FDA Clears Pulse Biosciences to Study Nanosecond Cardiac Ablation Catheter

Pulse Biosciences has received FDA investigational device exemption (IDE) clearance to study its nPulse cardiac ablation catheter for drug-resistant paroxysmal atrial fibrillation (AFib). The device delivers nanosecond electrical pulses, shorter than the microsecond pulses used in existing pulsed field ablation (PFA) systems, allowing potentially safer, faster, and more precise lesion formation in a single energy application.

The NANOPULSE-AF study, a single-arm, multicenter trial, will evaluate the safety and effectiveness of the catheter. PFA is increasingly favored over traditional thermal ablation due to its ability to create targeted lesions while minimizing injury to surrounding tissue.

Pulse Biosciences aims to show that nPulse can reduce energy delivery, lower procedural risk, and improve freedom from arrhythmias. The company also plans to study a PFA clamp for AFib treatment during cardiac surgeries. Follow-up data from the trial are expected in 2026, as Pulse joins competitors including Boston Scientific, Medtronic, J&J, Abbott, and Kardium in the growing PFA market.

22-12-2025