Fill in the blank! Innovative medical management VenusP-Valve® by Venus Medical is approved for market by NMPA in China.

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On July 11, 2022, Venus Medical's self-developed innovative medical device - Transcatheter Pulmonary Valve Replacement (TPVR) VenusP-Valve®obtained approval from the National Medical Products Administration (NMPA) of China, suitable for patients with severe pulmonary valve regurgitation (≥3+) and autologous right ventricular outflow tract after congenital heart disease surgery. This approval of VenusP-Valve®becomes the first approved TPVR product in the Chinese market, marking another significant milestone after the product's CE MDR approval.

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As the first self-expanding TPVR product approved for market in China and europe, VenusP-Valve.®It has significant clinical value. Its unique double trumpet mouth design, bare bracket design at the outflow end ensures branch blood flow, stable multi-site anchoring features, simple release, no need to pre-place fixed brackets before implantation. The valve has multiple size specifications, wide applicability range, and can meet the needs of over 85% of large pulmonary valve patients in clinical practice.

In this market application, VenusP-Valve.®Accepted the foreign clinical trial route for the application, that is, used european clinical trial data for registration. In April of this year, the product has been approved for market under CE MDR and has been commercialized multiple times; in May, it was approved by the FDA for two humanitarian uses in the usa, and successfully completed the first use in June. In addition, VenusP-Valve®The United States IDE clinical research investigator meeting has been held, and through the Japan-US Harmonization By Doing project, plans to simultaneously start clinical trials in the United States and Japan to accelerate registration and listing in both countries.

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Since the first clinical surgery in 2013, VenusP-Valve has been used clinically for 9 years.®Out of humanitarian assistance, the clinical use of VenusP-Valve has involved nearly 300 cases, covering Asia, Europe, North America, South America, and more than 20 countries and regions. Clinical data from Europe and China have proven the long-term safety and efficacy of the product, and have been highly recognized by domestic and foreign experts.

VenusP-Valve®European three-year follow-up data shows that out of 64 patients who underwent TPVR surgery (some patients were not included due to the COVID-19 pandemic), the surgery success rate was 100%, with all-cause mortality and surgical re-intervention rates at 0. No patients experienced moderate or severe pulmonary valve regurgitation; 96.87% of subjects had tricuspid valve regurgitation and valve leaks within mild levels. China's five-year clinical follow-up results show that the five-year all-cause mortality rate post-surgery is only 3.64%.

It is worth mentioning that in March 2021, with the key materials and technology of minimally invasive intervention self-expanding pulmonary valve system, the company won the first prize of the Outstanding Achievement Award in Scientific Research of Higher Education Institutions in 2020 (Science and Technology). This technology is mainly used in VenusP-Valve.®Developed jointly by Qiming Medical and Sichuan University, and supported by the "Thirteenth Five-Year" National Key R&D Program.

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Academician Ge Junbo

Academician Ge Junbo, Director of the Cardiology Department of Zhongshan Hospital Affiliated to Fudan University, as VenusP-Valve®中国临床研究PI，对该产品此次NMPA获批上市表示祝贺。“2013年5月，我们开启了该产品的全球首例临床试验，术后即刻效果非常优异；VenusP-Valve®多中心研究的整体临床结果凸显了该产品对于患者心功能的改善持续，有效和稳定，为自主研发的国产瓣膜深感骄傲！不久前该产品首登欧洲市场、并在美国率先完成首例人道主义使用，也充分印证国际医学界给予的认可，这是一款真正造福全球医患的创新产品。”

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Academician Ge Junbo

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近年来，响应国务院关于药品医疗器械审评审批制度改革的要求，国家药品监督管理局医疗器械技术审评中心（简称“器审中心”）通过持续改进创新政策、提高审评质量和效率，不断优化审评工作，有效加快了国产创新器械的审评审批进度，助推产业高质量发展。器审中心先后发布了《创新医疗器械特别审批程序》《医疗器械优先审评程序》等政策，开通了临床急需创新医疗器械绿色通道，建立了“接受境外临床试验数据”等指导原则，集中体现了“科学审评、鼓励创新”的积极导向。

Mr. Zijun Zi

“此次VenusP-Valve®China's rapid approval cannot be separated from the strong support of the regulatory center, truly achieving a 'patient-centered' approach, and also driving the rapid development of innovative medical devices. Zizhenjun, co-founder and executive director of Qiming Medical, said, 'As one of the first companies in China to enter the field of structural heart disease interventional treatment devices, Qiming Medical firmly focuses on product innovation guided by clinical value, leading the development of innovative technologies in China, and persistently adheres to developing 'new to China, new to the world' innovative products. VenusP-Valve®The approval for the Chinese market of VenusP-Valve is a significant milestone following the CE MDR approval of the product, filling a gap in the domestic TPVR market and benefiting more Chinese patients and healthcare professionals.

Mr. Zijun Zi

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