On August 6, 2025, the Federal Trade Commission (FTC) issued an administrative complaint, and a concurrent complaint in the U.S. District Court for the District of Columbia seeking a preliminary injunction, challenging structural heart device supplier Edwards Lifesciences Corp.’s (Edwards) proposed $945m acquisition of JenaValve Technology, Inc. (JenaValve). In combination with Edwards’ recent acquisition of JC Medical, Inc. (JC Medical), the FTC claims Edwards’ acquisition of JenaValve would eliminate competition between the only two companies (JC Medical and JenaValve) developing medical devices for treating aortic regurgitation (TAVR-AR Devices), a potentially fatal heart condition affecting at least 8 million Americans.
Focus on Innovation
The FTC’s complaint is rooted in Edwards’ acquisitions of both JC Medical, first, and JenaValve, second. Prior to the proposed transaction with JenaValve in August 2024, Edwards acquired JC Medical, a medical device company testing a TAVR-AR Device, J-Valve, for aortic regurgitation. The only other company conducting administrative trials for TAVR-AR Devices is JenaValve, which is currently testing its TAVR-AR Device, Trilogy. TAVR-AR Devices are poised to be a less invasive treatment for aortic regurgitation than open-heart surgery – presently the only FDA-approved treatment for aortic regurgitation.
The FTC alleged TAVR-AR Devices have unique uses for which there are no adequate alternatives. In combination with Edwards’ acquisition of JC Medical, the FTC concluded the proposed acquisition of JenaValve would “eliminate the close and ongoing head-to-head competition between Edwards and JenaValve” in the future.
The FTC’s focus on pipeline products and innovation is a notable aspect of the agency’s intervention. The complaint centers on the harm caused to pipeline products – i.e., competition between products still in development but expected to enter the market in the near future. In the case of TAVR-AR Devices, by effectively consolidating the only two viable pipeline competitors, the FTC claims that Edwards would gain unilateral control over the pace and direction of innovation in TAVR-AR Devices. In the FTC’s view, this would likely slow the pace of innovation and increase the risk of either J-Valve or Trilogy being de-prioritized or abandoned.
The intervention in Edwards /JenaValve echoes the FTC’s ongoing interest in protecting innovation competition. In the complaint, the FTC emphasized that eliminating future market rivals by directly acquiring a competing developer would stifle innovation, reduce product quality, and harm consumers in markets where life-saving technologies were still under development. We expect this trend to be reflected in future FTC enforcement actions, particularly in light of the FTC’s growing focus on protecting nascent competition in high-stakes healthcare sectors.
Openness to Structural Remedies as a Litigation Tactic
According to the complaint, Edwards was given the opportunity to resolve antitrust concerns in November 2024, when Commission staff asked whether Edwards would divest JC Medical – a proposal the FTC says was continuously renewed over the following eight months. The complaint states that Edwards “repeatedly rejected the Commission's outreach to divest JC Medical” and sought instead to consummate its proposed acquisition of JenaValve.
The FTC’s references to settlement negotiations through its complaint underscores its renewed openness to remedies, which is a positive development for dealmakers. But there are no guarantees. If settlement negotiations fail, then parties should be prepared to defend the decision not to settle since the FTC is prepared to inform the court of its ongoing receptiveness to settlement and parties’ unwillingness to negotiate.
Key Takeaways
- The FTC is serious about innovation competition: Neither of the Parties’ TAVR-AR Devices are commercially available, but the complaint alleges the acquisition would reduce the incentive to innovate while both devices are undergoing FDA clinical trials. The FTC’s emphasis on preserving innovation in emerging markets signals heightened scrutiny of deals that threaten to eliminate potential rivals before products reach commercialization.
- The FTC is open to settlements and will highlight refusals to negotiate: The complaint mentions the FTC’s attempts to settle the case with the Parties and its requests for relief reads more like the terms of a consent decree, including a compliance monitor, compliance reports, a prior notice, and a prior approval provision – signaling the FTC’s openness to structural remedies. If settlement negotiations fall though, parties should expect the FTC to maintain a clear record with the court of its willingness to engage in settlement negotiations, and parties may need to defend their rationale for not settling.
- The life sciences sector remains an area of focus for this administration: In keeping with the FTC’s challenge of the GTCR/Surmodics acquisition, a joint FTC and DOJ listening session on lowering Americans’ drug prices through competition and recent Executive Orders concerning MFN clauses for prescription drugs (signed May 12, 2025) and lowering drug prices (signed April 15, 2025), this matter shows that the FTC is laser-focused on the healthcare sector. Dealmakers should prepare for regulatory scrutiny, engage antitrust counsel early, and consider remedy strategies – particularly for companies operating in innovative sectors.
Joseph Pridmore (Trainee Associate) contributed to this article.
