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.

New coverage for colorectal cancer screening to drive US markets for gastrointestinal endoscopy devices in 2010

According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, new coverage instituted under the Patient Protection and Affordable Care Act of 2010 will remove the financial disincentives associated with colorectal cancer screening for a large segment of the US population. As a result of these changes in reimbursement, a growing number of colorectal cancer screening procedures will be performed through 2014, driving sales of many gastrointestinal endoscopy devices, including videoscopes and biopsy forceps.

20 Aug 2010

$Study demonstrates efficacy of vertebroplasty in treatment of acute vertebral compression fractures$

Study demonstrates efficacy of vertebroplasty in treatment of acute vertebral compression fractures

Orthovita, Inc., an orthobiologics and biosurgery company, notes that the August 10, 2010 online edition of The Lancet includes the largest peer-reviewed study to date demonstrating the efficacy of vertebroplasty in the treatment of acute vertebral compression fractures compared to conservative treatment.

12 Aug 2010

Talecris and Grifols receive 'Second Request' from FTC regarding proposed merger

Talecris Biotherapeutics Holdings Corp. today announced that Talecris and Grifols S.A. have each received a request for additional information and documentary material, often referred to as a "Second Request," from the U.S. Federal Trade Commission (FTC) in connection with their proposed merger.

10 Aug 2010

IL releases new HemosIL HIT-Ab(PF4-H) assay

Instrumentation Laboratory (IL) today announced the release of the new HemosIL HIT-Ab(PF4-H) assay as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Delivering results in minutes, the HemosIL HIT-Ab(PF4-H) assay detects total immunoglobulin against Platelet Factor 4-Heparin complexes, the antibodies associated with the pathology of HIT.

4 Aug 2010

Orthovita second-quarter operating income improves to $0.4 million

Orthovita, Inc., an orthobiologics and biosurgery company, reported financial results for the quarter ended June 30, 2010. Product sales for the second quarter of 2010 were $23.9 million compared to $24.5 million for the second quarter of 2009. Product sales for the second quarter of 2009 included $0.6 million from the sale of Vitomatrix™, a bone graft material used in dental products. There were no Vitomatrix sales in the second quarter of 2010 and no further sales of Vitomatrix are currently expected.

3 Aug 2010

Talecris Biotherapeutics Holdings second-quarter 2010 net revenue increases 7.3% to $402.8 million

Talecris Biotherapeutics Holdings Corp. today announced its financial results for the three and six months ended June 30, 2010 and filed its 2010 Form 10-Q with the U.S. Securities and Exchange Commission.

29 Jul 2010

FDA clears IL's new point-of-care total bilirubin assay

Instrumentation Laboratory (IL) today announced that it has received clearance from the US Food and Drug Administration (FDA) to market the first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns.

28 Jul 2010

Cardiva Medical, Advanced Vascular Dynamics sign agreement to distribute hemostasis products

Cardiva Medical, Inc. announced today that it has signed an agreement with Advanced Vascular Dynamics to distribute several products used for postcatheterization femoral and radial artery hemostasis in the U.S.

27 Jul 2010

Orthovita's PMA supplement for new collagen processing facility receives FDA approval

Orthovita, Inc., an orthobiologics and biosurgery company, reported today that the U.S. Food and Drug Administration (FDA) approved Orthovita's PMA supplement for a new collagen processing facility in Malvern, Pennsylvania. Orthovita will use the new facility to process the highly purified form of collagen used in its VITAGEL™ Surgical Hemostat product. VITAGEL is a composite liquid hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

26 Jul 2010

Pfizer to present results of hemophilia studies at WFH 2010 Congress

Pfizer Inc, the world's leading biopharmaceutical company, today announced that the results of a number of hemophilia studies will be presented at the World Federation of Hemophilia 2010 Congress taking place July 10-14, 2010, in Buenos Aires, Argentina. Key research includes a pre-clinical evaluation of recombinant factor Xa as a potential new approach to restoring hemostasis, as well as a study assessing the potential for an engineered recombinant factor VIIa molecule to improve therapeutic outcomes in mouse models of hemophilia.

