Boston Scientific has claimed a new approval from the FDA for its Farapulse pulsed field ablation system, expanding its use into patients with persistent atrial fibrillation lasting at least seven days.
The company first received a green light in January 2024 for treating people with an intermittent irregular heartbeat, and specifically those showing afib symptoms such as palpitations, shortness of breath and fatigue.
In its first year on the market, carrying just that indication, Farapulse brought in more than $1 billion in revenue, with its offer of efficacy similar to traditional thermal cardiac ablation but with a lower risk of dangerous complications.
Now, Boston Scientific aims to approximately double its reach to the full treatable afib population—which it estimates totals about 59 million people worldwide. The company said it expects to acquire similar regulatory clearances in Europe, Japan and China within the coming months.
The company presented data from a successful clinical trial in persistent afib earlier this year, dubbed ADVANTAGE-AF, where 81% of treated patients showed no symptomatic recurrence of the arrhythmia after 12 months.
“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,” Brad Sutton, chief medical officer of Boston Scientific’s afib solutions business, said in a statement.
“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,” Sutton added.
That includes the recently launched ReMATCH IDE study, which will test the platform’s Farawave catheter in both posterior wall ablation and pulmonary vein isolation, as well as studies of the company’s Farapoint catheter for cavotricuspid isthmus ablation and the treatment of atrial flutter.
Boston Scientific has also been studying Farapulse as a first-line therapy, given ahead of anti-arrhythmia medications.
Last September, researchers at the University of California San Francisco said they reviewed the medical records of nearly 30 million patients in the state and found that the nationwide prevalence of afib may be as much as three times higher than previous estimates. The condition, which carries a greatly increased risk of stroke, may affect more than 10.5 million people in the U.S., according to their study, which was published in the journal JACC.