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Radio Frequency Renal Ablation Device and Disposable Reticular Renal Denervation RF Ablation Catheter Approved for Marketing

CCFDIE| Updated: 2025-02-19

     

Recently, the two innovative products "Radio Frequency Renal Ablation Device" and "Disposable Reticular Renal Denervation RF Ablation Catheter" of Shanghai Golden Leaf Med Tec Co., Ltd. are approved by China NMPA.

The Radio Frequency Renal Ablation Device consists of a main unit, a foot switch, a main unit connecting cable, a neutral electrode connecting cable, and a power cord. The Disposable Reticular Renal Denervation RF Ablation Catheter consists of a mesh basket stent, an ablation electrode, a protective sheath, a handle, and a connector. These two products are used in conjunction with each other for the adjunctive treatment of patients with refractory hypertension and drug-intolerant hypertension.

The Disposable Reticular Renal Denervation RF Ablation Catheter has six electrodes arranged in a spiral pattern, which can effectively improve the ablation efficiency, and the design of mesh basket makes the blood flow not blocked during ablation, which is unique in China and the world. The temperature and impedance measurement and feedback control algorithm used in the Radio Frequency Renal Ablation Device makes the procedure easier to operate. The launch of this product is conducive to the promotion of the clinical application of RF ablation technology, which can further reduce the cost of clinical treatment and benefit more patients with refractory hypertension and drug-intolerant hypertension.

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