The Food and Drug Administration has approved Covidien's DuraSeal, a fast-acting spine sealant, for use in the United States, the company has announced.
The sealant has been approved for use in conjunction with suturing to repair an intraoperative dural tear, which Covidien says occurs in “nearly 10% of all spinal surgeries.” The sealant can be prepared in 2 minutes and takes 3 seconds to set. Covidien also says a U.S. study has shown DuraSeal to create “an intraoperative watertight seal 100% of the time,” compared with other sealing methods that created a watertight seal 64% of the time.
Covidien plans to launch DuraSeal for spine surgeries “in the next few weeks.”
Irene Tsikitas
