Cohera Medical has applied for CE Mark approval for its Sylys Surgical Sealant, which will help reduce anastomotic leakage in gastrointestinal procedures.
Applied as a viscous fluid, the sealant cures by creating a flexible, elastic seal over the anastomosis site.
Cohera Medical clinical, regulatory and legal affairs vice president Chad A. Coberly said, "The submission signifies that we have completed the rigorous clinical and pre-clinical testing, quality, and performance requirements of the EU authorities, and we look forward to working with our notified body during the approval process."
Sylysis is the first synthetic sealant and prevents the occurrence of anastomotic leaks that occur in up to 23% of patients undergoing colorectal surgery, according to the company.
The company further said at least one-third of the post-surgical mortality after colorectal surgery is attributed to leaks, and survivors generally have protracted recoveries, and the additional care required to manage this serious complication can cause up to a five-fold increase in patient management costs.
The Western Pennsylvania Hospital Colorectal Surgery Division chief James McCormick said anastomotic leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality.
"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," McCormick added.
Expected to be granted by the end of 2014, the CE Mark approval will enable the company to market the sealant in the European Union and other countries.