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Total 52 results found since Jan 2013.
Cohera Medical, Inc.® Receives PMA Approvable Letter from U.S. FDA for TissuGlu® Surgical Adhesive
PITTSBURGH, Jan. 6, 2015 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) that the pending Premarket Approval Application (PMA) for its TissuGlu® Surgical Adhesive is Approvable. The receipt of the Approvable Letter means that the FDA has largely approved all parts of the PMA. The Company expects to work with the FDA to reach a final approval on the application within a few weeks."The receipt of the PMA Approvable Letter is a truly significant mileston...
Source: Medical Hemostat - January 6, 2015 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Comparison of methods to achieve artery closure following coronary angiography
Stefanie Schulz-Schupke, M.D., of the Deutsches Herzzentrum Munchen, Technische Universitat, Munich, Germany and colleagues assessed whether vascular closure devices are noninferior (not worse than) to manual compression in terms of access site-related vascular complications in patients undergoing diagnostic coronary angiography. The study appears in the November 19 issue of JAMA, a cardiovascular disease theme issue.Percutaneous (through the skin) coronary angiography and interventions have become a cornerstone in the diagnosis and treatment of coronary artery disease. A substantial proportion of the adverse effects assoc...
Source: Medical Hemostat - November 16, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Start-up pitches high-tech glue for surgical leaks
TEL AVIV — An Israeli medical-device start-up is tackling one of the most dangerous occurrences in surgery — and it's doing it with glue.LifeSeal is a glue-like substance that augments and, in some surgeries like hernias, replaces the traditional and painful sealing procedures of staples, tacks and sutures.The privately-owned Israeli company behind the high-tech glue, LifeBond, says it should help in the treatment of post-operative leaks in closures of gastrointestinal and other surgical wounds. Patients get back up to speed more quickly and are more comfortable as they do.Orahn Preiss-Bloom, one of LifeBond's co-found...
Source: Medical Hemostat - November 16, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Synthetic platelets helps clot blood faster
New York: Taking a cue from the human body’s own blood-clotting process, researchers at University of California, Santa Barbara have developed synthetic platelets that can do more than clot blood.By creating nanoparticles that mimic the shape, flexibility and surface biology of the body’s own platelets, the team was able to accelerate natural healing processes while opening the door to therapies and treatments that can be customised to specific patient needs.“This is a significant milestone in the development of synthetic platelets, as well as in targeted drug delivery,” said Samir Mitragotri, director of Center fo...
Source: Medical Hemostat - November 16, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Interesting Thrombin Slides
https://drive.google.com/file/d/0B6J8c60Kq5rVekNoT0sxcEVmbzg/view?usp=sharing
Source: Medical Hemostat - November 3, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
HaemoCer approved for use in China and Canada
BioCer Entwicklungs GmbH (BCE), a German implantable biological medical device development and manufacturing company, announced today that it has achieved approval to commence sales of HaemoCer™, an Absorbable Polysaccharide Hemostat (APH), in the People's Republic of China."BioCer has now achieved near comprehensive Asia-Pacific regional representation, and the addition of the PRC approval of HaemoCer™ is a significant milestone," Dr Markus Heinlein, Managing Director stated. "The entry into China of our first product HaemoCer™ has been assisted by the early establishment of region...
Source: Medical Hemostat - October 8, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Cardiva Medical, Inc. Announces Completion of the first two tranches of Series 3 Private Equity Financing and the Closing of a Senior Secured Debt Facility with GE Capital
SUNNYVALE, Calif., Aug. 19, 2014 /PRNewswire/ -- Cardiva Medical, Inc. announced today that it has closed the first two tranches of a$16.5 million Series 3 private equity financing and a $12.5 million senior secured facility with GE Capital. The Company will use the proceeds of the Series 3 private equity financing and debt facility to expand commercial efforts for its VASCADE® Vascular Closure System in the United States.Investing in Series 3 private equity financing was a new investor, Canepa Advanced Healthcare Fund, L.P., who joined existing investors PTV Sciences, AmKey Ventures and...
Source: Medical Hemostat - August 19, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Transluminal Tech’s velox CD Arterial Closure Device Gets EU Approval
Transluminal Technologies LLC. out of Syracuse, New York won the CE Mark for its velox CD Vascular Closure Device used to close arteriotomies following percutaneous femoral procedures. Closing arteries can be a challenge, eating up surgeons’ time just when it’s optimal to move the patient out of the OR. The velox CD device speeds up this process by delivering an implant that plugs the vessel wall from within.The implant consists of an intraluminal footplate that absorbs within about 24 hours and a extraluminal plug that takes two weeks to absorb. The components are made of a proprietary magnesium alloy that breaks...
