October 10, 2025 — Leads & Copy — Pulse Biosciences, Inc. (Nasdaq: PLSE) has announced late-breaking clinical study results from the nPulse™ Cardiac Surgical System first-in-human feasibility study at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark.
The study assessed the initial safety and efficacy of the nPulse Cardiac Surgical System for Atrial Fibrillation (NCT06355063). To date, 44 patients have been treated by investigators in Europe, including Dr. Bart van Putte, Dr. Bart Maesen, and Dr. Antoine Driessen. In the initial cohort, 24 patients had ablation effectiveness and durability evaluated by electroanatomical mapping at approximately three months post-procedure.
Dr. Bart van Putte noted that the electroanatomical mapping results for the first 24 patients treated show durable and consistent pulmonary vein isolation (PVI) and posterior box isolation, achieved safely with rapid ablation times. The early results suggest the speed, safety and effectiveness of the nPulse Surgical Cardiac Clamp’s efficient workflow has the potential to significantly expand the use of cardiac surgical ablation for patients suffering from atrial fibrillation.
All (100%) posterior box isolations were acutely successful in the high-dose cohort. The success rate of PVI (per vein) at ~3 months was 94% (63/67). The average total ablation time was 50 seconds with an average number of 13 applications. There were no reports of esophageal or phrenic nerve damage and no ablation-related severe or major adverse events.
Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences, stated that the company is the first to bring PFA into the cardiac surgical field for atrial fibrillation treatment. He believes the nonthermal nPulse technology offers advantages in safety, efficacy, and speed compared to traditional thermal ablation methods like radiofrequency and looks forward to continued collaboration with leading physicians as the company works toward commercial approval and broader patient access.
Note: Dr. Bart van Putte serves as a consultant to Pulse Biosciences.
Contact: Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences.
Source: Pulse Biosciences
