a plasma protein therapy, albumin, is used in critical care settings, when treating severe trauma, burns and during major surgery.

Plasma, a biological material that cannot be manufactured, is used to create lifesaving therapies that come solely from committed plasma donors. The state of Minnesota is home to 11 plasma collection centers. As Minnesota celebrates the generosity of its donors and raises awareness for the rare diseases that are treated with the therapies during Plasma Protein Therapies Month, we encourage everyone to donate and to help ensure a higher quality of life for patients across the United States and around the world.

"Always serious and often life-threatening, patients requiring plasma protein therapies suffer from serious diseases and disorders and need access to critical therapies manufactured from high-quality plasma from dedicated donors such as those in Minnesota," said Josh Penrod, Vice President, PPTA Source. "Donors continue to be recognized and valued as a critical component in the production of these therapies."

For more information about plasma protein therapies, the diseases they treat and donating plasma, please go to www.donatingplasma.org.

The Plasma Protein Therapeutics Association (PPTA) represents the world's leading manufacturers of plasma-derived and recombinant biological therapies, collectively known as plasma protein therapies and the collectors of source plasma. These critical therapies are infused or injected by more than 1 million people worldwide to treat a variety of rare, life threatening diseases and serious medical conditions. PPTA members produce in excess of 80 percent of the plasma protein therapies used in the United States today and more than 60 percent worldwide. PPTA is a global trade association that administers international, voluntary standards programs to help ensure the highest quality and safety of plasma protein therapies and the plasma collected to manufacture them. Additionally, PPTA works in partnership with the patient community and consumer advocates to help ensure continued access to lifesaving plasma protein therapies.

Baxter - Naughty advertisements say FDA

Federal regulators are warning Baxter Healthcare that it is overstating the benefits of Aralast, an emphysema drug, and say they have noticed that the company has a disturbing trend of overstating the effectiveness of its drugs and medical products. On August 3, the FDA sent a warning letter to Baxter CEO

Robert Parkinson, Jr., accusing the company of deceptive advertising in a physician brochure for Aralast NP. The FDA has determined that the brochure misbrands Aralast NP illegally, making overstated claims of efficacy. The FDA warning letter states that the Aralast brochure makes the drug appear to be more effective than has been demonstrated by implying that its alpha1 – antitrypsin levels have a protective effect and clinical benefits that have not actually been clinically proven. In an unusual move, the agency also admonishes the company for its trend toward misleading advertising. “[W]e are very concerned by your continued violative promotion of your products,” the letter states, and then points out that the FDA has cited Baxter for similar violations of overstated efficacy and “unsubstantiated claims of superiority” in letters on April 14, 2009 and July 7, 2008. The April 2009 warning letter cited the company for false and misleading advertising for TISSEEL, a hemostatic surgical tissue glue. Baxter claimed that TISSEEL was 97.5% effective in achieving hemostasis in patients undergoing a cardiopulmonary bypass while on Baxter’s blood thinner, Heparin. The FDA said that claim was unsubstantiated. The July 2008 warning letter chastised the company for also overstating the efficacy of FEIBA VH, a freeze-dried, sterile form of human plasma used to control bleeding in patients with hemophilia in an e-mail. The company claimed that the substance controlled bleeding in 60% of cases within 12 hours of the first infusion. The FDA said that was inconsistent with the prescribing information, which only noted a success rate of 36% with one infusion. The FDA also said the company understated the risk of serious thrombotic events. In its latest warning letter, the FDA has demanded that Baxter not only fix the misleading Aralast information, but is also requiring the company to come up with a plan in writing that will put policies and procedures in place in the company to prevent future misleading advertising problems. If the company fails to comply it could be subject to FDA regulatory action, including seizures and injunctions.

