Pulse Biosciences, Inc. announced on October 7, 2026, that it has achieved its enrollment target for the NANOPULSE-AF study. The company reported that 164 evaluable patients have been enrolled across 15 clinical sites.
The NANOPULSE-AF study is a prospective, multicenter, non-randomized Investigational Device Exemption (IDE) pivotal clinical investigation. The study is designed to evaluate the safety and effectiveness of the nPulse Cardiac Catheter System in treating patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation.
Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital in New York, serves as the National Principal Investigator of the study. The first patients were treated in April 2026 at St. Bernards Medical Center in Jonesboro, Arkansas, under the leadership of Dr. Devi Nair.
Primary safety and effectiveness endpoints of the study will be assessed at 6 and 12 months post-ablation. The company stated that the study reached its enrollment target three months ahead of its original timeline.
Pulse Biosciences plans to provide additional updates on the study as patients complete follow-up and expects to present pivotal data at a future medical society conference.
