The U.S. District Court for the District of Columbia granted the Federal Trade Commission's request for a preliminary injunction blocking Edwards Lifesciences Corp.'s proposed $945 million acquisition of JenaValve Technology, Inc. on Jan. 9, following a six-day trial. The ruling represents a major antitrust victory for the FTC in the healthcare sector and preserves competition in the specialized market for transcatheter aortic valve replacement devices.
The FTC originally challenged the deal in August 2025, alleging that Edwards' acquisition of JenaValve would substantially reduce competition in the U.S. market for TAVR-AR devices, which are used to treat aortic regurgitation, a potentially fatal heart condition. The commission argued that combining these companies would result in reduced innovation, diminished product quality, and potentially higher prices for patients who need these lifesaving devices.
The case centers on Edwards' strategy to acquire both leading competitors in the TAVR-AR device market. In 2024, Edwards executed agreements to acquire both JenaValve and JC Medical, the two primary companies competing to bring TAVR-AR devices to the U.S. market. Edwards successfully completed its acquisition of JC Medical in July 2024, making the proposed JenaValve acquisition particularly concerning to antitrust regulators.
TAVR-AR devices represent a specialized segment of the medical device industry focused on treating aortic regurgitation through minimally invasive procedures. The technology allows doctors to replace faulty aortic valves without open-heart surgery, providing critical treatment options for patients with severe heart conditions. The proposed acquisition would have combined the only two companies with ongoing clinical trials in the United States for TAVR-AR devices.
FTC Bureau of Competition Director Daniel Guarnera emphasized the significance of the victory in his statement following the court's decision. "This is a major victory for the Trump-Vance FTC, American patients, and U.S. healthcare innovation," Guarnera said. "The court's decision preserves the head-to-head competition between Edwards and JenaValve that has expanded treatment options for patients suffering from potentially fatal heart conditions."
The FTC's successful challenge reflects the agency's broader commitment to protecting competition in healthcare markets. Guarnera noted that Americans benefit when companies compete to create innovative, lifesaving medical technologies. The agency has positioned this case as part of its ongoing efforts to enforce antitrust laws that protect consumers and improve U.S. healthcare through lower costs, higher quality care, and continued innovation.
The preliminary injunction temporarily prevents Edwards from completing the JenaValve acquisition while the FTC's broader antitrust challenge proceeds. This type of relief is significant because it maintains the competitive landscape during litigation, preventing potentially irreversible harm to competition that could occur if the merger were allowed to proceed.
Edwards Lifesciences, a major player in the cardiovascular medical device industry, has been pursuing a strategy of acquiring emerging competitors in specialized valve replacement technologies. The company's acquisition of JC Medical earlier in 2024 had already consolidated part of the TAVR-AR market, making the proposed JenaValve deal particularly scrutinized by regulators.
The FTC's litigation team, led by the Mergers I Division and the agency's Litigation Group, successfully demonstrated to the court that the acquisition would harm competition. The six-day trial provided an opportunity for both sides to present evidence about market conditions, competitive dynamics, and the potential impact of the proposed merger on innovation and patient care.
This victory is part of a broader pattern of FTC enforcement actions in the healthcare sector under the current administration. The agency has taken multiple steps to protect American patients and reduce healthcare costs, including Chairman Andrew N. Ferguson's issuance of noncompete warning letters to healthcare employers and staffing companies in September 2025.
The case highlights the complex intersection of antitrust law and healthcare innovation. While mergers and acquisitions can sometimes promote efficiency and innovation, the FTC determined that this particular combination would harm competition in a market where patients depend on continued innovation for lifesaving treatments.
The court's decision preserves the competitive dynamic between Edwards and JenaValve that has driven innovation in TAVR-AR devices. This competition has expanded treatment options for patients with aortic regurgitation, a condition that can be fatal without proper intervention. By maintaining separate companies pursuing independent research and development paths, the market is more likely to continue producing innovative solutions for patients.
The FTC's success in obtaining preliminary relief demonstrates the agency's commitment to vigorous antitrust enforcement in healthcare markets where competition directly affects patient outcomes and costs. As the case proceeds, it will serve as an important precedent for evaluating future healthcare mergers and acquisitions in specialized medical device markets.