Archive for the 'Mesh' Category

Atrium Medical receives FDA nod for two new Omega 3 surgical mesh products

C-QURAtrium Medical Corporation has obtained FDA 510(K) approval for two new Omega 3 surgical mesh products; C-QUR Edge V-Patch and C-QUR Lite V-Patch. These new products are indicated for use in the surgical repair and reinforcement of soft tissue, including hernia repair. 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.

Angiotech halts trials for Vascular Wrap

Angiotech LogoAngiotech Pharmaceuticals is halting enrollment in clinical trials for Vascular Wrap, which is being evaluated in patients undergoing surgery for hemodialysis access, pending a safety review. The company has been conducting the study in the U.S. and Europe on two groups, one which received the wrap in combination with a graft and one which received the graft alone. After reviewing a summary of interim adverse events, a data safety monitoring board has informed the company that one of the two study groups had a greater incidence of implant site infection.