The U.S. Federal Trade Commission said it will challenge Edwards Lifesciences’ planned acquisition of JenaValve, a move that could reshape the emerging market for heart valves treating aortic regurgitation.

The FTC filed a complaint arguing that the deal would eliminate competition in the development of transcatheter aortic valve replacement for aortic regurgitation (TAVR‑AR). Currently, Edwards’ subsidiary JC Medical and JenaValve are the only companies advancing devices specifically designed for the condition.

JenaValve, a German‑based device maker, is seeking U.S. Food and Drug Administration approval for what would be the first TAVR system designed to treat aortic regurgitation, with a goal of securing clearance by late 2025.

Edwards announced plans to acquire the company in July 2024, pending regulatory approval.

GlobalData, a data and analytics firm, said the FTC’s challenge could slow development and delay patient access to the devices. “TAVR‑AR devices are likely to be a significant step forward for the treatment of aortic valve regurgitation,” David Beauchamp, a medical analyst at GlobalData, said in a statement. “However, the FTC inquiry into the acquisition of JenaValve could delay the entry of both products into the market.”

Edwards is already a major player in transcatheter aortic valve replacement, which is currently approved only for aortic stenosis. Competitors such as Medtronic and Abbott are active in that segment but have not announced plans to pursue TAVR devices for regurgitation.

According to GlobalData, the U.S. TAVR market is valued at about $3.2 billion and is projected to grow 6.56% annually over the next decade.

More than 1.6 million adults in the U.S. are estimated to have some degree of aortic regurgitation, which can require open‑heart surgery in severe cases. TAVR‑AR devices are seen as a less invasive option.

If the acquisition goes forward, Edwards would become the sole developer of advanced TAVR‑AR devices, a prospect the FTC warned could stifle competition and innovation.

Edwards has contested the agency’s complaint, but the case could take months to resolve.

FTC moves to block Edwards Lifesciences’s acquisition of JenaValve

The U.S. Federal Trade Commission has filed a complaint to block Edwards Lifesciences’ planned purchase of German‑based valve maker JenaValve, arguing that the deal would eliminate competition in the emerging transcatheter aortic valve replacement for aortic regurgitation (TAVR‑AR) market. JenaValve is seeking FDA approval for the first TAVR system for aortic regurgitation, targeting clearance by late 2025. The FTC’s challenge could delay the entry of both companies’ devices, potentially stifling innovation and patient access.