FDA Grants Priority Review Status to Cohera Medical’s Sylys Surgical Sealant

Pittsburgh, Pa.-based Cohera Medical said Wednesday that the FDA has agreed to a priority review of its Sylys Surgical Sealant, hastening the product’s path to approval. In granting priority review status, the FDA cited the sealant’s potential to address a critical, unmet need in treating life-threatening gastrointestinal anastomosis leaks, which can occur during GI surgery.

A resorbable synthetic sealant, Sylys provides added support to the anastomosis during the first days of healing following gastrointestinal surgery when leaks are most likely to occur, Cohera says.

Chad Coberly, vice president of clinical, regulatory and legal affairs at Cohera, hailed the priority review designation, saying it is “first step in the company’s plan to work with the FDA under its draft program for expedited access to premarket devices intended for unmet medical needs.”

The market for effective sealants is significant, with more than a million GI procedures a year, says Cohera. According to company, leakage occurs in anywhere from 3 percent to 23 percent of patients undergoing GI procedures and can lead to severe peritonitis, septic shock, multiple organ dysfunction or death. Roughly a third of post-colorectal surgery deaths are attributed to leaks, and patients who survive have long and costly recoveries, the devicemaker adds. — Kellen Owings