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Atrium Medical receives FDA approval for its novel C-QUR™ Coated Mesh. |
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11 Apr 2006 |
HUDSON, NH, USA | Apr 10, 2006 | Atrium Medical Corporation is pleased to announce it has obtained US FDA 510(K) approval for a new bio-absorbable coated surgical mesh product called C-QUR™ Mesh .
This new product is indicated for use in the surgical repair and reinforcement of soft tissue, including hernia repair - a common procedure performed more than 700,000 times in the US each year. This novel technology combines Atrium's industry leading ProLite Ultra™ polypropylene surgical mesh with a proprietary, pharmaceutical grade Omega 3 fatty acid bio-absorbable coating. Atrium's discovery of combining an inert thin wall polypropylene mesh with an Omega 3 biological coating in pre-clinical studies has demonstrated a minimization of peritoneal tissue attachment as well as a significant reduction in both foreign body reaction and inflammation, resulting in a well healed, reinforced repair.
The use of Atrium's all natural Omega 3 bio-absorbable coating with its advanced lightweight surgical mesh provides today's clinicians with a broad spectrum of options for both laparoscopic and open surgical repair. This is the first known non-polymeric, bio-absorbable coating which has demonstrated in pre-clinical studies to significantly improve anatomical conformance by reducing aggressive, dense acellular collagen formation. These same studies confirmed that with the addition of Atrium's proprietary Omega 3 coating technology, C-QUR Mesh also experienced less material contraction following healing when compared with other non-coated “bare polymer” surgical films and more rigid composite surgical mesh products.
About Atrium
Atrium Medical Corporation of Hudson, New Hampshire, celebrating 25 years of US based healthcare innovation manufactures over two million sterile medical devices each year which are distributed worldwide. Atrium's vast expertise in developing medical device technologies for the treatment of cardiovascular disease has brought a number of breakthrough advances in several diversified healthcare markets including interventional cardiology, chest trauma care and thoracic drainage, vascular surgery, hernia and soft tissue repair. Maintaining a commitment to the latest ISO13485 Quality Standards, state-of-the-art manufacturing and automation, cell biology and biomaterial discovery programs, Atrium continues to excel in several specialty healthcare markets requiring surgical intervention. For more information call 800-370-7899 or visit Atrium's website www.atriummed.com
SOURCE: Atrium |
