On July 8, Boston Scientific's official WeChat account announced:The FARAPULSE™ series of pulsed field ablation products, including the FARAWAVE single-use cardiac pulsed field ablation catheter and the FARASTAR cardiac pulsed field ablation system, have received approval from the National Medical Products Administration (NMPA).。

Thus, Boston Scientific's FARAPULSE™ PFA System is the world's only PFA system to have received approval for market release from the EU CE, the U.S. Food and Drug Administration (FDA), and China's National Medical Products Administration (NMPA).

Pulsed Field Ablation (PFA)It is an emerging atrial fibrillation ablation technology that generates a strong electric field by delivering ultra-fast (microsecond to nanosecond) electrical pulses, capable of selectively damaging myocardial tissue without harming adjacent non-myocardial tissue.

Atrial fibrillation is a global health challenge. According to research data from a 2022 study published in a subsidiary journal of The Lancet,China Has Nearly 20 Million Patients with Atrial Fibrillation, affected by the aging population, the number of patients is expected to further increase in the future.

Compared with traditional radiofrequency ablation and cryoablation, PFA has significant advantages such as reducing tissue damage and shortening operation time. Clinical studies have shown thatPotentially higher safety.

A survey by research firm BTIG of 25 cardiologists shows,They expect that within three years, half of the atrial fibrillation ablation procedures will switch to PFA.。

Based on the huge market potential, international giants are clustering to make strategic moves.PFA Field.

Before entering the Chinese market,Boston Scientific's Farapulse PFA System received CE certification in 2021 and FDA approval in January 2024. It is reported that,Boston Scientific's PFA product has treated more than 70,000 patients worldwide to date.

Other major device companies are naturally not willing to be outdone.

Medtronic announced in November 2023 that its PFA product, PulseSelect, received FDA approval for the treatment of paroxysmal and persistent atrial fibrillation just one month after obtaining CE approval, becoming the first pulse field ablation technology to gain FDA approval.

Varipulse Pulse Field Ablation (PFA) by Biosense Webster, a Johnson & Johnson companyRecently received CE approval for listing, and is expected to become the third company with PFA technology to receive FDA approval for the treatment of atrial fibrillation.

Abbott's new Volt™ Pulsed Field Ablation (PFA) system has also been officially applied to humans,And completed the enrollment for the clinical study required for CE registration of Volt PFA in March.