Pulse Biosciences Nabs FDA IDE Approval for nPulse Cardiac Catheter Ablation System Study

Pulse Biosciences Inc. has earned U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to begin its nPulse Cardiac Catheter Ablation System Study (NANOPULSE-AF) for paroxysmal atrial fibrillation (PAF) treatment.

“This FDA IDE approval is a major milestone for Pulse Biosciences and is a testament to the strength of our preclinical and human clinical data,” Pulse Biosciences Co-Chairman/CEO Paul LaViolette stated. “With the support of leading electrophysiologists, we believe our proprietary nanosecond PFA represents a next-generation energy modality with the potential to improve the safety, effectiveness, and efficiency of AF ablation through a simpler, clinician-friendly procedure. We look forward to sharing follow-up data in 2026.”

This single-arm, multicenter, prospective study aims to demonstrate primary safety and effectiveness of the proprietary Nanosecond Pulsed Field Ablation (nanosecond PFA or nsPFA) Cardiac Catheter System in treating recurrent drug-resistant symptomatic paroxysmal atrial fibrillation (AF). Up to 30 sites, including three outside the United States, will enroll as many as to 145 patients.

“Pulsed field ablation has already reshaped how we treat atrial fibrillation, but its full potential is just emerging. This IDE represents a critical next step—evaluating nanosecond pulsed field ablation across U.S. centers and select European sites to further improve safety and durable freedom from atrial arrhythmias,” said Dr. David Kenigsberg, chief medical officer, Electrophysiology at Pulse Biosciences. “Unlike existing systems, which rely on microsecond energy delivery, our nanosecond PFA platform is designed to deliver meaningfully lower total energy with the potential to further reduce collateral injury to surrounding structures. Specifically designed for pulmonary vein isolation, the nPulse Cardiac Catheter has the potential to set a new standard for AF ablation.”

The nPulse Cardiac Catheter is designed to deliver a complete circumferential lesion in a single, brief energy application without the need to stack lesions, and eliminating the need to stop, rotate and reposition the catheter. The company’s ongoing feasibility study in Europe with the nPulse Cardiac Catheter has now enrolled 150 patients with subject follow-up ongoing. Positive initial clinical outcomes support a strong foundation of real-world evidence to support broader global adoption of nsPFA treatments.

“This technology offers a highly intuitive and user-friendly experience, with a pliable catheter designed for precise positioning and consistent energy delivery to achieve durable, transmural pulmonary vein isolation,” stated principal study investigator Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital (New York, N.Y.). “Based on my hands-on experience with the nPulse Cardiac Catheter, the combination of a differentiated nanosecond pulsed-field energy source and thoughtful catheter design has the potential to deliver effective lesion formation with a favorable safety profile, while simplifying workflow in the EP lab. We look forward to the results of this IDE as the clinical data continue to evolve.”

Pulse Biosciences is a bioelectric medicine company whose proprietary nPulse technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The company is actively pursuing the development of its nPulse technology for use in the treating atrial fibrillation and in a select few other markets where it could have a profound positive impact for both patients and providers, such as surgical soft tissue ablation.