Second phase of ADVANTAGE AF study of FARAPULSE™ Pulsed Field Ablation System meets primary safety and efficacy endpoints

Rhea-AI Summary

Boston Scientific (NYSE: BSX) announced positive 12-month results from the second phase of the ADVANTAGE AF clinical trial for their FARAPULSE™ Pulsed Field Ablation System. The study evaluated the treatment of persistent atrial fibrillation using the FARAWAVE™ PFA Catheter and FARAPOINT™ PFA Catheter.

Key findings include:

• 73.4% freedom from AF, AFL and atrial tachycardia, exceeding the 40% performance goal
• 2.4% safety event rate with no reports of major complications
• 81% freedom from symptomatic documented AF recurrence
• 96.4% of patients treated with FARAPOINT PFA Catheter showed no AFL recurrence

The trial involved 255 patients across 29 U.S. sites. Boston Scientific expects FDA approval to expand labeling for persistent AF and regulatory approvals for the FARAPOINT PFA Catheter in H2 2025.

Positive

• Trial exceeded efficacy goals with 73.4% freedom from AF/AFL/AT vs 40% target
• Excellent safety profile with only 2.4% event rate vs 12% threshold
• High success rate (96.4%) for FARAPOINT PFA Catheter in preventing AFL recurrence
• Potential market expansion with FDA approval expected in H2 2025

Negative

• 26.6% of patients still experienced some form of arrhythmia post-treatment
• 48% of patients showed residual atrial arrhythmia events after blanking period

Insights

Medical Device/Cardiology Expert

Boston Scientific's ADVANTAGE AF trial shows outstanding safety and efficacy for PFA in persistent atrial fibrillation, supporting upcoming regulatory approvals.

The second phase ADVANTAGE AF clinical trial results represent a significant advancement in treating persistent atrial fibrillation, which affects approximately 25% of all AF patients and is notably more difficult to treat than paroxysmal AF.

The data is particularly impressive, with 73.4% of patients achieving freedom from AF, AFL, and AT, substantially exceeding the 40% performance goal. The safety profile is equally compelling with just a 2.4% event rate (well below the 12% threshold) and notably, no instances of serious complications like pulmonary vein stenosis or atrio-esophageal fistula.

The trial's methodological strength comes from its use of continuous monitoring via the LUX-Dx Insertable Cardiac Monitor, capturing both symptomatic and asymptomatic arrhythmia recurrences – a more comprehensive approach than typically seen in regulatory trials. This revealed that 71.6% of patients had virtually no atrial arrhythmia burden post-procedure, a metric associated with improved quality of life and reduced clinical interventions.

The FARAPOINT PFA Catheter demonstrated remarkable efficacy for atrial flutter, with 96.4% of treated patients remaining flutter-free. This navigation-enabled catheter creates focal and linear lesions with integration into Boston Scientific's mapping system, enabling more precise ablation.

With FDA approval anticipated in H2 2025 to expand labeling for persistent AF and approve the FARAPOINT catheter, Boston Scientific is poised to address a broader, more challenging segment of the AF market with a comprehensive, multi-device treatment approach.

Trial achieves positive results in the treatment of persistent atrial fibrillation

MARLBOROUGH, Mass. and SAN DIEGO, April 24, 2025 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced positive 12-month primary endpoint results from the second phase of the ADVANTAGE AF clinical trial evaluating the use of the FARAPULSE™ Pulsed Field Ablation (PFA) System* and adjunctive use of the FARAPOINT™ PFA Catheter in patients with persistent atrial fibrillation (AF).  Key findings from the study were presented at the second annual PFA Live Case Summit in San Diego and simultaneously published in Circulation.

Persistent AF, which accounts for approximately 25%¹ of all AF cases, is an abnormal, rapid heartbeat that lasts for at least seven days in a row and can lead to complications such as blood clots, stroke and heart failure. The second phase of the ADVANTAGE AF trial 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), a type of heart rhythm disorder. All patients in the trial were continuously monitored after their procedure with the LUX-Dx™ Insertable Cardiac Monitor (ICM) System, which is designed to detect recurrence of cardiac arrhythmias and assess AF burden. Findings from the trial met all pre-specified safety and effectiveness endpoints and demonstrated:

• 73.4% freedom from AF, AFL and atrial tachycardia (AT), which exceeded the performance goal of 40% or higher.
• A safety event rate of 2.4% and no reports of pulmonary vein stenosis, atrio-esophageal fistula or phrenic nerve palsy which met the performance goal of 12% or lower.
• 81.0% freedom from symptomatic documented AF recurrence, which is defined as arrhythmia, clinical intervention or use of escalated or new Class I/III anti-arrhythmic drugs.
• 71.6% of patients had 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 patients treated with the FARAPOINT PFA Catheter had no recurrence of AFL.

"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, M.D.**, 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 prospective, single arm trial included 255 patients enrolled at 29 U.S. sites who were treated with the FARAWAVE PFA Catheter, and of those, 141 patients also received CTI ablation with the FARAPOINT PFA Catheter for AFL. The FARAPOINT PFA Catheter is a navigation-enabled point catheter that uses a smaller ablation footprint to create focal and linear-shaped lesions and integrates with the Boston Scientific OPAL HDx™ Mapping System to provide visualization of catheter placement during procedures.

"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."

Boston Scientific anticipates U.S. Food and Drug Administration approval to expand the instructions for use labeling for the FARAPULSE PFA System to include persistent AF as well as European and U.S. regulatory approvals for the FARAPOINT PFA Catheter in the second half of 2025.

Learn more about the ADVANTAGE AF study here.

About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.

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Media Relations
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Rebecca.Johnson@bsci.com 

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*CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Ablation of patients with persistent atrial fibrillation or ablation beyond pulmonary vein isolation are outside the labeled indication(s) for use of the FARAWAVE™ PFA Catheter with the FARAPULSE PFA System. The FARAWAVE™ NAV PFA Catheter was not used in this study. The second phase of the trial included the addition of studying the focal FARAPOINT™ Pulsed Field Ablation Catheter for cavotricuspid isthmus (CTI) ablation to treat typical atrial flutter, which is not available for sale.

**Dr. Vivek Reddy is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.

¹Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014;6:213-220. doi: 10.2147/CLEP.S47385

 

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SOURCE Boston Scientific Corporation

FAQ

What were the key results of BSX's ADVANTAGE AF trial phase 2?

The trial showed 73.4% freedom from AF/AFL/AT, 2.4% safety event rate, and 81% freedom from symptomatic AF recurrence. The FARAPOINT PFA Catheter achieved 96.4% success in preventing AFL recurrence.

When does Boston Scientific expect FDA approval for the FARAPULSE PFA System's expanded use?

Boston Scientific anticipates FDA approval for persistent AF labeling and regulatory approvals for the FARAPOINT PFA Catheter in the second half of 2025.

How many patients were enrolled in the BSX ADVANTAGE AF phase 2 trial?

The trial included 255 patients across 29 U.S. sites, with 141 patients receiving additional CTI ablation with the FARAPOINT PFA Catheter.

What is the significance of BSX's FARAPULSE trial for persistent AF treatment?

The trial demonstrated safety and efficacy in treating persistent AF, which accounts for 25% of all AF cases, potentially expanding treatment options for patients at risk of complications like stroke and heart failure.