The regulatory nod in Japan further expands the reach of the system, which in December became the first PFA system approved in the United States to treat paroxysmal and persistent atrial fibrillation (AFib). Since then, Boston Scientific’s Farapulse system won FDA approval to treat paroxysmal AFib, where the heart’s beating returns to normal within seven days, with plans to seek approval for persistent AFib.

Pulsed field ablation has generated a great deal of excitement in the medical device industry. Its potential advantages versus radiofrequency ablation or cryoablation include the characteristic that heart muscle tissue can be especially susceptible to it, while other types of surrounding tissue are injury-resistant.

More than 250 physicians worldwide have successfully treated more than 3,000 patients with PulseSelect — together with the company’s bi-directional 10F FlexCath Contour sheath, according to Medtronic.

Japanese Ministry of Health, Labour and Welfare approval came after the pivotal PULSED AF trial, a global, multi-center IDE study that included centers in Japan.