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 <140 mmHg, with only four targeted ablations per renal main artery. The results have been published in The Lancet/eClinicalMedicine (EClinicalMedicine 2024 May 7; 72:102626. doi: 10.1016/j.eclinm.2024.102626.).
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. NMPA described the msRDN system as below:
"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." (https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20240806143238168.html)
The proprietary msRDN system is based on a solid patent portfolio, comprised of countries and regions including China, United States, Canada, European Union, Japan, South Korea, Russia, Australia, Singapore, Israel, and South Africa, et al.
SyMap is focused on developing revolutionary device therapies for the unmet clinical needs of cardiovascular and pulmonary diseases including hypertension, heart failure, arrhythmia, asthma and early-stage lung cancer. Since its establishment in 2012, SyMap Medical has established a product pipeline using proprietary interventional approaches to treat major cardiovascular and respiratory diseases. The approval of the msRDN system by the NMPA demonstrates SyMap Medical's leading position in the RDN field. The novel and proprietary features of the msRDN system place SyMap Medical in a strong position for commercialization and competing with other RDN products.
Applications of the msRDN system will benefit patients with drug-resistant hypertension or drug intolerance, and who need to reduce medication use. There are millions of hypertension patients around the globe, with the awareness rate / treatment rate and control rate in particular being extremely low. Applications of the msRDN system will enable more patients to reduce antihypertensive drug burdens and to control blood pressure per clinical guidelines.
SyMap Medical Ltd: https://www.symapmedical.com/
