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…
- GMDN category: Dura mater sealant
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.