JenaValve’s Trilogy Heart Valve System Evaluated in First Commercial Implantations in Europe

June 28, 2022—JenaValve Technology, Inc., a developer and manufacturer of transcatheter aortic valve replacement (TAVR) devices, announced results from the first commercial implantations of the Trilogy heart valve system in high-surgical-risk patients with severe symptomatic aortic stenosis (AS) or aortic regurgitation (AR) in Europe.

In October 2021, JenaValve announced the launch of the Trilogy heart valve system in Europe. The Trilogy heart valve is limited by federal law to investigational use in the United States, advised JenaValve.

The findings from the first procedures were initially presented by Matti Adam, MD, of University Hospital in Cologne, Germany, and Alexander R. Tamm, MD, of Johannes Gutenberg-Universität in Mainz, Germany, at the EuroPCR 2022 conference held May 17-20 in Paris, France.

Dr. Adam reported the first 28 commercial implants of the Trilogy heart valve system for AS at six high-volume German centers. Dr. Tamm presented data on 45 AR patients from the same six German heart centers.

According to the company, all patients in Dr. Adam’s series presented with severe AS. At baseline, 61% of the patients presented with New York Heart Association (NYHA) class III or IV heart failure, and 29% had a left ventricular ejection fraction (LVEF) of ≤ 50%. The outcomes were positive, achieving 100% technical success, zero conversions to open surgery, zero new permanent pacemakers, and one patient death, which was not device related. Postoperatively, 86% of the patients had none or trace paravalvular regurgitation (PVL) and no incidence of moderate or greater PVL.

“The JenaValve Trilogy is specifically and uniquely designed with locators that align the valve with the native cusps, providing excellent commissural alignment with easy access to the coronary arteries, and form a secure seal for minimal PVL,” commented Dr. Adam in the company’s press release. “Given the unique design, we are seeing very positive results in AS patients, as well as in the AR cohort.”

In Dr. Tamm’s series, all patients presented with moderate-severe or severe AR. At baseline, 71% of the patients presented with NYHA III/IV, and 58% had an LVEF ≤ 50%. The outcomes of the AR series were also positive, with technical success achieved in all patients. There were no conversions to open surgery, stroke, or death. Postoperatively, 92% of the patients had no or trace PVL, and nine patients required a new pacemaker. Of the patients requiring a pacemaker, at least 33% of the patients had pre-existing conduction system abnormalities.

In the press release, Dr. Tamm commented, “Before Trilogy’s CE Mark approval, TAVR for AR was performed off label using devices designed for AS—which posed procedural challenges with poorer outcomes.”

Dr. Tamm concluded, “The Trilogy valve is a game-changer, which delivers solid anchoring and commissural alignment due to the locator technology while also limiting protrusion into the left ventricle. Additionally, the hemodynamics are the best in class.”