$16.8 million grant awarded to develop platelet recovery treatments

SEATTLE – The National Heart, Lung and Blood Institute of the National Institutes of Health has awarded a $16.8 million, seven-year grant to launch a bicoastal research partnership between

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium and Children's Hospital of Philadelphia.
The collaboration, led by scientists at the Hutchinson Center, will develop molecular- and cell-based therapies for a range of blood diseases, with an initial focus on a life-threatening complication of stem-cell transplantation called thrombocytopenia. The condition, which is sometimes associated with abnormal bleeding, is caused by a delayed recovery of blood-clotting cells called platelets.
The problem is that some stem cell transplant patients, particularly those receiving stem cells from cord blood, often do not produce enough platelets in a timely fashion which puts them at risk for life-threatening bleeding. Platelet production can be delayed by several months in persons who receive a stem cell transplant to treat certain cancers. Transfusions can help, but the number of platelet donors is limited, transfusions carry a risk of blood-borne diseases, and patients who receive multiple transfusions can develop antibodies that destroy the platelets.
According to principal investigator Beverly Torok-Storb, Ph.D., a member of the Hutchinson Center's Clinical Research Division, the goal is to control the process of blood cell production so that all types of blood cells - red cells to carry oxygen, white cells to fight infection and platelets to prevent bleeding - recover together within a few days.
The partner institutions will focus on two complementary strategies to address delayed platelet production. Scientists at the Hutchinson Center and the UW will develop reagents that can be administered to patients to stimulate the differentiation and proliferation of precursor cells into platelets. The Philadelphia group will work to generate "ex vivo," or outside the body, platelets and their precursors from embryonic stem cells for use as cell therapy. The principal investigator in Philadelphia is Mortimer Poncz, M.D., chief of the Division of Hematology at Children's Hospital of Philadelphia.
The Hutchinson Center/UW group will receive a total of $8.2 million during the seven-year grant; the Philadelphia research group will receive $8.6 million.
"This coast-to-coast collaborative effort will take advantage of complementary skills and interests in these two institutions to develop new therapies for all patients needing platelet transfusions," Poncz said.
At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. For more information, please visit HERE.

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.'

Vascular Solutions - UBS Global Life Sciences Conference

Cryolife - UBS Global Life Sciences Conference

Orthovita - UBS Global Life Sciences Conference

Z-Medica QuikClot Interventional Hemostatic Bandages Now Available for Use During Catheterization Procedures

SAN FRANCISCO--(BUSINESS WIRE)--Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced the availability of the QuikClot® Interventional™ hemostatic bandage, on display at booth #1338 at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. One of the primary applications for the new QuikClot® Interventional™ hemostatic bandage is to control arterial and venous bleeding following cardiac catheterization or other vascular access procedures that traditionally have required considerable manual compression time or clamping which can be painful for the patient.
QuikClot® Interventional™ is a non-invasive, easy to use hemostatic bandage indicated for use in the local management and control of external bleeding from vascular access sites and percutaneous catheters or tubes utilizing sheaths of up to 12 Fr. It is safe to use and proven effective for use on femoral and other arterial and venous bleeds. It contains an inert and inorganic mineral that has no known contraindications and accelerates the body’s natural hemostatic process. For ease of use, the product does not require any advance preparation and is double-packaged in a blister package and a foil pouch for aseptic technique. It includes a 3M® Tegaderm® adhesive bandage for easy application.
QuikClot® Interventional™ is applied in three simple steps and requires no special training. The health care professional removes the hemostatic pad from the packaging and places it into the sterile field using sterile technique. The hemostatic pad is then placed on the puncture site and manual pressure is applied for at least five minutes or until bleeding stops. Finally, without moving or lifting the pad, the 3M® Tegaderm® adhesive bandage is applied over the pad and secured to the skin, while manual compression is maintained. The QuikClot® hemostatic pad may be left in place for up to 24 hours and can be removed by gently peeling away the Tegaderm® bandage and removing the pad. QuikClot® Interventional™ is currently being used in several interventional cardiology and radiology laboratories across the U.S. Recently, Z-Medica Corporation has gathered over 300 documented reports of human use of this product with an overall success rate of 98.2%, meaning that this novel device was able to achieve hemostasis in virtually all cases following arterial and venous catheterization.

