Persistent AFT occurs when individuals experience an irregular or rapid heartbeat that lasts longer than seven days and which represents 25% of all AF cases. Credit: Shutterstock / Good dreams – Studio

US healthtech giant Boston Scientific’s pulmonary vein isolation (PVI) device trial has met its primary endpoint in patients with paroxysmal atrial fibrillation (AF) as the company looks to expand into new indications.

Results from the Advantage AF study (NCT05443594) found that the company’s pulsed field ablation (PFA) system and the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) devices were able to reduce the rate at which patients living with AF experienced heart flutters and other cardiac events.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Boston Scientifics FARAPULSE PFA System is approved for pulmonary vein isolation (PVI) in patients who have paroxysmal AF, a condition that manifests itself in the form of an irregular heartbeat. The Advantage AF study is looking to expand the device into both PVI and posterior wall ablation (PWA) in patients who have persistent AF.

Persistent AFT occurs when individuals experience an irregular or rapid heartbeat that lasts longer than seven days and which represents 25% of all AF cases according to research published by the US National Institutes of Health (NIH). In the prospective, single-arm trial ADVANTAGE AF trial 260 patients were enrolled at 43 global sites who were drug intolerant to at least one class I/III anti-arrhythmic drug.

The trial met its 12-month primary safety endpoint in reducing serious adverse events related to either the use of an ablation catheter or the ablation procedure within seven days of the primary procedure and the requirement for pulmonary vein stenosis or atrioesophageal fistula after 12 months. This endpoint was met with a 2.3% event rate.

The primary effectiveness endpoint was freedom from AF, atrial flutter, atrial tachycardia, re-ablation, cardioversion and use of a new or escalated dose of Class I/III AAD. This was met in 63.5% of patients.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Brad Sutton, chief medical officer for Atrial Fibrillation Solutions at Boston Scientific, said: “These late-breaking studies provide valuable clinical evidence supporting our ablation and stroke prevention technologies that are designed to improve long-term outcomes for patients with atrial fibrillation.

“The positive findings support our focus on expanding the number of patients who can benefit from these life-changing therapies, which we will continue to advance through future clinical trials and product development.”

Elsewhere in the market of PFA, Johnson & Johnson MedTech’s Dual Energy THERMOCOOL SMARTTOUCH SF Catheter has gained the European CE mark approval for treating cardiac arrhythmias. Meanwhile, Abbott has reached two milestones in a pair of trials evaluating its PFA technology for the treatment of abnormal heart rhythms.