Pulse Biosciences receives FDA IDE approval for nsPFA Cardiac Surgery Study NANOCLAMP AF

PULSE BIOSCIENCES, INC.

FDA granted IDE approval for the NANOCLAMP AF study of nsPFA Cardiac Surgical System to treat atrial fibrillation.
Single-arm prospective study plans up to 20 sites (2 outside U.S.) enrolling up to 136 patients.
First-in-human EU feasibility study (since Aug 2024) treated over 40 patients with ablation times as short as 2.5 seconds.
nsPFA Cardiac Clamp received FDA Breakthrough Device Designation in July 2024 and is enrolled in the TAP program.

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