The Marlborough, Massachusetts-based company shared its findings, covering pulsed field ablation (PFA) and combined approaches with left atrial appendage closure (LAAC) to treat AFib, reduce stroke risk and support broader cardiac rhythm management, at Heart Rhythm Society (HRS) 2026 in Chicago.
Outcomes supported the use of the Farapulse PFA system, its Farawave catheter, its Faraflex catheter and the combination of PFA with the Watchman FLX Pro LAAC device. Boston Scientific also shared positive outcomes for its Emblem MRI subcutaneous implantable defibrillator (S-ICD).
Farapulse, a nonthermal treatment, uses electric fields to selectively ablate heart tissue. It delivers pulsed field energy with the Farawave ablation catheter, Farastar ablation generator and Faradrive steerable sheath. Faraflex, an investigational catheter system, is designed to optimize mapping and ablation in a single catheter with a wide-area tip and high-fidelity sensing electrodes.
The next-generation Watchman FLX Pro device can treat patients following catheter ablation for non-valvular AFib. It features a polymer coating, visualization markers and a broader size matrix. The company says this design helps to treat a wider range of patients.
“Together, these data demonstrate strong safety and effectiveness outcomes, support the expansion of the Farapulse PFA platform into more complex patient populations, and highlight the value of a combined therapeutic approach with the Watchman FLX Pro LAAC device,” a spokesperson said on behalf of Boston Scientific.
A look at the Boston Scientific findings
At HRS, Boston Scientific said that its randomized AVANT GUARD clinical trial met all safety and effectiveness endpoints. It also demonstrated the statistical superiority of the Farawave catheter over anti-arrhythmic drugs (AADs). That included “significantly higher” primary effectiveness.
The study evaluated drug-naïve patients with persistent AFib. Data showed a 56% primary effectiveness rate for PFA vs. 30.1% for AADs at 12 months. It also met its primary safety endpoint with a 5.1% major adverse event rate. Significantly more patients (51.7%) treated with Farawave had no atrial arrhythmia recurrence at 12 months compared to 32.2% in the AAD group.
Boston Scientific also shared findings from the ELEVATE-PF feasibility trial of Faraflex. It evaluated patients with paroxysmal or persistent AFib.
With ongoing PFA dosing and workflow refinements, data demonstrated pulmonary vein isolation durability of 96.4% at two months in the optimized group. That included 95.6% in patients with persistent AFib, specifically.
Meanwhile, results from the ALIGN-AF sub-study further backed concomitant procedures pairing Farawave and Watchman FLX Pro. Results demonstrated the procedure’s safety, with 100% acute procedural success. Investigators reported a 90.6% complete LAA closure at a mean of 66 days. They reported no clinically relevant leaks or device-related thrombus.
Finally, Boston Scientific shared results from the investigator-sponsored Praetorian DFT study of the Emblem MRI S-ICD. Findings met the primary endpoint, demonstrating non-inferiority in the likelihood of failed therapy when omitting defibrillation testing as guided by the PRAETORIAN score (an estimate of successful delivery of life-saving therapy) in patients receiving the device for the first time.
