Device typeMitral bi-leaflet mechanical heart valve prosthesis: An artificial substitute for a natural mitral heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. It consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about pyrolytic carbon or metal struts attached to the valve housing by hinges; the hinge points intersect the valve lumen resulting in a total of three openings. When pressurized blood hits the valve, the two halves of the circle fold away from the valve ring and allow blood to flow into the three openings before the valve flaps close again.
FDA categoryHEART-VALVE, MECHANICAL
Device ID05414734005913
Catalog number19M-101
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Outer Diameter19 Millimeter