CryoLife (CRY) And Medafor In Fight Over Hemostase

CryoLife, Inc. and Medafor, Inc. are parties to an exclusive distribution agreement whereby CryoLife distributes Hemostase, an absorbable blood clotting agent manufactured and developed by Medafor.

On September 18, 2009, Medafor informed CryoLife of its belief that CryoLife has materially breached its duties and obligations under the Agreement and gave CryoLife notice of its intent to terminate the Agreement if the breach is not cured within 30 days. While Medafor contends that a material breach has occurred because CryoLife has pursued regulatory approval to distribute Hemostase in Hong Kong, CryoLife believes a court would find that a material breach of the Agreement has not occurred, and that, in the event a breach has occurred, that CryoLife would be able to cure it within 30 days of CryoLife’s receipt of notice. As such, CryoLife does not believe the Agreement will terminate on October 18, 2009.
The Agreement has a three-year term from its effective date of May 1, 2008 and will automatically renew for an additional three-year period if

CryoLife makes minimum purchases as designated under the Agreement; however,

there is no contractual obligation for CryoLife to make minimum purchases. Per the terms of the Agreement, CryoLife is the exclusive distributor of Hemostase in the U.S. for cardiac and vascular surgery (excluding Department of Defense hospitals) and the exclusive distributor internationally (excluding China and Japan) for cardiac, vascular, and general surgery, other than orthopaedic and ear, nose and throat surgery.

As previously discussed in the Company’s Forms 10-Q for the quarters ended March 31, 2009 and June 30, 2009, CryoLife has filed a lawsuit against Medafor alleging that Medafor has violated the Agreement by, among other things, entering into exclusive distribution agreements with other companies with respect to distribution territories reserved for CryoLife per the terms of the Agreement.

Legally embroiled Medafor's issue with SMI (manufacturer of PerClot) was recently dismissed pending review, the court commenting "As a result, the court dismissed Medafor's trade secret claims ...."

Lifebond - Israel has developed a new surgical sealant

Lifebond out of Caesarea Industrial Park, Israel has developed a new surgical sealant which is apparently stronger than the currently used blood-derived fibrin glues. The LifeSeal SLR staple line reinforcement sealant and LifeSeal Surgery sealant for general surgery are two main products from the company that are based on its proprietary hydrogel matrix technology, in which individual protein molecules tend to cross-link and form fibrin-like networks. The company plans to ask for US and European approval to market the material next year.

LifeBond's technology functions through the rapid and biocompatible in situ cross-linking of structural proteins. As they cross-link, proteins in the physiological environment undergo a process of gelation to form an adhesive hydrogel matrix. The properties of the cross-linking reaction and the hydrogel matrix can be controlled to fit a variety of applications.

LifeSeal GI is comprised of LifeBond sealant provided in a specialized two-component applicator syringe. The mixed sealant is applied to anastomosis staple-line junctures in the GI tract to fortify the attachment and prevent leakage until full function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the staple-line juncture. The sealant can be applied manually or as a gas-assisted spray.

Application of LifeSeal GI onto the staple line moderates tension on the staple line because it stabilizes the tissue sections in relation to each other and adds adhesive strength to the junction. Furthermore, LifeSeal GI seals off the staple holes and narrows the spaces in between each staple. Thus, leakage, bleeding, and tearing at the staple line can be reduced, especially in diseased and fragile tissue.

LifeSeal Surgical sealant is provided in a variety of specialized two-component applicators. The mixed sealant is applied to a wound site or staple-line juncture to prevent fluid or blood leakage until full physiological function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the wound site or staple-line juncture. The sealant can be applied manually or as a gas-assisted spray. The precise application method can be altered to optimize sealant use for specific applications.

