The USFDA has recently approved a tricuspid valve replacement system for treating severely leaky tricuspid valves. This artificial heart valve can be implanted using a delivery catheter without open-heart surgery. Notably, this is the first transcatheter replacement device approved by the FDA for use in the tricuspid position. The System The tricuspid valve replacement system comprises a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from bovine pericardial tissue.
The valve will be available in three sizes. Clinical trial The tricuspid valve replacement system was approved based on a clinical trial conducted on 150 patients with severe tricuspid regurgitation (TR). The implanted valve significantly reduced TR levels to moderate and mild grades in 98.8 % and 93.4% of patients at six months. Additionally, improved quality of life and functional…
