On Oct. 24, 2025, Pulse Biosciences announced the enrollment of the first patient in its NANOCLAMP AF Study, a single‑arm, prospective multicenter trial evaluating the company’s nPulse Cardiac Surgical System for atrial fibrillation during concomitant cardiac surgery. The procedure was performed at St. Helena Hospital in St. Helena, California, marking the first U.S. surgical use of the nsPFA technology.
The study follows the recent FDA Investigational Device Exemption (IDE) approval granted earlier this year, allowing the company to conduct clinical trials of its nanosecond pulsed field ablation (nsPFA) system. The nPulse Cardiac Surgical System is a bipolar device designed to create continuous, full‑thickness ablation lines with a non‑thermal energy modality, aiming to improve safety and procedural efficiency compared to conventional thermal ablation.
Pulse Biosciences said the first patient enrollment demonstrates the feasibility of the nsPFA approach in a real‑world surgical setting and sets the stage for broader enrollment across multiple U.S. and international sites. The company plans to expand the study to include additional centers, with the goal of generating robust safety and efficacy data that could support future regulatory submissions and market adoption.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.