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Renal Denervation RF Generator and Disposable Renal Denervation RF Ablation Catheter Approved for Marketing

CCFDIE| Updated: 2025-02-19

     

Recently, the two innovative products "Renal Denervation RF Generator" and "Disposable Renal Denervation RF Ablation Catheter" of Suzhou SyMap Medical Devices Co., Ltd. are approved by China NMPA.

The Renal Denervation RF Generator consists of a main unit, a foot switch, a hand control, a neutral electrode cable, an equipotential equalization wire and a power cord. The Disposable Renal Denervation RF Ablation Catheter consists of an ablation catheter and a connecting cable. The Renal Denervation RF Generator delivers RF energy through a single channel, which is transmitted via the catheter electrode to the renal artery vascular endothelium, using the current thermal effect to inactivate the sympathetic nerves around the renal artery vasculature, and block the sympathetic nerve's excitatory conduction. Additionally, the catheter electrode can deliver electrical stimulation signals to map the renal artery, identifying sympathetic nerves through changes in blood pressure, thereby enabling selective ablation. This product is indicated for hypertensive patients with a need for reduction in drug use in adjunctive therapy for refractory hypertension and drug-intolerant hypertension.

This product is the world's first renal denervation RF ablation system capable of mapping renal nerves. It provides precise ablation positioning for renal sympathetic denervation and offers effective feedback during and after the procedure to evaluate the immediate effects of the denervation, meeting the clinical needs of renal denervation surgery in clinical practice.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.