DuraSeal Dural Sealant System - Dura mater sealant

Intended purpose

The system is intended for use as an adjunct to standard methods of dural repair, such as sutures, 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 percursors link to form the surgical sealant that exits the tip of the applicator. The synthetic sealant is absorbed in sufficient time to allow for normal wound healing.