Suzhou, China – Suzhou Xinmai Medical Device Co., Ltd. ("Xinmai Medical") recently announced a registered clinical trial (SMART Study: Sympathetic) with the renal neural standard test/selective ablation system SyMapCath TM/SymPioneer TM for the treatment of hypertension protected by the global intellectual property system (CRT2012 Best Invention Award, the State Drug Administration's Special Review Procedure for Innovative Medical Devices / commonly known as the "Green Channel"). Mapping/Ablation Renal nerves for Treatment of hypertension Trial; NCT02761811) successfully completed all patient enrollment (n=220). This is the first clinically registered trial in the world to use targeted renal sympathetic technique (RDN) for the treatment of uncontrolled hypertension, and the results of this large-scale trial to complete patient enrollment mark the unique renal nerve standardization/selective ablation system of "Xinmai Medical" is a great step forward from the clinical practice of treating hypertensive patients, becoming the undisputed leader in this field at home and abroad.
"Xinmai Medical" is an innovative medical device enterprise based on China's local, global vision and operational capabilities. The SMART trial of "Xinmai Medical" was led by Huo Yong, Professor of Cardiology, Peking University First Hospital, Professor Sun Ningling, a well-known hypertension expert of Peking University People's Hospital, and Professor Ge Junbo, academician of the Chinese Academy of Sciences and director of the Department of Cardiology of Zhongshan Hospital Affiliated to Fudan University, as the main investigators, and there were well-known cardiovascular authorities/physicians Jiang Hong, Chen Minglong, Yin Yuehui, Lu Chengzhi, Chen Shaoliang, Wang Dongmei, Qi Xiaoyong, Ding Chao, Dang Yi, Li Hui, Pan Zhenhua, Ma Wei, Zheng Bo, Hu Jialu, Cui Kaijun, Lu Zhibing, Zhu Jiancheng, Professors/directors such as Wang Weimin, Liu Jian, Ma Yuliang, Dong Shaohong, Liang Xinjian, Cui Bo, He Qiang, Li Chengzong, Wang Zhirong, Wang Yanbin, Chen Hongwu, Chu Ming, etc. participated in the activities of 16 famous tertiary hospitals across the country. The multi-center, blind-randomized sham surgical control, and dual-major study endpoint clinical trials use forward-looking academic ideas and innovative theories, and have an international advanced level. The renal nerve standardization/selective ablation system used in this test can measure the renal sympathetic/parasympathetic sites, selectively remove the renal sympathetic nerve, and can immediately determine the surgical effect during the operation and confirm whether the renal sympathetic nerve is effective.
The SMART trial, which uses the "composite index" of antihypertensive drugs as one of the main clinical endpoints, will be able to answer this significant clinical question about the use of medication in patients after RDN surgery; this advanced concept has been endorsed by Medtronic SPYL HTN researchers in recent years and applied the drug index to the SPYR HTN ON-MED trial (Kandzari DE et al: EuroIntervention 2021; 16(18): e1496-e1502）。 The SMART test stipulates the type, dosage, manufacturer, and addition and subtraction rules of the antihypertensive drugs to be taken by patients during the trial (all drugs are supplied by "Xinmai Medical"), and the LC-MS/MS method is used to closely monitor the patient's medication compliance during the trial, thereby excluding the interference of antihypertensive drugs on the effect of RDN surgery. Its clinically practical, rigorous and scientific program design and strict operating procedures ensure the ultra-high quality of smart trials. The trial is jointly operated and managed by the medical device team of the famous CRO "Tigermed" and the clinical department of "Xinmai Medical", and the outstanding professional ability and rich experience of "Tigermed" provide further guarantee for the quality and progress of the trial. The data statistics/analysis work is undertaken by the team of Professor Yao Chen/Professor Yan Xiaoyan of the Clinical Research Institute of Peking University.
△ Professor Huo Yong's team celebrated the completion of the SMART trial
Professor Huo Yong, President of the Asian Heart Association, former Chairman of the Cardiology Branch of the Chinese Medical Association, and former President of the Cardiovascular Physician Branch of the Chinese Medical Doctor Association, pointed out: "The SMART trial is the world's first research that combines standard measurement and ablation in the field of RDN treatment of hypertension, with advanced concepts and rigorous design. The use of original Chinese instruments and equipment will lead the global research and industry development in this field. ”
△ Professor Sun Ningling's team celebrated the completion of the SMART trial
Professor Sun Ningling, former chairman/honorary chairman of the Hypertension Committee of the Chinese Medical Doctor Association, president of the Hypertension Branch of the Chinese Medical Association, and chairman of the Hypertension Committee of the Beijing Medical Doctor Association, commented: "The SMART trial designed the drug composite index as the main endpoint to answer the major clinical question of whether patients take antihypertensive drugs after the treatment of hypertension by devices. The subjects' medication adherence was strictly monitored in the trial, and the traceable electronic blood pressure measurement system ensured the reliability of the blood pressure data in the clinic. The academic foresight, scientific advancement, rigor and reliability of this experiment are indisputable. ”
△ Academician Ge Junbo's team celebrated the completion of the SMART experiment
Professor Ge Junbo, academician of the Chinese Academy of Sciences and Shanghai Zhongshan Hospital, said: "There is no doubt that renal nerve standardization/selective ablation technology is the world leader, and hopes to become a bellwether for the international use of RDN to treat uncontrolled hypertension and evaluate the effect of RDN during surgery."
"Xinmai Medical" was jointly founded by the world's top experts in the field of cardiovascular disease, the former dean of Nanjing University School of Medicine, the former executive vice president of Jiangsu Provincial Clinical Medical Research Institute, Professor Wang Jie of the Department of Cardiology of Jiangsu Provincial People's Hospital and Columbia University School of Medicine, and Jin Kewen, a senior medical industry person; "Jin Jiang Electronics" is deeply involved and long-term support in the early stages; It has received investment from well-known investment institutions including SoftBank China Capital, Yuanhe Origin, Sequoia China, Juming Venture Capital, Yipu Capital, Puhua Capital, Simiao Capital, Primavera Capital, Primavera Capital and Dingpei Group. "Sinomedia" has a complete product pipeline, and another clinical registration trial is ongoing for the BATA Study (Bronchial Ablation for Treatment of Asthma Trial, NCT03765307), an original bronchial radiofrequency ablation system for the treatment of severe asthma. This product has also entered the special review procedure for innovative medical devices of the State Drug Administration.