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/
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SOURCE SyMap Medical (Suzhou) Ltd.