9 Jul 2010

Ethicon launches OMNEX Surgical synthetic sealant

Ethicon, Inc., a worldwide leader in surgical care, announced today the introduction of ETHICON™ OMNEX™ Surgical Sealant, ETHICON™ Biosurgery's first synthetic sealant designed to achieve adjunctive hemostasis (stoppage of bleeding) in vascular reconstructions by mechanically sealing areas of leakage. The US Food and Drug Administration (FDA) recently granted approval of the Premarket Approval Application (PMA) for ETHICON™ OMNEX™ Surgical Sealant.

8 Jul 2010

NHLBI funds nine research grants to determine safety and efficacy of red blood cell transfusions

The National Heart, Lung, and Blood Institute, part of the National Institutes of Health, is funding nine research grants to determine if the safety and efficacy of red blood cell transfusions vary depending on how long the cells have been stored. One of the grants supports the first large, multi-center, randomized clinical trial to compare outcomes in heart surgery patients who receive transfusions of red blood cells that have been stored for shorter or longer amounts of time.

22 Jun 2010

Talecris CEO receives Ernst & Young Entrepreneur Of The Year 2010 Award

Lawrence D. Stern, chairman and CEO of Talecris Biotherapeutics, received the Ernst & Young Entrepreneur Of The Year® 2010 Award in the health sciences category in the Carolinas at a ceremony last night in Charlotte, N.C. The Ernst & Young awards program recognizes entrepreneurs who demonstrate extraordinary success in the areas of innovation, financial performance and personal commitment to their businesses.

19 Jun 2010

GTC Biotherapeutics closes new $7 million secured convertible debt financing

GTC Biotherapeutics, Inc. announced the closing of a new $7 million secured convertible debt financing by its strategic partner, LFB Biotechnologies SAS, in connection with a restructuring of GTC's operations which will result in a downsizing of approximately 30 full-time positions at its headquarters and an additional 20 positions at its farm facility.

16 Jun 2010

Minapharm Pharmaceuticals acquires 95% of the share capital of ProBioGen

ProBioGen AG announced today that Minapharm Pharmaceuticals, Cairo, has completed the acquisition of 95 % of the share capital of ProBioGen, an internationally renowned German cell line development and contract manufacturing specialist. The total purchase price of EUR 30.4 million includes earn-out payments which are conditional upon the achievement of defined milestones.

16 Jun 2010

Grifols to acquire Talecris Biotherapeutics

Grifols a global healthcare company and leading producer of plasma protein therapies, and Talecris a U.S.-based biotherapeutics products company, today announced that they have signed a definitive agreement through which Grifols will acquire Talecris for a combination of cash and newly-issued Grifols non-voting shares having an aggregate value today of approximately $3.4 billion (euro 2.8 billion), creating a global leader of life-saving and life enhancing plasma protein therapeutics.

7 Jun 2010

Cordis announces launch of ExoSeal Vascular Closure Device

Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced the launch of the ExoSeal(TM) Vascular Closure Device. ExoSeal(TM) incorporates a number of new advances in technology and simplicity of design to provide precise and secure extravascular arterial closure. Cordis Corporation received CE-Marking approval for ExoSeal(TM) Vascular Closure Device in May 2010.

27 May 2010

FDA approves ROXRO PHARMA's SPRIX Nasal Spray

ROXRO PHARMA, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SPRIX™ (ketorolac tromethamine) Nasal Spray, for the short-term (up to 5 days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level.

17 May 2010

EES launches two surgical staplers to optimize efficiencies and compression during open surgery

Ethicon Endo-Surgery today announced the launch of two new surgical staplers designed to optimize efficiencies and compression during open surgery. The Ethicon Endo-Surgery Linear Cutter 55/75, engineered with novel staple technology and selectable staple heights in one cartridge, provides superior hemostasis for patients and improved efficiencies to surgeons, nurses and facility administrations. The Ethicon Endo-Surgery Intraluminal Stapler, designed with a new tissue compression scale, provides surgeons improved flexibility and control so that they can address the individual needs of each patient.

15 May 2010

Boston Scientific's ACUITY Break-Away Lead Delivery System receives FDA clearance

Boston Scientific Corporation today announced U.S. Food and Drug Administration clearance of the ACUITY Break-Away Lead Delivery System for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, both of which treat heart failure.

14 May 2010