SyMap’s Renal Nerve Mapping and Selective RDN System Approved in China

August 12, 2024—China-based SyMap Medical (Suzhou) Ltd. announced that the company’s renal nerve mapping/selective renal denervation (msRDN) system—the SyMapCath I and Sympioneer S1—has been approved by the National Medical Products Administration of China and granted a Class III Medical Devices Certificate of Registration.

The system is indicated in China as an adjunctive treatment for drug-resistant hypertension patients or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications.

According to SyMap, the msRDN system consists of a disposable renal artery radiofrequency ablation catheter and a console with both electronic stimulation and radiofrequency ablation function.

The msRDN system is intended to accurately map the renal nerve sites to selectively denervate renal sympathetic nerves. The system can provide real-time feedback before, during, and after RDN procedure in order to achieve selective ablation of renal sympathetic nerves. It is designed to match the anatomical shape of the renal artery and provide flexible manipulability, guiding function, contrast injection, stimulation/mapping, temperature-controlled ablation, and manual irrigation.

The company advised that safety and efficacy of the msRDN system for treating patients with uncontrolled hypertension have been demonstrated by the SMART trial. SMART was led by Principal Investigator Yong Huo, MD, and conducted at prestigious hospitals in China. In the SMART trial, the msRDN therapy achieved the goals of reducing the drug burden of hypertension patients and controlling office systolic blood pressure < 140 mm Hg, with only four targeted ablations per renal main artery. The results are available online by Jie Wang, MD, et al in eClinicalMedicine, an open-access publication of The Lancet.