DuraSeal Exact Spine Sealant System - Dura mater sealant

Intended purpose

The DuraSeal Exact Spine Sealant System is intended for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.

Functional description

The system components include syringes, powder vial, applicator, spray tip and plunger cap. These components are combined for preparation and delivery of a synthetic absorbable surgical sealant. The sealant is composed of two solutions, a polyethylene glycol (PEG) ester solution and a trilysine amine solution. The mixed precursors link to form the surgical sealant that exits the tip of the applicator.