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Milestone: Renal Nerve Mapping / Selective Renal Denervation (msRDN) System by SyMap Medical Ltd Approved for Treatment of Uncontrolled Hypertension in China

By Manila Times - 3 months ago

SUZHOU, China, Aug. 12, 2024 /PRNewswire/ -- On August 6, 2024, the msRDN System (SyMapCath I®/ SYMPIONEER S1®), developed by Suzhou/China-based SyMap Medical Ltd. (SyMap Medical), was approved by the National Medical Products Administration (NMPA) of China and granted a Class III Medical Devices Certificate of Registration (National Medical Device Registration No. 20243011383/20243011384).

The msRDN system consists of a disposable renal artery radiofrequency ablation catheter, a console with both electronic stimulation and radiofrequency ablation function. The system can accurately map the renal nerve sites to selectively denervate renal sympathetic nerves, and has a good match with the anatomical shape of the renal artery with additional flexible manipulability, guiding function, contrast injection, stimulation/mapping, temperature-controlled ablation and manual irrigation. Thus, the system can provide real-time feedback before, during and after RDN procedure in order to achieve selective ablation of renal sympathetic nerves.

The safety and efficacy of the msRDN system for treating patients with uncontrolled hypertension have been demonstrated by SMART trial, which was led by renown cardiologists including Drs. HUO Yong, GE Junbo and SUN Ningling, and conducted at prestigious hospitals in China. The msRDN therapy achieved the goals of reducing the drug burden of hypertension patients and controlling office systolic blood pressure

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