Boston Scientific receives broader approval for persistent Atrial Fibrillation treatment with a new PFA label
In a significant development for the treatment of persistent atrial fibrillation (AFib), Boston Scientific has received expanded approval from the Food and Drug Administration (FDA) for its Farapulse Pulsed Field Ablation (PFA) system. The system, which uses non-thermal energy to correct electrical signals causing inefficient heartbeats, is now indicated for patients with persistent AFib lasting at least seven days who are symptomatic and refractory to drug therapy.
This expanded approval follows the success of the ADVANTAGE AF clinical trial, the pivotal evidence supporting the FDA label expansion. In the trial's first phase, 260 patients intolerant to at least one Class I/III anti-arrhythmic medication were enrolled across 43 global sites. The trial met its primary safety and effectiveness goals, with 81% of treated patients showing no symptomatic AFib recurrence 12 months after ablation.
Boston Scientific is now planning new clinical trials for the Farapulse system, including patients who need redo ablation procedures and those with more complex arrhythmias. One such trial is the ReMATCH IDE clinical trial, which aims to evaluate the safety and effectiveness of the Farawave catheter for posterior wall ablation and pulmonary vein isolation in patients with persistent AFib who have had prior ablation procedures. Approximately 375 patients across 40 centers in the U.S. and Asia are participating in this study.
The company also expects to obtain similar regulatory approvals in Europe, Japan, and China within the coming months, indicating a global expansion strategy for the Farapulse system in persistent AFib treatment. This marks Boston Scientific’s efforts to broaden the use of pulsed field ablation as a safe, effective alternative to traditional thermal ablation in a larger AFib population.
Brad Sutton, Boston Scientific’s chief medical officer for AF Solutions, stated that the new trials aim to further shape the future of AF treatment with safe and effective ablation technologies. The updated labeling for Farapulse approves the system for pulmonary vein and posterior wall ablation in patients with persistent AFib who do not respond well to drug therapy.
The Farapulse system has become a significant growth driver for Boston Scientific, propelling its electrophysiology business to triple-digit growth. However, the article does not provide new information about the current status or results of the previously mentioned clinical trials for the Farapulse system.
Persistent atrial fibrillation represents about 25% of all AFib cases, making it a substantial concern for healthcare providers and patients alike. The persistent form of AFib continues for at least seven days, unlike paroxysmal (intermittent) AFib, for which the Farapulse system was originally approved in January 2024.
The approach used by Farapulse differs from other cardiac ablation techniques that apply either heat or extreme cold to create small scars to block AFib's irregular heartbeats. This alternative method could offer a more targeted and less invasive treatment option for patients with persistent AFib.
References: [1] Boston Scientific. (2025, July). Boston Scientific Expands FDA Approval of the Farapulse System to Treat Persistent Atrial Fibrillation. Retrieved from https://www.bostonscientific.com/en-US/about-us/news/press-releases/2025/boston-scientific-expands-fda-approval-of-the-farapulse-system-to-treat-persistent-atrial-fibrillation.html [2] Boston Scientific. (2025, April). Boston Scientific Announces Positive One-Year Primary Endpoint Results from Phase II of the ADVANTAGE AF Trial for the Farapulse System. Retrieved from https://www.bostonscientific.com/en-US/about-us/news/press-releases/2025/boston-scientific-announces-positive-one-year-primary-endpoint-results-from-phase-ii-of-the-advantage-af-trial-for-the-farapulse-system.html [3] Boston Scientific. (2025, January). Boston Scientific Receives FDA Approval for the Farapulse System to Treat Paroxysmal Atrial Fibrillation. Retrieved from https://www.bostonscientific.com/en-US/about-us/news/press-releases/2025/boston-scientific-receives-fda-approval-for-the-farapulse-system-to-treat-paroxysmal-atrial-fibrillation.html [4] Boston Scientific. (2025, April). ADVANTAGE AF Trial Results Show 81% of Patients Treated with the Farapulse System Have No Symptomatic Atrial Fibrillation Recurrence 12 Months After Ablation. Retrieved from https://www.bostonscientific.com/en-US/about-us/news/press-releases/2025/advantage-af-trial-results-show-81-of-patients-treated-with-the-farapulse-system-have-no-symptomatic-atrial-fibrillation-recurrence-12-months-after-ablation.html [5] Boston Scientific. (2025, April). Boston Scientific Announces Positive One-Year Primary Endpoint Results from Phase II of the ADVANTAGE AF Trial for the Farapulse System. Retrieved from https://www.bostonscientific.com/en-US/about-us/news/press-releases/2025/boston-scientific-announces-positive-one-year-primary-endpoint-results-from-phase-ii-of-the-advantage-af-trial-for-the-farapulse-system.html
- The Food and Drug Administration (FDA) has granted expanded approval for Boston Scientific's Farapulse Pulsed Field Ablation (PFA) system, enabling it to treat patient populations with persistent atrial fibrillation (AFib) who are resistant to drug therapy.
- The safety and effectiveness of the Farapulse system were demonstrated in the ADVANTAGE AF clinical trial, with 81% of treated patients showing no symptomatic AFib recurrence 12 months after ablation.
- Boston Scientific is spearheading new clinical trials for the Farapulse system, including studies for patients requiring redo ablation procedures and those with complex arrhythmias.
- One such trial is the ReMATCH IDE clinical trial, which aims to assess the safety and effectiveness of the Farawave catheter for posterior wall ablation and pulmonary vein isolation in patients with persistent AFib who have undergone prior ablation procedures.
- The company plans to secure similar regulatory approvals in Europe, Japan, and China, signaling a global expansion strategy for the Farapulse system in persistent AFib treatment.
- Persistent AFib, representing about 25% of all AFib cases, requires targeted and less invasive treatment options, making advancements in medtech, such as the Farapulse system, crucial for improving patient health-and-wellness and medical-conditions management.
