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FTC Lays Out Antitrust Concerns Over Edwards Lifesciences’ Planned JenaValve Acquisition

By  |  November 26, 2025

The Federal Trade Commission has begun publicly detailing why it moved to block Edwards Lifesciences’ proposed $945 million acquisition of heart implant maker JenaValve, according to a statement included in an opening presentation posted to the agency’s website. The FTC challenged the deal earlier this year and is now outlining its case as proceedings continue in federal district court in Washington, D.C.

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    Per a statement from the agency, regulators argue that allowing the transaction to proceed would give Edwards control over the only two minimally invasive transcatheter aortic valve replacement systems specifically designed to treat aortic regurgitation—a condition affecting more than 8 million people in the United States. Although several TAVR devices have FDA approval for aortic stenosis, no such devices have yet been cleared for regurgitation, which often requires open-heart surgery.

    The FTC linked the JenaValve acquisition, first announced in July 2024, to Edwards’ nearly simultaneous $316 million purchase of JC Medical and its J-Valve implant. Both JC Medical’s technology and JenaValve’s Trilogy device are undergoing pivotal U.S. trials for aortic regurgitation, and according to a statement from the commission, the two companies had been in a direct race for FDA authorization while competing for clinical trial sites and seeking to serve the broadest possible patient population.

    In documents cited by the FTC, JenaValve executives appeared to express concern about the unfolding situation and frustration over not being informed of Edwards’ dual-track dealmaking. One internal document quoted JenaValve CEO John Kilcoyne saying: “This is not the transaction we signed on for: we would have negotiated different transaction terms (breakup fee, IP, divestiture) but more than likely no deal.” In another email highlighted by the agency, Kilcoyne wrote: “Based upon what I read in the FTC report—I don’t trust EW and don’t think I would want to work there anyway.”

    The commission also pointed to a text exchange in which Kilcoyne asked an Edwards executive whether the JC Medical acquisition was “done or pending?” After being told the transaction was completed, Kilcoyne asked if it had required Hart-Scott-Rodino review. The Edwards executive responded: “Nope below the threshold! Intentional,” according to the FTC.

    Regulators further alleged that Edwards sought to slow JenaValve’s progress after signing the acquisition agreement. In an email dated Aug. 7—one day after the FTC announced its challenge—Edwards CEO Bernard Zovighian wrote: “Disappointing … knew it was risky … we did our best … nothing to regret,” and added that the company should now focus on ensuring JC Medical’s technology becomes “the first and best.”

    The antitrust case is set to continue as the agency works to halt the merger, which it argues could allow Edwards to dominate the emerging market for TAVR treatments for aortic regurgitation.

    Source: Fierce BioTech