October 30, 2026- Abbott announced it has initiated the CROWN-MV pivotal trial evaluating the safety and effectiveness of its investigational Cephea™ Mitral Valve System in treating people with symptomatic mitral valve disease who are not candidates for surgery and transcatheter repair. The first enrollment in the CROWN-MV study occurred at Ascension Via Christi Hospital in Wichita, Kan., led by Bassem Chehab, M.D.
The prospective study will enroll up to 585 people in the U.S., Canada and Europe diagnosed with either moderate-to-severe or severe mitral regurgitation (MR, or a leaky mitral valve) or mitral valves that are not functioning properly due to a buildup of calcium in the base of the valves (known as mitral annular calcification, or MAC).