Pulse Biosciences, Inc. , a company leveraging its novel nPulse technology using its proprietary Nanosecond Pulsed Field Ablation energy, announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company’s Investigational Device Exemption (IDE), allowing Pulse Biosciences to proceed with the initiation of its nPulse Cardiac Catheter Ablation System Study for the treatment of paroxysmal atrial fibrillation.
Health Technology Insights: Cencora Fast-Tracks OneOncology Acquisition to Expand Services
This single-arm, multicenter, prospective study is designed to demonstrate primary safety and effectiveness of the nsPFA Cardiac Catheter System for the treatment of recurrent drug-resistant symptomatic paroxysmal AF. Up to 30 sites, including three sites outside the United States, are planned to enroll up to 145 patients. Additional details of the study are available on clinicaltrials.gov (NCT07018596).
“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 leading 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.”
Health Technology Insights: Pharmanovia Launches Korjuny for Malignant Ascites in Germany
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 by leading investigators 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 novel 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,” said Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY, and principal investigator of the study. “Based on my extensive 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.”
“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,” said Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences. “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.
Health Technology Insights: LEO Pharma Submits Adolescent Label Expansion Application for Anzupgo to EMA
To participate in our interviews, please write to our HealthTech Media Room at info@intentamplify.com
