Edwards Lifesciences Faces FTC Roadblock in JenaValve Acquisition

On August 6, 2025, the Federal Trade Commission (FTC) took legal action against Edwards Lifesciences Corporations (Edwards) to halt its proposed $945 million acquisition of JenaValve Technology, Inc. (JenaValve). The FTC filed a motion for preliminary injunction and an in-house administrative complaint against the merger, arguing that it would eliminate the only existing competition in the market for transcatheter aortic valve replacement devices designed specifically for aortic regurgitation (AR) treatment. Both companies are the sole participants in the clinical trials for these devices, purportedly to offer a less invasive alternative treatment for high-risk AR patients who currently rely on surgical aortic valve replacement. The FTC asserts that the proposed merger would substantially reduce competition and risk creating a monopoly, contrary to Sections 7 of the Clayton Act and 5 of the FTC Act. Conversely, Edwards claims that the acquisition will expedite the innovation and availability of life-saving AR treatment. A court-issued temporary restraining order prevents the acquisition until the court resolves the FTC's preliminary injunction. A hearing on the matter is scheduled for January 7, 2026.