HAYWARD, Calif. — Pulse Biosciences, Inc. (Nasdaq: PLSE), a company advancing its proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology, announced late-breaking clinical data from the first-in-human feasibility study of the nPulse Cardiac Surgical System at the 39th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Copenhagen, Denmark.
The ongoing feasibility study (NCT06355063) is designed to assess the initial safety and efficacy of the nPulse Cardiac Surgical System for the treatment of atrial fibrillation. To date, 44 patients have been treated at multiple European centers, including St. Antonius Hospital Nieuwegein, Maastricht UMC+, and Amsterdam UMC. In the first 24 patients evaluated by electroanatomical mapping approximately three months after ablation, investigators observed durable and consistent pulmonary vein isolation and posterior box isolation achieved safely with rapid ablation times.
“Electroanatomical mapping results for the first 24 patients treated with the nPulse Cardiac Surgical System show durable and consistent pulmonary vein isolation and posterior box isolation, achieved safely with rapid ablation times,” said Dr. Bart van Putte, Cardiothoracic Surgeon at St. Antonius Hospital Nieuwegein in the Netherlands. “This feasibility study represents the first use of an epicardial PFA surgical technology, and 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.”
In the initial cohort, all posterior box isolations were acutely successful in the high-dose group. The success rate of pulmonary vein isolation per vein at three months was 94 percent (63 of 67). Average total ablation time was approximately 50 seconds, requiring about 13 applications per procedure. There were no reports of esophageal or phrenic nerve damage and no ablation-related severe or major adverse events.
At the EACTS meeting, a recorded “live-in-a-box” case performed and presented by Dr. van Putte highlighted the nPulse system’s ability to rapidly achieve pulmonary vein isolation and posterior box isolation through a fast, efficient surgical workflow.
“Pulse Biosciences is the first company to bring pulsed field ablation into the cardiac surgical field for the treatment of atrial fibrillation,” said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. “We believe our novel and proprietary nonthermal nPulse technology offers significant advantages in safety, efficacy, and speed compared to traditional thermal ablation methods such as radiofrequency. We remain on track to initiate an IDE study this year to clinically validate the nPulse Cardiac Surgical System, and we look forward to continued collaboration with leading physicians as we work toward commercial approval and broader patient access.”
The early results underscore the potential of Pulse Biosciences’ nsPFA technology to deliver a new, nonthermal approach to cardiac surgical ablation with enhanced safety, speed, and efficiency for patients with atrial fibrillation.
