Boston Scientific Bags PDMA Nod in Japan for FARAPULSE PFA System

Boston Scientific Corporation, a leading company in the field of global medical technology, stated that it has been granted approval by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is a new option for treating paroxysmal atrial fibrillation by isolating pulmonary veins, replacing the traditional thermal ablation method.

"The FARAPULSE PFA System is the most clinically studied PFA system and its use in treating more than 125,000 patients globally to date continues to reinforce its strong safety, efficacy and efficiency profile," said Nick Spadea-Anello, president, electrophysiology, Boston Scientific. "The rapid adoption of the FARAPULSE PFA System, which is now approved in more than 65 countries, indicates a paradigm shift for the treatment of paroxysmal AF – one that has clinical benefits to both physicians and patients – and we look forward to bringing this differentiated technology to Japan."

AF can increase the chances of dying, having a stroke or heart failure, and it is present in over one million individuals in Japan. The global estimate is that around 38 million people are affected by AF. Contrary to conventional thermal ablation methods for treating AF by applying extreme temperatures to cardiac tissue, the FARAPULSE PFA System utilizes non-thermal electrical fields to prevent harm to nearby structures.

"Clinical evidence and extensive real-world use have demonstrated the FARAPULSE PFA System to be an efficient and more predictable procedure than traditional thermal ablation and a proven safe technology," said Kazuhiro Satomi, M.D., Ph.D., professor, Department of Cardiology and director, Heart Rhythm Center, Tokyo Medical University Hospital. "This technology has the potential to rapidly advance clinical practice and improve outcomes and is anticipated to further expand the range of treatment options for AF that can be tailored to each patient's condition."