Cohera Medical’s Sylys surgical sealant has garnered an expedited access pathway designation from the FDA as a solution to the unmet needs of patients suffering from gastrointestinal leaks.
Anastomotic leakage is a serious surgical complication occurring in 3 percent to 23 percent of patients who undergo gastrointestinal surgery. The problem can lead to severe peritonitis, septic shock, multiple organ dysfunction and death.
The resorbable, synthetic device works by supporting anastomosis during the first days of healing, which is when leaks are most likely to happen.
The expedited access pathway program was put in place in April to give patients faster access to critical medical devices. The program helps streamlines clinical data collection and premarket approval. — Jason Scott