Cohera Medical Inc. has received CE Marking approval for its Sylys Surgical Sealant, a synthetic sealant designed specifically to help reduce leaks after gastrointestinal procedures.

The initial indication for the Sylys sealant is intended for use as an adjunct to standard closure techniques for the reinforcement and protection of anastomotic junctions in ileostomy reversal procedures, a Cohera news release stated.

Sylys Surgical Sealant is applied during gastrointestinal procedures to help prevent the occurrence of anastomotic leaks --- a serious complication that occurs in up to 23 percent of patients undergoing colorectal surgery. At least one-third of the post-surgical mortality after colorectal surgery is attributed to leaks, and survivors generally have protracted recoveries, industry data show. The additional care required to manage this complication can cause up to a five-fold increase in patient management costs.

“Anastomotic leak is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality,” said James T. McCormick, D.O., F.A.C.S., F.A.S.C.R.S., program director of General Surgery at Allegheny Health Network and chief of the Division of Colon and Rectal Surgery at Forbes Hospital in Monroeville, Pa. “We have made tremendous strides in curtailing the risk associated with intestinal anastomosis, but we are always striving for further improvement and greater patient safety.”

Sylys surgical sealant is designed to help reduce anastomotic leakage in gastrointestinal procedures by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur.  The sealant is applied as a viscous fluid which cures rapidly to create a flexible, elastic seal over the anastomosis site. In-vivo, the product degrades in a few weeks and is resorbed, company executives said.

“CE marking approval for Sylys Surgical Sealant, a Class III implant technology, represents a significant milestone and achievement,” said Chad A. Coberly, vice president of Clinical, Regulatory and Legal Affairs for Cohera Medical. “The approval signifies that we have completed the clinical and pre-clinical testing, quality, and performance requirements of the EU authorities.”

“The Sylys Surgical Sealant CE marking approval represents a significant milestone towards the commercialization of our second product and demonstrates the commitment we have to our future customers, partners, and investors,” agreed Patrick Daly, Cohera Medical president/CEO. “We look forward to making Sylys available to surgeons and patients throughout the world.”

Based in Pittsburgh, Pa., Cohera Medical develops a line of surgical adhesives and sealants. The Sylys Surgical Sealant are currently indicated for investigational use only in the United States and have not yet been approved for use by the U.S. Food and Drug Administration.

Watch an animation of the Sylys Surgical Sealant below: