Cohera Medical, Inc.® has received Investigational Device Exemption (IDE) approval from the FDA to start a prospective, randomized clinical trial for TissuGlu® Surgical Adhesive in the US.
Slated to begin in the first quarter of 2012, the new multi-center study of 150 patients will investigate the effectiveness of TissuGlu and its effect on wound drainage and associated complications in abdominoplasty surgeries. There are currently no FDA-approved medical devices for a synthetic adhesive indicated for approximation of tissues in large flap surgeries.
“We are pleased to have FDA approval to begin this pivotal trial that validates the biocompatibility, pre-clinical testing profile and clinical trial design of TissuGlu,” said Chad Coberly, Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical, in a press release.
Cohera Medical recently received CE Marking approval for TissuGlu in Europe, and began selling the product to hospitals and surgeons throughout Germany in September 2011. The company plans to expand the commercial availability of TissuGlu to additional European markets in early 2012. CE Marking refers to a manufacturer’s declaration that the product complies with the essential requirements of the relevant European governing bodies.
Source: Cohera Medical