JenaValve’s Trilogy TAVR Systems Implanted in First Procedures in Asia

June 2, 2023—JenaValve Technology, Inc. recently announced the completion of the first two commercial Trilogy heart valve system implantations in Asia, which were performed by Michael Lee, MD, and team at Queen Elizabeth Hospital in Hong Kong, China, in conjunction with Peijia Medical, JenaValve’s China distribution partner. JenaValve is headquartered in Irvine, California, with additional locations in Leeds, United Kingdom, and Munich, Germany.

Dr. Lee with Ivan Wong, MD, and Angus Chui, MD, successfully completed the first two transcatheter aortic valve replacement (TAVR) procedures in approximately 25 minutes. The procedures were conducted under the proctorship of Professor Andreas Baumbach, MD, of the Barts Heart Centre and Queen Mary University of London, United Kingdom. Both implantations resulted in significantly improved hemodynamics immediately post procedure.

“The Trilogy Heart Valve System is a highly innovative treatment option licensed for both severe aortic regurgitation (AR) and severe aortic stenosis (AS) patients in Asia. We are inspired that the Trilogy procedure was quite predictable due to the valve’s solid anchoring and locator technology. The acute results of our first two cases on patients with inoperable AR were successful,” said Dr. Michael Lee, Head of Cardiology, Consultant Cardiologist at Queen Elizabeth Hospital. “These two AR cases are the first implantations with an on-label TAVI transfemoral system in Asia. We do hope that the Trilogy technique could save more patients who are suffering from severe AR related disease in the future.”

According to JenaValve, Peijia Medical entered into a license and development agreement with the company in December 2021 to collaborate in the creation and development of certain proprietary medical device products for minimally invasive treatment of both severe AR and AS. Under the agreement, JenaValve granted Peijia Medical an exclusive license and other rights to develop, manufacture, and commercialize the products in the greater China region.

JenaValve’s Trilogy TAVR system is designed to treat patients with symptomatic, severe aortic regurgitation (ssAR) and symptomatic, severe aortic stenosis (ssAS) in high surgical risk patients. The Trilogy system received European CE Mark approval in May 2021.

JenaValve has received FDA Breakthrough Device designation to facilitate the review of the ALIGN-AR United States pivotal trial, as part of its premarket approval application for the Trilogy heart valve system for the treatment of ssAR in high surgical risk patients, advised the company.