St. Jude Medical to Showcase Complete Cardiovascular Access, Intervention and Hemostasis Management Solutions at Transcatheter Cardiovascular Therapeu

ST. PAUL, Minn.--(Business Wire)-- St. Jude Medical, Inc. (NYSE:STJ) today announced it will display products and technologies from the company`s portfolio of solutions for cardiovascular healthcare professionals at the 21st annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco. The featured products reflect the company`s continued commitment to developing comprehensive, high-performance solutions which advance the practice of interventional cardiology by improving efficiencies and giving physicians more control. The company`s latest products and technologies for access, intervention, hemostasis management, cardiac rhythm management, and valve replacement will be demonstrated and on display on Sept. 23 and Sept. 24 from 9 a.m. to 5 p.m. and Sept. 25 from 9 a.m. to 2 p.m. at the St. Jude Medical booth (#1704) including:

Hemostasis Management:

From active vascular closure to compression-assist devices, St. Jude Medical has the most complete portfolio of products to aid physicians in achieving hemostasis following cardiovascular interventions. St. Jude Medical presents the eighth generation of the successful Angio-Seal product family with the most advanced design yet - the Angio-Seal Evolution. With the addition of two compression-assist devices following the acquisition of Radi Medical Systems, RadiStop Compression-Assist Device and FemoStop Gold Compression-Assist Device, the company can now offer physicians a full spectrum of closure technology to aid hemostasis. * Angio-Seal Evolution Vascular Closure Device: The new Angio-Seal Evolution device incorporates its repeatedly proven active closure system using a fully bioabsorbable anchor with a new, simpler system for deployment. This next-generation product from the industry-leading Angio-Seal product line was designed to reduce the number of necessary steps for closure and to assist physicians in overcoming procedural variables. The need to manually compact the collagen was eliminated, and only one suture cut is required. The Angio-Seal Evolution has received FDA and CE Mark approval. * Other Products on Display: Angio-Seal VIP, RadiStop Compression-Assist Device and FemoStop Gold Compression-Assist Device.

Irish Medical Tech Breakthrough

An Irish medical technology firm has developed a breakthrough device that will propel the company to tap into a US$1bn market. Its first product will launch in the European market in the first half of 2010.
Dublin-based Vasorum Ltd, which specialises in the interventional cardiology and radiology markets, will present the initial results of its First-in-Man clinical study for its flagship device AstraPlug at the world-renowned TCT (Transcatheter Cardiovascular Therapeutics) in San Francisco today.
The AstraPlug system delivers a miniature medical grade biocompatible stainless steel implant which allows immediate control of blood flow on removing a catheter from the groin following minimally invasive procedures such as angiogram, angioplasty or stent placement.
European market launch for AstraPlug is anticipated in the first half of 2010.
About 10 million patients undergo cardiac and peripheral catheterisation procedures annually. This involves the temporary insertion of the catheter into an artery through a vascular puncture.
While a variety of legacy methods cause significant discomfort and require several hours of bed rest, AstraPlug was able to achieve an excellent average time to haemostasis (30 seconds) in a painless manner in the trial group.
“Results from this First-in-Man study are very encouraging,” explained Dr Niall Mulvihill, Department of Cardiology, St James's Hospital, Dublin.
“AstraPlug achieved excellent results even in patients on anticoagulation and suffering from peripheral vascular disease. The rapid haemostasis, minimal training requirement, lack of necessity to exchange the procedure sheath and excellent patient comfort are clear advantages of using the AstraPlug device,” said Mulvihill.
CEO Dr James Coleman, R&D director Christopher Cummins and Dr Robert Perryman, CEO of AltaScience Limited, founded Vasorum Ltd in October 2005.
The trial included the AstraPlugTM device in both 5F and 6F sizes and comprised both diagnostic and interventional cases. The study has been carried out at St. James's Hospital Dublin, by Mulvihill, Dr Peter Crean, chief Dr med Eberhard Grube and colleagues at the Helios Heart Centre in Siegburg, Germany.
“Vasorum has endeavoured to develop the ideal percutaneous arterial puncture closure device,” explained Coleman.
“We believe that this innovative technology will impact very positively on the clinical management of patients undergoing percutaneous interventional vascular procedures.”
“With the market estimated to hit US$1 billion by 2010, the health-care industry in both the US and Europe is crying out for a device such as AstraPlug which will address both hospital’s need for cost effectiveness and patient needs for a speedy recovery,” Dr Coleman added.

Hemostasis, Control of Bloodloss - War, EMS, Military,First Resonders, Ambulance

Cryolife, Bioglue - Chronic Inflammation and Foreign-Body Reaction

Vascular Solutions and Orthovita to present at UBS Global Life Sciences Conference

MINNEAPOLIS, Sept. 15, 2009 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to present at the 2009 UBS Global Life Sciences Conference in New York City on Tuesday, September 22, 2009 at 8:00am (EDT). Howard Root, Chief Executive Officer of Vascular Solutions, will deliver the Company's presentation. To hear the live audio webcast and view the slides of the Vascular Solutions' presentation, go to the investor relations page of the Company's web site http://www.vascularsolutions.com and click on the "IR Conferences" icon a few minutes prior to start time to download any necessary software.

