Healthcare Industry News:  C-QUR Edge 

Devices FDA

 News Release - May 8, 2008

Atrium Medical Receives FDA Approval for its Novel C-QUR Lite(TM) V-Patch and C-QUR Edge(TM) V-Patch

HUDSON, N.H., May 8 (HSMN NewsFeed) -- Atrium Medical Corporation is pleased to announce it has obtained US FDA 510(K) approval for two new Omega 3 surgical mesh products; C-QUR Edge(TM) V-Patch and C-QUR Lite(TM) V-Patch.

These new products are 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 ProLite Ultra(TM) polypropylene surgical mesh with a proprietary, pharmaceutical grade Omega 3 fatty acid bio-absorbable gel 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 tissue attachment as well as a significant reduction in both foreign body reaction and inflammation, resulting in a well healed, reinforced repair.

C-QUR Edge(TM) V-Patch and C-QUR Lite(TM) V-Patch are designed to simplify umbilical, epigastric, trocar-site, and other small abdominal wall hernia repairs. C-QUR Edge(TM) V-Patch offers long-term protection from visceral tissue attachment when placed intra-abdominally while the C-QUR Lite(TM) version offers superior handling and healing characteristics for a pre-peritoneal 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 soft tissue repair. Atrium's C-QUR Edge(TM) V-Patch and C-QUR Lite(TM) V-Patch will be available in a variety of sizes mid-year 2008.

About Atrium

Atrium's vast expertise in medical device technologies for the treatment of cardiovascular disease, hernia and adhesion prevention has brought a number of breakthrough advances in several diversified healthcare markets including interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery, 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 those healthcare segments that require more advanced surgical intervention for improvements in patient outcome. For more information, call 800-370-7899 or visit http://www.atriummed.com.


Source: Atrium Medical

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