Sylys® Surgical Sealant
A Revolutionary Solution Designed to Help Reduce Anastomotic Leakage After Colorectal Surgeries.
Sylys® Surgical Sealant* is an elastic, resorbable, synthetic sealant designed to help reduce anastomotic leakage in colorectal surgical procedures. Used in conjunction with standard anastomotic closure techniques such as sutures or staples, Sylys protects the suture or staple line, supporting the anastomosis during the first few days of healing when leaks are most likely to occur.
Designed for Surgeons
Cohera Medical, Inc.® researchers developed Sylys Surgical Sealant to serve the needs of colorectal and general surgeons who perform colorectal anastomotic procedures. Sylys is designed to improve patient outcomes by helping reduce the likelihood of post-surgical complications from leakage, thereby providing surgeons the best possibility for a successful procedure.
Addresses a Serious Clinical Need
Anastomotic leakage rates following colon resection range on average from 3-15%.1 Such leakage is considered the most serious complication of bowel repair, causing one third of mortalities occurring after colorectal surgery. There is a high clinical and economic need for a product that effectively reduces anastomotic leakage rates, due to the following:
- Leaking anastomoses double the length of stay and increase mortality rates as much as ten-fold
- Reoperation rates after leakage can be as high as 87%
- Beyond the initial mortality risk, overall five year survival rates for patients with anastomotic leakage are reduced by 20%
- Anterior rectal resections have the highest leakage rate, up to 24%
- Crohn’s disease patients carry a significant risk of anastomotic dehiscence (12%) even when macroscopically normal margins are obtained
Cohera Medical’s Sylys Surgical Sealant will be the first synthetic resorbable sealant to fill this clinical need.
Preclinical Safety and Effectiveness
Pre-clinical biocompatibility testing has shown that Sylys Surgical Sealant passes all required ISO 10993 testing for implantable devices. A pre-clinical mouse study was conducted that showed that Sylys reduced leaks by 57% and decreased mortality by 87% when compared to animals that received no sealant over an incomplete anastomosis repair. Sylys has been approved for investigational use in humans in Europe, and enrollment for a first-in-human safety trial was completed in May 2013.
- Kirchoff et al., Complications in colorectal surgery: risk factors and preventative strategies. Patient Safety in Surgery 4:5 (2010)
*Disclaimer: Sylys Surgical Sealant is not currently available for sale or distribution and has not been approved by the U.S. FDA or any other country’s regulatory authority. The device described is currently limited to investigational use only in the E.U.