The FDA has approved St. Jude Medical, Inc.’s Trifecta Valve, clearing the aortic replacement for use the United States. The device, which was CE marked last year, consists of a titanium base and valve leaflets made of pericardial tissue, which result in a better approximation of natural valve function. The Trifecta Valve comes in six different sizes to accommodate a larger range of patients, and also incorporates a special holder which helps surgeons select the right size valve for each patient.
From the press release:
Building upon more than 30 years of St. Jude Medical experience in developing heart valves, the Trifecta valve was designed for excellent hemodynamic performance (the optimization of blood flow through the valve) and long-term durability. To ensure the structural integrity of the valve, the Trifecta valve 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 (stent-to-leaflet) 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 mineralization (hardening), one of the primary causes of valve deterioration.
Press release: St. Jude Medical Announces FDA Approval of Trifecta Valve…
Product page: Trifecta™ Valve…
Flashback: SJM’s Aortic Trifecta Valve Gets European Clearance