Boston Scientific receives FDA approval for expanded labeling of FARAPULSE™ Pulsed Field Ablation System

Rhea-AI Summary

Boston Scientific (NYSE:BSX) has received FDA approval for expanded labeling of its FARAPULSE™ Pulsed Field Ablation (PFA) System to treat persistent atrial fibrillation (AF). The system, which delivers pulsed field energy through a catheter to ablate heart tissue, demonstrated strong clinical results in the ADVANTAGE AF trial with a 85.3% symptomatic AF recurrence-free rate.

The trial, involving 260 patients across 43 global sites, showed no major complications and an improved success rate of 91.4% among experienced physicians. Boston Scientific expects CE mark approval and regulatory clearances in Japan and China soon, while also initiating the ReMATCH IDE trial to study the system's effectiveness in approximately 375 patients across 40 centers in the U.S. and Asia.

Positive

• Clinical trial showed strong 85.3% symptomatic AF recurrence-free rate
• No reported major complications including stroke or pulmonary vein stenosis
• Higher success rate of 91.4% observed with experienced physicians
• Expansion into persistent AF market, which affects a significant portion of 59 million AF patients worldwide

Negative

• Pending regulatory approvals in key markets (CE mark, Japan, and China)
• Additional clinical trials needed for more complex arrhythmias and re-do ablations

Insights

Medical Device Regulatory Expert

Boston Scientific's expanded FDA approval for FARAPULSE PFA System significantly increases its addressable market for treating persistent atrial fibrillation.

Boston Scientific has secured a significant regulatory milestone with the FDA's approval to expand the labeling for its FARAPULSE PFA System to include treatment of persistent atrial fibrillation (AF lasting at least seven days). This expansion substantially increases the system's addressable market, as persistent AF represents a large portion of the 59 million people worldwide affected by atrial fibrillation.

The approval is particularly valuable because it's supported by compelling clinical evidence from the ADVANTAGE AF trial, which demonstrated both safety and effectiveness. The trial showed zero incidences of serious complications like stroke or pulmonary vein stenosis, while achieving an impressive 85.3% symptomatic AF recurrence-free rate. Even more promising, this rate improved to 91.4% among more experienced physicians, suggesting a favorable learning curve.

The company's regulatory strategy appears well-coordinated globally, with CE mark and approvals in Japan and China anticipated in coming months. This sequential approach to global market access maximizes revenue potential while managing regulatory resources efficiently. Additionally, the initiation of the ReMATCH IDE clinical trial demonstrates forward thinking by targeting patients who experienced recurrence after previous ablation procedures – a challenging but potentially lucrative patient segment that could further differentiate Boston Scientific in the competitive electrophysiology market.

The FARAPULSE PFA System now approved for pulmonary vein and posterior wall ablation in patients with persistent atrial fibrillation

MARLBOROUGH, Mass., July 7, 2025 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use (IFU) labeling for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The updated labeling now includes approval for the system in the treatment of drug refractory, symptomatic persistent atrial fibrillation (AF), an arrythmia in which the heart beats abnormally for at least seven days.

AF affects an estimated 59 million people worldwide and many have the persistent form of the condition, which can cause dizziness, fatigue, shortness of breath and increase the risk of stroke. The FARAPULSE PFA System treats AF by delivering pulsed field energy through a catheter to ablate heart tissue. This approval updates the IFU for both the FARAWAVE™ PFA Catheter and the FARAWAVE NAV™ PFA Catheter to include treatment for patients with persistent AF.

"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, M.D., 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."

The FDA approval for expanded labeling was supported by clinical evidence from phase one of the ADVANTAGE AF clinical trial presented at AF Symposium 2025 and recently published in the Journal of the American College of Cardiology and met both the primary safety and effectiveness endpoints. In the prospective, single-arm trial, 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 AF recurrence-free rate was 85.3%. Observationally, among physicians that performed three or more procedures, the symptomatic recurrence-free rate increased to 91.4%.

Boston Scientific 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 approximately 375 patients across 40 centers in the U.S. and Asia. The study will evaluate the safety and effectiveness of the FARAWAVE PFA Catheter for posterior wall ablation and pulmonary vein isolation in patients with persistent AF 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.

More information on the FARAPULSE PFA System is available 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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Becca Johnson
Media Relations
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Rebecca.Johnson@bsci.com

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1 Linz, Dominik, et al. Atrial fibrillation: epidemiology, screening and digital health. Lancet Reg Health Eur. 2024 Feb 1:37:100786^.

*CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. 

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SOURCE Boston Scientific Corporation

FAQ

What is the new FDA approval for Boston Scientific's FARAPULSE PFA System?

The FDA approved expanded labeling for the FARAPULSE PFA System to treat drug refractory, symptomatic persistent atrial fibrillation, which is an arrhythmia lasting at least seven days.

What were the clinical trial results for BSX's FARAPULSE PFA System?

The ADVANTAGE AF trial showed an 85.3% symptomatic AF recurrence-free rate with no major complications, improving to 91.4% among experienced physicians.

How many patients were involved in the ADVANTAGE AF trial for BSX's FARAPULSE System?

The trial enrolled 260 patients across 43 global sites who were drug intolerant to at least one Class I/III anti-arrhythmic drug.

What are Boston Scientific's next steps for the FARAPULSE PFA System?

BSX is pursuing CE mark approval and regulatory clearances in Japan and China, while initiating the ReMATCH IDE trial to study 375 patients across 40 centers for additional applications.

What is the market potential for BSX's FARAPULSE PFA System?

The system addresses the persistent AF market, part of the estimated 59 million people worldwide affected by atrial fibrillation, representing a significant market opportunity.