Edwards Lifesciences has announced that the US District Court for the District of Columbia has approved an injunction motion issued by US Federal Trade Commission (FTC), putting the brakes on the medtech giant’s plans to acquire JenaValve.
Edwards will no longer proceed with the acquisition of JenaValve, maker of a transcatheter aortic valve replacement system for aortic regurgitation (TAVR-AR). Disagreeing with the court’s decision, Edwards emphasised that the acquisition would have been in the best interests of a “large, growing and underserved” patient population.
Due to this development, Edwards is revising its full-year 2026 earnings guidance to between $2.90-$3.05 per share from $2.80-$2.95 previously.
Edwards added that it will continue its focus on advancing the SOJOURN transcatheter AR valve and enrolling patients into JOURNEY, a pivotal trial (NCT06455787) evaluating the J-Valve TAVR AR system. Edwards inherited J-Valve from JC Medical after acquiring the US company from Singapore-based Genesis MedTech in August 2024.
JenaValve’s lead product for TAVR-AR is the Trilogy Heart Valve. The system is currently pending market approval from the FDA, having been in clinical trials under an investigational device exemption (IDE) granted in 2021. Edwards reached an agreement to acquire JenaValve in July 2024 alongside Endotronix in a combined $1.2bn deal to strengthen the company’s structural heart portfolio.
No TAVR devices with an AR indication are currently available on the US market, with JC Medical and JenaValve the farthest along in their devices’ clinical development. For this reason, the FTC sued Edwards in August 2025 to halt its acquisition of JenaValve. With JC Medical now a subsidiary of Edwards, the FTC claimed the company’s acquisition of JenaValve stood to eliminate competition that has spurred innovation in the TAVR-AR space.
At the time, Daniel Guarnera, director of the FTC’s Bureau of Competition, said: “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.”
Edwards’ share price on the New York Stock Exchange (NYSE) fell by 1.32% to $84.01 in pre-market trading on 12 January, down from an $85.13 close on 9 January. Edwards, which has a market cap of $50bn, released its statement after markets closed on 9 January.
According to GlobalData analysis, the overall TAVR market is growing at a compound annual growth rate (CAGR) of 7.2% and forecast to double its valuation to $12.8bn in 2034. GlobalData analysts previously stated that the addition of AR as a new indication in the treatment modality could potentially accelerate the market’s CAGR into double digits.
