Edwards Lifesciences, a medical device supplier, faces a Federal Trade Commission (FTC) challenge to its proposed $945 million acquisition of JenaValve Technology. The FTC alleges the deal would harm competition in the market for transcatheter aortic valve replacement devices for aortic regurgitation (TAVR-AR devices), a potentially fatal heart condition affecting over 8 million Americans. Edwards had already acquired JC Medical in July 2024, and JenaValve is poised to be the first to commercially launch a U.S. TAVR-AR device, Trilogy. The FTC claims the transaction would combine the only two companies conducting U.S. clinical trials for such devices, reducing innovation, product quality, and potentially increasing prices.
The FTC’s complaint states that direct competition between Edwards’ JC Medical unit and JenaValve has accelerated product development and expanded treatment options. Daniel Guarnera, Director of the FTC’s Bureau of Competition, stated, “Edwards’ attempt to buy the U.S. market for TAVR-AR devices would eliminate the head-to-head competition that has spurred innovation for lifesaving artificial heart valves.” The Commission voted 3-0 to authorize legal action and seek a temporary restraining order and preliminary injunction in the U.S. District Court for the District of Columbia to block the deal pending an administrative proceeding.
