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Atrium granted approval for hernia repair devices

Atrium Medical has obtained US FDA 510(K) approval for two new Omega 3 surgical mesh products - C-QUR Edge V-Patch and C-QUR Lite V-Patch.

C-QUR Edge V-Patch and C-QUR Lite V-Patch are designed to simplify umbilical, epigastric, trocar-site, and other small abdominal wall hernia repairs. C-QUR Edge V-Patch offers long-term protection from visceral tissue attachment when placed intra-abdominally while the C-QUR Lite version offers superior handling and healing characteristics for a pre-peritoneal repair.

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 polypropylene surgical mesh with a proprietary, pharmaceutical grade Omega 3 fatty acid bio-absorbable gel coating.

The use of Atrium’s all natural Omega 3 bio-absorbable coating with its advanced lightweight surgical mesh is said to provide clinicians with a broad spectrum of options for soft tissue repair. Atrium’s C-QUR Edge V-Patch and C-QUR Lite V-Patch will be available in a variety of sizes mid-year 2008.