MALVERN, Pa.--(Business Wire)-- Orthovita, Inc. (NASDAQ:VITA), an orthobiologics and biosurgery company, announced today that it will present at the UBS Global Life Sciences Conference in New York City. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Monday, September 21st, at 1:00 p.m. Eastern Time, at the Grand Hyatt New York, 109 East 42nd Street at Grand Central Terminal, New York, New York. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://cc.talkpoint.com/ubsx001/092109a_ke/?entity=67_MRUUVNQ.

Thrombin in Children

Please find below another reader supplied paper. Thanks to contributor's for assisting further understanding for our community. If you have further articles you consider valuable inclusions for our Clinical Papers Section of the blog please forward to me for review. Of course you can post your own thoughts directly in the forum, available for direct communication with other users.

Thanks HG

Haemacure presentation

MONTREAL, Sept. 14 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX : HAE) reported today on current activities and released the financial results of its third quarter endedJuly 31.
Current Activities
Haemacure and Angiotech Pharmaceuticals, Inc. started work pursuant to the strategic collaboration entered into inJune 2009, including the shipment of product to Angiotech. This collaboration provides Angiotech with license, distribution and supply rights for Haemacure's all-human fibrin sealant and thrombin products, both of which are in development.
Haemacure is actively preparing for the pivotal phase II/III clinical trials for its fibrin sealant and is seeking additional financing.
"We are very pleased with the strategic collaboration Haemacure entered into with Angiotech, which provides liquidity and an important validation of our company and its product candidates." said Joseph Galli, Chairman and Chief Executive Officer of Haemacure. "In addition, we are in discussion with other parties who need fibrin sealant and thrombin to enable their products." concluded Mr. Galli.
Financial Position
Cash, cash equivalents and investments amounted to$336,598 as at July 31, 2009, as compared to $4.6 million as at October 31, 2008. Haemacure estimates that it has cash, and access to liquidity as a result of the transaction with Angiotech, to enable it to operate until the end of calendar year 2009.
Results
Revenues amounted to $15,390, as compared to $25,593 for the same quarter last year. Revenues were exclusively derived from the sale of legacy fibrin sealant application devices. Operating expenses amounted to $824,634, down from $2 million for the same quarter last year. The decrease was mainly attributable to foreign exchange fluctuation and the major cost cutting measures implemented in February 2009 to preserve cash. The consolidated net loss for the quarter amounted to $798,852, or nil per share, as compared to $2 million, or $0.01 per share, for the same quarter last year.

Zymogenetics - Webcast

Full webcast available at www.zymogenetics.com

CryoLife Announces First Clinical Use of BioFoam

ATLANTA and LONDON, Sept. 10 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced the first clinical implant of its BioFoam(R) Surgical Matrix, which received CE mark approval in August 2009. BioFoam was used in a liver resection procedure following tumor removal as a supplemental measure to promote hemostasis (a complex process that stops bleeding) by sealing vessels. "Despite advances in surgical technique, bleeding complications continue to be a problem in liver resection surgery and can be life-threatening," said Professor Brian Davidson, MD,

FRCS, Professor of Surgery, Department of Surgery, Royal Free Hospital in London who performed the procedure on September 9. "We are very hopeful that BioFoam will reduce the time required to achieve hemostasis during liver resection surgery and will reduce the number of complications following surgery."

