The Japanese Ministry of Health, Labor and Welfare (MHLW) has cleared St Jude Medical's Trifecta aortic stented, pericardial tissue valve to treat patients with diseased, damaged or malfunctioning aortic heart valves.
The Trifecta valve is constructed using a polyester and tissue-covered, fatigue resistant titanium stent to ensure structural integrity of the valve.
The valve featuring a tri-leaflet stented pericardial design offers hemodynamic performance (circulation and blood flow through the valve) and long-term durability.
St Jude said the design allows the leaflets to open more fully, mimicking the performance of a healthy aortic heart valve, while also mitigating tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact.
St Jude Medical president William Phillips said: "The Trifecta valve continues our legacy of market-leading valves and reflects our commitment to providing products that improve physician control, reduce patient risk and improve patient outcomes in Japan."