FDA rules CollPlant wound dressing a device

The US Food and Drug Administration (FDA) has ruled that the CollPlant Holdings Ltd's (TASE: CLPT) wound dressing product, Vergenix, will undergo the certification process by the Center for Devices and Radiological Health (CDRH), which oversees medical devices.
Vergenix Wound Dressing is wound care sheet composed of pure recombinant human collagen scaffold that provides a moist wound healing environment. The product, a type I collagen, is produced by transgenic tobacco plants. It is designed to treat acute and chronic wounds, such as pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds, abrasions, and second-degree burns.
US licensing procedures for medical devices are shorter than the procedure for pharmaceuticals. CollPlant believes that while Vergenix is based on human recombinant collagen produced through advanced biotechnological techniques, the FDA decision that the CDRH will review the product is very important for the company, as the regulatory procedures are significantly simpler, shorter, and cheaper than for biological and pharmaceutical products. This is a breakthrough since Vergenix will be a pioneering product for CollPlant's subsequent products.
CollPlant's share price rose 9.9% by mid-afternoon to NIS 1.20, giving a market cap of NIS 126 million.
Published by Globes [online], Israel business news - www.globes-online.com - on August 29, 2010

Cutting back on blood use could halt infections, illness — and even death

SEATTLE — As a doctor and a patient, Dale Reisner knows the value of donated blood. But when the Seattle obstetrician had to have heart surgery four years ago, she did everything possible not to get a single drop.
“I don’t have any religious problems with it. If I was near death, I definitely would have taken blood, no question,” said Reisner, who is fine now at age 62. “But if I could avoid a transfusion by better pre-op preparation, then I was interested.”
Dr. Dale Reisner actively avoided a blood transfusion during surgery to repair a mitral valve in her heart.
Long dominated by Jehovah’s Witnesses — whose faith forbids blood transfusions — bloodless surgeries and blood conservation programs are now attracting mainstream patients worried about what some experts say are clear risks, including more infections, longer recuperation, increased illness and even death.
"The best blood is in your own veins,” said Dr. Lori Heller, medical director of the blood management program at Swedish Medical Center in Seattle, where Reisner had her surgery — without any transfusion. “We want to think before we transfuse.”
Decades of experience with Jehovah’s Witness patients, including 1.5 million members in the United States, has helped propel the new emphasis on blood management, said Sherri Ozawa, clinical director of the Institute for Patient Blood Management at Englewood Hospital and Medical Center in New Jersey.
“In the early days, it was, ‘We have Witness patients, what in the world do we do with them?’” she recalled. “Now we believe it should be the standard of care.”
More doctors, from cardiac surgeons to orthopedists, are offering patients ways to conserve their own blood and avoid transfusions. From drugs that boost blood levels before surgery to cell salvage and blood diversion techniques during operations and lower thresholds for giving blood at all, the techniques are a sea change in the attitude that more blood is always better.

Egypt - Nearly 7 out of every 1,000 Egyptians acquire HCV infections every year, suggesting intense ongoing transmission

The Arab Republic of Egypt has the highest rates of new hepatitis C virus (HCV) infection in the world, according to a new study published today in the prestigious Proceedings of the National Academy of Sciences. The study also estimates more than 500,000 new HCV infections occur in Egypt every year, likely signaling an epidemic in a country of more than 77 million people. This high rate of HCV transmission may be due to the lack of sufficient standard safety precautions in medical and dental facilities, the authors suggest. “Nearly 7 out of every 1,000 Egyptians acquire HCV infections every year, suggesting intense ongoing transmission. This is the highest level of HCV transmission ever recorded at a national level for a blood borne infectious disease transmitted parenterally, that is, by use of non-sterile medical instruments,” said Dr. F. DeWolfe Miller, lead author of this study and professor of epidemiology at the Department of Tropical Medicine and Medical Microbiology and Pharmacology at the University of Hawaii.Although the high prevalence of hepatitis C in Egypt has been well established for many years, and linked in part to limited safety measures during anti-bilharzia campaigns, published estimates of prevalence from different Egyptian communities failed to provide a nationwide picture of the magnitude of ongoing HCV infection transmission.

To estimate the rate of new HCV cases of infection in Egypt, the authors of the study performed epidemiologic modeling of data from a range of studies, including a 2008 national HCV survey with a representative sample and well-documented study design.“The study opened our eyes to a disease burden similar in scale and challenge to the HIV problem in sub-Saharan Africa: Millions of cases of an infection for which there is no vaccine, no effective treatment, and where case management is so expensive that it is beyond the reach of most patients,” said Dr. Laith J. Abu-Raddad, co-author of the study and assistant professor of public health at the Infectious Disease Epidemiology Group at the Weill Cornell Medical College–Qatar.

