Healthcare Industry News:  bioabsorbable 

Devices Surgery FDA

 News Release - April 9, 2007

Atrium Medical Receives FDA Approval for its Novel C-QURLite(TM) Mesh

HUDSON, N.H., April 9 (HSMN NewsFeed) -- Atrium Medical Corporation is pleased to announce it has obtained US FDA 510(K) approval for a new Omega 3 surgical mesh product called C-QURLite(TM) 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 ProLite Ultra(TM) polypropylene surgical mesh with a proprietary, pharmaceutical grade Omega 3 fatty acid bio-absorbable gel coating. Unlike traditional tissue separating mesh products, C-QURLite Mesh enhances the handling stiffness and healing response in pre-peritoneal placement when compared to other "bare" polymer mesh products currently used for hernia repair.

C-QURLite Mesh is constructed from the refined ProLite Ultra polypropylene monofilament, providing a low profile, strong, lightweight base structure. The novel all natural Omega 3 gel coating is then applied in a proprietary method, coating each monofilament of the mesh to enhance material handling and subsequent healing. This non-polymeric, bio-absorbable coating has demonstrated in pre-clinical studies to significantly improve anatomical conformance by reducing aggressive, dense acellular collagen formation known to induce adhesions following surgery.

Atrium's discovery of combining inert thin wall polypropylene mesh with an Omega 3 biological coating in pre-clinical studies has demonstrated minimization of peritoneal tissue attachment as well as a significant reduction in both foreign body reaction and inflammation, resulting in a well healed, reinforced soft tissue repair. The novel C-QURLite Mesh BAO coating (bioabsorbable Oil) also enhances ease of handling and tissue plane placement, which subsequently forms into an elegant soft and flexible implant. It offers improved stiffness and handling qualities preferred by many of today's discriminating surgeons while maintaining excellent see-thru visibility to underlying tissue landmarks for improved anatomical orientation during surgical installation.

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 first to market BAO coating technology enables cells to freely grow through the porous mesh implant during healing immediately following soft tissue repair. Atrium's C-QURLite Mesh will be available in a wide variety of preferred anatomical laser cut shapes and sizes mid-year 2007.

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 Atrium's website http://www.atriummed.com.


Source: Atrium Medical

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