Covidien DuraSeal Exact Gets U.S. Green Light

Covidien has just announced that FDA gave its approval for the company’s DuraSeal Exact spine sealant, a device designed to help to fix teared dura during spinal surgeries. The material was developed for quick setting so as to prevent unnecessary leaking of spinal fluid, and comes in attractive blue so as to be easily seen when applying.

DuraSeal Exact spine sealant was shown in clinical trials to deliver an intra-operative watertight seal of the dura, in the per protocol population, 100% of the time.1 In contrast, the control group, treated with standard methods of dural closure including fibrin sealants, achieved an intra-operative watertight seal only 79% of the time.
DuraSeal Exact will be launched this quarter and follows Covidien’s 2009 launch of DuraSeal spine sealant, the only dural spine sealant approved by the FDA. The compound is a 100% synthetic absorbable hydrogel that provides excellent tissue adherence and a consistent watertight seal around the dura.
DuraSeal Exact spine sealant is formulated with a lower molecular weight than its predecessor, resulting in decreased post-application swelling and allowing surgeons to confidently use the product in spinal surgery. The product is absorbed over a 9-12 week time period, demonstrating a much longer persistence than fibrin glues.
The DuraSeal Exact spine sealant is designed to be a quicker solution than conventional sealing methods for surgeons who are faced with a sutured dural tear, occurring in approximately 10% of all spinal surgeries.3 The self-contained hydrogel takes only two minutes to prepare for use and three seconds or less to set, so surgeons can quickly complete an intra-operative seal. In addition, DuraSeal Exact spine sealant’s distinctive blue colorant provides excellent visualization to the surgeon to immediately confirm coverage and thickness of the seal, on the target application site.

Press release: Covidien Announces DuraSeal(TM) Exact Spine Sealant Receives FDA Approval…