The study necessitates not only further analysis of HCV transmission in Egypt but also justifies the immediate increase of resources to strengthen public health measures aimed at reducing the transmission of HCV in clinical and non-clinical settings, according to the authors. Failure to address this problem will result in a massive disease burden in the nation in terms of HCV infection complications, including active liver disease, liver failure, or liver cancer.
“There is only one way to deal with the HCV challenge in this country: HCV prevention,” warned Dr. Miller. “Effective and stronger HCV prevention programs are urgently needed in Egypt. Failure to act could swamp the public health system over the coming decades with millions of cases of HCV disease complications with an economic and social cost that this nation does not have the means to confront.”
Key scientific findings of the study
• Nearly 7 out of each 1,000 Egyptians acquire HCV infection every year for a total of 537,000 new HCV infections every year. This is by far the largest ever recorded rate of occurrence of HCV at a national level of all countries in the world.
• One in every 10 Egyptians is a carrier of the HCV infection, which means that there are at least 4,459,000 persons infected with HCV who are infectious to others. This is the largest reservoir of HCV infection in the world.
• Contrary to the widely-held perception that this rate of occurrence reflects merely the limited safety measures during anti-bilharzia campaigns, HCV incidence likely continues at alarming levels due to limitations in the implementation and enforcement of stringent standard precautions in public and private medical and dental facilities.

Victim of blood products sues for hep C relief

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.

Animal Products

Following on from the Bleeding Calf Syndrome posting available HERE and other postings available Here regarding risks of animal sourced products.

I have provided further info above provided by DEFRA. To the best of my knowledge only the UK and Scotland are acting to investigate?

You can follow this link for further details also 'This intriguing disease captures the imagination. The VLA will be working with others to help discover the cause.'

I expect manufacturers will focus efforts on recombinant, plant-based technologies.

While our industry battles achieving financial success in the market with the ideal of creating an agent that is:

• of minimized risk
• efficaious
• cost effective,
• easily deliverable
• and applicable to multiple surgeries

The removal of King Pharmaceuticals crown as leader in the multi- $million Thrombin market by Zymogenetics is

a sure indicator as to market preference and acceptance of these benefits. J&J have a human sourced Thrombin following theirpurchase of Omrix.

Certainly reconstituted animal based technologies are facing severe threats currently as the link between zoonotic diseases (animal/human transfer) become more widely known. While BNP (Bleeding Calf Syndrome) transmission is far from clear it should be of concern. The lack of reporting and individual Government action highlight the inadequacies of public protection even with a cursory investigation.

While Bleeding Calf Syndrome may not pose infection risks via medical devices it exemplifies the public vulnerabilities to weak protection measures from their Governments. This is weak response and is exactly the response delivered that saw vCJD, and Prion borne infections escalate. Harvesting Bovine Materials HERE

Cow Products - Why ?

Bovine Neonatal Pancytopaenia (BNP) is a newly emerging disease syndrome of calves less than one-month-old which has recently been reported in Britain and Europe.
It is often referred to as calf haemorrhagic disease, haemorrhagic diathesis, bleeding calf syndrome or blood sweating disease.
The first cases of the condition were reported in Germany in 2007.Since then, reports of confirmed cases have slowly risen in a number of European countries while the first confirmed case was recently diagnosed in Ireland and there have been four cases confirmed in Northern Ireland to date.

Typically, the clinical signs in young calves can include excessive bleeding from small abrasions of the skin, or even from injection sites, and the passing of large clots of blood in the dung.

Temperature

Calves affected with the condition normally have a high temperature and become rapidly depressed. In the majority of cases, death follows within 24 to 48 hours (mortality of about 90% is commonly reported), with aggressive veterinary treatment, including blood transfusions, normally providing only a temporary respite for the animal.

The disease syndrome tends to affect single calves in a herd although multiple calves have been affected in some herds in Britain and Germany.

Affected calves tend to be found in larger well-managed herds with a large proportion of affected farms also keeping sheep as well as cattle.

