For Release
FTC Challenges Anticompetitive Medical Device Deal
Edwards Lifesciences’ acquisition of JenaValve threatens to disrupt competition for revolutionary heart condition device, the FTC alleges
The Federal Trade Commission today moved 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 FTC alleges that over the span of two days in July 2024, Edwards executed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring to market transcatheter aortic valve replacement devices that treat a heart condition called aortic regurgitation (TAVR-AR devices). 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. The deal threatens to reduce competition in the TAVR-AR market, likely resulting in reduced innovation, diminished product quality, and potentially increased prices for consumers, according to the complaint.
“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.”
More than 8 million Americans suffer from aortic regurgitation, which occurs when the heart’s aortic valve does not close properly, causing blood to backflow into the heart. Currently, surgical valve replacement via open heart surgery is the only U.S. Food and Drug Administration (FDA) approved procedure to treat aortic regurgitation, and TAVR-AR devices offer a new and less invasive way to treat the condition.
JenaValve is poised to become the first company to bring a TAVR-AR device, called Trilogy, to the commercial market in the United States. If Edwards acquires JenaValve, Edwards would gain control over the two most advanced TAVR-AR devices, the FTC complaint alleges. FDA approval or commercialization of any other TAVR-AR device in the United States by another company, aside from Edwards and JenaValve, is not expected for the foreseeable future.
Direct head-to-head competition between Edwards, through its now-subsidiary JC Medical, and JenaValve has driven the two companies to accelerate the development of their TAVR-AR devices, the FTC’s complaint alleges. 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.
The competition concerns caused by Edwards’ dual acquisition strategy are predicated on Edwards owning both JenaValve and JC Medical simultaneously, 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 Commission vote to issue an administrative complaint and authorize staff to seek a temporary restraining order and a preliminary injunction was 3-0.
The federal court complaint and request for preliminary relief was filed in the U.S. District Court for the District of Columbia to halt the transaction pending an administrative proceeding.
NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The issuance of the administrative complaint marks the beginning of a proceeding in which the allegations will be tried in a formal hearing before an administrative law judge.
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