Research Reports

Key takeaways

Sustained 100% procedural success at 6 months (95/95) and 96% at one year (51/53) demonstrates high durability.

90% Kaplan-Meier estimate of freedom from AF/AFL/AT at one year indicates strong long-term efficacy.

Efficient procedural performance with left atrial dwell time of 18.6 minutes and total procedure time of 60.2 minutes.

Low serious adverse event rate of 1.7% (3/177) supports favorable safety profile.

Data presented at Heart Rhythm 2026, a major cardiology conference, enhances credibility.

Expanded cohort sizes (95 at 6 months, 53 at 12 months) strengthen statistical confidence.

Full analysis

Pulse Biosciences announced positive updated clinical data from its first-in-human feasibility study of the nPulse Cardiac Catheter System for treating atrial fibrillation. The late-breaking presentation at Heart Rhythm 2026 showed sustained high durability and procedural efficiency. The 6-month cohort expanded to 95 subjects with 100% procedural success, and the 12-month cohort to 53 subjects with 96% success. The 90% Kaplan-Meier estimate of freedom from AF/AFL/AT at one year underscores the potential of nsPFA technology. Procedural metrics, including left atrial dwell time of 18.6 minutes and total procedure time of 60.2 minutes, indicate efficient workflow. The safety profile remained favorable with a 1.7% serious adverse event rate. These results, presented by principal investigator Dr. Vivek Reddy, reinforce the potential of the nPulse system to advance atrial fibrillation ablation. The company also posted an updated investor deck on its website.

PLSE · Pulse Biosciences, Inc.

Summary

Key takeaways

Full analysis