Details
Device typeAortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft: An artificial substitute for a natural aortic heart valve fitted with a length of biologic-polymer blood vessel (vascular graft) intended to be implanted during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending aorta (e.g., in cases of aneurysm, dissection or dilatation). The valve component consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about struts attached to the valve housing by hinges; the synthetic polymer blood vessel is designed to conform to the aortic root anatomy and is impregnated with a bioabsorbable animal-derived gelatin.
FDA categoryHEART-VALVE, MECHANICAL
Device ID08022057013477
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional