JenaValve announced the completion of the 1,000^th commercial Trilogy transcatheter heart valve (THV) procedure, performed in Cologne, Germany.

The company said this marks a significant milestone that shows the platform’s rising popularity to treat patients with asymptomatic, severe aortic regurgitation (AR) who had limited treatment options in the past.

“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.”

University Hospital Cologne’s Dr. Matti Adam was one of the surgeons performing the 1000^th case. Dr. Adam said as an interventional cardiologist, he’s constantly thinking about how to best treat patients with limited options and Trilogy is a fundamental shift in how to approach patients with severe AR.

“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,” Dr. Adam told the press.

Dr. Stephen Baldus of University Hospital, Cologne performed the surgery alongside Dr. Adam. He said a dedicated device like Trilogy has given them an important tool in their toolbox.

“Often times patients with aortic regurgitation are sent to our team quite late, largely due to lack of awareness for this disease,” said Dr. Baldus. “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,” added John Kilcoyne, CEO of JenaValve. “This large and growing body of real world evidence provides a strong foundation for future growth and adoption.”

Earlier this year, the company began enrolling patients in its ARTIST study, which will compare Trilogy to surgical aortic valve replacement in aortic regurgitation patients.