The device can be used as an adjunct to standard closure techniques to strenghten and protect anastomotic junctions in colorectal and ileorectal anastomosis procedures.
It is a resorbable synthetic sealant that will help in lowering anastomotic leakage by offering further support to the anastomosis when the development of leaks are expected to take place in the initial days of healing.
Last year, the device obtained expedited access pathway (EAP) status from the FDA.
The device has also received CE Mark approval in Europe as an adjunct to standard closure in ileostomy reversal procedures.
Anastomotic leakage is believed to be the serious surgical complication, which can result in severe peritonitis, septic shock, multiple organ dysfunction and death.
Cohera chief clinical and legal officer Chad Coberly 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.
“The company greatly appreciates the cooperation and high level of interaction with the FDA during the review of this potentially life-saving healthcare innovation.”
Cohera produces TissuGlu surgical adhesive, which is indicated for the approximation of tissue planes in abdominoplasty procedures in the US.
In the European Union, TissuGlu received approval for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.
Image: The FDA campus is located at 10903 New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.
