– Peijia Medical takes China into the “Recoverable Era” with its TAVR products featuring a second-generation transcatheter aortic valve replacement system approved for commercialization
SUZHOU, China , June 28, 2021 / PRNewswire / – The TaurusElite ® Transcatheter Aortic Valve Replacement System (hereinafter referred to as “TaurusElite ® “) and which has been developed by Peijia Medical (9996. HK) It has been approved for marketing through the National Medical Products Administration (NMPA) since June 2021 (registration number GXZZ 20213130464). This approval will accelerate the transition of China’s TAVR practice into the recoverable era.
TaurusElite ® is the second generation TAVR system that has been developed through Peijia Medical, and it is also the second and the last recoverable TAVR system approved in China . Similar in design to TaurusOne®, TaurusElite® uses bovine material for the prosthetic aortic valve and has ideal radial support and flexibility that has been taken into account by the large patient cohort in Chinawho experience calcification of the upper aortic valve, bicuspid aortic valves, and other similar lesions. TaurusElite® is widely accepted by investigators at clinical institutions for its improved delivery system, improved axial support, and flexibility to traverse the aortic arch, repeated retrievability in situ or via high segment release, permitted transvalvular procedures after recovery and other benefits that provide an advantage. TaurusElite® is expected to improve the safety of TAVR surgeries and reduce the learning period for surgeons, in order to accelerate the advancement of TAVR approaches and benefit more patients.
China’s TAVR technology is currently progressing from an early stage to a rapid development stage. So far, a total of more than 6,000 cases of TAVR surgeries have been successfully performed in China . Following the Frost & Sullivan analysis, the number of patients with aortic stenosis in China is approximately 4.5 million in 2021 and is expected to increase to 4.9 million by 2025, with approximately 23% suffering severe aortic valve stenosis. The aging of the Chinese population and the expansion of the TAVR operation will result in more patients with aortic stenosis receiving TAVR treatment in the near future.
Academician Han Yaling, from the North Theater Command General Hospital , carried out the task of Coordinating Investigator of the clinical trial of the TaurusElite® TAVR System which was completed by several organizations (listed in order of the initials of the Chinese Pinyin of the Institute ): Zhongshan Hospital of Fudan University, Guangdong Province Hospital, Second Affiliated Hospital of Harbin Medical University , Xijing Hospital of Air Force Military Medical University, West China Hospital of University of Sichuan , Beijing Anzhen Hospital of the Capital Medical University, the Second Affiliated Hospital of the University ofZhejiang , the South Central University Second Xiangya Hospital, the North Theater Command General Hospital, and the Fuwai Hospital of the Chinese Academy of Medical Sciences.
Peijia Medical Chairman and CEO Dr. Zhang Yi explained: “TaurusOne®, our first-generation TAVR that was approved in April through NMPA, has treated many patients and achieved great success. However, we are still witnessing growing clinical needs for a better and safer TAVR product. Also, considering the limited survival time of patients with severe AD, the speed of expansion of TAVR in Chinadetermine whether the large number of patients can be treated in time. Right now, when we have our second-generation TaurusElite® TAVR approved for commercialization, Peijia is going to start promoting this latest iteration as soon as possible. Globally, these first-generation unrecoverable TAVR products are rarely used now, as recoverable TAVR contributes to an overall reduction in surgical risk while shortening the learning curve for clinicians. We hope that TAVR in China can evolve into a fully recoverable era to mitigate unnecessary risks and reduce pressures on the physicians performing the operation, and most important of all, benefit a greater number of patients. “
Peijia Medical has a comprehensive global design of the line of products and technologies for structural heart disease, covering the aortic valve, mitral valve, tricuspid valve and covering surgical accessories at the same time. Thanks to the commercialization of TaurusElite®, Peijia Medical will provide a range of clinical products portfolio, demonstrating its entire R&D process and its productive capacity within this field. Peijia Medical is committed to the creation of Yijia College, a global platform for professional education of TAVR techniques for heart valve disease, developing diversified and multidimensional clinical techniques and also providing opportunities for academic exchange and cooperation with internationally and nationally renowned interventional valve disease therapy centers, which jointly reinforce the support for the training of surgeons, basic education and the dissemination of knowledge, with the aim of making continuous efforts for the technical promotion of interventional therapy for valvular heart disease in China and being able to benefit more patients.
Peijia Medical was founded in 2012 and its headquarters are located in Suzhou, Jiangsu Province , China . It has been listed on the Hong Kong Stock Exchangein May 2020. With a vision of the type “Devotion to the heart, reverence for life”, Peijia Medical has always put life and safety first, striving to maintain human life and health since its years dedicated to exploration in technology and its innovative persistence. The strategic design of Peijia Medical can be summarized as the “Simultaneous Treatment of Cardiovascular and Cerebrovascular Diseases Oriented to Innovation”. The company is dedicated to the innovation, R&D and production of high-end medical devices for structural heart disease and cerebrovascular interventions, covering the aortic valve, mitral valve, tricuspid valve, surgical accessories and bleeding-related diseases, ischemia and routes of cerebrovascular intervention. It has launched a relatively comprehensive range of portfolios dedicated to integrated products and solutions in the field of structural heart disease and cerebrovascular interventions with the goal of being used across the board.China .
