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FTC Sues to Halt Edwards Lifesciences’ Acquisition of JenaValve

By  |  August 6, 2025

The U.S. Federal Trade Commission (FTC) has filed a lawsuit in federal court seeking to block medical device giant Edwards Lifesciences Corp’s planned acquisition of JenaValve Technology Inc., citing antitrust concerns over the potential reduction in competition within a critical segment of heart treatment technology.

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    According to Reuters, the lawsuit, filed Wednesday in Washington, centers on transcatheter aortic valve replacement (TAVR) devices used to treat aortic regurgitation—a life-threatening condition in which the aortic valve of the heart fails to close properly. The FTC argues that Edwards and JenaValve are currently the only companies conducting clinical trials in the U.S. for TAVR devices aimed specifically at this condition.

    Per Reuters, the agency contends that if the acquisition proceeds, it would eliminate the only viable competition in this niche market. This could hinder innovation, limit future treatment options for patients, and potentially drive up costs. “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,” said Daniel Guarnera, head of the FTC’s Bureau of Competition, in an official statement.

    Edwards Lifesciences, a California-based leader in structural heart disease technologies, voiced its opposition to the FTC’s move. The company 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.” Edwards anticipates a final decision on the matter by early 2026.

    JenaValve, for its part, reaffirmed its support for the merger and said it would work alongside Edwards to defend the deal in court. The companies maintain that the acquisition is in the best interest of advancing treatment access for patients with limited options.

    Edwards first announced its intention to acquire JenaValve in July 2024. The proposed purchase was unveiled alongside another acquisition—Endotronix, a maker of heart failure monitoring devices. Combined, the two deals are worth roughly $1.2 billion and are part of Edwards’ broader strategy to expand its suite of products for treating structural heart conditions.

    Source: Reuters