Device Dossier

Supple Peri-Guard - Cardiovascular patch, animal-derived

Device Dossier for Supple Peri-Guard - Cardiovascular patch, animal-derived (Cardiovascular patch, animal-derived, Class III, sponsor Baxter Healthcare).…

Intended purpose

SUPPLE PERI-GUARD is used as a prosthesis for pericardial closure and repair of intracardiac and great vessel defects.

Functional description

Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Supple Peri-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide.

TGA Public Summary