The Federal Trade Commission has moved to block Edwards Lifesciences’ planned acquisition of JenaValve Technology, citing concerns that the deal threatens to reduce competition in the market for devices to treat aortic regurgitation.
The agency alleged that over two days in July 2024, Edwards signed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring transcatheter aortic valve replacement devices to market to treat the potentially fatal heart condition. Edwards closed the acquisition of JC Medical in August 2024.
The FTC said Edwards’ proposed $945 million acquisition of JenaValve would combine the only two companies conducting U.S. clinical trials for a TAVR aortic regurgitation, or 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,” the agency stated in a federal court complaint.
The commission voted 3-0 to issue an administrative complaint and seek a temporary restraining order and a preliminary injunction to halt the transaction pending an administrative proceeding. The complaint and injunction request were filed in the U.S. District Court for the District of Columbia.
JenaValve is poised to become the first company to bring a TAVR-AR device, called Trilogy, to the U.S. market, the FTC said. Food and Drug Administration approval of a TAVR-AR device by another company besides Edwards and JenaValve is not expected in the foreseeable future.
“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,” Daniel Guarnera, director of the FTC’s Bureau of Competition, said in the agency’s Wednesday statement.
Edwards’ stance
Edwards said Wednesday that it disagrees with the FTC’s decision and believes it will limit the treatment options for patients with aortic regurgitation. Edwards argued that the acquisition will actually “accelerate the availability, adoption and continued innovation of a life-saving treatment for patients suffering from AR.”
The company plans to continue to pursue regulatory approval for the deal and expects a final determination by the end of the first quarter of 2026.
JenaValve also said that it remains committed to completing the transaction and is confident in the rationale for the merger and the value it will bring to patients. The company intends to join Edwards to defend the case in court.
Edwards increased its forecast for 2025 adjusted earnings per share to the high end of a range of $2.45 to $2.55, up from the high end of a range of $2.40 to $2.50, to reflect the impact of the FTC’s action. The company said there is no impact to revenue guidance.
Edwards agreed to pay $1.2 billion combined in July 2024 to buy JenaValve and Endotronix, which makes an implantable heart failure sensor. With the Endotronix transaction completed, Edwards was expecting the JenaValve deal to close in the middle of this year.
