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St Jude Medical Receives CE Mark For Trifecta Valve

St Jude Medical has received CE mark approval for the Trifecta valve, marking its launch into the market for pericardial aortic stented tissue valves.

The Trifecta tissue valve is used to replace a patient’s diseased, damaged or malfunctioning aortic heart valve, which controls blood flow from the heart to the rest of the body. The tissue valve has a tri-leaflet stented pericardial design which offers high hemodynamic performance, or nearly unobstructed blood flow, in order to mimic as closely as possible the flow of a natural, healthy heart.

The valve design includes leaflets manufactured from pericardial tissue attached to the exterior of the valve stent which open more fully and efficiently to perform like a natural heart valve. The valve’s titanium stent, which provides a fatigue resistant frame to support the valve within a patient’s heart, is covered with pericardial tissue to allow tissue-to-tissue contact when the leaflets open and close, which reduces the amount of wear and deterioration.

Additional attributes contributing to the Trifecta valve’s durability include tissue fixation and St Jude Medical’s patented Linx AC Technology, an anticalcification treatment designed to reduce tissue mineralization (hardening).

The Trifecta valve is available in a wide range of sizes to offer physicians more control in choosing the appropriate replacement valve for each patient’s heart. The Trifecta stented tissue valve further expands St Jude Medical’s valve product portfolio which includes mechanical heart valves, valve annuloplasty rings and porcine tissue valves with superior durability for both the aortic and mitral valve.

Volkmar Falk, professor and chair of the division of cardiac and vascular surgery at University Hospital Zurich, said: “The Trifecta valve’s superior hemodynamic performance helps to make it attractive for aortic valve replacement, especially in a small aortic annulus. The construction and design of the Trifecta valve allows it to work seamlessly with the patient’s heart to generate adequate blood flow, which can offer patients an improved quality of life.”

Frank Callaghan, president of cardiovascular division at St Jude Medical, said: “St Jude Medical’s Trifecta has been specifically designed for improved hemodynamics, durability and implantability, and we are proud to offer it to the cardiac surgery community. The Trifecta valve marks an important milestone for St Jude Medical, and it reflects our commitment to developing products which improve physician control, reduce patient risk and improve patient outcomes.”