FTC Seeks to Block Edwards Acquisition of JenaValve

August 6, 2025—The Federal Trade Commission (FTC) announced it has moved to block Edwards Lifesciences’ proposed acquisition of JenaValve Technology, Inc. because of concerns that the acquisition would limit patient access to lifesaving transcatheter aortic valve replacement (TAVR) medical devices used to treat aortic regurgitation (AR).

As noted in its press release, the FTC voted 3-0 to issue an administrative complaint and authorize staff to seek a temporary restraining order and a preliminary injunction. The federal court complaint and request for preliminary relief was filed in the US District Court for the District of Columbia to halt the transaction pending an administrative proceeding.

The FTC press release stated that in July 2024, Edwards executed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring to market TAVR-AR devices.

Edwards closed its acquisition of JC Medical from Genesis MedTech in July 2024—which was announced by Genesis on August 19, 2024.

According to the FTC, Edwards’ proposed $945 million acquisition of JenaValve—announced on July 25, 2024—would combine the only two companies with ongoing clinical trials in the United States for a TAVR-AR device.

The FTC advised that its administrative complaint, available online, states that the transaction threatens to reduce competition in the TAVR-AR market, likely resulting in reduced innovation, diminished product quality, and potentially increased prices for consumers.

In a press release from Edwards, the company stated that it disagrees with FTC’s decision, which it believes will limit the availability of an important treatment option for patients with AR. The company further believes the acquisition of JenaValve will accelerate the availability, adoption, and continued innovation of a life-saving treatment for patients with AR.

Edwards noted that it intends to continue to pursue regulatory approval of the acquisition and estimates a final determination by the end of Q1 2026.

In a separate press release, JenaValve stated that it respectfully disagrees with the FTC’s decision and remains committed to completing the acquisition. Additionally, the company remains confident in both its rationale for the transaction and the value it will bring to the hundreds of thousands of patients with AR. JenaValve further advised that it intends to join Edwards to defend this case in court to complete the acquisition.