DuraSeal Exact spine sealant is a low-swell formulation of dural sealant designed as an adjunct to suturing to repair the dura during spine surgery. The sealant is a 100 percent synthetic, absorbable hydrogel that provides tissue adherence and a watertight seal around the dura.
The spine sealant has a lower molecular weight than its predecessor, resulting in decreased post-application swelling. The product, which is absorbed over a 9-12 week time period, demonstrates a much longer persistence than fibrin glues.
DuraSeal Exact will be launched this quarter.
Read other coverage about FDA approvals:
– Integra LifeSciences Receives FDA 510(k) Clearance for 3 Spine Devices
– 22 Spine Devices Receive FDA 510(k) Clearance in March
– 56 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in March
