FTC wins challenge that halts Edwards Lifesciences' proposed acquisition of JenaValve

The FTC said the deal was anticompetitive because Edwards had already bought JC Medical and was trying to buy JenaValve, the only two companies running U.S. clinical trials for transcatheter aortic valve replacement devices to treat aortic regurgitation (TAVR‑AR). Combining JenaValve with Edwards (which already owned JC Medical) would:

• Give Edwards control of the only two advanced TAVR‑AR devices and effectively a monopoly in this new niche market.
• Eliminate head‑to‑head competition between JenaValve and Edwards/JC Medical that was driving faster innovation, broader patient eligibility, and product improvements.
• Likely lead to reduced innovation, diminished product quality, and potentially higher prices and worse access for patients needing TAVR‑AR devices. The FTC also highlighted Edwards’ “dual acquisition” strategy and its refusal to divest JC Medical as aggravating the competitive harm.

Edwards Lifesciences is a large U.S. medical‑technology company based in Irvine, California, best known for artificial heart valves and related cardiac technologies, including its Sapien family of transcatheter aortic valve replacement (TAVR) systems, primarily used to treat aortic stenosis.

JenaValve Technology is a heart‑valve company developing the Trilogy transcatheter aortic valve replacement system specifically for patients with severe aortic regurgitation (AR). JenaValve and Edwards (through its JC Medical subsidiary) compete in the emerging U.S. market for TAVR devices designed to treat aortic regurgitation (often called TAVR‑AR devices).

The six‑day trial was held in the U.S. District Court for the District of Columbia before Judge Rudolph Contreras. On January 9, 2026, Judge Contreras granted the FTC’s request for a preliminary injunction, temporarily blocking Edwards from acquiring JenaValve while the FTC’s administrative case proceeded. The detailed opinion was initially filed under seal, with the public order simply stating that the preliminary injunction was granted.

Legally, the court “halted” the deal by issuing a preliminary injunction—this is a temporary order that prevents Edwards from closing the acquisition while the FTC’s full case is heard. It is not itself a permanent ban.

However, immediately after the injunction, Edwards announced it would not proceed with acquiring JenaValve. Because the buyer has walked away, the proposed deal is effectively dead in practice. To move forward in the future, the parties would need to negotiate a new transaction and undergo a new regulatory review, potentially with different remedies (such as divestitures) acceptable to the FTC.

Both the FTC and the court concluded that allowing Edwards to own both JenaValve and JC Medical would likely reduce competition in TAVR‑AR devices, leading over time to less innovation, lower product quality, and potentially higher prices and worse access for patients with aortic regurgitation.

By blocking the deal and prompting Edwards to abandon it, the decision preserves two separate competitors—JenaValve and Edwards/JC Medical—in the race to bring TAVR‑AR devices to market. In principle, that should:

• Maintain pressure to innovate and expand eligibility for minimally invasive treatment of aortic regurgitation.
• Help keep future device prices lower than if a single firm controlled both leading products.
• Increase the likelihood that clinicians and patients will have more than one TAVR‑AR option once these devices win FDA approval.

In the short term, patient access is unchanged because TAVR‑AR devices are still in clinical trials; open‑heart surgical valve replacement remains the standard U.S. treatment for aortic regurgitation.

Key case documents are available from the FTC and the federal court system:

• FTC administrative complaint and related filings: On the FTC’s case page “Edwards Lifesciences Corp. and JenaValve Technology, Inc., In the Matter of,” which hosts the administrative complaint, briefs, and orders.
• Federal court complaint and injunction order: The FTC’s August 6, 2025 press release links to the federal district court complaint and preliminary‑injunction filings; the January 12, 2026 statement describes the court’s preliminary‑injunction order. Full court filings (including the judge’s opinion) can be accessed via the U.S. District Court for the District of Columbia’s docket on PACER.

The trial transcript and full trial record are not posted in one public package by the FTC; they would need to be obtained from the court docket (PACER) or commercial legal‑research services.