The U.S. Federal Trade Commission secured a court injunction on January 9, 2026 that prevents Edwards Lifesciences Corp. from completing its proposed purchase of JenaValve Technology Inc. The U.S. District Court for the District of Columbia issued the ruling, effectively stopping the transaction that would have added JenaValve’s Trilogy Heart Valve System to Edwards’ portfolio.
Edwards had agreed to pay approximately $1.2 billion upfront for JenaValve, with the possibility of additional milestone payments that could bring the total to $1.6 billion when combined with the acquisition of Endotronix. The FTC’s complaint cited a $945 million valuation for the JenaValve portion, underscoring the size of the deal and the potential market impact.
The company’s stated rationale was to broaden its aortic regurgitation (AR) offering and to bring the Trilogy system—designed to treat both AR and aortic stenosis—to market faster. Edwards argued that the acquisition would benefit patients by accelerating access to a first‑in‑class transcatheter therapy for a condition that is often underdiagnosed and carries high mortality when untreated.
The FTC’s concern centered on competition. At the time, Edwards and JenaValve were the only two U.S. companies conducting clinical trials for transcatheter aortic valve replacement devices for AR. The agency argued that the merger would eliminate head‑to‑head competition, potentially stifling innovation, reducing product quality, and driving up prices for patients and payers.
The blocked deal has immediate financial implications. Edwards revised its full‑year 2026 adjusted earnings‑per‑share guidance to $2.90–$3.05, down from $2.80–$2.95, reflecting the loss of the expected contribution from the JenaValve acquisition. The company also highlighted that the AR market serves roughly 50,000 U.S. patients annually, a niche that is both deadly and under‑treated, underscoring the strategic importance of the deal that was now denied.
Looking ahead, Edwards will continue to push its SOJOURN transcatheter AR program and the JOURNEY pivotal trial, while navigating heightened regulatory scrutiny. The company’s focus remains on expanding its structural heart portfolio, but the FTC’s action signals that future acquisitions in low‑competition markets will face stricter antitrust review.
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