FDA approves Trifecta valve


St. Jude Medical announced that it has received FDA approval for its Trifecta valve. The valve, a clinically-proven replacement for diseased, damaged or malfunctioning aortic heart valves, mimics the flow of a natural, healthy heart and represents a significant new product in the pericardial aortic stented tissue valve market.

“The Trifecta valve will continue the ongoing transformation of stented aortic valve replacement,” said Joseph E Bavaria, Roberts-Measy director and vice chief of cardiovascular surgery at the University of Pennsylvania in Philadelphia, USA. “While each new technology that extends the portfolio of tissue valve solutions for physicians is critical for enhanced patient care, the Trifecta valve is a significant step forward for cardiac surgeons in the United States. The valve is already becoming known for its exceptional haemodynamic performance, one factor that is particularly important for the treatment of patients with diseased aortic heart valves.”


Building upon more than 30 years of St. Jude Medical experience in developing heart valves, the Trifecta valve was designed to optimise the blood flow through the valve and it has long-term durability.


To ensure the structural integrity of the valve, Trifecta is constructed using a polyester and tissue-covered titanium stent, or base. 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 and limiting tissue abrasion through tissue-to-tissue contact. Also contributing to the valve’s durability, the Trifecta valve offers the St. Jude Medical patented Linx AC technology, an anticalcification treatment designed to reduce tissue mineralisation, one of the primary causes of valve deterioration.


The Trifecta valve offers several features that improve the ease of implantation, including the valve’s unique holder, designed to improve visibility and cuff access for suturing, and customised sizer, offering physicians more control in choosing the appropriate replacement valve for each patient’s heart.


The Trifecta valve was approved by regulatory authorities in Europe and Canada in 2010.