Pulse Biosciences Releases Cardiac Catheter Clinical Data
Pulse Biosciences announced late-breaking clinical data from the nPulse Cardiac Catheter first-in-human feasibility study. The study demonstrates successful treatment of atrial fibrillation in 150 patients with rapid procedure times and minimal adverse effects. The data were presented today at the 31st Annual AF Symposium 2026 meeting, taking place February 5-7, 2026, in Boston, MA. "These 6- and 12-month data demonstrate a strong safety profile with highly effective and durable PVI achieved with the nPulse Cardiac Catheter Ablation System, suggesting that this system has the ability to considerably advance the treatment of atrial fibrillation (AF)," said Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY. "The conformable catheter design, differentiated energy, and zero rotation workflow have produced highly efficient and effective results when compared to other AF feasibility studies in my experience, highlighting the nPulse Cardiac Catheter's simple and effective workflow for PVI." The ongoing feasibility study is assessing the initial safety and efficacy of the nPulse Cardiac Catheter System for the treatment of AF. To date, a total of 165 patients have been treated by nine investigators in Europe, including the Na Homolce Hospital in Prague led by Dr. Vivek Reddy and Prof. Petr Neuzil, Jessa Hospital in Hasselt led by Dr. Johan Vijgen, and Tor Vergata Hospital in Rome, led by Dr. Andrea Natale. The initial cohort of treated patients has been evaluated by remapping at ~3 months and for rhythm control completed at 6 and 12 months post ablation procedure.
