The company reported primary endpoints results from the second phase of ADVANTAGE AF, with findings published in Circulation. Investigators presented key findings at the second annual PFA Live Case Summit in San Diego.
Farapulse, a pulsed-field ablation (PFA) system for treating AFib, received a much-anticipated FDA approval last year.
ADVANTAGE AF looked at Farapulse along with adjunctive use of the Farapoint PFA catheter in patients with persistent AFib. Its second phase studied the Farawave 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 patients in the trial received continuous monitoring with the Lux-Dx insertable cardiac monitor (ICM). Boston Scientific designed it to detect recurrence of arrhythmias and assess AFib burden. The company said study outcomes met all pre-specified safety and effectiveness endpoints.
“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 Dr. Vivek Reddy, director, Cardiac Arrhythmia Services, Mount Sinai Health System and 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.”
A look at the results from the Boston Scientific Farapulse study
The prospective, single-arm trial included 255 patients across 29 U.S. sites treated with Farawave. Of those, 141 also received CTI ablation with Farapoint. Farapoint uses a smaller ablation footprint to create focal and linear-shaped lesions. The navigation-enabled point catheter integrates with the Opal HDx mapping system for catheter placement visualization.
Subjects demonstrated 73.4% freedom from AF, AFL and atrial tachycardia (AT). That exceeded the performance goal of 40% or higher. The study also had a safety event rate of 2.4% with no reports of pulmonary vein stenosis, atrio-esophageal fistula or phrenic nerve palsy. That met the performance goal of 12% or lower.
Boston Scientific reports 81% freedom from symptomatic documented AFib recurrence. Additionally, 71.6% of patients had virtually no atrial arrhythmia (AA) burden. Data showed that lower AA burden can be associated with fewer clinical interventions and improved quality of life. More than half of patients (52%) had no residual AA events after the blanking period.
The study found that 96.4% of patients treated with Farapoint had no recurrence of AFL.
“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 Dr. Brad Sutton, chief medical officer, AFib 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 AFib.”
Boston Scientific expects FDA approval to expand Farapulse’s labeling to include persistent AFib in the second half of this year. It also anticipates U.S and European regulatory approvals for Farapoint in that time frame.
