On Friday, the U.S. District Court for the District of Columbia granted the motion from the U.S. Federal Trade Commission (FTC) for an injunction blocking Edwards Lifesciences Corp’s (NYSE:EW) proposed acquisition of JenaValve Technology Inc.
As a result, Edwards will not acquire JenaValve.
Edwards said it disagrees with the decision and believes that the acquisition would have been in the best interest of a large, growing, and underserved group of patients.
Aortic regurgitation (AR) is a heart condition where the aortic valve doesn’t close tightly, causing blood to leak backward from the aorta into the left ventricle, making the heart work harder.
The company on Friday said AR is typically under-detected and under-referred, and carries very high mortality if left untreated.
Edwards said it is advancing the SOJOURN transcatheter AR valve and enrolling patients in the JOURNEY pivotal trial.
Guidance Revision
In light of this update, Edwards is revising its full-year 2026 adjusted EPS guidance to $2.90 – $3.05 compared to the consensus of $2.87, from earlier guidance of $2.80 – $2.95.
Background
In August 2025, the FTC moved to block medical device supplier Edwards Lifesciences’ proposed acquisition of JenaValve Technology for approximately $1.2 billion, announced in July 2024.
“Edwards’ attempt to buy the U.S. market for TAVR-AR devices would eliminate the head-to-head competition that has spurred innovation for lifesaving artificial heart valves,” said Daniel Guarnera, Director of the FTC’s Bureau of Competition.
The deal would limit patient access to lifesaving medical devices, the FTC argues.
The deal threatens to reduce competition in the TAVR-AR market. This would likely result in reduced innovation, diminished product quality, and potentially increased prices for consumers, according to the complaint.
In December 2025, Edwards Lifesciences said its SAPIEN M3 mitral valve replacement system became the first transcatheter therapy utilizing a transseptal approach to receive U.S. Food and Drug Administration (FDA) approval for mitral regurgitation (MR).
The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is indicated for symptomatic moderate-to-severe or severe MR in patients who are deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy.
It is also indicated for symptomatic mitral valve dysfunction in patients who are deemed unsuitable for surgery or TEER therapy by a multidisciplinary heart team.
In October 2025, Edwards Lifesciences announced that Scott Ullem, the company’s chief financial officer, had decided to transition from his role by midyear 2026.
Following the appointment of a new CFO, Ullem will continue in an advisory role.
EW Price Action: Edwards Lifesciences shares were up 1.21% at $86.16 during premarket trading on Monday. The stock is approaching its 52-week high of $87.89, according to Benzinga Pro data.
Photo via Shutterstock
Recent Comments