Medtronic Receives NMPA Approval for Innovative Pulse Field Ablation System for Atrial Fibrillation Treatment
Medtronic
Chronic Disease Medical Device and Therapy Developer
Recently, the National Medical Products Administration approved Medtronic's registration applications for two innovative products: the "Cardiac Pulsed Field Ablation System" and the "Single-Use Cardiac Pulsed Field Ablation Catheter."
The cardiac pulse electric field ablation system consists of a generator, a controller (optional), a foot pedal switch (optional), an EGM cable, and a disposable catheter interface cable. The disposable cardiac pulse electric field ablation catheter is composed of electrodes, a catheter body, and a handle.
The above two products are used in conjunction, utilizing the non-thermal effects principle of pulsed electric fields to treat drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation or drug-refractory, recurrent, symptomatic persistent atrial fibrillation (with episodes lasting less than one year). Compared with traditional radiofrequency ablation and cryoablation products, this product can achieve selective destruction of myocardial tissue, avoiding the risk of surrounding tissue damage caused by temperature conduction.
The drug regulatory department will strengthen the post-marketing supervision of this product to protect the safety of patients using the device.
Source: National Medical Products Administration
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