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Tigermed-Jyton Supports the Approval of the World’s First Renal Nerve Mapping Renal Artery Radiofrequency Ablation Product (msRDN)

On August 6th, Symap Medical (Suzhou. announced that its self-developed renal nerve Mapping/Selective Renal Denervation (msRDN) system, consisting of a disposable renal artery radiofrequency ablation catheter and a renal artery radiofrequency ablation generator (SyMapCath I®/SYMPIONEER S1®), has been approved by the NMPA and received the Class III medical device registration certificate (NMPA Registration No. 20243011383/20243011384). Tigermed-Jyton provided full-process service covering from clinical trial to registration services for this product.

Intelligent Ablation for Precise Blood Pressure Reduction: A Boon for Hypertension Patients

The renal nerve Mapping/Selective Renal Denervation (msRDN) system, which passed the "Special Review Procedure for Innovative Medical Devices," is the first msRDN device to be approved by the NMPA for market entry. It is intended for adjunctive treatment of resistant hypertension and hypertension intolerant to medications, especially for patients who need to reduce medication use. This globally first-of-its-kind RDN system, capable of mapping renal nerves and selectively ablating renal sympathetic nerves, is built on Symap Medical’s robust and comprehensive intellectual property system. This system comprises multiple layers of patents across 11 countries/regions, including China, the United States, the European Union, Japan, South Korea, Russia, Australia, Singapore, Israel, South Africa, and Canada, with 8 China patents, 21 U.S. patents, and 6 EU patents.

The msRDN system consists of a disposable renal artery radiofrequency ablation catheter and a renal artery radiofrequency ablation generator. The disposable catheter can accurately map renal nerve sites, closely matches the anatomical structure of the renal artery, and features flexible maneuverability. It integrates guidance, imaging, stimulation/mapping, temperature-controlled ablation, and manual perfusion functions into one device. The ablation generator controls the power, temperature, and stimulation intensity of the catheter’s electrodes while monitoring power, temperature, and impedance in real time.

A Decade of Commitment and Adaptability: Tigermed-Jyton’s Professional Service

This project’s rigorous, scientific, and advanced design imposed high demands on the clinical trial execution process. The project used a combination of clinical consulting room’s systolic blood pressure target rate and medication composite index as the joint endpoints, which significantly increased the requirements for drug management during the trial. These included not only drug transfer, storage, and dispensing but also the challenge of strict protocol adherence by researchers in adjusting medications and managing patient compliance. The application of the globally pioneering and unique renal nerve mapping/selective ablation technology further complicated data monitoring during the trial.

The greater challenge, however, was the nearly decade-long duration of the clinical trial, during which regulations continuously evolved, and industry knowledge deepened. Throughout the trial, Tigermed-Jyton’s clinical team maintained an open mindset, communicated efficiently, prioritized client needs, and swiftly adjusted to changes. Their professional service consistently upheld high standards in clinical operations, meeting the ever-changing requirements of all parties involved.

About Symap Medical

Symap Medical is an internationally leading company focused on the research, development, production, and sales of breakthrough innovative minimally invasive interventional products for the treatment of major cardiovascular and respiratory diseases.