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August 12, 2024 – SyMap Medical (Suzhou) Ltd. , in China, announced that its renal nerve mapping/selective renal dernervation (msRDN) formula, SyMapCath I and Sympioneer S1, has been approved through China’s National Medical Device Products Administration and received a Class III medical tool registration certificate.
The formula is indicated in China as an adjunct treatment for patients with drug-resistant high blood pressure or patients who are not very liberal to pharmacological treatment and, in either case, deserves to reduce antihypertensive medications.
According to SyMap, the msRDN formula consists of a disposable catheter for radiofrequency ablation of the renal artery and a console with electronic stimulation function and radiofrequency ablation function.
The msRDN formula is intended to exactly map the sites of the renal nerves to selectively denervate the renal sympathetic nerves. The formula can provide real-time feedback before and after the RDN procedure to achieve selective ablation of the renal sympathetic nerves. It is designed to conform to the anatomical shape of the renal artery and provide flexible manipulation, steering function, contrast injection, stimulation/mapping, temperature-controlled ablation, and manual irrigation.
The company said that the protection and efficacy of the msRDN formula in treating patients with out-of-control high blood pressure has been demonstrated through the SMART trial. SMART was led by principal investigator Yong Huo, MD, and conducted at prestigious hospitals in China. In the SMART trial, treatment with msRDN achieved the goals of reducing the pharmacological burden of hypertensive and constant patients and controlling in-office systolic blood pressure < 140 mm Hg, with only 4 targeted ablations compatible with the main renal artery. The findings can be obtained online from Jie Wang, MD, et al at eClinicalMedicine, an open-access publication of The Lancet.