DuraSeal Xact Sealant System - Dura mater sealant

Intended purpose

The system is intended for use during spine procedures as a adjunct to standard methods of dural repair, such as sutures, to provide watertight closure.

Functional description

The system consists of components for preparation and delivery of a synthetic absorbable sealant. The sealant is composed of two solutions, a polyethylene glycol (PEG) ester/trilysine amine solution and a borate buffer solution. When mixed together, the precursors cross link to form the sealant. The hydrogel sealant is absorbed in sufficient time to allow for healing.