CryoLife is conducting a controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. The objectives of this 45-patient controlled launch, in which BioFoam is used as a surgical hemostatic adjunct in the open repair of liver parenchyma following liver resection and/or liver transplant surgery, are to (1) collect additional clinical data supporting the safety and performance of BioFoam and (2) further refine the optimal application technique. "The clinical availability of BioFoam is another milestone in the company's corporate objective of providing world-class surgical options for the control of intraoperative bleeding," said Steven G. Anderson, CryoLife president and chief executive officer. "We believe the unique adherence and expansion characteristics of this product make it useful for organ sealing and other future surgical applications. It is a wonderful complement to our existing hemostasis products, BioGlue(R) and HemoStase(TM)." In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the company's BioFoam IDE submission for liver parenchymal sealing. The feasibility phase will enroll a total of 20 subjects at two investigational sites in the U.S. Before beginning this phase, the Company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the study from the U.S. Department of Defense. CryoLife is in the final stages of this approval process and expects to start enrollment in Q4 2009. During the European Association of Cardio-Thoracic Surgery (EACTS) annual meeting in Vienna, Austria Oct. 17-21, booth 43, CryoLife will be soliciting input from the attendees on potential future clinical applications for the use of BioFoam in cardiothoracic surgery. About BioFoam BioFoam, a protein hydrogel biomaterial developed by CryoLife, contains an expansion agent which generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis. It is easily applied and can be used intraoperatively to control internal organ hemorrhage, limit blood loss, and reduce the need for future reoperations in liver resections. BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed. BioFoam received CE mark approval for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.

Haemacure announces its presentation at the Rodman Renshaw 11th Annual Healthcare Conference

MONTREAL, Sept. 8/PRNewswire-FirstCall/ - Haemacure Corporation (TSX:HAE), a specialty bio-therapeutics company, announces that its Chairman and CEO, Mr. Joseph Galli, will present at the Rodman Renshaw 11th Annual Healthcare Conference onSeptember 9, 2009 at 2:00 p.m. at the New York Palace Hotel in New York.
The presentation will be live by webcast at http://www.wsw.com/webcast/rrshq15/hae.to. Please visit the site at least five minutes prior to start time for instructions.

DuraSeal Spine Sealant Receives FDA Approval

WALTHAM, Mass.--(Business Wire)--
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has approved DuraSeal spine sealant for use in the United States. This is the first product that has been approved specifically as an adjunct to suturing for intra-operative dural sealing in spine procedures.
DuraSeal spine sealant has been shown in a U.S. pivotal study to deliver an intra-operative watertight seal 100% of the time1. In the same study, commonly used sealing methods achieved an intra-operative watertight seal only 64% of the
time. The remaining patients were treated with additional products and/or techniques to achieve a watertight seal.
"DuraSeal continues Covidien`s dedication to scientific, evidence-based innovation that improves patient outcomes," said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, Covidien.
"There`s a critical need to resolve cerebrospinal fluid leaks within the OR. We cannot continue with the procedure until we`ve dealt with the leak," said Dr. Neill Wright, Associate Professor, Neurological & Orthopedic Surgery, Washington University School of Medicine.
The DuraSeal spine sealant is designed to be a quicker solution than conventional sealing methods, for surgeons who are faced with a dural tear:
* The fast-acting, self-contained sealant gives surgeons the only FDA-approved, easy-to-use solution for sutured dural tears, which occur in nearly 10% of all spinal surgeries.
* The DuraSeal spinal sealant only takes two minutes to prepare for use and three seconds to set, so surgeons can quickly complete an intra-operative dural seal.
* The same formulation was approved by the FDA in 2005 and is currently on the market for cranial procedures. Since its approval, more than 210,000 units have been sold worldwide. DuraSeal Cranial and DuraSeal Xact ABS (spine) are also available in Europe and other international markets.
Covidien expects to launch DuraSeal spine sealant in the next few weeks.

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.”

Irish HIQA will look at prion test for vCJD

Ireland - The Health Information and Quality Authority (HIQA) is to examine the introduction of prion testing and prion filtration to safeguard against the transmission of variant Creutzfeldt Jakob disease (vCJD) from blood donations.
Irish Medical Times has learned that the Chief Medical Officer of the Department of Health, Dr Tony Holohan, is due to discuss with HIQA the question of an ‘appropriate assessment with regard to the potential introduction of these technologies in the future’.
Such a review is likely to take the form of a Health Technology Assessment (HTA), designed to inform decision makers on safe and effective health policies that are patient-focused and achieve best value for money. The Irish Blood Transfusion Service (IBTS) has already estimated that introducing the technologies could cost up to E75 million over the next five years.
However, it believes applying formal evaluations to the cost of prion filtration and prion testing is ‘fraught with difficulty’.
IBTS Medical and Scientific Director Dr Willie Murphy told IMT that blood products had a ‘special status’, equivalent more to pharmaceuticals than healthcare interventions. “We don’t say to the pharmaceutical manufactures that we’ll leave out that safety step, or drop that quality control, to take 10 cent off the price.
“If a new, better test for HIV becomes available, of course we spend the money to do it. As a nation, we would be appalled if we didn’t,” Dr Murphy added.

