Hemostasis News and Research

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Hemostasis or haemostasis is a complex process which causes the bleeding process to stop. Most times this includes the changing of blood from a fluid to a solid state. Intact blood vessels are central to moderating blood's tendency to clot.

First successful closure of gastro-cutaneous fistulas with newly designed OTSC

Gastrointestinal (GI) chronic perforations require closure and control of extraluminal collections and sepsis. Covered self-expandable metal stents or plastic stents are an effective method in more than 80% of cases, but have many drawbacks.

12 Apr 2010

FDA approves TachoSil adjunctive hemostatic agent for use in cardiovascular surgery

Baxter International Inc. and Nycomed today announced the U.S. Food and Drug Administration (FDA) approval of TachoSil (Absorbable Fibrin Sealant Patch) for use as an adjunct to hemostasis in cardiovascular surgery. TachoSil is the first and only adjunctive hemostatic agent available in the U.S. that combines a collagen patch with a coating of human coagulation factors.

From Baxter International Inc. 7 Apr 2010

Cook Medical launches new NavAlign femoral delivery system at SIR Annual Scientific Meeting

Physicians placing inferior vena cava (IVC) filters to prevent life-threatening pulmonary emboli now have access to the latest iteration of Cook Medical’s advanced NavAlign™ delivery system, a deployment system designed to minimize the risk of vessel trauma and streamline filter placement.

15 Mar 2010

Z-Medica announces the launch of QuikClot Grant for U.S. military veterans attending Marietta College

Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced the launch of its QuikClot Grant for U.S. military veterans attending Marietta College. The $25,000 grant will support Marietta College’s Yellow Ribbon Program, which allows qualified veterans to attend the college as undergraduate students and receive full tuition scholarships.

From Medica Corporation 15 Mar 2010

Medafor, Magle Life Sciences of Sweden sign long-term raw material supply agreement

Medafor Inc. announced today that it has signed a long-term raw material supply agreement with Magle Life Sciences of Sweden, the supplier of the key powder component for Medafor’s patented MPH(R) (Microporous Polysaccharide Hemosphere) surgical product, which is used by surgeons to control bleeding in complex surgical operations.

15 Mar 2010

Promising preliminary results from ProFibrix' Phase II trial of hemostat Fibrocaps

ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced the conclusion of the first Phase II trial testing its unique new hemostat Fibrocaps(TM). Promising preliminary data from the European multicenter, open-label trial show compelling safety and efficacy (time to hemostasis) profiles for Fibrocaps, and good performance of the delivery device.

11 Mar 2010

Scientists discover genetic cause of Quebec Platelet Disorder

For some Canadians, any cut such as from dental work or surgery can cause days or more of bleeding. Although they are not hemophiliacs, for some an ordinary bruise can balloon into the size of an orange.

4 Mar 2010

OrthoDynamix' ArthroSteer 3.5mm Ablator for general surgical use receives FDA clearance

OrthoDynamix announced today that it has received FDA clearance for its new device, ArthroSteer 3.5mm Ablator, a mono polar electrosurgical device, for general surgical use, including the orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulating soft tissue in, but not limited to the knee, shoulder, and primarily the hip.

3 Mar 2010

GTC Biotherapeutics achieves high-level production of TG20 monoclonal antibody

GTC Biotherapeutics, Inc. announced that it has achieved high-level production of TG20; an anti-CD20 monoclonal antibody (MAb). The TG20 MAb, which is produced in the milk of transgenic goats, is being co-developed by GTC and LFB as part of the LFB-GTC joint venture.

2 Mar 2010

Bayer HealthCare Pharmaceuticals' RECOTHROM solution receives Health Canada approval

Bayer HealthCare Pharmaceuticals announced today that RECOTHROM(R) (Thrombin alfa (Recombinant)), the first recombinant, plasma-free thrombin approved by Health Canada, is now available for use as a topical hemostatic solution. According to a recent clinical study, RECOTHROM(R) was found to successfully stop 80 per cent of surgical bleeding within three minutes and 95 per cent of bleeding within 10 minutes.