Source: Medical Hemostat - August 5, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Clot-building nanoparticles raise survival rate following blast trauma Read more: Clot-building nanoparticles raise survival rate following blast trauma
A type of artificial platelet being developed to help natural blood platelets form clots faster offers promise for saving the lives of soldiers, as well as victims of car crashes and other severe trauma.In preclinical tests led by a Case Western Reserve University researcher, the artificial platelets, called "hemostatic nanoparticles," when injected after blast trauma dramatically increased survival rates and showed no signs of interfering with healing or causing other complications weeks afterward."The nanoparticles have a huge impact on survival—not just in the short term, but in the long term," said Erin Lavik, an ass...
Source: Medical Hemostat - June 30, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
A device to control bleeding in brain surgery receives Phase 2 SBIR grant
A medical device developer got a big boost in its efforts to develop a surgical sealant for brain surgery. Endomedix received a $1.49 million Phase 2 Small Business Innovation Research grant to help control bleeding for surgical procedures, according to a company statement. It received the grant from the National Institute of Neurological Disorders and Stroke.The funding will go toward safety studies, in vivo performance studies and developing an applicator device. The sealant is a hydrogel that includes two processed biocompatible polysaccharides. They are simultaneously mixed and sprayed onto a surgical site.Typically, a...
Source: Medical Hemostat - June 3, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Cohera Medical, Inc.® Files for CE Mark Approval for Sylys® Surgical Sealant
PITTSBURGH, May 15, 2014 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has applied for CE Mark approval for Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks in gastrointestinal procedures. CE Mark approval, expected by the end of 2014 based on this filing, will allow for marketing of the product in the European Union and other countries.Sylys is applied during gastrointestinal procedures to help prevent the occurrence of anastomotic leaks ...
Source: Medical Hemostat - May 18, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Z-Medica Bolsters Hemostatic Product Line with Acquisition of Novacol®
WALLINGFORD, CONN. — Z-Medica, a leading developer and marketer of hemostatic agents, today announced that they have signed a definitive agreement with TAUREON, headquartered in The Netherlands, to acquire Novacol®, a Class III resorbable hemostatic product.Novacol is currently sold in Europe and South Korea. Z-Medica will continue to support that marketing strategy while making plans to expand the product offering into other countries.“Given our QuikClot portfolio of hemostatic dressings, it was a natural fit for us to augment both our product line and our international presence with Novacol,” said Z-Medica’s Pre...
Source: Medical Hemostat - May 5, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
The Medicines Company Adds Novel, Approved, Surgical Sealant to Its Surgical Hemostasis Portfolio Acquires Tenaxis Medical, Inc.
PARSIPPANY, NJ and MOUNTAIN VIEW, CA -- (Marketwired) -- 04/23/14 -- The Medicines Company (NASDAQ: MDCO) and Tenaxis Medical, Inc. (Tenaxis) today announced an agreement for The Medicines Company to acquire Tenaxis. Tenaxis's sole product, which mechanically seals both human tissue and artificial grafts is approved, but not launched in the US -- having received US PMA approval from the FDA in March 2013 as a vascular sealant. The product is also approved with a European CE Mark as a surgical sealant applicable to cardiovascular, general, urological, and thoracic surgery. The addition of the Tenaxis product adds another so...
Source: Medical Hemostat - April 23, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
FDA Accepts Biologic License Application for Fibrocaps Hemostatic Agent
The Medicines Company has announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical. The FDA action date (PDUFA date) for Fibrocaps is January 31, 2015. In August 2013, The Medicines Company announced that the Phase III trial, FINISH-3, which studied a total of 719 patients across 54 sites in the U.S. and W...
Source: Medical Hemostat - April 5, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Drug companies developing longer-acting clotting agents for hemophiliacs
Several drug companies, such as Biogen Idec and Novo Nordisk, are developing new, longer-acting versions of the blood clotting factors used by people with hemophilia. Patients with severe forms of the disease need regular infusions, lasting 30 minutes or more, of relatively short acting and very expensive clotting factors.The new longer-lasting hemophilia B products can be given every 10 days or two weeks, offering significant advantages for patients, especially young children, who now need infusions every two or three days.Hemophilia is hereditary, passed from parent to child through genes. People with hemophilia have lit...
Source: Medical Hemostat - March 23, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
