The Federal Trade Commission moved to block Edwards Lifesciences Corp.'s proposed $945 million acquisition of JenaValve Technology Inc., arguing the deal would eliminate competition in a critical market for life-saving heart devices. The FTC filed its complaint citing concerns that the acquisition would limit patient access to innovative medical devices used to treat aortic regurgitation, a potentially fatal heart condition affecting more than 8 million Americans.

The commission alleges that Edwards executed a strategic acquisition spree over two days in July 2024, securing agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring transcatheter aortic valve replacement devices for aortic regurgitation (TAVR-AR devices) to market. Edwards completed its acquisition of JC Medical in July 2024, and the proposed JenaValve deal would consolidate control over the only two companies with ongoing clinical trials in the United States for TAVR-AR devices.

"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."

Aortic regurgitation occurs when the heart's aortic valve fails to close properly, causing blood to backflow into the heart. Currently, surgical valve replacement through open heart surgery represents the only FDA-approved procedure to treat this condition in the United States. TAVR-AR devices offer a revolutionary, less invasive alternative treatment option that could transform patient care.

JenaValve stands positioned to become the first company to bring a TAVR-AR device, called Trilogy, to the commercial U.S. market. The company's pioneering position in this emerging field makes it a particularly valuable acquisition target. According to the FTC's complaint, if Edwards succeeds in acquiring JenaValve, the combined entity would control the two most advanced TAVR-AR devices under development.

The timing of Edwards' acquisition strategy raises particular concerns for regulators. By securing both leading competitors within a 48-hour window, Edwards appears to have attempted to corner an entire emerging market before meaningful competition could develop. This strategy could deny patients the benefits of competitive innovation in a field where technological advancement can mean the difference between life and death.

The FTC's complaint emphasizes that no other company is expected to achieve FDA approval or commercialization of a TAVR-AR device in the United States for the foreseeable future, beyond Edwards and JenaValve. This market reality underscores the potential anticompetitive impact of the proposed acquisition, as it would effectively eliminate all meaningful competition in this specialized medical device segment.

The commission argues that the deal threatens to reduce competition in the TAVR-AR market, potentially resulting in reduced innovation, diminished product quality, and increased prices for consumers. These concerns reflect broader antitrust principles that competition drives innovation and keeps prices in check, benefits that prove particularly crucial in healthcare markets where patients have limited alternatives.

For the millions of Americans suffering from aortic regurgitation, the FTC's intervention could preserve access to competing treatment options and ensure continued innovation in this critical medical field. The less invasive nature of TAVR-AR devices compared to traditional open heart surgery could make treatment accessible to patients who might not be candidates for more invasive procedures.

The case represents part of the FTC's broader scrutiny of healthcare consolidation, particularly in markets where a small number of companies control access to essential medical technologies. The commission has increasingly focused on preventing acquisitions that could stifle innovation in emerging medical device markets, recognizing that early-stage competition often determines long-term market dynamics.

Edwards Lifesciences, as an established medical device supplier, likely viewed the acquisition as an opportunity to strengthen its position in the cardiovascular device market. However, the FTC's challenge suggests that regulatory authorities will closely examine attempts to consolidate control over emerging medical technologies, particularly when such consolidation could eliminate head-to-head competition.

The outcome of this case could establish important precedent for how antitrust authorities evaluate acquisitions in emerging medical device markets. As healthcare technology continues to advance, the balance between allowing companies to invest in innovation and preserving competitive markets remains a critical regulatory challenge. The FTC's action demonstrates its commitment to ensuring that Americans continue to benefit from competition between medical device makers, just as they do in other markets.