Pulse Biosciences Enrolls First Patients in NANOPULSE-AF IDE Pivotal Clinical Study

Pulse Biosciences, Inc. has announced the enrollment of the first patients in its NANOPULSE-AF study, a pivotal clinical investigation evaluating the nPulse™ Cardiac Catheter System for treating paroxysmal atrial fibrillation. The study, which aims to enroll approximately 215 participants across multiple sites, will assess primary endpoints at 6 and 12 months post-ablation. The first seven patients were treated at St. Bernards Medical Center by Dr. Devi Nair. This milestone follows a European feasibility study where the nPulse System demonstrated a 96% procedural success rate at 12 months. The nPulse Cardiac Catheter System utilizes proprietary nanosecond pulsed field ablation (nsPFA™) energy, designed for precise, durable lesion formation with an efficient workflow. The system is integrated with Abbott’s EnSite X system for enhanced visualization and navigation. The study is led by Principal Investigator Dr. Vivek Reddy from Mount Sinai Fuster Heart Hospital.