OFICIAL Boston Scientific News

Data at Heart Rhythm 2026 highlight key Boston Scientific therapies

What happened
Based on Boston Scientific News · Apr 26, 2026

Boston Scientific presented clinical data at Heart Rhythm 2026 supporting the safety and effectiveness of its FARAPULSE Pulsed Field Ablation Platform and WATCHMAN Left Atrial Appendage Closure devices across multiple studies.

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Key points
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Positive data for FARAPULSE™ Pulsed Field Ablation and WATCHMAN™ LAAC Devices underscore therapy safety and effectiveness in late-breaking clinical trial sessions MARLBOROUGH, Mass.
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All data the company is presented at Heart Rhythm 2026, the annual meeting of the Heart Rhythm Society, held in Chicago from April 24-26.
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The trial is the first randomized pivotal study to evaluate patients with persistent atrial fibrillation (AF) who had not previously been treated for their condition – a historically understudied, high-risk population.
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Patients the company is randomized or assigned to receive pulmonary vein isolation (PVI) and left atrial posterior wall isolation (PWI) using the FARAWAVE™ PFA Catheter or given AADs for treatment.
Key numbers
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A multi-center real-world study, ALIGN-AF, assessed the safety of combining FARAWAVE PFA Catheter and WATCHMAN FLX Pro LAAC Device procedures in 122 patients across 12 sites.
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The interim analysis found no compromise in acute procedural success, with peri-device leak assessments ongoing between 45 and 90 days post-implant.

Boston Scientific announced positive results from the AVANT GUARD trial, which met all safety and effectiveness endpoints for its FARAPULSE Pulsed Field Ablation (PFA) Platform. The randomized study compared PFA with anti-arrhythmic drugs in patients with persistent atrial fibrillation who had not received prior treatment, demonstrating statistical superiority in primary effectiveness. The findings were simultaneously published in The New England Journal of Medicine.

Interim results from the ELEVATE-PF feasibility study evaluated the FARAFLEX PFA Catheter, designed for complex arrhythmias, in patients with paroxysmal and persistent atrial fibrillation. The trial uses a sequential design to refine dosing and workflow, incorporating high-density remapping to assess safety and effectiveness in three patient groups.

A multi-center real-world study, ALIGN-AF, assessed the safety of combining FARAWAVE PFA Catheter and WATCHMAN FLX Pro LAAC Device procedures in 122 patients across 12 sites. The interim analysis found no compromise in acute procedural success, with peri-device leak assessments ongoing between 45 and 90 days post-implant.

A sub-analysis of the CHAMPION-AF trial compared WATCHMAN FLX LAAC therapy to non-vitamin K antagonist oral anticoagulants in patients with and without prior ablation for non-valvular atrial fibrillation. The device showed statistically significant protection from non-procedural bleeding and similar efficacy to NOACs in both patient groups.

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