China’s National Medical Products Administration (NMPA) has granted a Class III Medical Devices Certificate of Registration for the msRDN radiofrequency renal denervation system (SyMap Medical).
The msRDN system consists of a disposable renal artery radiofrequency ablation catheter, a console with both electronic stimulation and radiofrequency ablation function.
According to SyMap Medical, 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 a renal denervation 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 the SMART trial, which was led by Huo Yong (Peking University First Hospital, Beijing, China), Ge Junbo (Zhongshan Hospital, Fudan, China) and Sun Ningling (Peking University People’s Hospital, Beijing, China). The msRDN therapy achieved the goals of reducing the drug burden of hypertension patients and controlling office systolic blood pressure <140mmHg, with only four targeted ablations per renal main artery. The results have been published in The Lancet/eClinicalMedicine.
NMPA described the msRDN system as, “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.”
