Boston Scientific’s Farapulse PFA Nabs FDA Approval for Persistent AFib

Boston Scientific has earned U.S. Food and Drug Administration (FDA) approval to expand the instructions for use (IFU) labeling for its Farapulse pulsed field ablation (PFA) system.

Updated labeling now includes the system’s approval to treat drug refractory, symptomatic persistent atrial fibrillation (AFib), an arrythmia in which the heart beats abnormally for at least seven days.

Farapulse treats AFib by delivering pulsed field energy through a catheter to ablate cardiac tissue. This approval updates the IFU for both the Farawave PFA catheter and Farawave NAV PFA catheter to include treating patients with persistent AFib.

The FDA approval was supported by data from phase one of Boston Scientific’s ADVANTAGE AF trial, recently published in the Journal of the American College of Cardiology. 260 patients who were drug intolerant to at least one Class I/III anti-arrhythmic drug (AAD) were enrolled at 43 global sites. There were no reported incidences of stroke, pulmonary vein stenosis, atrio-esophageal fistula, or major access complications and the symptomatic AFib recurrence-free rate was 85.3%. Among physicians that performed three or more procedures, the symptomatic recurrence-free rate increased to 91.4%.

The company anticipates CE mark as well as approval in Japan and China in the coming months. The company also recently initiated the ReMATCH IDE clinical trial, which will study about 375 patients across 40 centers in the U.S. and Asia. The study will evaluate the Farawave PFA Catheter for posterior wall ablation and pulmonary vein isolation in patients with persistent AFib who previously received an ablation with a PFA, radiofrequency, or cryoablation catheter and experienced a recurrence of the condition.

It will also evaluate adjunctive use of the Farapoint PFA catheter for cavotricuspid isthmus ablation and left atrial ablation of the mitral isthmus in the same patient population.

“Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AF treatment with safe and effective ablation technologies,” said Brad Sutton, MD, chief medical officer, AF Solutions, Boston Scientific. “We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation.”

In October, the company earned FDA approval for its navigation-enabled Farawave NAV ablation catheter to treat paroxysmal atrial fibrillation (AFib) and 510(k) clearance for new Faraview software. These two technologies were also immediately launched in the U.S.