Last Friday, the U.S. District Court for the District of Columbia sided with the Federal Trade Commission (FTC), granting an injunction that blocks Edwards Lifesciences Corporation's intended purchase of JenaValve Technology, Inc. This injunction brings a halt to the $1.2 billion acquisition attempt announced in mid-2024, terminating Edwards Lifesciences' plans to integrate JenaValve into its portfolio.
Edwards Lifesciences expressed disagreement with the court's ruling, maintaining that the acquisition would have served the interests of a significant and underserved patient population suffering from aortic regurgitation (AR). AR is a cardiovascular disorder characterized by the aortic valve's inability to close properly, resulting in blood leakage from the aorta back into the left ventricle. This backward flow forces the heart to exert increased effort to maintain circulation, posing serious health risks if left unaddressed.
The company emphasized that AR frequently goes underdiagnosed and undertreated despite its association with high mortality rates when untreated. Highlighting its commitment, Edwards reported ongoing advancement of its SOJOURN transcatheter AR valve system and the active enrollment of patients in the pivotal JOURNEY clinical trial, intending to address this clinical gap through innovative therapeutic solutions.
In light of the court decision, Edwards revised its full-year 2026 adjusted earnings per share (EPS) guidance upward to a range of $2.90 to $3.05, slightly exceeding analyst consensus estimates pegged at $2.87. This revised guidance contrasts with its prior forecast of $2.80 to $2.95, signaling resilience despite the blocked transaction.
The FTC's initial move to block the acquisition came in August 2025, a little over a year after Edwards announced its plan to acquire JenaValve. Daniel Guarnera, Director of the FTC’s Bureau of Competition, articulated the agency’s stance that Edwards’ attempt to consolidate the U.S. market for transcatheter aortic valve replacement therapy specifically targeting AR would eliminate crucial competition. This competition, according to the FTC, has been instrumental in driving advancements and innovation for these life-preserving artificial heart valve technologies.
The FTC asserted that completing the deal would likely restrict patient access to vital medical devices, as it would reduce competition in the TAVR-AR market segment. The complaint further indicated that this diminished competition could lead to decreased innovation, lower product quality, and possibly higher prices affecting consumers.
Separately, Edwards Lifesciences reported a regulatory milestone in December 2025. Their SAPIEN M3 mitral valve replacement system received approval from the U.S. Food and Drug Administration (FDA), marking it as the first transcatheter therapy to use a transseptal approach for treating mitral regurgitation (MR). The SAPIEN M3 system is specifically indicated for patients with symptomatic moderate-to-severe or severe MR who are unsuitable candidates for surgery or transcatheter edge-to-edge repair (TEER). Its indication also includes symptomatic mitral valve dysfunction patients deemed ineligible for surgery or TEER by a multidisciplinary heart team.
On the corporate leadership front, Edwards announced in October 2025 that Scott Ullem, the company’s chief financial officer, planned to step down from his role by mid-2026. Ullem is expected to continue contributing to the company in an advisory capacity following the appointment of a new CFO.
Following the court’s injunction, Edwards Lifesciences' stock experienced an uptick, rising 1.21% to $86.16 during Monday’s premarket trading session, edging close to its 52-week high of $87.89, according to market data.