Pulse Biosciences Receives FDA IDE for Multisite Atrial Fibrillation Study

Pulse Biosciences has received FDA approval for its investigational device exemption (IDE) to begin the NANOCLAMP AF clinical study of its nanosecond pulsed field ablation (nsPFA) Cardiac Surgery System for treating atrial fibrillation (AF). This single-arm, prospective study will enroll up to 136 patients across up to 20 sites, including two outside the U.S., aiming to demonstrate the device's primary effectiveness during concomitant surgical procedures. The nsPFA technology offers a nonthermal mechanism of cardiac ablation, delivering ultrashort electrical pulses that ablate cardiac tissue quickly and with reduced risk of collateral damage compared to traditional thermal methods like radiofrequency ablation. Early feasibility data from Europe, where over 40 patients have been treated since August 2024, show rapid ablation times as short as 2.5 seconds and consistent, fully transmural lesions. The device also holds FDA Breakthrough Device designation and participates in the FDA’s Total Product Life Cycle Advisory Program, underscoring its potential as a safer, faster alternative for surgical cardiac ablation. Pulse Biosciences executives express confidence in the technology's safety, effectiveness, and speed improvements and look forward to expanding the clinical study.