Antitrust Law Daily Wrap Up, ACQUISITIONS & MERGERS—D.D.C.: Opinion granting FTC win in Edwards Lifesciences case details reasoning, (Jan 27, 2026)

By Donielle Tigay Stutland, J.D.

Consummating the transaction would de-incentivize Edwards to continue to innovate.

In a sealed opinion originally issued on January 9, 2026, and publicly released with redactions on January 23, the federal district court in Washington D.C. detailed its reasoning for granting the FTC’s request for a preliminary injunction to temporarily prevent Edwards Lifesciences Corp. from acquiring JenaValve Technology, Inc. In August 2025, the FTC had brought a challenge against Edwards’ acquisition of JenaValve, arguing that it would reduce competition in the U.S. market for transcatheter aortic valve replacement devices (TAVR-AR devices). In granting the injunction, the court concurred with the FTC that the Proposed Transaction is likely to have extensive anticompetitive effects. First, the court reasoned that Edwards and JenaValve are currently the only two competitors in the TAVR-AR market in the United States. Second, the court found that substantial evidence demonstrates that Edwards and JenaValve vigorously compete in that market. Third, the court noted that the Proposed Transaction is likely to lessen that competition substantially. The court reasoned that Edwards’s incentives to innovate would be decreased if the transaction were consummated (FTC v. Edwards Lifesciences Corp., No. 1:25-cv-02569-RC (D.D.C. Jan. 9, 2026)).

Background. In August 2025 the FTC initiated an administrative proceeding along with filing a complaint and request for preliminary relief in the District of Columbia federal district court seeking to block Edwards’ proposed acquisition due to concerns that the acquisition would limit patient access to lifesaving medical devices used to treat a potentially fatal heart condition. The agency complaint said that the deal threatens to eliminate the existing vigorous head-to-head competition in the market because it would collect under one roof the only two transcatheter aortic valve replacement (TAVR) device companies conducting ongoing clinical trials with the FDA.

According to the FTC, in July 2024, Edwards executed agreements to acquire both JenaValve and JC Medical, the two leading companies competing to bring to market TAVR devices that treat a heart condition called aortic regurgitation (TAVR-AR). 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 administrative complaint charged that the proposed acquisition would consolidate the TAVR-AR device market in the U.S. and give Edwards a TAVR-AR monopoly. The revolutionary technology behind these devices offers a safe and effective treatment for AR, with the only other alternative being invasive open-heart surgery that is not recommended for high-risk patients, including those who are older or frail. If consummated, the deal would likely slow the pace of innovation in TAVR-AR devices and increases the risk that one of the existing devices being de-prioritized or abandoned because Edwards would have little reason to maintain two valves for treatment of the same condition.

Analysis. In reviewing whether the FTC would be successful on the merits, the court began by considering the relevant market in which to assess the likely effects of the Proposed Transaction, which it concluded is the market for the research, development, and commercialization of TAVR-AR devices in the United States. Next, the court assessed whether the Proposed Transaction is likely to substantially lessen competition in that market, in violation of Section 7 of the Clayton Act.

The court found that Edwards and JenaValve are currently engaged in active competition to develop superior TAVR-AR valves and bring their respective valves to market as quickly as possible, and that because the Proposed Transaction would eliminate this competition, there is a “reasonable probability” that it violates Section 7. Here, the court agreed with the FTC that the relevant market includes “the research, development, and commercialization of TAVR-AR devices in the United States.” The court also relied in the FTC’s economic expert, Dr. Wilson, who conducted the hypothetical monopolist test to determine the appropriate product market. Dr. Wilson concluded that the relevant market here includes “only TAVR-AR products that can be supplied to American consumers.”

Turning next to the likely effects of the Proposed Transaction on competition within that market, the court analyzed the FTC’s three arguments of how the Proposed Transaction would violate the Clayton Act. First, the FTC argued that the Proposed Transaction violates Section 7 because, by allowing Edwards to acquire its only competitor, it “tend[s] to create a monopoly.” Second, the FTC asserts that, by consolidating all current participants in the TAVR-AR market, the Proposed Transaction results in market shares and concentrations that are “so inherently likely to lessen competition” as to be presumptively unlawful. Third, the FTC maintained that the Proposed Transaction is likely to substantially lessen competition, in violation of Section 7, because it will eliminate substantial head-to-head competition between Edwards and JenaValve.

As to the second argument, the FTC’s economic expert calculated HHIs for the Proposed Transaction based on two metrics: the number of U.S. clinical trial sites enrolled in Edwards’s and JenaValve’s respective clinical trials and the number of TAVR-AR devices implanted by each company. The expert’s conclusion was that the Proposed Transaction is presumptively illegal because it will dramatically increase concentration in the U.S. TAVR-AR device market. The court reasoned however that considering the strength of the FTC’s other evidence establishing the Proposed Transaction’s anticompetitive effects, it was unnecessary to decide whether Dr. Wilson’s market share and concentration evidence entitles the FTC to a presumption of illegality.

With respect to the lessoning of competition, the court reasoned that consummating the transaction would de-incentivize Edwards to continue to innovate. Wrote the court, “If the Proposed Transaction is consummated, Edwards will no longer face the threat of a rival TAVR-AR valve beating it to market and cannibalizing its sales, reducing its current incentive to accelerate the development of SOJOURN. Furthermore, if Edwards owns both Trilogy and SOJOURN, it anticipates setting a premium price for its AR platform, as it would not have to contend with competitor devices.” The FTC’s economic expert, explained, “if two firms have products that will ‘contest’ with each other for sales,” a merger would reduce the combined firm’s “incentive to incur costs to develop [both] products.” The Court determined that in addition reducing competition and the incentive to innovate in both the pre-commercial and commercial TAVR-AR markets, the Proposed Transaction would be likely to produce anticompetitive unilateral effects once Trilogy and/or SOJOURN are commercialized. The court concluded that in addition to the immediate harm to innovation and competition threatened by the Proposed Transaction, the FTC had also shown a “reasonable probability” that a merger between Edwards and JenaValve may lessen competition substantially by granting Edwards a monopoly in the U.S. TAVR-AR market.

The Case is No. 1:25-cv-02569-RC.

Judge: Contreras, R.

Attorneys: Laura Hall for the FTC. Blair West Matthews (Cleary Gottlieb Steen & Hamilton LLP) for Edwards Lifesciences Corp.

Companies: Edwards Lifesciences Corp.

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