Clinical TrialApr 27, 2026, 09:26 AM
PLSE nPulse Cardiac Catheter Study Shows 100% Procedural Success at 6 Months
AI Summary
Pulse Biosciences, Inc. announced additional positive key findings from its first-in-human clinical study of the nPulse Cardiac Catheter System for atrial fibrillation, presented at Heart Rhythm 2026. The study demonstrated sustained 100% procedural success at 6 months and 96% at one year for evaluable patients. The system also showed efficient procedural performance and maintained a low serious adverse event rate of 1.7%.
Key Highlights
- Sustained 100% procedural success at 6 months for evaluable patients (95/95).
- Sustained 96% procedural success at one year for evaluable patients (51/53).
- Achieved 90% Kaplan-Meier estimate of freedom from AF/AFL/AT at one year.
- Average left atrial dwell time was 18.6 minutes.
- Average total procedure time was 60.2 minutes.
- Maintained a low serious adverse event rate of 1.7% (3/177 subjects).