Within countries that have identified cases, a geographical pattern to the occurrence of the disease has not been identified nor has any breed or gender association been established.

On post mortem examination of affected calves, significant damage to the bone marrow has been consistently reported.

The bone marrow is responsible for producing the blood cells. Red blood cells are responsible for transporting oxygen, while white blood cells play a role protecting against infection. Platelets are responsible for blood clotting.

Of these three, the platelets are most severely affected, giving rise to the typical clinical signs of poor clotting and widespread bleeding in the calf.

While the cause of the condition is unknown, there is no evidence that the condition is infectious or that it gives rise to food safety concerns.

The fact that apparently normal calves at birth can develop clinical signs rapidly after consuming colostrum has focused the attention of researchers on colostrum. It is possible that colostrum acts as a vehicle for the introduction into the calf of the agent which damages the bone marrow.

During the 24 hours that follow the birth of an animal, the intestine allows antibodies (a form of defence against disease) which are contained in the colostrum to pass from the gut into the blood stream. This is an important step in the transfer of immunity from the mother to her offspring and plays a vital role in preventing disease in the newborn calf.

It is possible that, in a very small percentage of calves, some of these antibodies target the bone marrow cells, leading to the clinical signs of the disease. Indeed, a similar mechanism is known to cause destruction of blood cells in some newborn foals and piglets. Researchers wish to ascertain whether this is the case in affected calves and, if so, to determine what has changed in the cow or her environment which has led to the occurrence of the condition.

The Department of Agriculture, Fisheries and Food's regional veterinary laboratories are available to assist herdowners and veterinary practitioners with laboratory diagnosis and investigation of any suspicious cases.

The Department has offered to provide free post mortem examinations of any young calf with clinical signs typical of the condition.

While the condition is rare, with minimal losses to date, the Department is always vigilant to the occurrence of novel diseases or novel presentations of existing diseases. Herd owners are asked to notify their veterinary practitioner of any young calves with apparent clotting difficulties.

CryoLife purchases recombinant human serum albumin and gluteraldehyde formula

ATLANTA, June 7 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company whose products include BioGlue Surgical Adhesive, announced today that it has completed the purchase of U.S. patent # 6,329,337. The patent involves the formulation and use of recombinant human serum albumin and gluteraldehyde, and now becomes part of CryoLife's protein hydrogel patent portfolio, which includes BioGlue.

"CryoLife will continue to invest in emerging and adjacent intellectual property and tools that will complement our portfolio of surgical adhesives and glues for surgeons," said CryoLife president and CEO Steven G. Anderson. "With our acquisition of this technology, we have an additional opportunity to expand and strengthen our surgical adhesive portfolio," Anderson added.

CryoLife's BioGlue Surgical Adhesive is the leading surgical adhesive used in cardiovascular surgery around the world and is used in a wide range of reconstruction procedures. Composed of purified bovine serum albumin (BSA) and gluteraldehyde, BioGlue has been used in more than 550,000 surgical procedures and has been published in more than 250 preclinical and clinical papers discussing safety, efficacy, and application techniques since its launch in 1998.

"The strength of BioGlue assures the surgeon that delicate tissues are well reinforced and assists in controlling bleeding in complex surgery. We believe that these and other properties of BioGlue Surgical Adhesive make it a leading sealant used in complex cardiac and vascular surgery," Anderson said.

Tachosil - IFU and FDA info

Horse tendons for production of Collagen Sponge are collected from slaughterhouses. ---(b)(4)-- (horse–(b)(4)) slaughterhouses are certified by authorities of the European Union. -----(b)(4)---- slaughterhouses possess an approval of the EU veterinary authorities and are listed on the FSIS (USDA) list as certified facilities. All slaughterhouses are regularly inspected and approved by the national veterinary authorities and are audited by Nycomed. Each batch of horse tendons supplied to Nycomed is accompanied by a veterinary certificate and by a QA certificate issued by a quality responsible person at the slaughterhouse.

Transmissible Spongiform Encephalopathy

TachoSil has an acceptable safety profile with regard to prions. TachoSil does not contain any bovine ingredients. According to current knowledge, horses do not develop prion disease. Measures to avoid cross contamination of the equine tendons are in place at the slaughterhouses. For the Active Substances - Human Fibrinogen and Human Thrombin - strict plasma donor selection criteria are employed by the manufacturer.........Full FDA document with IFU available below.....

