On January 9, 2026, the U.S. District Court for the District of Columbia granted the U.S. Federal Trade Commission’s request for a preliminary injunction blocking Edwards Lifesciences’ proposed $945 million acquisition of JenaValve Technology.

The ruling is significant because the Court recognized – for the first time – a market encompassing research & development and commercialization for products not yet commercially available, finding that the loss of competition to innovate at the R&D stage could violate U.S. antitrust law.

Background on innovative treatment for AR

The case centers on treatments for severe aortic regurgitation (AR). Today, the only U.S. Food and Drug Administration‑approved AR treatment is open‑heart surgery. Medical device companies, however, have recently been developing transcatheter aortic valve replacement devices to treat AR (referred to as "TAVR‑AR"), which allow physicians to replace diseased aortic valves via catheter rather than surgery. According to the Court, Edwards and JenaValve were the only two companies with TAVR‑AR devices in U.S.-based clinical trials at the time of the proposed acquisition. This meant they were the only firms positioned to reach the U.S. market in the foreseeable future.

A market defined by competition at the research & development stage

The FTC argued—and the Court agreed—that although no TAVR‑AR device is yet FDA‑approved, competition during the research and development phase meaningfully shapes device design, clinical‑trial strategy, speed to market, and ultimately patient outcomes. For that reason, the Court held that a relevant product market can consist of products on the path to commercialization, even before regulatory approval. This decision builds on the 5^th Circuits affirmation of a "research, development, and commercialization" market in the FTC's successful challenge of the Illumina/Grail merger in 2023.  There, the relevant market consisted of both pre-commercial and commercialized products.

The Court found that rivalry between Edwards and JenaValve was already influencing innovation: the companies were pushing to improve device size ranges, expand patient indications, accelerate clinical trials, and refine performance metrics. Eliminating this head‑to‑head competition, the Court held, would likely slow innovation, weaken product quality, and reduce future patient choice.

"Competitors" that the court excluded – and why

The Court rejected the parties proposed broader market that would include alternative therapies for AR, such as open‑heart surgery or other structural‑heart interventions. These therapies were excluded because they are different in character and use—they are far more invasive and intended for different patient populations than the minimally invasive TAVR‑AR devices under development.

Likewise, the Court excluded TAVR‑AR companies outside the United States because none had begun U.S. clinical trials, and therefore they were not reasonably likely to enter the U.S. market in the relevant time frame. With the FDA approval process requiring five to seven years, non‑U.S. developers were considered multiple years behind.

What this means for medical device and life sciences companies

The decision reinforces that:

• Pre‑commercial pipelines can be relevant antitrust product markets, such that overlaps in clinical‑stage assets may trigger scrutiny even when no product has launched.
• The FTC – and now federal courts – view R&D stage competition as essential to innovation, clinical outcomes, and future pricing.

Alternative therapies and global competitors may – or may not – be considered as part of the relevant market based on the specific facts around their substitutability with the overlapping products.