The milestone procedure took place in Cologne, Germany, demonstrating the growing adoption of the Trilogy valve for 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, JenaValve chief medical officer. “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.”
Dr. Matti Adam and Dr. Stephan Baldus of University Hospital, Cologne, performed the procedure. Adam said Trilogy “represents a fundamental shift in how we approach patients suffering from severe aortic regurgitation.”
JenaValve currently stands as the only company with an approved transcatheter valve indicated for AR in Europe, according to a news release. Its ALIGN-AR pivotal trial for its Trilogy valve helped inform the updated guidelines. Edwards is trying to acquire JenaValve in the face of regulatory scrutiny.
At the start of this year, GlobalData analysts said they expect the FDA to approve JenaValve’s TAVR device for AR by late 2025.
“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.”