Tachosil - Report Fails to Impress

A new product — a sponge-like patch — is now on the market to help decrease bleeding during cardiovascular surgery.
The sealing patch, called TachoSil, helps prevent bleeding and — better yet — never needs to be removed. It simply dissolves within the body over time.
“TachoSil is the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels when standard surgical techniques are ineffective or impractical,” said Dr. Michelle Yeboah.
The new product received approval in April from the Center for Biologics Evaluation and Research, the part of the Food and Drug Administration that regulates biological products for human use.
The absorbable fibrin sealant patch is unique. It is the first product of its kind available in the United States, said Laura Jacobs, corporate communications official with Baxter Pharmaceuticals.
Officially, the patch is considered an adjunctive hemostatic agent, used to control bleeding during surgery, Jacobs said.
TachoSil is a sponge-like material made up of naturally occurring proteins found in mammals. The product is covered with two proteins: fibrinogen and thrombin.
Together they cause chemical reactions that produce fibrin, which is a protein that brings about blood clots.
This sealant patch is biodegradable, which means that it breaks down within the body in less than six months.
TachoSil does not require preparation and can be applied directly to the bleeding area during both open and minimally invasive surgeries.
“In the presence of saline, blood or other bodily fluids, the coagulation factors in TachoSil dissolve to form a mechanical fibrin clot, which adheres the patch to the bleeding surface and achieves hemostatis,” Jacobs said.
It can be used in cardiovascular surgery when bleeding cannot be controlled by standard surgical techniques such as suture, ligature or cautery. It is not a replacement but rather an additional tool to what is currently available to surgeons.
The patch comes in various sizes. The surgeon can use scissors to cut the patch to a specific size or can overlap patches if the patch is not large enough.
In instances of heavy bleeding, excess blood is to be wiped away before TachoSil is applied.
One side of the patch is yellow, and that is the side that should cover the wound. It is dyed with riboflavin to indicate that the side contains active ingredients.
It is critical to apply pressure on the patch for three minutes.
After the surgery, imaging scans such as X-rays, ultrasounds and CT scans will show evidence that TachoSil was used. The clarity of the image depends on the specific site of application.
No product comes without risk, however.
It is not common, but some patients experience hypersensitivity or allergic reactions. In rare cases, it could turn into severe hypersensitive reaction. Those who are prone to having a systemic reaction to horse proteins or human blood products are not good candidates for use of TachoSil.
TachoSil comes in double packaging which makes it extra sterile. This allows someone to assist during surgery and open one layer of the package while leaving the inner package on the table with the other instruments ready for use.
The sealant patch is a significant advance for cardiologists and represents another tool surgeons can use to address the many types of bleeding challenges in cardiovascular surgery, Jacobs said.
TachoSil has more than 15 years of documented clinical experience and a strong safety record, Jacobs said.
The product, manufactured by Nycomed Austria, is available in more than 50 markets, in addition to the United States.

Source: Reporter News

Old red blood cells may double mortality in trauma patients

Severe trauma patients requiring a major transfusion are twice as likely to die if they receive red blood cells stored for a month or longer, according to research published in BioMed Central's open access journal Critical Care. The increased rate of death was measured up to six months post transfusion which is consistent with previous reports in cardiac surgery patients.
Philip Spinella and Christopher Carroll, both paediatric intensivists from Connecticut Children's Medical Centre, Hartford, Connecticut, USA and their team studied 202 severe trauma patients treated at Hartford Hospital following a critical injury with five or more units of red blood cells. They found that even one unit of red blood cells stored more than 28 days doubled the incidence of deep vein thrombosis and increased death secondary to multiple organ failure. Though medical experts had long suspected that older red blood cells caused complications, this is one of the first studies to strongly support this dramatic link. This study differs from previous studies since the amount of RBC units transfused to the fresh and old RBC study groups were equal. As a result, this eliminated the major criticism of previous studies that it is the amount of RBCs transfused not the storage age that was affecting outcomes.
Over 29 million units of blood were transfused in the United States in 2004, and this is a routine and reliable part of trauma care treatment around the world. However, red blood cell transfusion continues to be associated with adverse complications. This study provides evidence that allows doctors to reduce these risks by giving fresher red blood cells to severe trauma patients who need these major transfusions for life-saving procedures.
According to Spinella, 'The preferential use of younger RBCs to critically ill patients has the potential to increase waste due to outdating. Since blood is often a scarce resource this is important and methods need to be developed to minimise waste while providing the most efficacious and safe blood product for a given patient.
The authors speculate, 'These important findings should encourage research into the effects of old blood and coagulation in critically ill patients. With the widespread of use of red blood cell transfusion for critically injured patients, this study has the potential to cut deaths in hospitals around the world.'

