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Atrium’s “lite” mesh gets 510(k)

This article was originally published in The Gray Sheet

Executive Summary

Atrium Medical gains 510(k) clearance for C-QURLite Mesh, indicated for surgical repair and reinforcement of soft tissue, including hernia repair, the firm says April 9. The device combines the firm's ProLite Ultra polypropylene monofilament surgical mesh with a proprietary, pharmaceutical grade Omega 3 fatty acid gel coating that is bio-absorbable. The Omega 3 coating minimized peritoneal tissue attachments and reduced both foreign body reaction and inflammation in pre-clinical studies, the firm says. Atrium's ProLite Ultra mesh received 510(k) clearance March 8. The firm's C-QUR Mesh was 510(k)-cleared in March 2006...

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