
Developer of Transcatheter Heart Valve Solutions

Developer of Cardiac and Cerebrovascular Interventional Medical Devices

Source: Medical Device Business Review
On January 9, 2026, a judge in Washington, D.C. granted the preliminary injunction request filed by the U.S. Federal Trade Commission (FTC), halting Edwards Lifesciences' acquisition of JenaValve.
Subsequently, Edwards announced that it would not proceed with the acquisition after the legal proceedings with the FTC concluded.As of this point, this project, which was launched in July 2024 and is valued at $1.2 billion (approximately RMB...8.3 billion) was forced to halt its acquisition plan after months of review.


Source: Edwards Lifesciences official website
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In July 2024, Edwards Lifesciences, headquartered in Irvine, California, agreed to acquire JenaValve.
In August 2025, the FTC filed a lawsuit alleging that the acquisition was anti-competitive. The FTC pointed out that Edwards and JenaValve are the only two companies in the United States developing transcatheter aortic valve replacement (TAVR) technology for the treatment of aortic regurgitation (AR).
On January 9, 2026, the court approved the FTC's injunction, and Edward subsequently officially announced the termination of the acquisition.
JenaValve is headquartered in Munich, with its core product beingTrilogy Heart Valve System,SystemThe world's first and onlyOne Approved(CE)Transfemoral TAVR for the treatment of severe symptomatic aortic regurgitation or aortic stenosis.

Source: JenaValve Trilogy Official Website
The origin of JenaValve can be traced back to the design concept proposed by Dr. Hans Figulla and Dr. Markus Ferrari from Friedrich Schiller University in 1995. The founders obtained their first patent for a percutaneous self-expanding aortic stent in 1999.
In 2006, JenaValve was officially established. In 2018, the company initiated the ALIGN-AR pivotal trial in the United States, utilizing its transfemoral porcine pericardial valve to treat aortic regurgitation.
In 2021, the company raised $100 million in a Series C financing round aimed at obtaining FDA approval for its Trilogy heart valve system, which is designed for high surgical risk patients with symptomatic severe aortic regurgitation (AR).
In the same year, the leading enterprises in China's cardiovascular industryPeijia MedicalPeijia Medical signed an exclusive license for the Trilogy™ Heart Valve System in the Greater China region with JenaValve and became one of the minority shareholders of JenaValve. After the completion of this transaction, Peijia Medical will continue to hold the rights to the JenaValve Trilogy THV system in...Exclusive Authorization in Greater China。
In October of the year before last, JenaValve debuted at the Transcatheter Cardiovascular Therapeutics conference.(TCT)Meeting, ALIGN-ARCo-principal investigator Vinod Thourani announced the experimental results,It was announced that the study met its primary safety endpoint, which was to evaluate the safety of the Trilogy THV system 30 days after implantation. Regarding efficacy, the researchers indicated significant improvements in left ventricular systolic diameter, systolic volume, and mass regression.

Previously, officials from Edwards Lifesciences mentioned,The JenaValve Trilogy Heart Valve System for treating aortic regurgitation may receive FDA approval by the end of 2025.
In the press release announcing the termination of the acquisition, Edwards said:
Will continue to focus on leading the treatment of aortic regurgitation and providing innovative solutions for patients.
Will continue to advance the development of its Sojourn transcatheter valve for the treatment of AR and evaluate the J-Valve system acquired from JC Medical through the JOURNEY pivotal trial.
The company raised its full-year adjusted earnings per share guidance for fiscal 2026 to $2.90–$3.05 (from the previous expectation of $2.80–$2.95).
Following the announcement, the company raised its full-year adjusted earnings per share guidance for fiscal year 2026 to a range of $2.90 to $3.05. Previously, after factoring in the acquisition, the company had forecasted earnings per share of $2.80 to $2.95.
The content of this article is for reference only and does not constitute investment advice. Readers are advised to effectively distinguish.If any platform reprints this article, it must take responsibility for the content of the article. Medical Device Business Review is not responsible for the impact of secondary dissemination caused by reprints.
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