Cohera receives IDE approval to begin TissuGlu U.S. trial
Cohera Medical, a developer of absorbable surgical adhesives and sealants, has received Investigational Device Exemption (IDE) approval from the FDA to begin a prospective, multicenter, randomized clinical trial for its lead product, TissuGlu Surgical Adhesive in the U.S.
The study will investigate the effectiveness of TissuGlu and its effect on wound drainage and associated complications in abdominoplasty surgeries. There are currently no medical devices approved by the FDA, or in pivotal clinical trials, for a synthetic adhesive indicated for approximation of tissues in large flap surgeries.
"We are pleased to have FDA approval," said Chad Coberly, vice president of clinical, regulatory and legal affairs of Cohera Medical. "Initiation of this study is planned in the first quarter of 2012 and will be conducted at five clinical sites with 150 patients, and upon favorable conclusion will allow the company to complete a PMA application for TissuGlu with the FDA."
Cohera Medical recently received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. The company plans to expand the commercial availability of TissuGlu to additional European markets in early 2012.