SUJOU, China, June 28, 2021 / PRNewswire / – The TaurusElite® Catheter 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 (Registration number GXZZ 20213130464). This approval will accelerate the transition of TAVR practice in China to a recoverable era.
Taurus Elite® is the second generation TAVR system developed by Peijia Medical, and is also the second and last recoverable TAVR system approved in China. Similar to the design of TaurusOne®, TaurusElite® uses bovine material for the prosthetic aortic valve, and has ideal radial support and flexibility that took into account from China large cohort of patients with high calcification of the aortic valve, bicuspid aortic valves and other such lesions. Taurus Elite® is widely accepted by researchers in clinical institutions for its improved delivery system, improved axial support and flexibility for passage through the aortic arch, its ability to repeatedly recover in situ or during the release of high segments, transvalvular procedures allowed after recovery and other beneficial benefits. Taurus Elite® is expected to improve the safety of TAVR surgeries and reduce the learning period for surgeons, with the aim of accelerating the advancement of TAVR approaches and benefiting more patients.
TAVR technology in China is currently moving from an early stage to a rapid development stage. In total, more than 6,000 cases of TAVR surgeries have been successfully performed in China nowadays. According to the analysis by Frost & Sullivan, the number of patients with aortic stenosis in China is around 4.5 million in 2021 and is expected to grow to 4.9 million by 2025, of which around. 23% will have severe aortic valve stenosis. The aging of the Chinese population and the expansion of the TAVR operation will result in more aortic stenosis patients receiving TAVR treatment in the near future.
Academician Han Yaling of the Northern Theater Command General Hospital served as the coordinating investigator for the TaurusElite® The TAVR system clinical trial which was carried out by several organizations (listed in the order of the 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 Military Medicine of the Air Force University, West China Hospital of Sichuan University, Beijing Anzhen Hospital of the Capital Medical University, the Second Affiliated Hospital of Zhejiang University School of Medicine, the Second Xiangya Hospital University of the South, North Theater Command General Hospital and Fuwai Hospital Chinese Academy of Medical Sciences.
Chairman and CEO of Peijia Medical Dr. Zhang Yi proclaimed that: “TaurusOne®, our first generation TAVR which received NMPA approval in April, has treated many patients with great success. However, we are still seeing an increasing clinical need for a better and safer TAVR product. In addition, given the limited survival time of patients with severe AS, the rate of expansion of TAVR in China determine whether the large number of patients can receive treatment on time. Now that we have our second generation TAVR TaurusElite® approved for commercialization, Peijia will begin promoting this latest iteration as soon as possible. Globally, these first generation sunk TAVR products are rarely used today, as recoverable TAVR contributes to an overall reduction in surgical risk, while shortening the learning curve for physicians. We hope that TAVR in China can evolve into the recoverable era to mitigate unnecessary risk and reduce pressure on doctors performing the operation. Ultimately and most important of all, bring benefits to more patients. “
Peijia Medical has a comprehensive global network of structural heart disease product and technology pipelines, covering aortic valve, mitral valve, tricuspid valve and surgical accessories. With the commercialization of TaurusElite®, Peijia Medical will supply a range of clinical products, demonstrating its entire R&D process and production capacity in the field. Peijia Medical is committed to building Yijia College, a global professional training platform for TAVR techniques for valvular heart disease, developing diversified and multidimensional clinical techniques and offering the possibility of academic exchanges and cooperation with centers for interventional therapy of valvular diseases of international and national renown, thereby improving support for surgeon training, basic education and knowledge dissemination, in order to make continuous efforts for the technical promotion of interventional therapy for valve disease in China and benefit more patients.
Peijia Medical was founded in 2012 and its head office 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 at the forefront, striving to maintain human life and health through its years of exploration in technology and its development. innovative persistence. Peijia Medical’s strategic layout can be summed up as “Innovative Concurrent Treatment of Cardiovascular and Cerebrovascular Diseases”. It is dedicated to innovation, R&D and production of high-end medical devices for structural heart disease and cerebrovascular procedures, covering aortic valve, mitral valve, tricuspid valve, surgical accessories and diseases. related to hemorrhage, ischemia and cerebrovascular pathways. He has built a relatively comprehensive line of product and solution portfolios in the area of structural heart disease and cerebrovascular interventions for use throughout. China.
SOURCE Peijia Medical Limited