Cohera Medical today said it received an "approvable letter" from the FDA for its TissuGlu surgical sealant, noting that it expects to win pre-market approval "within a few weeks."
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 receipt of the PMA approvable letter is a truly significant milestone for the company," president & CEO Patrick Daly said in prepared remarks. "We are excited about the pending approval for TissuGlu and are looking forward to making TissuGlu available to surgeons and patients throughout the United States."
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.
“TissuGlu, which has the potential to eliminate wound drainage issues from abdominoplasty procedures, represents a major advance in helping patients recover faster and more comfortably following these procedures," Dr. Joseph Hunstad of Charlotte’s Hunstad-Kortesis Center said in a statement. "When approved, it will bring great benefits to both patients and surgeons."
"Having the PMA approved, minus a few small labeling changes, signifies the FDA has approved the years of scientific, engineering, manufacturing, quality, and clinical work conducted by the Cohera Medical team," added Chad Coberly, Cohera’s vice president of clinical, regulatory & legal affairs.
Cohera is also pursuing FDA approval for its Sylys anastomosis sealant, which won priority review at the safety bureau last month.
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