Boston Scientific's Farapulse PFA System Gains Approval in Japan for Paroxysmal Atrial Fibrillation Treatment

Sep 28, 2024 17:34 CST Updated 17:34

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Source: Shouzheng Yongqi 888

Boston Scientific Continues to Expand the Coverage of Its Farapulse Pulsed Field Ablation System for Treating Atrial Fibrillation.

Marlborough, Mass.-based Boston Scientific Corporation announced on September 27 that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has approved Farapulse for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.

Medtronic announced in May that Japan had approved its competitor, the PulseSelect PFA System.

Nick Spadea-Anello, President of Electrophysiology at Boston Scientific Corporation, stated: "The Farapulse PFA System is the most extensively clinically studied PFA system, and to date, it has treated more than 125,000 patients globally, further demonstrating its robust safety, efficacy, and efficiency."

"The Farapulse PFA System has now been approved in more than 65 countries, and its rapid adoption marks a paradigm shift in the treatment of paroxysmal atrial fibrillation —— offering clinical benefits for both physicians and patients —— and we look forward to bringing this differentiated technology to Japan."

PFA Creates a Stir in Cardiology Due to Its Non-Thermal Nature, Unlike Existing Radiofrequency Ablation Systems. Compared with Radiofrequency or Cryoablation, Its Potential Advantages Include Myocardial Tissue Being Particularly Susceptible to PFA. In Contrast, Other Types of Surrounding Tissues Are Resistant to PFA-Induced Injury, a Factor That May Reduce Complications.

Boston Scientific Corporation announced in January that it had received FDA approval to use Farapulse for treating drug-resistant, recurrent, symptomatic, paroxysmal AFib. The company became the second, after Medtronic, to receive FDA approval for using a pulsed field ablation (PFA) system to treat AFib.

Farapulse received Chinese approval in July.

Boston Scientific Corporation acquired Farapulse in 2021 for nearly $300 million – the same year the system received the CE mark in Europe.

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