Procedural success was achieved in 100% of evaluable patients at 6 months and 96% in 12 months
Pulse 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.
Key study findings include:
- 100% procedural success of evaluable patients at 6 months (75/75)
- 96% procedural success of evaluable patients at one year (45/47)
- Average number of applications were 16.1 ± 5.2 per procedure
- Total procedure and fluoroscopy times were 65 ± 28 and 9.8 ± 5.8 minutes, respectively
- Left atrial dwell time was 21.0 ± 13.3 minutes
- Safety profile: 1.3% (2/150) subjects had an SAE related to the primary safety endpoint
“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 (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 and for rhythm control completed at 6 and 12 months post ablation procedure.
“This dataset marks an important milestone for Pulse Biosciences and highlights an exceptional combination of improved workflow and outcomes results. These results validate the safety, effectiveness, lesion quality, and speed benefits that clearly differentiate the nPulse Cardiac Catheter Ablation System as a first-in-class system showing the potential to be best in class,” said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. “We extend our gratitude to all the electrophysiologists, staff and patients who continue to support our clinical work.”
“These impressive results highlight the nPulse Cardiac Catheter as a first-in-class system for treating AF. In a clinical field where a 20-25% recurrence rate is expected, these results exceed expectations for PVI. Nanosecond PFA energy and integration into a 3D mapping system has the ability to offer precise, lasting pulmonary vein isolation. We’re poised to revolutionize atrial fibrillation treatment, and we are excited to begin treating additional patients in Europe and the U.S. as we initiate our pivotal IDE study,” said Dr. David Kenigsberg, Chief Medical Officer, Electrophysiology at Pulse Biosciences.
