TGmed Consulting Supports Sima Medical's Global First-in-Class Mapping-Enabled Renal Denervation System (msRDN) in Achieving NMPA Approval

On August 6, SyMap independently developed the renal nerve mapping/selective ablation (msRDN) system: a disposable renal artery radiofrequency ablation catheter/renal artery radiofrequency ablation instrument.（SyMapCath I®/ SYMPIONEER S1®）, approved by the National Medical Products Administration (NMPA) to obtain a Class III medical device registration certificate (Registration No.20243011383/20243011384）。BEIJING JYTON AND KANNEL MEDICAL TECH.CO.,LTD. provided SyMap with full-process services for clinical trials and registration applications.

The msRDN (Renal Nerve Mapping/Selective Ablation) system has been approved for marketing by the National Medical Products Administration through the "Special Review Procedure for Innovative Medical Devices." It is the world's first RDN system capable of mapping renal nerves and selectively removing renal sympathetic nerves, designed to assist in the treatment of resistant hypertension and drug-intolerant hypertension, particularly for patients with a need to reduce medication usage. This system is built on SyMap's robust and comprehensive intellectual property framework for renal nerve mapping/selective ablation, which includes dozens of multi-level patents covering 11 countries/regions: China, the United States, the European Union, Japan, South Korea, Russia, Australia, Singapore, Israel, South Africa, and Canada. This portfolio comprises 8 Chinese invention patents, 21 U.S. invention patents, 6 EU invention patents, among others.

The msRDN system consists of a disposable renal artery radiofrequency ablation catheter and a renal artery radiofrequency ablation generator. The disposable renal artery radiofrequency ablation catheter can accurately map renal nerve sites, exhibits excellent compatibility with the anatomical structure of the renal artery, and offers flexible maneuverability. It integrates guiding, angiography, stimulation/mapping, temperature-controlled ablation, and manual perfusion functions. The renal artery radiofrequency ablation generator can control the power, temperature, and stimulation intensity of the electrodes on the ablation catheter while monitoring power, temperature, and impedance in real time.

The project's rigorous, scientific, and advanced design imposes extremely high demands on the execution of clinical trials. With the combined endpoints of office systolic blood pressure target achievement rate and drug combination index, the trial requires not only drug distribution, storage, and dispensing but also presents the dual challenges of investigators strictly adjusting medications according to the protocol and managing participants' adherence to medication. Additionally, the world's first and only application of renal nerve mapping/selective ablation technology increases the complexity of data monitoring during the trial.

The greater challenge was that the clinical trial lasted nearly 10 years, during which time it underwent constant changes in regulations and continuous improvements in industry understanding. Throughout the trial process, the BEIJING JYTON AND KANNEL MEDICAL TECH.CO.,LTD. clinical team consistently maintained an open mindset, efficient communication, prioritized customer needs, made timely adjustments, and upheld a professional service attitude. They consistently ensured high-standard clinical operations to meet the ever-changing requirements of all parties involved.

SyMap is an internationally leading company focused on the research, development, production, and sales of breakthrough innovative minimally invasive interventional products for treating major diseases in the cardiovascular and respiratory fields. It has a rich pipeline of products at various stages: the world's first/leading renal nerve mapping/selective ablation (msRDN) system for treating hypertension.SYMPIONEER S1®/SyMapCath I®, is the first domestically produced RDN device in China to be approved for marketing by the National Medical Products Administration (NMPA) through the special review process for innovative medical devices. The new generation msRDN system will enter clinical trials; Elation®, a bronchoscopic radiofrequency ablation system for treating severe asthma, is the only product in this field that has been approved by the NMPA to enter the special review process for innovative medical devices. It has completed clinical trials and is currently applying for registration. The world's first virtual electrode system developed for precise treatment of early-stage lung cancer and pulmonary nodules via bronchoscopy.Hypertonic Assisted, Precisely Controlled RF System——"Zedan" System Completed in AustraliaFirst in Human(FIH)Clinical research presented at the 32nd European Respiratory Society (ERS) annual meeting revealed preliminary efficacy and safety results of the "Zedan" system in treating early-stage lung tumors, with further clinical trials underway in multiple countries.

Source of some content: SyMap Official Account