Peijia Medical’s TaurusTrio TAVR Pivotal Trial Completes Enrollment

January 29, 2024—Peijia Medical Limited, headquartered in Suzhou, China, announced the completion of patient enrollment in its clinical trial of the TaurusTrio transcatheter aortic valve replacement (TAVR) system.

According to Peijia, the multicenter trial used the TaurusTrio TAVR system to treat pure aortic regurgitation (AR) in 116 patients across 13 hospitals in China. Peijia announced the initiation of enrollment in August 2023.

The company stated that the trial is designed to assess the safety and efficacy of the TAVR system in treating patients with native, symptomatic, severe AR who were deemed to be at high or greater risk for surgical aortic valve replacement. Results of the clinical trial will be included in Peijia’s future submission of registration application to China’s National Medical Products Administration.

Peijia Medcal’s TaurusTrio is a part of the licensed-in Trilogy heart valve system for AR from JenaValve Technology, Inc. The licensing agreement with Peijia was announced was announced by JenaValve in January 2022.

According to the company, under the licensing agreement with JenaValve, Peijia obtained the exclusive rights to develop and commercialize the Trilogy heart valve system in the Greater China region under the TaurusTrio brand.

“We are very pleased to have completed patient enrollment in the trial sooner than anticipated, having performed all implantations within approximately 6 months of the first procedure in July,” commented Michael Zhang, PhD, in the company’s Peijia Medical’s press release. “There is a substantial clinical need for a pure AR solution in China, and as our partnership with JenaValve evolves, we look forward to providing even more patients the opportunity to access innovative technology and superior care.” Dr. Zhang is Chairman and CEO of Peijia Medical.

Dr. Michael Zhang continued, “Following the exceptional results of the Trilogy ALIGN-AR pivotal trial as presented by JenaValve in a late-breaking clinical trial presentation at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium, we remain encouraged about the trial design here in China.”

“The TaurusTrio TAVR system represents a significant commercial opportunity for Peijia’s structural heart division, and we are eager to announce the results of this domestic trial as a part of our mission to improve patient care and outcomes across China,” commented Dr. Zhang.

John Kilcoyne, CEO of JenaValve, stated in the press release, “We are excited to see the TaurusTrio trial advance, bringing Peijia and JenaValve one step closer to our shared goal of delivering innovative TAVR technology to potentially millions of patients in China.”