St Jude Medical, a US-based developer of medical technologies, has reported positive results from a multi-centre, prospective study of its Trifecta biological pericardial aortic valve, designed for patients requiring aortic valve replacement surgery.
Constructed from a polyester and tissue-covered titanium stent, the Trifecta valve features three leaflets made of pericardial tissue, and is connected by a polyester sewing cuff.
The leaflets are attached to the exterior of the stent, whichallows them to open fully, mimicking the hemodynamic performance of a healthy aortic heart valve and limiting tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact to help protect the valve against mechanical wear.
The valve also features an anti-calcification treatment that is designed to reduce tissue mineralisation, which can lead to valve deterioration over time.
The study followed 1,014 patients implanted with the Trifecta valve, as part of the US Food and Drug Administration’s (FDA) pre-market approval study.
The results demonstrated favourable hemodynamic performance and confirmed the safety and ease-of-use the valve.
The study reported a survival rate of 94.5% at two years, an extremely low rate of paravalvular leak (blood leakage around the area where the valve is sewn in place) and minimal valve regurgitation (a backflow of blood from the aorta into the left ventricle).
University of Pennsylvania cardiovascular surgery vice-chief Dr Joseph Bavaria said; "I have used this valve for more than five years and have found it easy to implant and very reliable, making it an excellent choice for managing patients who require valve replacement."
The study data was also used to secure CE mark approval in 2010, FDA approval in 2011 and regulatory approval of the Trifecta valve in Japan in 2012.
Image: Trifecta biological pericardial aortic valve treats patients requiring aortic valve replacement surgery. Photo: Courtesy of St Jude Medical, Inc.