Peijia Medical Announces Successful Completion of Patient Enrollment for Pivotal TaurusTrio™ Transcatheter Aortic Regurgitation Clinical Trial
Clinical StudyLicense out/in
SUZHOU, China, Jan. 29, 2024 /PRNewswire/ -- Peijia Medical Limited (Peijia, (9996.HK)), a leading Chinese domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets, today announced the completion of patient enrollment and implantation of the TaurusTrioTM Transcatheter Aortic Valve Replacement (TAVR) system clinical trial. TaurusTrioTM is a part of the licensed-in TrilogyTM Heart Valve System for Aortic Regurgitation (AR) from JenaValve Technology, Inc.
The multi-center trial utilized the TaurusTrioTM TAVR system to treat pure AR in 116 patients across 13 hospitals within China and 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 Peijia's future submission of registration application to the National Medical Products Administration (NMPA).
"We are very pleased to have completed patient enrollment in the trial sooner than anticipated, having performed all implantations within approximately six months of the first procedure in July," said Dr. Michael Zhang, Chairman and Chief Executive Officer of Peijia Medical. "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. 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 TaurusTrioTM 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."
"We are excited to see the TaurusTrioTM 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," said John Kilcoyne, Chief Executive Officer of JenaValve. Congratulations to the Peijia team. The pace of enrollment in this trial was exceptional and outstanding news for all those suffering from aortic regurgitation."
About Peijia
Peijia Medical (9996.HK) was established in 2012 and is headquartered in Suzhou, China. Peijia Medical focuses on the high-growth interventional procedural medical device market in China, and aims to become a world-renowned medical device platform that provides comprehensive treatment solutions for structural heart and neurovascular diseases. The Company now has two generations of TAVR systems and fifteen neurointerventional devices commercialized in China and various innovative product candidates at different stages of development. For more information about Peijia visit peijiamedical.com/about.
SOURCE Peijia Medical
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-Drugs
-Chat with Hiro
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.