Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter and Symplicity G3™ Renal Denervation RF Generator Approved for Marketing
Recently, the innovative products Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter and Symplicity G3™ Renal Denervation RF Generator of Medtronic, Inc. were approved by China NMPA.
The Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter consists of an electrode array, catheter, catheter handle, catheter connecting cable, and straightening tool, and the Symplicity G3™ Renal Denervation RF Generator consists of generator, remote control, power cord, and DVI-D cable. The above two products are used together, the RF Generator can transmit the radiofrequency energy through the catheter electrode to the renal artery vascular endothelium, use the current thermal effect to inactivate the sympathetic nerves around the renal artery vasculature, and block the sympathetic nerve's excitatory conduction, so as to achieve the purpose of reducing the patient’s blood pressure.
This product reduces blood pressure through physically blocking sympathetic nerve excitatory conduction, which can effectively avoid the influence of patient compliance, drug half-life and other factors compared with traditional drug treatment, and provides a new adjunctive treatment for patients with refractory hypertension.
The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.