Statement on FTC Victory Halting Anticompetitive Medical Device Deal

The Federal Trade Commission secured an important victory to lower healthcare costs and expand access to lifesaving medical devices for Americans by halting Edwards Lifesciences Corp.’s (Edwards) proposed acquisition of JenaValve Technology, Inc (JenaValve). On January 9, 2026, after a six-day trial, the U.S. District Court for the District of Columbia granted the FTC’s request for a preliminary injunction to temporarily prevent Edwards from acquiring JenaValve.

The FTC challenged the deal in August 2025, alleging that Edwards’ acquisition of JenaValve would reduce competition in the U.S. market for transcatheter aortic valve replacement devices (TAVR-AR devices), which treat a heart condition called aortic regurgitation.

In response to the district court’s order, the FTC’s Bureau of Competition Director Daniel Guarnera issued the following statement:

“This is a major victory for the Trump-Vance FTC, American patients, and U.S. healthcare innovation. The court’s decision preserves the head-to-head competition between Edwards and JenaValve that has expanded treatment options for patients suffering from potentially fatal heart conditions. Americans win when companies compete to create new and, in this case, lifesaving innovations. The FTC will continue vigorously enforcing the antitrust laws to protect American consumers and improve U.S. healthcare for patients and their families through lower costs, higher quality, and more innovation.

I want to congratulate the FTC’s trial team, led by the Mergers I Division and our Litigation Group, for its work on this important matter.”

In 2024, Edwards executed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring TAVR-AR devices to market in the United States. Edwards closed its acquisition of JC Medical in July 2024, and its proposed $945 million acquisition of JenaValve would combine the only two companies with ongoing clinical trials in the United States for a TAVR-AR device.

The FTC alleged that Edwards’ acquisition of JenaValve would result in reduced innovation, diminished product quality, and potentially increased prices for consumers in need of a TAVR-AR device.

The FTC’s victory follows several recent FTC actions to protect American patients and lower healthcare costs. These actions include:

• FTC Chairman Andrew N. Ferguson’s issuance of noncompete warning letters in September 2025 to healthcare employers and staffing companies.
• The FTC’s renewed challenges, filed in May 2025, against dozens of improperly listed device patents that shield brand-name epinephrine autoinjectors and asthma, diabetes, and COPD drugs from generic competition. This challenge led to Teva Pharmaceuticals removing more than 200 improper patent listings from the Food and Drug Administration’s Orange Book.

In response to the federal court ruling granting the FTC’s request for a preliminary injunction, Edwards announced that it is no longer acquiring JenaValve.