Antitrust Law Daily Wrap Up, ACQUISITIONS & MERGERS NEWS: FTC sues to halt combination of heart valve medical device makers, (Aug 7, 2025)

By Peter Reap, J.D., LL.M.

Edwards Lifesciences Corp.’s proposed acquisition threatens competition, could lead to higher prices.

The FTC announced that it has initiated and administrative proceeding along with filing a complaint and request for preliminary relief in the District of Columbia federal district court seeking to block medical device supplier Edwards Lifesciences Corp.’s (Edwards) proposed acquisition of JenaValve Technology, Inc. (JenaValve) due to concerns that the acquisition would limit patient access to lifesaving medical devices used to treat a potentially fatal heart condition. The agency complains that the deal threatens to eliminate the existing vigorous head-to-head competition in the market because it would collect under one roof the only two transcatheter aortic valve replacement (TAVR) device companies conducting ongoing clinical trials with the FDA (In the Matter of Edwards Lifesciences Corp., FTC Dkt. No. 9442).

Background. According to the FTC, in July 2024, Edwards executed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring to market TAVR devices that treat a heart condition called aortic regurgitation (TAVR-AR). 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.

FTC’s Guarnera comments.“Edwards’ attempt to buy the U.S. market for TAVR-AR devices would eliminate the head-to-head competition that has spurred innovation for lifesaving artificial heart valves,” said Daniel Guarnera, Director of the FTC’s Bureau of Competition. “The FTC is taking action to stop this anticompetitive deal and ensure that JenaValve and Edwards’ JC Medical subsidiary continue competing to innovate, expand treatment eligibility, and keep down costs. Americans deserve all the benefits that come from competition between medical device makers, just as they do in other markets.”

Complaint allegations. The FTC’s administrative complaint charges that the proposed acquisition would consolidate the TAVR-AR device market in the U.S. and give Edwards a TAVR-AR monopoly. The revolutionary technology behind these devices offers a safe and effective treatment for AR, with the only other alternative being invasive open heart surgery that is not recommended for high-risk patients, including those who are older or frail. If consummated, the deal would likely slow the pace of innovation in TAVR-AR devices and increases the risk that one of the existing devices being de-prioritized or abandoned because Edwards would have little reason to maintain two valves for treatment of the same condition.

Ultimately, patients will benefit if JenaValve and Edwards continue to directly compete to complete their separate TAVR-AR device clinical trials, product improvements, and commercialization plans. But Edwards has elected to attempt to buy JenaValve while retaining its ownership of JC Medical. Edwards has not been willing to engage on divesting JC Medical to resolve the competition concerns with the proposed JenaValve acquisition, according to the complaint.

The defendants cannot demonstrate that new entry of TAVR-AR devices would be timely, likely, or sufficient to offset the anticompetitive effects of the deal, the complaint continues. Nor can they show sufficient cognizable, verifiable, or merger-specific efficiencies that would offset the likely and substantial competitive harm.

Edwards’ reaction. In a press release noting the FTC move to block the company’s proposed acquisition of JenaValve Technology, Edwards said it “disagrees with FTC’s decision and believes it will limit the availability of an important treatment option for patients suffering from aortic regurgitation (AR). The company further believes the acquisition of JenaValve will accelerate the availability, adoption and continued innovation of a life-saving treatment for patients suffering from AR.” The company added that it “intends to continue to pursue regulatory approval of the acquisition and estimates a final determination by the end of Q1 2026.” It also adjusted its 2025 financial guidance based on the FTC action.

Companies: Edwards Lifesciences Corp.; JenaValve Technology, Inc.; JC Medical

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