SUZHOU, China, June 26, 2021 /PRNewswire/ -- The TaurusElite® Transcatheter Aortic Valve Replacement System (hereinafter referred to as "TaurusElite®") developed by Peijia Medical (9996. HK) is approved for marketing by the National Medical Products Administration (NMPA) in June 2021 (Reg. No. GXZZ 20213130464). This approval will accelerate the transition of China TAVR practice into retrievable era.
TaurusElite® is the second-generation TAVR system developed by Peijia Medical, and is also the second and the latest retrievable TAVR system approved in China. Similar to the design of TaurusOne®, TaurusElite® uses bovine material for prosthetic aortic valve, and has ideal radial support and flexibility that has taken consideration of China's large cohort of patients experiencing high aortic valve calcification, bicuspid aortic valves and other such lesions. TaurusElite® is widely accepted by clinical institution researchers for its improved delivery system, enhanced axial support and flexibility for passing through the aortic arch, ability of repeated retrieval in situ or during high segment release, transvalvular procedures permitted after retrieval, and other advantageous benefits. TaurusElite® is expected to improve the safety of TAVR surgeries and curtail the learning period of surgeons, with an aim to accelerate the advancement of TAVR approaches and to benefit more patients.
TAVR technology in China is currently progressing from an early stage to a rapid development stage. A total of more than 6000 cases of TAVR surgeries have been successfully performed in China as of today. According to the analysis of Frost & Sullivan, the number of patients with aortic stenosis in China is approximately 4.5 million in 2021 and it is expected to increase to 4.9 million by 2025, within which approx. 23% will have severe aortic valve stenosis. The aging of the Chinese population and the expansion of TAVR operation will result in more aortic stenosis patients receiving TAVR treatment in the near future.
Academician Han Yaling of General Hospital of Northern Theater Command served as Coordinating Investigator for the TaurusElite® TAVR System's clinical trial that was completed by multiple organizations (listed in order of Chinese Pinyin of the Institute's initials): Zhongshan Hospital of Fudan University, Guangdong Provincial People's Hospital, the Second Affiliated Hospital of Harbin Medical University, Xijing Hospital of Air Force Military Medical University, West China Hospital of Sichuan University, Beijing Anzhen Hospital of Capital Medical University, the Second Affiliated Hospital of Zhejiang University School of Medicine, the Second Xiangya Hospital of Central South University, General Hospital of Northern Theater Command and Fuwai Hospital Chinese Academy of Medical Sciences.
Chairman and CEO of Peijia Medical Dr. Zhang Yi proclaimed that: " TaurusOne®, our first-generation TAVR that received NMPA approval in April, has treated many patients with great success. However, we still see growing clinical needs for a better and safer TAVR product. In addition, given the limited survival time of severe AS patients, the speed of TAVR's expansion in China will determine whether the large number of patients can receive treatment in time. Now that we have our second-generation TAVR TaurusElite® approved for commercialization, Peijia will start promote this latest iteration as soon as possible. Globally, those first-generation irretrievable TAVR products are rarely used today, as the retrievable TAVR contributes to an overall reduction of surgical risk, while also shortening the learning curve of doctors. We do hope that TAVR in China can evolve in the retrievable era to mitigate unnecessary risks and reduce the pressures on doctors conducting the operation. In the end and most important of all, to bring benefit to more patients. "
Peijia Medical has a comprehensive global layout of product pipeline and technologies for structural heart disease, covering aortic valve, mitral valve, tricuspid valve and surgical accessories. With the marketing of TaurusElite®, Peijia Medical will provide an array of clinical product portfolio, demonstrating its whole R&D process and productive capacity within the field. Peijia Medical is committed to building Yijia College, a global professional education platform of TAVR techniques for valvular heart disease, developing diversified and multi-dimensional clinical techniques and providing opportunity for academic exchange and cooperation with internationally and domestically renowned interventional valvular disease therapy centers, together enhancing surgeon training support, basic education and knowledge propagation, so to make continuous efforts for the technical promotion of interventional therapy for valvular disease in China and benefit more patients.
Peijia Medical was founded in 2012 and its headquarter is based in Suzhou, Jiangsu Province, China. It was listed on the Hong Kong Stock Exchange in May 2020. With "Devotion to the Heart, Reverence for Life" as its vision, Peijia Medical always puts life and safety in the first place, striving to maintain human life and health from its years of exploration in technology and its innovative persistence. Peijia Medical's strategic layout can be summarized as the "Innovation-oriented, Simultaneous Treatment of Cardiovascular and Cerebrovascular Diseases". It is dedicated to the innovation, R&D and production of high-end medical devices for structural heart disease and cerebrovascular interventions—covering aortic valve, mitral valve, tricuspid valve, surgical accessories, and diseases related to hemorrhage, ischemia and pathways in cerebrovascular intervention. It has built a relatively comprehensive array of product and solution portfolios in the field of structural heart disease and cerebrovascular interventions for use throughout China.