Comparitive Presentation of Human Derived Thrombin vs. Bovine

Pathogen Safety of Evithrom

UK - vCJD Testing by Coroners called for...

Coroners are refusing to carry out post-mortem tests for an infection that

causes the human form of mad cow disease, despite pleas that they could help to monitor the disease.

Professor John Collinge, a leading expert on variant Creutzfeldt-Jakob Disease (vCJD), warned that systematic testing was vital to find out whether many people were “silently infected” with the potentially fatal condition.So far 164 people are confirmed to have died of the disease but scientists say that there is no accurate indication of how many people may be carrying it.“There is a concern that what we have seen so far may be the first wave, occurring in individuals who are particularly genetically susceptible, but there may be more people who are silently infected in the community than the number of clinical cases we have seen would suggest,” Professor Collinge told BBC Radio 4’sToday programme. But experts in the law governing coroners courts say that the tests can be ordered only if the Government changes the law. The Spongiform Encepalopathy Advisory Committee (SEAC), whose job is to monitor the progress of the disease and advise the Government, has been warning for two years that it was important to find out how many people were carrying the infection. The only reliable way of doing that, SEAC says, would be to ask coroners to test the brain and spleen of young people during post-mortem examinations so that they could be tested for the presence of the infectious agent, a protein known as a prion. Professor Collinge, a member of SEAC, said that systematic testing was needed to establish how many more people were likely to get the disease and whether the current measures to protect the spread of infection were appropriate. He urged coroners to request the test when ordering post-mortem examinations. “I would hope that they would be able to help with this because I don’t see any other way for us to get this information at the moment,” he said. “We have been very vocal in terms of saying these data are absolutely vital if we really want to manage the process properly," said Professor Graham Medley, another member of SEAC. “My understanding is the Department of Health is very keen to push this forward, it’s really just using coroners as an opportunity to do some sampling. I’m not sure why there has been some apparent reluctance on behalf of coroners.” In response, Dr Michael Powers, QC, an expert in coronial law, said that coroners would be happy to order the test if the Government changed the law. He told Today that at present they are able to order a post-mortem examination only to find the cause of death, and not test for other infections that may have been present. Dr Powers said: “This is a function which is outside the coroners’ statutory authority. Because they are not, those tests, directed to ascertaining the death in an individual case.” The Coroners and Justice Bill going through Parliament could be altered to put a duty on coroners to order the test, he said. “That would completely solve the problem,” he said. Christine Lord, whose son Andy Black died of vCJD, told Today: “This is a public health issue. I, as a mum, have lost a child, a very dear, loved child, through an avoidable disease. “The coroners, by actually blocking this, are actually not protecting public health. They just seem to be protecting their particular role in Government. “At the end of the day, they are public servants and their job is to protect us.” A Department of Health spokesman said that a pilot study will take place later this year, with the co-operation of some coroners, to obtain tissue samples from post-mortem examinations. “It is important to obtain a better understanding of the prevalence of vCJD so that we can prevent secondary transmission from person to person,” the spokesman said. “SEAC has recommended that studies of tissues, such as spleen, collected at post-mortem would provide important data on the prevalence of vCJD infection in the population. “The Health Protection Agency is running the pilot with the co-operation of NHS Bereavement Services and NHS Blood and Transplant’s consent team. “Some coroners have agreed to participate in the pilot study and appropriate funding will be made to them and to the other organisations incurring additional costs.”