On August 6, 2025, the Federal Trade Commission (“FTC”) filed a motion for preliminary injunction to block Edwards Lifesciences Corporation’s (“Edwards”) $945 million proposed acquisition of JenaValve Technology, Inc. (“JenaValve,” collectively “Defendants”) in the District of Washington. Complaint, FTC v. Edwards Lifesciences Corp. et. al., No. 1:25-cv-02569, ECF No. 1 (D.D.C. 2025) (“Complaint”). On the same day, the FTC also filed an in-house administrative complaint to stop the proposed acquisition. In re Edwards Lifesciences Corp & JenaValve Technology, Inc., Docket No. 9442 (F.T.C. Aug. 6, 2025). Both Edwards and JenaValve develop medical devices to treat patients with structural heart conditions, though neither company’s product has yet been commercialized. Even so, the FTC alleges that the acquisition would eliminate the only existing competition in the market for a particular device.
Background
Both Edwards and JenaValve are currently developing transcatheter aortic valve replacement devices to treat patients with aortic regurgitation (“AR”). According to the Complaint, over 8 million Americans over age fifty suffer from AR, and about one in four people diagnosed with severe and symptomatic AR will die within a year if untreated. Complaint at 3. Currently, the only FDA-approved treatment for AR is surgical valve replacement through open heart surgery, called surgical aortic valve replacement. This treatment is not recommended for high-risk patients, including patients who are older, frailer, or have certain co-morbidities. Beyond this surgery, according to the FTC, “there is no suitable treatment option available for people with AR.” Id. at 4.
If successful, the transcatheter aortic valve replacement devices (“TAVR-AR” devices) that Edwards and JenaValve are developing would provide an alternative to open heart surgery and create treatment opportunities for high-risk patients. Id. at 4, 11. Treatment through TAVR-AR devices would offer a new and much less invasive procedure that only requires a small incision in the patient’s groin. Id. at 11. Other TAVR devices are commercially available, but those devices treat diseases other than AR. Id. at 12.
The FTC’s Lawsuit
The FTC alleges that Edwards and JenaValve are the “only two companies that are currently conducting clinical trials on TAVR-AR devices” and are “the only two competitive participants in the TAVR-AR device market” in the United States. Id. at 2, 15. The FTC argues that this competition “generate[s] superior clinical outcomes,” which ultimately benefits consumers. Id. at 21. For example, the FTC alleges that the companies currently compete in “clinical trial sites at major medical research institutions” and compete for the best “TAVR specialists to serve as principal investigators for their clinical trials.” Id. But if the proposed acquisition were “consummated,” the FTC claims, “the number of competitors in the TAVR-AR device market would shrink from two to one.” Id. at 16. The FTC alleges that the “relevant product market” is TAVR-AR devices that “are designed specifically to treat AR.” Id. at 14. The FTC also alleges that Edwards and JenaValve “cannot demonstrate that entry of other TAVR-AR device companies would be timely, likely, or sufficient to offset the anticompetitive effects” of the proposed acquisition. Id. at 22. Further, the FTC asserts that Defendants cannot show any “merger-specific efficiencies that would offset the likely and substantial competitive harm” from the proposed acquisition. Id.
As a result, the FTC argues, the proposed acquisition would “substantially lessen competition or tend to create a monopoly in the TAVR-AR device market in the United States by eliminating vigorous head-to-head competition between” Defendants, in violation of Section 7 of the Clayton Act and Section 5 of the FTC Act. Id. at 16. According to a statement by the Director of the FTC’s Bureau of Competition, Daniel Guarnera, “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 . . . The FTC is taking action to stop this anticompetitive deal and ensure that JenaValve and Edwards . . . continue competing to innovate, expand treatment eligibility, and keep down costs.”
On the other hand, according a statement by Edwards, the FTC’s lawsuit will “limit the availability of an important treatment option for patients suffering from aortic regurgitation” and the proposed acquisition “will accelerate the availability, adoption and continued innovation of a life-saving treatment for patients suffering from AR.” Edwards “intends to continue to pursue regulatory approval of the acquisition.”
To succeed on its motion for a preliminary injunction, the FTC must show that it is likely to succeed on the merits of its claim, it is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in the FTC’s favor, and that an injunction is in the public interest. E.g., Starbucks Corp. v. McKinney, 602 U.S. 339, 346 (2024).
Following the Complaint, the FTC filed an unopposed temporary restraining order preventing the proposed acquisition until after January 9, 2026, or the fifth business day after the Court rules on the FTC’s motion for a preliminary injunction, whichever occurs earlier in time. United States District Court Judge Rudolph Contreras granted the FTC’s motion. FTC v. Edwards Lifesciences Corp. et. al., No. 1:25-cv-02569, ECF No. 8, at 2 (D.D.C. 2025 August 7, 2025).
Edwards and JenaValve’s answer to the Complaint is currently due on October 6, 2025. FTC v. Edwards Lifesciences Corp. et. al., No. 1:25-cv-02569, ECF No. 30, at 1 (D.D.C. 2025 August 12, 2025).
The FTC intends to begin administrative proceedings on the merits of its in-house claim on January 7, 2026.
