Edwards Lifesciences has announced that it will not be pursuing its acquisition of JenaValve Technology, after the US District Court for the District of Columbia granted the motion from the US Federal Trade Commission (FTC) for an injunction blocking the proposed acquisition.
In a statement, Edwards said that it disagrees with the decision and believes that the acquisition “would have been in the best interest of a large, growing and underserved group of patients”.
JenaValve is the developer of the Trilogy TAVI system, a transfemoral TAVI system which carries a CE mark for the treatment of aortic regurgitation (AR) and aortic stenosis (AS). The device is seen as meeting an unmet need for the treatment of AR, particularly among patients who are deemed to be at too high risk for surgery.
In July 2024 Edwards announced plans to acquire the company, one of several acquisitions to expand its structural heart division, following the sale of its Critical Care product group to BD in June of the same year. This was a part of a raft of acquisitions that also saw Edwards’ complete a deal for JC Medical, which included the intellectual property and commercial rights to the J-Valve, another TAVI system designed for the treatment of AR.
However, FTC sought to block the JenaValve deal in August 2025, claiming that the acquisition would combine the only two companies with ongoing clinical trials in the USA for a TAVI-AR device, threatening to reduce competition in the market and likely resulting in reduced innovation, diminished product quality, and potentially increased prices for consumers.
The competition concerns caused by Edwards’ dual acquisition strategy were predicated on Edwards owning both JenaValve and JC Medical simultaneously.
In light of this development, Edwards states that it remains committed to leading the AR therapy for patients in need. “The company will continue to deliver novel therapies and world-class evidence to transform patient care, including advancing the Sojourn transcatheter AR valve and enrolling patients in the JOURNEY pivotal trial,” its statement adds.
