Pulse Biosciences passes enrollment midpoint in atrial fibrillation study
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Pulse Biosciences, Inc. (Nasdaq: PLSE) announced that its NANOPULSE-AF pivotal study has surpassed its enrollment midpoint, according to a press release from the company. The study, which uses the company's nanosecond pulsed field ablation technology to treat atrial fibrillation, began enrolling patients in April 2026.
The NANOPULSE-AF study is an Investigational Device Exemption (IDE) pivotal trial evaluating the company's nPulse Cardiac Catheter System for pulmonary vein isolation in patients with atrial fibrillation.
Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital and National Principal Investigator of the study, cited the ease of use of the catheter as a factor in enrollment momentum. "Reaching the halfway mark so rapidly is a true testament to the ease of use of this catheter, and the excitement it engenders in the investigators," Reddy said.
Frank Cuoco, MD, Director of Cardiac Electrophysiology at HCA Trident Health in Charleston, South Carolina, and a top-enrolling investigator, said the system's workflow "integrates seamlessly into our existing ablation practice."
David Kenigsberg, MD, Chief Medical Officer of Pulse Biosciences, noted the company's collaboration with the FDA as the study progresses toward completion.
Pulse Biosciences said it plans to provide additional commentary on the study's progress during an earnings conference call scheduled for August 6 at 1:30 p.m. PT.
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