Recently, the two innovative products "PulseSelect™ Pulsed Field Ablation (PFA) Generator" and "PulseSelect™ Pulsed Field Ablation (PFA) Loop Catheter" of Medtronic, Inc. are approved by China NMPA.

The PulseSelect™ Pulsed Field Ablation (PFA) Generator consists of a generator, a controller (optional), a foot switch (optional), an EGM cable, and a disposable catheter interface cable. The PulseSelect™ Pulsed Field Ablation (PFA) Loop Catheter consists of an electrode, a body and a handle.

The above two products are used in conjunction for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation or drug-refractory, recurrent, symptomatic persistent atrial fibrillation (with episodes lasting less than 1 year) by utilizing the principle of the non-thermal effect of a pulsed electric field. Compared with conventional radiofrequency ablation and cryoablation products, this product enables selective destruction of myocardial tissue and avoids the risk of surrounding tissue damage due to temperature transfer.

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