JenaValve Announces 1,000th Case with the Trilogy™ Transcatheter Heart Valve (THV) System
IRVINE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the completion of its 1,000th commercial Trilogy procedure, performed in Cologne, Germany, marking a major milestone demonstrating the platform’s growing adoption in treating patients with symptomatic, severe aortic regurgitation (AR) who previously had limited treatment options.
"This 1,000th case represents 1,000 patients who now have their lives back," said Dr. Duane Pinto, Chief Medical Officer at JenaValve. "This milestone speaks to the vast unmet need for patients suffering from AR. We are quickly finding that there are indeed patients with AR that need less invasive solutions. In Europe, more and more patients are being referred that would not have historically been identified as a candidate for treatment or even diagnosed."
"As an interventional cardiologist, I am constantly thinking about how to best treat patients whose options are limited," said Dr. Matti Adam, University Hospital Cologne. "Trilogy represents a fundamental shift in how we approach patients suffering from severe aortic regurgitation. These 1,000 implants represent patients who, just a few short years ago, would have had no viable options; yet today, after a procedure that I have found to be safe, reproducible, with consistent outcomes, they’re walking out of the hospital with their lives significantly improved."
"A dedicated device like the Trilogy valve has given us an important new tool in our toolbox," said Dr. Stephan Baldus, University Hospital, Cologne, who performed the case alongside Dr. Adam. "Often times patients with aortic regurgitation are sent to our team quite late, largely due to lack of awareness for this disease. We previously would be faced with a challenging decision of performing open surgery on a sick patient, or attempting a TAVR with a device designed for aortic stenosis. The trilogy has undoubtedly elevated outcomes for patients with AR."
"We set out to transform the treatment landscape for severe AR and this milestone validates our mission," said John Kilcoyne, Chief Executive Officer of JenaValve. "This large and growing body of real world evidence provides a strong foundation for future growth and adoption."
About JenaValve
JenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative THV solutions for the treatment of patients suffering from heart valve disease. The Company's Trilogy THV System is a TAVR system designed to treat patients with symptomatic, severe AR, and symptomatic, severe aortic stenosis who are at high surgical risk. The Trilogy THV System received CE Mark approval, providing European physicians with the first TAVR device with true dual-disease treatment capabilities. In the US, the Trilogy THV System is limited to investigation use only.
JenaValve is headquartered in Irvine, California, with additional locations in Leeds, United Kingdom, and Munich, Germany.
JenaValve is backed by Bain Capital Life Sciences, Andera Partners, Valiance Life Sciences, Rosetta Capital, Cormorant Asset Management, Legend Capital, NeoMed Management, RMM, VI Partners, Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited.
US: CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.
Additional information is available at www.jenavalve.com.
JenaValve Contact:
Daniel Sun
dsun@jenavalve.com
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