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Pulse Biosciences Presents Late-Breaking Data from nPulse™ Cardiac Catheter System First-In-Human Feasibility Study at the AF Symposium
Procedural success was achieved in 100% of evaluable patients at 6 months and 96% in 12 months HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc.
About this update from Pulse Biosciences, Inc
[{"type":"text","content":"\nProcedural success was achieved in 100% of evaluable patients at 6 months and 96% in 12 months\n\n\n HAYWARD, Calif.--(BUSINESS WIRE)--\nPulse Biosciences, Inc. (Nasdaq: PLSE), developer of the novel nPulse™ technology using proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today 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.\n\n\nKey study findings include:\n\n\n\n100% procedural success of evaluable patients at 6 months (75/75)\n\n\n\n96% procedural success of evaluable patients at one year (45/47)\n\n\n\nAverage number of applications were 16.1 ± 5.2 per procedure\n\n\n\nTotal procedure and fluoroscopy times were 65 ± 28 and 9.8 ± 5.8 minutes, respectively\n\n\n\nLeft atrial dwell time was 21.0 ± 13.3 minutes\n\n\n\nSafety profile: 1.3% (2/150) subjects had an SAE related to the primary safety endpoint\n\n\n\n“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.”\n\n\nThe ongoing feasibility study is assessing the initial safety and efficacy of the nPulse Cardiac Catheter System for the treatment of AF (NCT06696170). 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 a...