Pulse Biosciences Receives Authorization to Initiate nPulse Cardiac Catheter Ablation Study

Pulse Biosciences, Inc. has received Investigational Device Exemption approval from the U.S. Food and Drug Administration to initiate its nPulse Cardiac Catheter Ablation System Study (NANOPULSE-AF) for the treatment of paroxysmal atrial fibrillation. 

The system uses the company’s proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, designed to deliver precise cardiac ablation with lower total energy and reduced risk to surrounding tissue.

The single-arm, multicentre, prospective study will enroll up to 145 patients across 30 sites, including three outside the U.S., to evaluate the safety and effectiveness of the nPulse system for patients with recurrent, drug-resistant symptomatic PAF. 

The nPulse Cardiac Catheter is designed to create a complete circumferential lesion in a single brief energy application, without the need to reposition or stack lesions. 

An ongoing feasibility study in Europe has enrolled 150 patients, with initial outcomes supporting the potential safety and efficacy of the system and providing real-world evidence for broader adoption of nsPFA treatments.

The IDE approval marks a significant milestone for Pulse Biosciences, advancing clinical evaluation of its next-generation energy platform. 

The study aims to provide robust data on safety, durable pulmonary vein isolation, and procedural efficiency, supporting future global use of the nPulse system in atrial fibrillation treatment.