The FDA today said it granted pre-market approval to Cohera Medical‘s TissuGlu surgical sealant, making good on the approvable letter it sent to Cohera in early January.
TissuGlu is a polyurethane-based sealant designed for use in large-flap surgical procedures including abdominoplasty. It’s been on the market in Europe since September 2011 for the same indication.
"The FDA’s approval of the first synthetic adhesive for internal use will help some abdominoplasty patients get back to their daily routine after surgery more quickly than if surgical drains had been inserted," Dr. William Maisel, deputy director for science at FDA’s Center for Devices & Radiological Health, said in prepared remarks.
An advisory panel for the watchdog agency last August narrowly recommended approval for the TissuGlu adhesive, voting unanimously that TissuGlu is safe; 6-5 that it is effective; and 6-4 with 1 abstention that its benefits outweigh its risks. The FDA sent an approvable letter to Cohera Jan. 6.
Cohera is also pursuing FDA approval for its Sylys anastomosis sealant, which won priority review at the safety bureau last month.
"FDA approval of TissuGlu is the most significant milestone in the company’s history," president & CEO Patrick Daly said in a statement. "We are excited about the approval and look forward to making TissuGlu available to surgeons and patients in the United States."
"The PMA approval for TissuGlu culminates years of work by the company, its clinical partners, and the FDA," added vice president of clinical, regulatory & legal affairs Chad Coberly. "The company would like to thank the FDA and its review team for all their efforts on the PMA over the years."