The U.S. Food and Drug Administration (FDA) has approved Abbott’s TriClip Transcatheter Tricuspid Valve Repair System to treat tricuspid regurgitation (TR), the device manufacturer announced Tuesday. The approval follows a favorable review by FDA’s Circulatory System Devices Panel, which unanimously agreed that the device is safe, voted 12-2 that it is effective, and voted 13-1 that the benefits outweigh the risks. “The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues,” said Paul Sorajja, MD, the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE Pivotal trial, in an Abbott news release. “With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker.” TRILUMINATE formed the basis of the favorable review and approval. The pivotal trial showed that treatment of severe, symptomatic TR with the TriClip was superior to medical therapy alone 1 year. What drove the result was quality of life as measured by the Kansas City Cardiomyopathy Questionnaire – a point the advisory committee noted in its review of the device. TriClip’s tricuspid transcatheter edge-to-edge repair joins the EVOQUE transcatheter tricuspid replacement device (Edwards Lifesciences) as approved treatments for TR. FDA approved EVOQUE as TR treatment in February. Image Credit: Courtesy of Abbott