St Jude Medical has 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.
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 haemodynamic 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 Yoshiki Sawa, Cardiovascular Surgery, Osaka University Hospital, Japan. “The smaller valve is more suitable for Japanese patients, and also offers exceptional haemodynamic 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 Hiroshi Niinami, Cardiovascular Surgery, Saitama Medical University International Medical Center, Japan.
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 mineralisation, one of the primary causes of valve deterioration.
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.