Edwards Lifesciences (NYSE: EW) announced today that the U.S. Federal Trade Commission (FTC) seeks to block its planned $1.2 billion acquisition of JenaValve.
Irvine, California–based Edwards agreed to acquire the heart valve technology maker about a year ago. JenaValve develops the Trilogy transcatheter heart valve (THV) system for high-risk patients with symptomatic, severe aortic regurgitation (AR). TAVR currently serves as an option to treat aortic stenosis (AS). Expanding its indications to include AR could help a previously underserved population. An approval would also widen Edwards’ share in the TAVR market.
Analysts last month upgraded Edwards in anticipation of approval for Trilogy later this year. However, the FTC now aims to stop that from happening.
“Edwards disagrees with FTC’s decision and believes it will limit the availability of an important treatment option for patients suffering from [AR],” the company said in a news release. “The company further believes the acquisition of JenaValve will accelerate the availability, adoption and continued innovation of a life-saving treatment for patients suffering from AR.”
Despite the FTC’s attempt to block the deal, Edwards intends to continue pursuing regulatory approval of the acquisition. It expects a final determination by the end of the first quarter of 2026. In light of the action, the company revised its full-year guidance. It expects no impact to revenue but it increased its adjusted EPS guidance to the high end of $2.45-$2.55, rising from the high end of $2.40-$2.50. The company anticipates minimal impact to its third-quarter adjusted EPS guidance.
JenaValve said it intends to join Edwards to defend the case in court to complete the acquisition.
“JenaValve respectfully disagrees with the FTC’s decision and remains committed to completing the acquisition,” 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.”
