Boston Scientific Releases Positive Farapulse, Farapoint PFA Data

Boston Scientific released positive 12-month primary endpoint results from the second phase of its ADVANTAGE AF trial, which is evaluating the Farapulse pulsed field ablation (PFA) system and adjunctive use of the Farapoint PFA catheter in patients with persistent atrial fibrillation (AFib).

The trial’s second phase studied the Farawave PFA catheter for both pulmonary vein isolation (PVI) and posterior wall ablation (PWA) and the Farapoint PFA catheter for cavotricuspid isthmus (CTI) ablation to treat typical atrial flutter (AFL). All trial patients were continuously monitored after their procedure with the LUX-Dx insertable cardiac monitor (ICM), which detects recurrence of arrhythmias and assess AFib burden.

73.4% freedom from AFib, AFL, and atrial tachycardia (AT) was achieved, exceeding the 40% or higher performance goal. The safety event rate was 2.4% with no reports of pulmonary vein stenosis, atrio-esophageal fistula or phrenic nerve palsy—surpassing the goal of 12% or lower.

There was 81% freedom from symptomatic AFib recurrence, which is defined as arrhythmia, clinical intervention or use of escalated or new Class I/III anti-arrhythmic drugs. 71.6% of patients has virtually no atrial arrhythmia (AA) burden, in which data shows lower AA burden can be associated with fewer clinical interventions and improvements in quality of life, and 52% of patients had no residual AA events after the blanking period.

96.4% of subjects treated with the Farapoint PFA catheter had no AFL recurrence.

“Continuous rhythm monitoring in phase two of the ADVANTAGE AF study allowed for a detailed picture of patients’ cardiac rhythm after ablation, including asymptomatic AF recurrence, which is not often captured in U.S. Food and Drug Administration clinical trial monitoring but is important for the ability to provide more individualized care to patients,” said Vivek Reddy, MD, director, Cardiac Arrhythmia Services, Mount Sinai Health System and Leona M. and Harry B. Helmsley Charitable Trust professor of medicine, Cardiac Electrophysiology, Icahn School of Medicine and study principal investigator. “The data collected in this trial continues to support the FARAPULSE PFA System as a safe and effective therapy, now with evidence highlighting positive results for its use in treating patients who suffer from persistent AF.”

This trial included 255 patients enrolled at 29 U.S. sites who were treated with the Farawave PFA catheter. Of those, 141 patients also received CTI ablation with the Farapoint PFA catheter for AFL. Farapoint is a navigation-enabled point catheter that uses a smaller ablation footprint to create focal and linear-shaped lesions and integrates with the OPAL HDx mapping system to visualize catheter placement during procedures.

Boston scientific expects FDA approval to expand instructions for use labeling for Farapulse to include persistent AFib, as well as European and U.S. regulatory approvals for Farapoint in H2 2025.

“These positive study results are an important step forward in the continued innovation of the proven Farapulse PFA System and our broader portfolio of products that treat AF,” said Brad Sutton, M.D., chief medical officer, AF Solutions, Boston Scientific. “The performance of the devices in this trial—the Farapoint and Farawave PFA catheters as well as the LUX-Dx ICM system—is an encouraging sign as we work towards expanding our portfolio to provide physicians with an even more robust toolset to treat the growing number of patients with AF.”