Medical Device Takeover Falls Apart

Federal Trade Commission website homepage screenshot.

FTC secures major victory by halting Edwards Lifesciences’ bid to monopolize life-saving heart valve technology, protecting American patients from higher prices and stifled innovation under President Trump’s pro-competition enforcement.

Story Highlights

Edwards Lifesciences abandoned its $945 million acquisition of JenaValve after FTC lawsuit and court order blocked the anticompetitive deal.
Deal would have eliminated the only two competitors developing TAVR-AR devices for aortic regurgitation, a condition affecting millions of older Americans.
FTC action preserves rivalry, ensuring lower costs, better quality, and faster innovation in critical heart treatments.
Edwards’ dual acquisitions in July 2024 triggered scrutiny, rejecting inadequate divestiture proposals.
Victory signals stronger antitrust oversight in medical devices, aligning with Trump administration priorities for patient access and market fairness.

FTC Blocks Anticompetitive Acquisition

The Federal Trade Commission filed an administrative complaint and motion for preliminary injunction on August 6, 2025, targeting Edwards Lifesciences Corp.’s proposed $945 million purchase of JenaValve Technology, Inc. U.S. District Court in Washington, D.C., granted a temporary restraining order through January 9, 2026. This action addressed Edwards’ strategy to acquire both JenaValve and JC Medical within two days in July 2024, consolidating the sole active U.S. clinical trials for transcatheter aortic valve replacement devices treating aortic regurgitation (TAVR-AR). FTC Bureau of Competition Director Daniel Guarnera stressed preserving head-to-head competition for these lifesaving devices.

Dual Acquisition Threatens Patients and Innovation

Aortic regurgitation impacts millions of Americans over age 50, leading to heart failure without less-invasive treatments like TAVR-AR devices, delivered via catheter. Edwards, a dominant player in structural heart devices, closed its JC Medical acquisition immediately after signing the JenaValve deal. This left no other firms with ongoing U.S. trials, risking reduced innovation, inferior product quality, and elevated prices. High FDA barriers deter new entrants, amplifying concerns in this nascent market. FTC applied 2023 Merger Guidelines, presuming harm from such concentration.

Court Intervention Forces Deal Termination

Edwards terminated the JenaValve acquisition following FTC’s dual-track litigation in court and administrative proceedings. The temporary restraining order halted progress, and with no cooperation on divestitures like spinning off JC Medical, the deal collapsed. FTC viewed this as a win for competition, maintaining separate development paths for Trilogy and other TAVR-AR systems nearing commercialization. Patients stand to benefit from sustained rivalry driving expanded eligibility and improved outcomes. The administrative case now appears moot post-termination.

Edwards executives pursued portfolio expansion in the structural heart market but faced rejection of their remedies. JenaValve, developer of the Trilogy device, sought funding for U.S. launch, while FTC prioritized patient access over corporate consolidation. This outcome underscores power dynamics where regulatory leverage countered Edwards’ market dominance in related TAVR technologies for stenosis.

Broader Implications for Medical Device Markets

Short-term, the block averts monopoly in TAVR-AR, preserving dual development tracks. Long-term, it incentivizes research and development, potentially accelerating treatments for heart failure patients. Economic effects include prevented price increases and bolstered R&D investment. Socially, better access aids older Americans reliant on innovative devices. Politically, it reinforces FTC enforcement in life sciences under President Trump, signaling rigorous review of mergers with high entry barriers. Industry parallels include the GTCR/Surmodics challenge, where divestitures resolved similar issues.

Statement on FTC victory halting anticompetitive medical device deal: https://t.co/byXzpRWs8W

— FTC (@FTC) January 12, 2026

Legal experts highlight FTC’s structural presumption against concentrated markets and “litigate-the-fix” approach. Freshfields notes intensified focus on medical devices post-2023 guidelines. While Edwards implied disagreement by terminating without concessions, the precedent influences M&A strategies, demanding robust remedies upfront. Patients and the sector gain from this pro-competition stance, aligning with conservative values of limited government interference yielding fair markets and individual health protections.