1 Mar 2010

LFB Biotechnologies provides new loan financing to GTC Biotherapeutics for key strategic programs

GTC Biotherapeutics, Inc. (“GTC”, NASDAQ: GTCB) announced that it has entered into an agreement with its strategic partner, LFB Biotechnologies (Les Ulis, France), pursuant to which LFB has agreed to provide $7 million of new loan financing to GTC.

23 Feb 2010

HealthTrust Purchasing Group signs 3-year vascular graft procurement contract with MAQUET Cardiovascular

MAQUET Cardiovascular, LLC, a leading provider of cardiovascular technologies, announced today that it has signed a three year contract with HealthTrust Purchasing Group, LP to provide woven and knitted textile vascular grafts to the HealthTrust membership. The contract includes the HEMASHIELD product line and other vascular grafts, which are used to surgically repair or replace damaged blood vessels, including the aorta.

18 Feb 2010

Health Canada approves Talecris Biotherapeutics' PROLASTIN-C for AAT deficiency

Talecris Biotherapeutics announced today that it has received approval from Health Canada for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more purified and concentrated version of PROLASTIN® produced using advances in manufacturing technology. A similar approval for PROLASTIN-C was granted by the U.S. Food and Drug Administration on October 17, 2009.

17 Feb 2010

FDA grants Talecris Biotherapeutics orphan drug designation for Alpha1-Proteinase Inhibitor to treat AAT deficiency

Talecris Biotherapeutics, Inc. announced today that it was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the development of an aerosol formulation of Alpha1-Proteinase Inhibitor (Human, A1PI) to treat congenital alpha1-antitrypsin (AAT) deficiency. AAT deficiency is a chronic, hereditary condition that increases the risk of certain diseases, especially emphysema, which typically emerges in the fourth decade of life. Currently, there are no approved, inhaled treatments available for the treatment of AAT deficiency.

5 Feb 2010

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

ZymoGenetics, Inc., today announced the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins.

2 Feb 2010

Aubrey receives FDA clearance to market bioengineered wound dressings in U.S.

Aubrey Inc., an advanced wound care company, announced it has received clearance from the US Food and Drug Administration (FDA) to market the AWBAT Plus product line in the United States.

28 Jan 2010

FDA approves Novo Nordisk's Victoza for type 2 diabetes

Novo Nordisk, a global healthcare company, announced today the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza® (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

27 Jan 2010

Novo Nordisk on FORTUNE's "100 Best Companies to Work For" list for second consecutive year

Novo Nordisk, a global healthcare company focusing on diabetes care, has been named to FORTUNE Magazine's list of "100 Best Companies to Work For" 2010. This is the second consecutive year that Novo Nordisk has been recognized with this prestigious award. Novo Nordisk moved up to 25 from 57 in the overall list and is only one of two pharmaceutical/biotechnology companies so honored.

From Novo Nordisk 22 Jan 2010

Three hospitals selected as recipients of the 2009 DVTeamCare Hospital Award

The North American Thrombosis Forum (NATF), in coordination with Eisai Inc., announced today that three hospitals have been selected as recipients of the 2009 DVTeamCare Hospital Award. This new award was established by Eisai to recognize hospitals that have made a significant commitment to preventing deep vein thrombosis (DVT) and its potentially fatal complications, including pulmonary embolism (PE).

20 Jan 2010

New analysis finds cost of diabetes and pre-diabetes reached $218 billion in 2007

A new analysis found that the cost of diabetes and pre-diabetes reached $218 billion in 2007, with the exploding number of cases of type 2 diabetes responsible for the majority of the costs. The National Changing Diabetes® Program (NCDP), a program of Novo Nordisk, commissioned the analysis, published online as a Web First article today in Health Affairs and performed by researchers at The Lewin Group.

13 Jan 2010