Pulse Biosciences, Inc. developer of nPulse technology using proprietary nanosecond pulsed field ablation (nsPFA) energy, announced enrollment of the first patients in its NANOPULSE-AF study, a prospective, multicenter, IDE pivotal clinical investigation currently evaluating the nPulse Cardiac Catheter System for treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF). The first seven patients in this study were treated at St. Bernards Medical Center in Jonesboro, Arkansas.
The performance of the nPulse System, combined with integrated catheter mapping using the investigational EnSite X software from Abbott, provides a very user-friendly experience and supports an efficient, reproducible and streamlined workflow. This milestone builds on Pulse Biosciences? first-in-human feasibility study, which showed 96% procedural success at 12 months and 100% acute success, exceeding expectations in a field where 20-25% recurrence is typical.
Outcomes were reproducible across operators and achieved without anti-arrhythmic drugs. The nPulse Cardiac Catheter System delivers energy in billionths of a second ? nanoseconds ?
compared with conventional, slower microsecond-based systems. This ultra-fast, non-thermal energy is designed to create precise, durable PVI while minimizing impact to surrounding cardiac structures. Key design features of the System include: Precise Lesion Formation: Creates deep, circumferential lesions without stacking applications or rotating the catheter. Efficient Workflow: Isolates pulmonary veins with minimal applications and ultra-fast delivery (~5 seconds per application).
Procedure Efficiency: Prior feasibility study showed median left atrial dwell time of 21 minutes and total procedure time of approximately 65 minutes. Enhanced Visualization: Integrated magnetic EP mapping with catheter-embedded sensors compatible with Abbott?s EnSite X system for real-time 3D electroanatomical visualization to provide a stable location reference, constructing anatomical shells, and standardizing electrophysiological maps to guide therapy. The NANOPULSE-AF Study is a prospective, multicenter, non-randomized IDE pivotal clinical investigation designed to evaluate the safety and effectiveness of the CellFX nsPFA Cardiac Catheter System in patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation.
The Study plans to enroll approximately 215 participants across multiple clinical sites, with the first patients treated at St. Bernards Medical Center in Jonesboro, Arkansas. Primary endpoints will be assessed at 6 and 12 months post-ablation to measure procedural success and safety outcomes, supporting the broader clinical development of the nPulse system.
