Cohera Medical has announced that the US Food and Drug Administration (FDA) General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted unanimously, 11 to 0, on the Safety, 6 to 5 on Efficacy, and 6 to 4 (with one abstention) on the Risk/Benefit of TissuGlu Surgical Adhesive as presented to the Panel.
The indication for use considered during the Panel Meeting was for the use of TissuGlu for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in large flap surgical procedures such as abdominoplasty. If approved, TissuGlu would become the first internal surgical adhesive of its kind approved for large flap surgeries in the United States.
The meeting of the General and Plastic Surgery Devices Advisory Panel was convened by the FDA as part of the PMA review process for TissuGlu. The Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational general and plastic surgery devices and makes appropriate recommendations to the FDA. The FDA is not bound by the Committee’s guidance, but takes its advice into consideration when reviewing medical devices.
In addition to reviewing the Company’s clinical data and product information, the Panel considered data presented by the FDA and testimonies from patients, surgeons and other healthcare professionals shared during the public comment session.
TissuGlu is designed to meet surgeons’ need for a strong, biocompatible, and easy-to-use surgical adhesive. The clinical data submitted in the PMA supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains in large flap procedures, reducing the number of post-operative invasive treatments and improving the patient recovery process.
"Today’s positive Panel outcome is one of the final, and most critical, milestones towards the commercialization of TissuGlu in the U.S., and is the result of a coordinated and collaborative effort by the Cohera Medical team," said Patrick Daly, Cohera Medical president and CEO. "We are very pleased with the outcome of today’s meeting and will continue to work with the FDA to make TissuGlu available to surgeons and patients throughout the United States."
"TissuGlu, which 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," said Joseph P. Hunstad MD, FACS, of The Hunstad-Kortesis Center, Charlotte, N.C. "If approved, it will bring great benefits to both patients and surgeons."
"The positive outcome today is a testament to the scientific leadership and expertise of the Cohera Medical team, which has advanced TissuGlu from concept to commercialization," said J. Peter Rubin, MD, Chief of Plastic Surgery at the University of Pittsburgh. "It is a market innovation that can have a tremendously positive impact on patient care for large flap surgeries."
TissuGlu is targeted for use in large flap surgery procedures in which drains are used to control fluid output and seroma formation. There are approximately 1M US-based large flap procedures per year, growing at an annual rate of 4.8 percent that could utilize TissuGlu. The product has been on the market in the EU since 2011, and currently more than 1,500 procedures have been conducted with TissuGlu bringing great benefit to patients, surgeons, and caregivers.