Device typePulmonary open-surgery heart valve bioprosthesis: A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair/replace a dysfunctional pulmonary heart valve, or to replace a pulmonary valve in patients undergoing a pulmonary autograft (Ross) procedure. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.
FDA categoryheart-valve, non-allograft tissue
Device ID00681490908818
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
SizeValve Size 22 MM