The US Federal Trade Commission (FTC) is suing Edwards Lifesciences to prevent it from acquiring JenaValve, citing anticompetitive concerns.
In July 2024, Edwards announced plans to acquire JenaValve and JC Medical, both leading players developing transcatheter aortic valve replacement devices to treat aortic regurgitation (TAVR-AR).
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Edwards completed the acquisition of JC Medical from Singapore-based Genesis MedTech for around $320m in August 2024. In the event the proposed $945m acquisition of JenaValve was to also proceed, the FTC noted that Edwards would combine the only two companies with ongoing clinical trials in the US for a TAVR-AR device.
JenaValve’s Trilogy Heart Valve System for treating severe aortic regurgitation is currently under evaluation in the ALIGN-AR pivotal trial. (NCT04415047). Trilogy became the first EU CE-marked device specifically designed for treating the condition in 2021.
JC Medical received a breakthrough device designation from the US Food and Drug Administration (FDA) for J-Valve Transfemoral (TF) in 2023 and is currently evaluating the device in the JOURNEY pivotal trial (NCT06455787).
According to Daniel Guarnera, director of the FTC’s Bureau of Competition, Edwards’ attempt to “buy the US market” for TAVR devices for aortic regurgitation stands to eliminate competition that has spurred innovation in the space.
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By GlobalDataGuarnera 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.
“Americans deserve all the benefits that come from competition between medical device makers, just as they do in other markets.”
The federal court complaint and request for preliminary relief were filed in the US District Court for the District of Columbia to halt the transaction pending an administrative proceeding.
Edwards has disagreed with the FTC, claiming its acquisition of JenaValve will accelerate the “availability, adoption and continued innovation” of treatments for patients with aortic regurgitation. The medtech giant said it intends to continue pursuing regulatory approval for the acquisition and expects a “determination” reached by Q1 2026.
In light of the FTC action, the company revised its full-year 2025 guidance. Revenue guidance remains unchanged, but the company adjusted Earnings Per Share (EPS) guidance for the full year to $2.45-$2.55, up from $2.40-$2.50.
JenaValve also disagreed with the FTC. Vowing to join Edwards to defend the case in court, a spokesperson for the company said: “JenaValve remains confident in both its rationale for the transaction and the value it will bring to the hundreds of thousands of patients suffering from aortic regurgitation.”
According to GlobalData analysis, the global TAVR market is growing at a CAGR of 8.1% and is expected to reach a $14.9bn valuation by 2034, up from $6.8bn in 2024.
