Device Dossier

TissuePatchDural™ Dural Sealant and Barrier - Dura mater sealant

Device Dossier for TissuePatchDural™ Dural Sealant and Barrier - Dura mater sealant (Dura mater sealant, Class III, sponsor Bard). ARTG record, intended…

Intended purpose

TissuePatchDural is indicated for use to seal and reinforce against fluid (including cerebrospinal fluid (CSF)) and/or blood leakage where repair of the dura mater is required. TissuePatchDural is intended for use as an adjunct.

Functional description

TissuePatchDural is a clear, four layer film. The Poly(lactide-co-glycolide) films act as a cohesive matrix within the patch and as an anti-adhesion barrier film on the patch's top surface. The film of TissueBond becomes adhesive when applied to tissue and immediately adheres to the surface and acts as a sealant to prevent leakage. The patch remains in position while it slowly degrades until substantially absorbed.

TGA Public Summary