Federal court blocks medical device merger after FTC antitrust challenge

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Andrew N. Ferguson Chairman | Federal Trade Commission

Federal court blocks medical device merger after FTC antitrust challenge

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The Federal Trade Commission (FTC) has successfully blocked the proposed acquisition of JenaValve Technology, Inc. by Edwards Lifesciences Corp., a move expected to help lower healthcare costs and improve access to lifesaving medical devices in the United States. On January 9, 2026, the U.S. District Court for the District of Columbia granted a preliminary injunction at the FTC’s request, temporarily stopping Edwards from proceeding with its purchase of JenaValve.

The FTC initially challenged this deal in August 2025, arguing that combining Edwards and JenaValve would reduce competition in the U.S. market for transcatheter aortic valve replacement devices (TAVR-AR devices). These devices are used to treat aortic regurgitation, a heart condition that can be fatal if left untreated.

Following the court’s decision, Daniel Guarnera, Director of the FTC’s Bureau of Competition, stated: “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 entered into agreements to acquire both JenaValve and JC Medical—the two main companies developing TAVR-AR devices for the U.S. market. While Edwards completed its acquisition of JC Medical in July 2024, it was still seeking approval for its $945 million deal with JenaValve at the time of legal challenge. Both companies were running ongoing clinical trials for these specialized heart valves.

The FTC alleged that allowing Edwards to buy JenaValve would stifle innovation in TAVR-AR device development while also risking reduced product quality and potentially higher prices for consumers who need these critical medical products.

This court ruling adds to several recent actions by the FTC aimed at protecting patients’ interests and reducing healthcare costs across various sectors. Among those efforts were noncompete warning letters sent out by Chairman Andrew N. Ferguson in September 2025 targeting healthcare employers and staffing firms; as well as renewed legal challenges filed earlier in May 2025 against improperly listed patents shielding brand-name drug-device combinations from generic competition—a move which prompted Teva Pharmaceuticals to remove over 200 improper patent listings from regulatory records maintained by federal authorities.

After learning of the federal court's decision granting an injunction against its planned acquisition of JenaValve, Edwards announced it will not pursue purchasing JenaValve further.

The Federal Trade Commission continues its mission to promote competition while educating consumers about their rights within marketplace transactions.

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