Zymogenetics - Webcast

SEATTLE--(Business Wire)--
ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today that senior executives will provide updates on company activities at two upcoming investor conferences. James A. Johnson, Executive Vice President and Chief Financial Officer, will
present at the Thomas Weisel Partners Healthcare Conference in Boston on Thursday, September 10, 2009 at 3:15 p.m. Eastern Time. Douglas E. Williams, Ph.D., Chief Executive Officer, will present at the UBS Global Life Sciences Conference in New York City on Wednesday, September 23, 2009 at 9:30 a.m. Eastern Time.

Live webcasts of the presentations can be accessed by going to:
www.zymogenetics.com. The webcasts will be archived for 30 days.

Accumetrics, Inc. Forms Partnership With Grifols as Its Distributor in Spain, Portugal...

SAN DIEGO, Sept. 2 /PRNewswire/ -- Accumetrics, Inc. has announced the signing of a new exclusive distribution agreement for its VerifyNow(R) System in Spain, Portugal and Chile with Grifols S.A.. This distribution agreement will continue to expand Accumetrics' reach in both scope and geography, and add to the growing numbers of countries where physicians have access to the VerifyNow System. The VerifyNow System assesses response to life-saving antiplatelet therapies, such as aspirin, Plavix(R), Effient(R) and GP IIb/IIIa inhibitors. Patients respond to antiplatelet medications differently and these tests help physicians ensure their patients are receiving the optimal treatment. "We're extremely excited to see distribution of our VerifyNow System reach Spain, Portugal and Chile. We have chosen Grifols as our exclusive partner based on their demonstrated market development expertise as well as their existing customer base," said Timothy I. Still, President and CEO of Accumetrics. "This partnership continues to emphasize our focus on expanding our global distribution channels, and supports our vision to provide

physicians access to critical information for managing their cardiovascular patients on antiplatelet therapies." "We are pleased to join forces with Accumetrics in the distribution of the VerifyNow System in the Spanish, Portuguese and Chilean markets. This system perfectly complements Grifols' Hemostasis line of products and aligns with our marketing and sales strategy," added Ramon Riera, Vice President of Grifols S.A.
About Accumetrics (www.accumetrics.com) Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment. Accumetrics' VerifyNow System is the first rapid and easy to use platform for measuring an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient(R)) and clopidogrel (Plavix)), and the GP IIb/IIIa inhibitors (e.g. ReoPro(R) and Integrilin(R)), the VerifyNow System provides a valuable tool to help physicians make informed treatment decisions. The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis. Effient is a registered trademark of Lilly-Daiichi Sankyo.
About Grifols (www.grifols.com) Grifols is a Spanish-based holding company specializing in the pharmaceutical-hospital sector and is present in more than 90 countries. Since 2006, the company has been listed on the Spanish Continuous Market and forms part of the Ibex-35. Currently it is the first company in the European sector in plasma derivatives and the fourth in production worldwide. In upcoming years, the company will strengthen its leadership in the industry as a vertically integrated company, thanks to recent investments and those which will be carried out in 2008-2012, representing 400 million euros. In terms of raw materials, Grifols has ensured its plasma supply with 80 plasmapheresis centers in the United States and in terms of fractionation, its plants in Barcelona (Spain) and Los Angeles (United States) will allow the company to respond to the growing market demand. Nevertheless, the company is preparing for sustained growth in the following 8-10 years and has launched an ambitious investment plan. Grifols has created three divisions to offer specialized products and services grouped according to the distinctive needs they serve: Bioscience, Hospital and Diagnostics. Distribution of the VerifyNow System will complement its Diagnostics division as well as provide significant leverage to its Hospital Supply division.

