Atrium Medical Corporation has announced it has obtained US FDA 510(K) approval for a new Omega 3 surgical mesh product called C-QURLite 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.