Device Dossier

Gore-Tex Cardiovascular Patch - Cardiovascular patch, synthetic

Device Dossier for Gore-Tex Cardiovascular Patch - Cardiovascular patch, synthetic (Cardiovascular patch, synthetic, Class III, sponsor W L Gore &…

Intended purpose

The GORE TEX Cardiovascular Patch is intended for use in carotid artery and congenital heart defect patching.

Functional description

The device is a durable, easy to handle, synthetic patch designed for optimal tissue ingrowth while minimizing aneurysmal dilation in a wide variety of cardiovascular applications. Constructed from multidirectional strength ePTFE, the patch is designed to resist aneurysmal dilation and optimize tissue ingrowth.

TGA Public Summary