Dive Brief:
- Edwards Lifesciences said Friday it has dropped plans to acquire JenaValve Technology after a U.S. district court granted the Federal Trade Commission’s motion for an injunction blocking the transaction.
- Edwards said it disagrees with the ruling, in the U.S. District Court for the District of Columbia, and believes the acquisition would have been in the best interest of a large underserved group of patients.
- As a result of the decision, Edwards revised its full-year 2026 adjusted per-share earnings forecast to a range of $2.90 to $3.05, up from earlier guidance of $2.80 to $2.95.
Dive Insight:
In August, the FTC challenged Edwards’ planned $945 million purchase of JenaValve, citing concerns that the acquisition would limit patient access to devices to treat aortic regurgitation, a potentially fatal heart condition. The move came roughly a year after Edwards announced the deal.
The FTC argued that Edwards’ purchase of JenaValve would combine the only two companies conducting U.S. clinical trials for a transcatheter aortic valve replacement device for aortic regurgitation, a condition where the valve does not close properly, allowing blood to leak backward into the heart.
The FTC alleged that in July 2024, Edwards signed agreements to acquire both JenaValve and JC Medical, the two leading companies developing TAVR technologies for aortic regurgitation. Edwards completed the JC Medical acquisition in August 2024.
The agency said the JenaValve acquisition threatened to reduce competition for treatments, diminish product quality and increase prices for consumers.
JenaValve’s Trilogy TAVR system is designed to treat patients with symptomatic severe aortic regurgitation and symptomatic severe aortic stenosis who are at high surgical risk. The device has received CE mark approval in Europe.
Edwards, in its statement, said it remained committed to leading treatment for patients with aortic regurgitation and would continue to advance its Sojourn transcatheter valve and enroll patients in the JOURNEY pivotal trial.
