China's SyMap Medical announces NMPA approval for selective Renal Denervation System

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China-based SyMap Medical Ltd announced the approval of its msRDN System (SyMapCath I/ SYMPIONEER S1 by the National Medical Products Administration (NMPA) of China and granted a Class III Medical Devices Certificate of Registration.

This is the world's first renal artery radiofrequency ablation product that can map renal nerves, can provide accurate ablation positions for renal sympathetic denervation, and can also provide effective feedback during and after the procedure to examine the immediate effect of renal sympathetic denervation, meeting the needs of renal denervation in clinical practice.

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 matches the anatomical shape of the renal artery with additional flexible manipulability, guiding function, contrast injection, stimulation/mapping, temperature-controlled ablation and manual irrigation. The system can provide real-time feedback before, during and after RDN procedure in order to achieve selective ablation of renal sympathetic nerves.  

This is the world's first renal mapping/selective RDN system approved by the NMPA. The system is indicated 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.