Specialist in absorbable surgical adhesives and sealant, Cohera Medical, Inc., tells us it has submitted an Investigational Device Exemption (IDE) to the U.S. FDA to study Sylys Surgical Sealant as an adjunct to standard closure techniques for the reinforcement and protection of anastomotic junctions in gastrointestinal surgical procedures.
Anastomotic leakage, which occurs in 3 percent to 23 percent of patients undergoing gastrointestinal surgery, is considered to be the most serious surgical complication encountered, frequently resulting in the rapid development of severe peritonitis, septic shock, multiple organ dysfunction, and death. At least one third of post-surgical deaths following colorectal surgery are attributed to leaks, and survivors generally have protracted and expensive recoveries.
Sylys is a resorbable synthetic sealant, conceived 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.
To date, the use of surgical sealants as adjuncts to anastomoses has not become standard practice, the challenge being that the bowel is a dynamic and challenging anatomical tissue type. Cohera’s press release says the randomized study submitted to the FDA will compare patients undergoing gastrointestinal anastomosis after resection with and without the sealant. Demonstrating a positive effect of sealant use on the bowel is tricky because of the significant sample size required, coupled with the challenge of effectively randomizing patients. A statistically significant difference between groups, even with randomization is likely to prove elusive, which may leave the conclusion being that use of the sealant is safe. Efficacy (reducing the leak rate) is a target outcome, so let’s wait and see.
Upon IDE approval by the FDA, the Company plans to initiate the study across multiple centers in the United States and use the pivotal safety and efficacy data to support a premarket approval application to the FDA for the product.
Currently, Sylys is only approved for investigational use in Europe.
If things work out the way Cohera no doubt hopes, the win bonus is significant: The market is estimated at more than one million procedures per year worldwide representing a multi-billion dollar opportunity.
“Anastomotic leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality,” said James McCormick, DO, FACS, FASCRS, Program Director, General Surgery, Allegheny Health Network. “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.”
“The submission of the IDE for a pivotal safety and efficacy study of Sylys marks a significant milestone in the development process of this breakthrough device,” said Chad Coberly, JD, vice president of Clinical, Regulatory, and Legal Affairs for Cohera Medical. “The review of the IDE by the FDA culminates the extensive preclinical and clinical testing conducted by the Company on the product.”
“This latest submission represents a giant leap towards the commercialization of our second product and demonstrates the commitment we have to our future customers, partners, and investors,” said Patrick Daly, Cohera Medical president and CEO. “We look forward to initiating the study and ultimately making Sylys available to surgeons and patients throughout the world.”
Source: Cohera Medical, Inc., PR Newswire