NANOPULSE-AF, an FDA investigational device exemption (IDE) study, evaluates the nPulse cardiac catheter system in the treatment of recurrent, drug-resistant, symptomatic paroxysmal AFib.
Hayward, California-based Pulse Biosciences won FDA IDE to conduct the study at the end of 2025. It looks to continue advancing nPulse, a pulsed-field ablation (PFA) platform through the U.S. regulatory process. Boston Scientific, Medtronic, Johnson & Johnson MedTech, Abbott and Kardium currently market FDA-cleared PFA technology.
Dr. Devi Nair led the treatment of the first seven patients at St. Bernards Medical Center in Jonesboro, Arkansas.
“This is a promising technology, and our team is pleased to have enrolled and treated the first patients in this pivotal trial,” said Dr. Nair. “The performance of the nPulse System, combined with integrated catheter mapping using the investigational EnSite X software from Abbott, provides a very user-friendly experience and supports an efficient, reproducible and streamlined workflow. This approach may potentially offer important advantages compared with existing technologies. I look forward to continued enrollment and further clinical evaluation of this strategy in atrial fibrillation ablation for the betterment of all involved.”
More about Pulse Biosciences and nPulse
Pulse Biosciences says this milestone builds on its first-in-human feasibility study, for which it shared findings in October. That study demonstrated 96% procedural success at 12 months and 100% acute success.
nPulse delivers a complete circumferential lesion in a single, brief energy application without the need to stack lesions. It also eliminates the need to stop, rotate and reposition the catheter. The technology utilizes its CellFX nanosecond pulsed field ablation (nsPFA) technology. It features a percutaneous electrode system, which the FDA cleared last year. It enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures. The company also picked up IDE for its Cardiac Clamp in September 2025.
The company recently announced a shift in organizational focus toward its PFA platform. It wants to prioritize and accelerate the development and future commercialization of nPulse.
“I am excited to initiate our IDE study with Dr. Nair, a leader in the EP ablation space. This marks an important advancing next step in the clinical development of our nanosecond PFA platform,” said Dr. David Kenigsberg, chief medical officer of Pulse Biosciences.
Pulse Biosciences plans to conduct its multicenter study at up to 30 centers across the U.S. and Europe.
“Enrolling the first patients in this study marks an important milestone for the Company as we build on the encouraging results from our impressive feasibility experience,” said Darrin Uecker, CTO and board member. “With our nanosecond pulsed field ablation technology and the cardiac catheter’s novel design, we are advancing an entirely differentiated approach that we intend to significantly alter AF treatments. We’re thrilled by this strong start to the NANOPULSE-AF study and look forward to its rapid expansion.”
