Yet again the CE vs FDA debate is brought into sharp relief with the news that Cohera Medical has announced that FDA has issued an Investigational Device Exemption for TissuGlu to be trialled in the United States. The product is already commercially available in Europe.
Last September we announced Cohera Medical’s gaining of CE mark status for TissuGlu Surgical Adhesive. Now the sealant company has announced today that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (“FDA”) to begin a prospective, multicenter, randomized clinical trial for the product in the United States.
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 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. “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.”
“IDE approval of the TissuGlu study is a significant strategic milestone for Cohera and its investors,” said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “We are encouraged by the initial positive outcomes with TissuGlu in clinical studies and commercial use outside the U.S., and we look forward to working with the FDA to bring this breakthrough technology to clinicians and patients here in the United States.”
Source: Cohera Medical