Device Dossier

XenoSure Biologic Patch - Cardiovascular patch, animal-derived

Device Dossier for XenoSure Biologic Patch - Cardiovascular patch, animal-derived (Cardiovascular patch, animal-derived, Class III, sponsor Emergo). ARTG…

Intended purpose

The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac and vascular reconstruction and repair.

Functional description

The XenoSure Biologic Patch consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. The XenoSure Biologic Patch is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution. The XenoSure Biologic Patch is designed to repair the body’s natural organs.

TGA Public Summary