The Federal Trade Commission (FTC) has moved to block Edwards Lifesciences’ proposed acquisition of JenaValve over concerns the deal would limit access to lifesaving devices to treat a potentially fatal heart condition.

The FTC alleged that over the span of two days in July 2024, Edwards began agreements to acquire both JenaValve and JC Medical, two leading companies competing to bring transcatheter aortic valve replacement (TAVR) devices to market to treat aortic regurgitation (TAVR-AR).

Edwards closed the transaction for JC Medical in August 2024, and the proposed $945 million acquisition of JenaValve would combine the only two companies with ongoing clinical trials in the U.S. for a TAVR-AR device. The FTC said the deal threatens to reduce competition in the market, possibly causing reduced innovation, diminished product quality, and increased prices for consumers.

JenaValve is poised to become the first company to bring a TAVR-AR device, called Trilogy, into the commercial U.S. market. FDA approval or commercialization of any other TAVR-AR device in the U.S. by another company, apart from Edwards and JenaValve, isn’t expected for the foreseeable future, the FTC complaint said.

Head-to-head competition between Edwards through now-subsidiary JC Medical and JenaValve has driven the two companies to compete to finish their separate TAVR-AR device clinical trials, product improvements, and commercialization strategy.

The concerns arose from Edwards’ dual acquisition strategy are based on Edwards owning both JenaValve and JC Medical at the same time, but Edwards elected to try to buy JenaValve while keeping ownership of JC Medical. Edwards hasn’t been willing to engage on divesting JC Medical to resolve the competition concerns with the proposed JenaValve acquisition, according to the complaint.

The Commission vote to issue an administrative complaint and authorize staff to seek a temporary restraining order and a preliminary injunction was 3-0.

“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.”

Edwards’ response to FTC action

Edwards said in a press release responding to the FTC announcement that it disagrees it will limit availability of the important treatment option for aortic regurgitation (AR). It further believes the acquisition of JenaValve will actually speed availability, adoption, and continued innovation of the life-saving AR treatment.

The company said it plans to continue to chase regulatory approval of the acquisition and expects a final determination by the end of Q1 2026.

Given the FTC’s action, Edwards revised its full-year 2025 financial guidance. There’s no impact to revenue guidance but the company is increasing its adjusted earnings per share (EPS) for the year to the high end of $2.45-$2.55, up from the high end of $2.40-$2.50.

The company also said there will be minimal impact to its adjusted EPS guidance for Q3.