Achy Breaky Heart: The FTC Blocks Edwards-JenaValve Aortic Device Deal

FTC's first successful judicial challenge to a pipeline-to-pipeline merger in the medical device or healthcare area

On January 9, 2026, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia granted the Federal Trade Commission's ("FTC") request for a preliminary injunction, blocking Edwards Lifesciences's acquisition of JenaValve Technology.¹ This was the first time that the FTC had convinced a court to block a merger with overlapping R&D products that were a number of years from obtaining FDA approval.

At issue was control of the emerging U.S. market for transcatheter aortic valve replacement ("TAVR") devices designed to treat aortic regurgitation ("AR"), a serious, often fatal heart condition whereby the aortic valve fails to close properly, allowing blood to flow backward into the heart. The standard treatment for severe AR is open heart surgery, but for many high-risk patients—older, frailer, or with comorbidities—surgery is not an option. TAVR-AR devices are being developed to provide a minimally invasive alternative.

The FTC alleged that two companies lead development of these devices in the U.S.:

• Edwards Lifesciences is a leading structural heart device manufacturer that pioneered TAVR devices to treat aortic stenosis ("AS") in 2011. Through its subsidiary JC Medical, Edwards is developing a TAVR-AR device—J-Valve—expecting FDA approval.
• JenaValve is a medical device manufacturer whose flagship product, a TAVR-AR device called Trilogy, is currently undergoing clinical trials, with FDA approval expected as well.

Under the proposed deal, Edwards would acquire substantially all of JenaValve's assets, consolidating the only two firms conducting U.S. clinical trials for TAVR-AR devices.

Court endorsed a relevant market for the research, development and commercialization of TAVR-AR devices in the United States

The court accepted the FTC's market definition: a U.S. market for the research, development, and commercialization of transfemoral TAVR-AR devices even though no TAVR-AR device is currently approved for commercial sale in the United States. Why did the court include commercialization in the relevant market even though neither of the parties' products were available for sale? Why were the FTC and the court unwilling to rely solely on an innovation market as the FTC had done in numerous challenges to pharmaceutical mergers that resulted in agency consent decrees? Although the answer remains unclear, litigation risk may have been a factor considering that no court had yet to invalidate a transaction due to anticompetitive effects solely in an innovation market.

Court declines to apply presumption of illegality based on market shares to pre-commercial R&D product markets

The decision is equally notable for rejecting the FTC's attempt to establish a presumption of illegality under Philadelphia National Bank. In a typical merger enforcement action (i.e. involving commercialized products), the FTC can establish a presumption that the merger is illegal under the Supreme Court case United States v. Philadelphia National Bank. 374 U.S. 321 (1963). If the FTC can show evidence of a high market share resulting from the merger, it is presumed illegal and the burden shifts to the merging parties to show otherwise. However, the court declined to extend Philadelphia National Bank to innovation markets, finding itself "not convinced" that market share statistics were sufficient for a presumption of illegality "[g]iven that the FTC's proposed market currently includes only pre-commercial products." The court determined that economic theory is less clear that fewer competitors results in less innovation and thus the FTC should not be entitled to a presumption of illegality simply based on market share and concentration statistics. Instead, the court made clear that it needed to consider the strength of the FTC's other evidence in assessing whether the transaction would lead to anticompetitive effects.

Court concluded that parties' ordinary course documents and testimony demonstrated substantial head-to-head competition

The court accepted the FTC's framing of the case as a two-to-one merger in a research, development, and commercialization market and credited extensive evidence from the parties' documents that Edwards and JenaValve currently compete head-to-head—on speed to market, valve size, clinical trial sites, physician relationships, and anticipated pricing. The court found it likely that the merger would reduce innovation and ultimately lead to monopoly pricing once a device is approved.

KEY TAKEAWAY

FTC will not shy away from filing suit in federal court to challenge mergers in which overlap products are only in the R&D phase and are years away from being commercialized

How many years from regulatory approval / commercial launch do the parties' products need to be for the FTC to view the antitrust market as too speculative and uncertain to warrant judicial intervention? The answer remains unclear. Although the projected launch dates for the JenaValve product are redacted in the court's decision, Edwards indicated that under the "best case scenario" its TAVR product was estimated to enter in 2029. In addition, the court stated that "-[b]oth devices are expected to go to market in the next few years."

Although the FTC has a long history of accepting consent orders and issuing complaints asserting a merger's adverse effects solely in innovation markets (dating back to the 1990s), this is the first instance of the agency winning such a challenge in federal court.

Against that backdrop, FTC scrutiny of innovation competition in healthcare mergers is likely to continue.

Footnote

1 On January 28, in light of the district court ruling, the court granted the parties' joint motion to dismiss the complaint, indicating that Edwards and JenaValve have "terminat[ed] their proposed transaction," and Edwards had "withdrawn its Hart-Scott-Rodino Notification and Report Forms and has no intent to refile."

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