Cohera Medical said this week that the FDA granted investigational device exemption for a clinical trial of its Sylys surgical sealant.
Raleigh, N.C.-based Cohera said the Sylys sealant, which won expedited access pathway status back in June 2015, is designed to be an adjunct to standard closure techniques in intestinal anastomosis procedures. The resorbable synthetic sealant aims to help eliminate leaks during the 1st few day post-procedure.
The trial is slated to compare colorectal and ileorectal anastomosis after resection with and without Sylys, Cohera said.
“We are pleased that the FDA has approved this IDE. This approval validates the Sylys surgical sealant biocompatibility, pre-clinical safety profile, and clinical trial design of the study,” chief clinical & legal officer Chad Coberly said in prepared remarks. “The company greatly appreciates the cooperation and high level of interaction with the FDA during the review of this potentially life-saving healthcare innovation.”
“It is tremendous that FDA has given investigational approval to this novel device that may help reduce the incidence of anastomotic leaks and their devastating impact,” added Dr. Deborah Nagle of Boston’s Beth Israel Deaconess Medical Center.
EAP designation was first proposed in 2014 to help reduce timeframes and costs with market authorization for products normally subject to pre-market approval or de novo registration, in cases where the product can benefit patients suffering from otherwise difficult-to-treat issues.
Cohera’s 1st product, the TissuGlu surgical sealant, won pre-market approval from the federal safety watchdog in February 2015. 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.