Device Dossier

Cardioroot Woven - Graft, vascular, synthetic

Device Dossier for Cardioroot Woven - Graft, vascular, synthetic (Graft, vascular, synthetic, Class III, sponsor Getinge). ARTG record, intended purpose,…

Intended purpose

The intended purpose is for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the aorta, both thoracic and abdominal, visceral arteries, and proximal peripheral arteries. Due to their low permeability, these products are recommended for use in patients requiring heparinization prior to, or during surgery.

Functional description

Made of woven polyester and coated with a highly purified form of cross-linked bovine collagen to minimize intraoperative bleeding and eliminate the need for preclotting at the time of implant. The INTERGARD woven vascular grafts have an integral water permeability specification of < 5 ml/cm²/min at 120 mmHg. CARDIOROOT graft features an uncrimped bulged section with a 1-cm collar at its proximal end. This design mimics the anatomy and blood flow dynamics.

TGA Public Summary