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FTC Files to Block Edwards Lifesciences’ $945 Million JenaValve Acquisition

Regulators warn the merger would unite the only two U.S. clinical trial leaders in TAVR-AR, threatening innovation and raising treatment costs.

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United States Federal Trade Commission logo and U.S. flag are seen in this illustration created on April 23, 2025. REUTERS/Dado Ruvic/Illustration/File Photo
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Overview

  • The FTC voted unanimously to file an administrative complaint in D.C. federal court seeking a temporary restraining order and preliminary injunction to halt the transaction.
  • Edwards Lifesciences’ proposed $945 million purchase of JenaValve would combine the sole developers conducting U.S. clinical trials for transcatheter aortic valve replacement in aortic regurgitation.
  • The agency argued the deal could stifle innovation, degrade device quality and drive up prices for patients needing less-invasive heart valve treatments.
  • Edwards Lifesciences and JenaValve have pledged to defend the acquisition in court and anticipate a final regulatory decision by the end of Q1 2026.
  • In August 2024, Edwards bolstered its TAVR-AR market position by acquiring JC Medical, setting the stage for its latest consolidation effort.