Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft

This category includes artificial aortic valve replacements combined with a synthetic blood vessel graft, designed to replace a diseased aortic valve and repair or replace a damaged section of the ascending aorta in a single surgical procedure. The valve uses two hinged leaflets made of pyrolytic carbon or polymer, while the graft portion is a bioabsorbable, animal-derived gelatin-impregnated synthetic tube that matches the aortic anatomy.

Devices in this category are implanted during open heart surgery and are intended for patients with concurrent aortic valve dysfunction and aortic pathology such as aneurysm, dissection, or dilatation. As implantable cardiovascular devices, they are subject to stringent regulatory controls as high-risk medical devices, with requirements varying by jurisdiction but generally involving premarket assessment and post-market surveillance due to their critical function and permanent implantation.