SUZHOU, China, Aug. 12, 2024 /PRNewswire/ — On August 6, 2024, the msRDN Device (SyMapCath I^®/ SYMPIONEER S1^®), advanced by means of Suzhou/China-based SyMap Scientific Ltd. (SyMap Scientific), used to be licensed by means of the Nationwide Scientific Merchandise Management (NMPA) of China and granted a Elegance III Scientific Units Certificates of Registration (Nationwide Scientific Software Registration Deny. 20243011383/20243011384).

The msRDN machine is composed of a one-use renal artery radiofrequency ablation catheter, a console with each digital stimulation and radiofrequency ablation serve as. The machine can correctly map the renal nerve websites to selectively denervate renal sympathetic nerves, and has a excellent fit with the anatomical climate of the renal artery with backup versatile manipulability, guiding serve as, distinction injection, stimulation/mapping, temperature-controlled ablation and guide irrigation. Thus, the machine can serve real-time comments prior to, all the way through and later RDN process to bring to reach selective ablation of renal sympathetic nerves.  

The protection and efficacy of the msRDN machine for treating sufferers with out of control high blood pressure were demonstrated by means of SMART trial, which used to be led by means of renown cardiologists together with Drs. HUO Yong, GE Junbo and SUN Ningling, and performed at prestigious hospitals in China. The msRDN treatment completed the targets of lowering the drug burden of high blood pressure sufferers and controlling place of job systolic blood force <140 mmHg, with handiest 4 centered ablations according to renal major artery. The effects were printed in The Lancet/eClinicalMedicine (EClinicalMedicine 2024 Would possibly 7; 72:102626. doi: 10.1016/j.eclinm.2024.102626.).

That is the arena’s first renal mapping/selective RDN machine licensed by means of the NMPA. The machine is indicated as an adjunctive remedy for drug-resistant high blood pressure sufferers or sufferers who’re illiberal to drug treatment and, in both case, wish to shed antihypertensive recoveries. NMPA described the msRDN machine as underneath:

“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 machine is in line with a cast patent portfolio, made from international locations and areas together with China, United States, Canada, Eu Union, Japan, South Korea, Russia, Australia, Singapore, Israel, and South Africa, et al.

SyMap is keen on creating innovative software treatments for the unmet scientific wishes of cardiovascular and pulmonary sicknesses together with high blood pressure, center failure, arrhythmia, bronchial asthma and early-stage lung most cancers. Since its established order in 2012, SyMap Scientific has established a product pipeline the usage of proprietary interventional approaches to regard main cardiovascular and respiration sicknesses. The esteem of the msRDN machine by means of the NMPA demonstrates SyMap Scientific’s chief place within the RDN farmland. The magazine and proprietary options of the msRDN machine park SyMap Scientific in a robust place for commercialization and competing with alternative RDN merchandise. 

Programs of the msRDN machine will get advantages sufferers with drug-resistant high blood pressure or drug intolerance, and who wish to shed recovery usefulness. There are literally thousands of high blood pressure sufferers around the world, with the attention fee / remedy fee and keep watch over fee particularly being extraordinarily low. Programs of the msRDN machine will permit extra sufferers to shed antihypertensive drug burdens and to keep watch over blood force according to scientific tips.

SyMap Scientific Ltd: https://www.symapmedical.com/

SOURCE SyMap Scientific (Suzhou) Ltd.