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Liwen RFTM Ablation System

Liwen RFTM ablation system, an innovative device for the treatment of HCM, was developed in-house by Hangzhou Nuocheng Medical Technology Co., Ltd., a wholly-owned subsidiary of Venus Medtech.

This product introduces a breakthrough therapy for HCM through the internationally pioneering echocardiography-guided percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) technique. It provides a safe, effective, precise and minimally invasive approach to treating HCM.

Confirmatory clinical trial of Liwen RF ablation system in China was led by Professor Liwen Liu of The First Affiliated Hospital of Air Force Medical University as the principal investigator (PI), with academicians Junbo Ge of Zhongshan Hospital, Fudan University and Yun Zhang of Qilu Hospital of Shandong University as co-PIs. The Enrollment of patients for its confirmatory clinical trial in China was completed in March,2023. 

Liwen RF ablation system offers technical advantages such as less trauma, precise localization, no target vessel restriction, significant reduction of septal thickness, and reduced risks of conduction system damage and other complications. It provides an innovative therapy for HCM that is safe, efficient, precise, and less invasive. In August 2022, the product was qualified for the Special Approval Procedures of Innovative Medical Devices promulgated by the National Medical Products Administration (NMPA).

Exploratory clinical results showed that compared with the traditional gold standard surgical procedure, the Liwen RF ablation system had an 88% success rate, no death case after operation one year, and significant improvements in patients' clinical performance, cardiac function and quality of life, and was significantly better than septal myectomy surgery and alcohol septal ablation, providing strong evidence of its safety and efficacy and superior performance. In January 2023, Liwen Procedure, as an innovative technique associated with the product, was selected as 2022 Level I Class A project in the category of new clinical techniques and therapies by Air Force Medical University.

In addition to 144 cases in earlier exploratory clinical trials, medium to long-term follow-up data of 200 HCM patients treated with the Liwen procedure showed an effective decrease in complications and mortality, as revealed in a recent study by Professor Liwen Liu and her team published in JAMA Cardiology in March 2022. Moreover, no permanent pacemaker was required from any patients. The results once again corroborated the long-term safety and efficacy of the product.