FDA
4th August 2014

FDA Device Panel Votes Favorably on TissuGlu Surgical Adhesive

On Friday, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee discussed, made recommendations and voted on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. TissuGlu Surgical Adhesive is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.

FDA Device Panel Votes Favorably on TissuGlu Surgical Adhesive

On Friday, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee discussed, made recommendations and voted on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. TissuGlu Surgical Adhesive is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.

TissuGlu is designed to provide surgeons with a strong, biocompatible, and easy-to-use surgical adhesive as an alternative to closed suction drains in large flap procedures, essentially reducing the frequency of post-operative invasive treatments to facilitate patient recovery. There are approximately 1M US-based large flap procedures per year, growing at an annual rate of 4.8 percent that could utilize TissuGlu. 

Panelists voted unanimously,11 to 0, that TissuGlu was safe for its indicated use, 6 to 5 that the device is efficacious for the proposed indication, and 6 to 4 (with one abstention) on the Risk/Benefit of TissuGlu Surgical Adhesive.

In addition to reviewing the Company’s clinical data and product information, the Panel considered data presented by the FDA and public session comments which included patient testimonies and comments from surgeons and other healthcare professionals.

Joseph P. Hunstad MD, FACS, of The Hunstad-Kortesis Center, Charlotte, N.C. stated that TissuGlu, “has the potential to eliminate wound drainage issues from large flap procedures, represents a major advance in helping patients recover faster and more comfortably following these procedures.” He added, “If approved, it will bring great benefits to both patients and surgeons.”

Cohera Medical, Inc. is a leading innovator and developer of absorbable surgical adhesives and sealants. This product has been on the market in the EU since 2011; however, if approved, TissuGlu would become the first internal surgical adhesive of its kind approved for large flap surgeries in the United States.

Importantly, the FDA is not bound by their Committee’s guidance or decisions, but takes it into consideration when reviewing medical devices. 

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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