St. Jude Medical Launches New Trifecta Heart Valve in Japan


April 19, 2012

April 19, 2012 - St. Jude Medical Inc., a global medical device company, announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and the launch of the Trifecta aortic stented, pericardial tissue valve. The first procedures in Japan were performed at Osaka University Hospital and Saitama Medical University International Medical Center.

For more than 30 years, St. Jude Medical has offered patients the gold standard in heart valve performance and tissue valve durability. The Trifecta valve is the company’s newest tissue valve for cardiac surgeons, and is clinically proven for patients with diseased, damaged or malfunctioning aortic heart valves. The next-generation tissue valve has a tri-leaflet stented pericardial design that offers excellent hemodynamic performance and long-term durability.

"The Trifecta valve is redefining the standard in cardiac surgery for tissue valves in its ability to improve patients’ quality of life, and I am pleased it is now available in Japan,” said Prof. Yoshiki Sawa M.D. of Cardiovascular Surgery at Osaka University Hospital. “The smaller valve is more suitable for Japanese patients, and also offers exceptional hemodynamic performance, which allows it to perform more like a natural heart valve.”

“The construction and design of the Trifecta valve enable it to work seamlessly with the patient’s heart to generate superior blood flow, which can offer patients an improved quality of life. I foresee that the number of patients with aortic valve diseases will continue increasing, and believe that those patients who are implanted with Trifecta will benefit from its performance,” said Prof. Hiroshi Niinami, M.D., of Cardiovascular Surgery at Saitama Medical University International Medical Center.

The valve is constructed using a polyester and tissue-covered, fatigue resistant, high strength titanium stent to ensure structural integrity of the valve. The valve features leaflets manufactured from pericardial tissue attached to the exterior of the valve stent. This design allows the leaflets to open more fully and efficiently, mimicking the performance of a healthy aortic heart valve, while also mitigating tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact. Also contributing to durability is the St. Jude Medical patented Linx AC Technology, a proprietary anti-calcification treatment designed to reduce tissue mineralization (hardening), one of the primary causes of valve deterioration.

“The launch of the Trifecta valve marks an important milestone for patients with aortic heart valve disease, and we are pleased to provide it to leading hospitals throughout the country,” said William Phillips, president of St. Jude Medical Japan. “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.”

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 the St. Jude Medical valve product portfolio, which includes market-leading mechanical heart valves, valve annuloplasty rings and porcine tissue valves with superior durability for both the aortic and mitral valve.

Symptoms of valve disease vary, but can include shortness of breath, dizziness, chest pain, or palpitations. Untreated aortic valve disease can eventually result in heart failure, severe infection, or sudden death. About two percent of the population over the age of 65 is estimated to have aortic stenosis.

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