The Federal Trade Commission has moved to block Edwards Lifesciences’ purchase of JenaValve Technology and its transcatheter heart valve implant for treating aortic regurgitation, which is expected to obtain FDA approval by the end of this year.
Edwards set its sights on JenaValve and its Trilogy system in July 2024, with plans to pay $500 million upfront plus another $445 million tied to regulatory and revenue milestones. The deal was announced alongside the company’s offer for Endotronix and its heart failure monitoring implant, which was finalized the following month for about $650 million in cash.
The FTC, however, has tied the JenaValve deal to Edwards’ separate $316 million acquisition of JC Medical—a U.S. maker of TAVR hardware also chasing aortic regurgitation, formerly owned by the Singapore-based Genesis MedTech—that closed at about the same time.
The federal antitrust watchdog claims that if Edwards obtains the assets of both JC Medical and JenaValve, then it will be in sole control of the only heart valves being developed for that specific indication.
Of the multiple TAVR systems currently on the market, such as Edwards’ Sapien implants, all have been approved for treating aortic stenosis—or a narrowing of the heart valve—and not for aortic regurgitation, where an insufficient seal allows blood to flow backwards with every contraction. The condition can contribute to heart failure if left untreated, and an FDA green light would represent a major expansion of the minimally invasive TAVR approach.
“Edwards’ attempt to buy the U.S. market for TAVR-AR devices would eliminate the head-to-head competition that has spurred innovation for lifesaving artificial heart valves,” Daniel Guarnera, director of the FTC’s competition bureau, said in a statement. “The FTC is taking action to stop this anticompetitive deal and ensure that JenaValve and Edwards’ JC Medical subsidiary continue competing to innovate, expand treatment eligibility, and keep down costs.”
The commission estimates that more than 8 million people in the U.S. suffer from aortic regurgitation, who currently have to undergo open surgery for treatment.
According to the FTC, Edwards “has not been willing to engage in divesting JC Medical to resolve the competition concerns.” While Genesis MedTech maintained the rights to JC Medical’s J-Valve technology in China, in 2024, the breakthrough-designated implant received a go-ahead from the FDA to launch a U.S. pivotal trial.
In its own statement, Edwards said it disagrees with the FTC’s belief that the acquisition will limit access to a new therapy option: “The company further believes the acquisition of JenaValve will accelerate the availability, adoption and continued innovation of a life-saving treatment for patients suffering from AR.”
Edwards also updated its most recent financial forecast, issued in late July. With the delays in spending planned for the JenaValve acquisition this year, the company increased the high-end of its 2025 earnings-per-share guidance to between $2.45 and $2.55, up from $2.40 to $2.50, with no change in predicted revenues.
Edwards said it plans to continue its pursuit of regulatory approval for the deal, and estimates a final determination by the end of March 2026.