The federal watchdog agency said the Waltham-based biomaterial product developer’s polymer-based sealant, designed to be sprayed into a surgical site to provide a watertight seal, is better than other options for preventing leaks after spinal procedures. Duraseal is already approved for use in cranial surgeries.
An FDA report indicated that although the Covidien subsidiary’s product and other seals showed the same rate of leaks 90 days after surgery, Duraseal offers more clinical benefits and fewer safety concerns.
“Duraseal is easier to use and takes less time than applying additional sutures, harvesting and sewing in muscle or fascial patches, or using fibrin glue which takes significant time to mix and heat,” according to the report.
The agency will ask a panel of outside experts today whether the product should be approved for spine operations; positive recommendations from the panel usually, but not always, lead to FDA approval, according to the news service.