Endoscopic ligation plus terlipressin prevents rebleeding of esophageal varices

NEW YORK (Reuters Health) - Combining the vasoconstrictor terlipressin with endoscopic variceal ligation reduces very early bleeding of esophageal varices significantly more than terlipressin alone, Taiwanese researchers report in the September issue of Gut.
"Acute esophageal variceal hemorrhage is a dreadful complication of portal hypertension," note Dr. Gin-Ho Lo and co-researchers at I-Shou University in Taipei. Even after treatment, "a high frequency of early rebleeding (30%-50%) may still be encountered in the first few days of acute hemostasis."
To see if dual therapy would lessen that risk, the research team studied 93 adult patients with cirrhosis who did not have active variceal bleeding at initial emergency endoscopy, comparing endoscopic variceal ligation plus two days of terlipressin infusion (intravenous infusion 1 mg every 6 hours for 48 hours) with five days of

terlipressin alone. Between February 2005 and January 2007, the study recruited patients from 18 to 75 years old, with 46 randomized to the terlipressin-only group and 47 assigned to the combination-therapy group.
Very early rebleeding (within 48 to 120 hours) was seen in seven patients in the terlipressin-only group, but in none of the patients who also received endoscopic variceal ligation (p = 0.006).
Treatment failure, defined as failure to control acute bleeding episodes or very early rebleeding or death within five days, occurred in 24% of the terlipressin-only group and only 2% of the combined-therapy group (p = 0.002). In addition, the need for transfusion was significantly lower in the terlipressin-plus-ligation group, as was the likelihood of needing intensive care.
Three patients died in the terlipressin group (two from variceal hemorrhage and aspiration pneumonia in one), and one patient in the combined group died of sepsis.
Nonetheless, the researchers noted that complication rates and 6-week survival were similar in both groups.
Although endoscopic therapy plus vasoconstrictors is the standard therapy for acute variceal hemorrhage, Dr. Lo told Reuters Health, there has been concern that the use of endoscopic therapy could increase adverse events.
An accompanying editorial by Drs. Francesco Salerno and Massimo Cazzaniga of the University of Milan, Italy, noted that the risk of death from shock, terminal liver failure, kidney failure, sepsis or multiorgan failure is "markedly increased by early rebleeding."
Both the report and the editorial noted that, considering the reasons for which patients were excluded from the study (such as hepatocellular carcinoma, age over 75 or taking beta-blockers), the results apply only to the specific subpopulation studied.
Gut 2009;58:1182-1183,1275-1280.

Safety of topical thrombins: the ongoing debate

Until recently, only bovine-derived thrombin was available for use as a stand-alone topical hemostat or as a component of other hemostatic devices. Concerns over a number of case reports of immune-mediated coagulopathies associated with the use of bovine-derived thrombin resulted in a United States Food and Drug Administration warning letter being issued in 1996 and the later addition of a boxed warning ("Black Box Warning") to all bovine-derived thrombin products.

Since 2007, both a human-pooled plasma thrombin product and a recombinant thrombin have entered the market.With the addition of these two products to the topical thrombin class, a unique situation has developed in which only a single member (bovine-derived thrombin) within the class carries the Food and Drug Administration's strongest cautionary language about possible adverse events related to an agent's use. Neither the human-pooled plasma thrombin nor the recombinant thrombin products have a boxed warning; although, the human-pooled plasma product does include a precaution/warning about infectious agent transmission - a warning common to products derived from human sources.

This report will address this unique situation and the impact, clinical and non-clinical, that thrombin choice may have. Since alternatives are now available, institutions may need to revisit their formulary choice of thrombin preparation, taking into consideration the potential risks associated with bovine-derived products.

Special Challenges of Hemophilia Patients and Their Families

PRINCETON, N.J., Aug. 27 /PRNewswire-FirstCall/ -- More than 160 families of patients living with a rare form of hemophilia are coming together at educational summits sponsored this fall by the National Hemophilia Foundation (NHF) and the Center for Biomedical Continuing Education (CBCE). For the fifth year, the Inhibitor Education Summits will connect patients and their families with expert healthcare professionals and fellow patients to address pertinent topics such as effective pain management, exercise and nutrition, financial security, and psychological wellbeing. The summits are supported by an educational grant from Novo Nordisk.

Hemophilia is a chronic, inherited bleeding disorder that occurs because certain blood clotting factors are missing or do not work properly. Spontaneous internal bleeding can occur, especially in the joints and muscles.

