Pulse Biosciences Unveils Groundbreaking Results for AF Treatment in Landmark Study

Pulse Biosciences has revealed promising results from its first-in-human study of the nPulse Cardiac Surgical System. The trial, designed to test the system's safety and effectiveness in treating atrial fibrillation (AF), showed high success rates and no serious complications. Findings were presented at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen.

The study involved 44 patients, with 24 evaluated around three months after the procedure. Pulmonary vein isolation (PVI) succeeded in 94% of cases (63 out of 67), while all posterior box isolations in the high-dose group were immediately successful. No severe adverse events linked to ablation occurred, and there were no reports of esophageal or phrenic nerve damage.

The average total ablation time per patient was just 50 seconds, using around 13 applications. Pulse Biosciences remains the first company to introduce pulsed field ablation (PFA) into cardiac surgery for AF treatment. The firm also plans to launch an Investigational Device Exemption (IDE) study later this year to further validate the system.

As of March 2026, only a few European centres—including sites in Germany, the UK, and Slovenia—have participated in the feasibility study. Key contributors include Dr. Borut Gersak at University Medical Centre Ljubljana, with no additional clinics or physicians publicly confirmed.

The study's early results suggest the nPulse Cardiac Surgical System is both safe and effective for AF treatment. With no major complications and a short ablation time, the technology shows potential for wider clinical use. Pulse Biosciences now moves toward a larger IDE study to gather further evidence.