Pulse Biosciences receives FDA IDE approval to initiate NANOPULSE-AF clinical study for paroxysmal atrial fibrillation

PULSE BIOSCIENCES, INC.

FDA approved IDE for Pulse Biosciences' nPulse Cardiac Catheter System to treat paroxysmal atrial fibrillation in NANOPULSE-AF study.
Study is single-arm, multicenter, prospective; up to 30 sites (3 outside US) and up to 145 patients planned.
Ongoing European feasibility study has enrolled 150 patients; positive initial outcomes support device's potential.
nPulse uses nanosecond PFA aiming for complete circumferential lesion in single energy application without stacking.
CEO Paul LaViolette calls FDA approval a major milestone; follow-up data expected in 2026.

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