The 2009 summits will take place in Hollywood, C.A., August 27-30 and in Washington, D.C., September 17-20. These summits are the first and only events of their kind that focus specifically on patients with inhibitors. Inhibitors are rare, affecting approximately 800 to 900 Americans. Inhibitors are a serious complication that can develop after treatment in as many as 30 percent of people with hemophilia, most commonly in young children. These patients develop antibodies (or inhibitors) that circulate in the blood stream and actually neutralize, or attack clotting replacements, resulting in an increased risk of bleeding, arthropathy (or joint disease), physical disability and death.

People living with this disease often navigate tremendous challenges, both physically and emotionally. Sid Ramirez, age 21, has lived with hemophilia his entire life. He developed inhibitors at the age of three. His condition led to significant problems with his knee joints, leaving Sid wheelchair bound by age 11. He underwent lateral knee replacement surgery as a teenager, which enabled him to walk again.

"The summits allow others living with inhibitors and their families to learn from each other's experiences and from experts. No one can understand what you go through as well as those who have experienced it themselves and their families," said Sid. "Hemophilia has significance in the decisions I make, but I will not let it be the deciding factor." Currently enrolled in culinary school to pursue his lifelong passion for cooking, Sid is excited about the future ahead.

NHF Chief Executive Officer Val Bias has a special reason for participating in the summits. He's also a person with hemophilia.

"Education has been a cornerstone of the NHF, and the Inhibitor Education Summit is a prime example of that," said Bias, who will also speak at both summits. "We believe it is critical to be able to provide these kinds of programs that help patients and their families achieve greater success in managing inhibitors."

In addition to education for patients and caregivers, there is a comprehensive Youth Camp for children with inhibitors and their siblings. Children attending the Youth Camp will have the opportunity to show their parents all that they have learned during their time at "camp." There is also ample time for networking with other families and "ask the experts" sessions to interact with physicians and other key opinion leaders in the field. Since the Inhibitor Education Summits began in 2005, hundreds of families have benefited from this unique opportunity to learn and connect with others who share their experience.

"Comprehensive management of hemophilia with inhibitors is vital for maximizing the quality of daily life for patients with this difficult condition," said Dr. Guy Young, Director, Hemostasis and Thrombosis Center, Childrens Hospital Los Angeles and co-chair of the summits. "The 2009 Inhibitor Education Summits provide patients and their families with the opportunity to learn effective management strategies, connect with expert medical professionals, and share experiences with other families." Dr. Leonard Valentino, Director, RUSH Hemophilia and Thrombophilia Center, RUSH University Medical Center, is also co-chair of the summits.

For more information about The Inhibitor Education Summits, log onto www.inhibitorsummits.org.

About the National Hemophilia Foundation (NHF)

The National Hemophilia Foundation is dedicated to finding better treatments and cures for bleeding and clotting disorders and to preventing the complications of these disorders through education, advocacy and research. Established in 1948, the National Hemophilia Foundation has chapters throughout the country. Its programs and initiatives are made possible through the generosity of individuals, corporations and foundations as well as through a cooperative agreement with the Centers for Disease Control and Prevention (CDC).

About CBCE(TM) (The Center for Biomedical Continuing Education)

The CBCE(TM) is a full-service provider of accredited CME/CE with a circular scope of capabilities. Since 1999, the CBCE has partnered with clinical experts in solid tumors and hematologic malignancies to develop and implement local, regional, national and international medical education initiatives designed to accelerate the adoption of best practices and clinical breakthroughs in oncology. The CBCE is dedicated to creating rigorous educational programs at the forefront of science, customized according to the target audience. Our unique experience in oncology and hematology has resulted in an in-depth understanding of the nuanced working lives and learning styles of the specialists, nurses, and pharmacists involved in cancer care, an understanding that informs the development of all interventions.

The CBCE vision is to encourage healthcare professionals to commit to change and to define distinct outcomes in their practices that will improve patient care and quality of life.

About Novo Nordisk

Novo Nordisk is a healthcare company with an 86-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs more than 27,000 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For global information, visit novonordisk.com; for United States information, visit www.novonordisk-us.com.

Gecko Stitches

Unlocking the gecko's ability to walk on walls is leading researchers to find a way to replace surgical stitches with sticky tape. As this ScienCentral News video explains, the challenge is to make a surgical tape that works in the wet conditions inside your body.