New AFib treatments show promise

Boston Scientific Corp highlighted its advancements in treating atrial fibrillation with its Farapulse Pulsed Field Ablation System and the Watchman FLX Left Atrial Appendage Closure Device at the AF Symposium 2025. The announcement emphasized the potential of these technologies to enhance safety and efficacy for patients living with AF.

Farapulse system benefits

The Farapulse PFA System, already approved for pulmonary vein isolation in patients with paroxysmal AF, was evaluated in the Advantage AF study for treating persistent AF. Persistent AF, characterized by irregular heart rhythms lasting more than seven days, accounts for 25% of all AF cases.

Key findings from the study, which involved 260 patients across 43 global sites, include:

• A primary safety endpoint met with a 2.3% event rate, reflecting minimal adverse events.
• A primary effectiveness endpoint of 63.5%, indicating freedom from AF recurrence and related complications.
• Symptomatic AF recurrence-free rates of 85.3%, increasing to 91.8% for physicians who performed three or more procedures.
• No incidences of stroke, pulmonary vein stenosis, or other major complications.

“In addition to the positive safety and efficacy outcomes achieved in the Advantage AF study, a significant number of patients were able to discontinue anti-arrhythmic drugs and see greater improvements in quality of daily life,” said Vivek Reddy, M.D., director of electrophysiology at Mount Sinai Fuster Heart Hospital in New York and the study’s principal investigator. “Data from trials such as Advantage AF further support the paradigm shift to PFA as a treatment for patients living with persistent and other complex forms of AF.”

OPTION trial sub-analysis validates Watchman FLX device

The company also presented a sub-analysis of the OPTION clinical trial, which evaluated the Watchman FLX device as an alternative to oral anticoagulants for patients with AF. The analysis of 1,600 patients who received the device either concurrently or sequentially with ablation revealed:

• A 44% reduction in non-procedural bleeding for concomitant implantation compared to OAC (8.% vs. 13.3%).
• A 62% reduction in non-procedural bleeding for sequential implantation compared to OAC (8.8% vs. 21.5%).
• Comparable stroke protection with the device versus OAC, regardless of implantation timing.

“These late-breaking studies provide valuable clinical evidence supporting our ablation and stroke prevention technologies designed to improve long-term outcomes for patients with atrial fibrillation,” said Brad Sutton, M.D., chief medical officer for Atrial Fibrillation Solutions at Boston Scientific. “The positive findings support our focus on expanding the number of patients who can benefit from these life-changing therapies.”

Boston Scientific said in a statement that these studies reinforce its commitment to advancing treatment options and improving patient outcomes. By offering safer and more effective solutions, the company aims to transform care for those living with AF, fostering better quality of life and long-term health.