Recently, the two innovative products,  "TRUPULSE™ Generator" and "Varipulse™ Bi-directional Catheter" of Biosense Webster (Israel) Ltd. are approved by China NMPA.

The TRUPULSE™ Generator consists of a control console, footswitch, connecting cables, and power cords, while the Varipulse™ Bi-directional Catheter consists of a ring-shaped distal end (with electrodes), catheter body, and handle. These two products are used in combination for the treatment of drug-refractory, recurrent, and symptomatic paroxysmal atrial fibrillation.

This product utilizes the principle of the non-thermal effect of the pulsed electric field to treat atrial fibrillation. It can achieve the selective destruction of myocardial tissue and avoid the risk of damage to surrounding tissues caused by heat transfer, unlike traditional radiofrequency and cryoablation products.

The NMPA will strengthen the post-marketing surveillance of the products to ensure the safe use of these medical devices.