PLSE reaches 164-patient enrollment target in nPulse cardiac ablation trial

Pulse Biosciences announced completion of enrollment in its NANOPULSE-AF pivotal IDE clinical study for the nPulse Cardiac Catheter System, enrolling 164 evaluable patients across 15 sites with first treatments in April 2026. Reaching enrollment target in a pivotal cardiac ablation trial is a material clinical milestone that removes execution risk and moves the company toward primary safety and effectiveness readout at 6 and 12 months, critical for potential FDA approval in a large symptomatic atrial fibrillation market.

A medical device company announced it successfully recruited all 164 patients needed for its key clinical trial testing a new cardiac ablation catheter, which is a major step toward getting FDA approval to sell the device.