Dive Brief:
- Pulse Biosciences said Thursday it got the Food and Drug Administration’s go-ahead to begin an investigational device exemption study of its cardiac catheter ablation system to treat drug-resistant paroxysmal, or intermittent, atrial fibrillation.
- The company has developed technology that delivers nanosecond electrical pulses to treat the heart rhythm condition. Nanosecond pulses are briefer in duration than the microsecond pulses used in other pulsed field ablation systems, which could offer advantages. The Pulse Biosciences catheter is designed to deliver a complete lesion in a single energy application.
- Pulse Biosciences will evaluate the safety and effectiveness of its nPulse ablation catheter in the single-arm, multicenter NANOPULSE-AF study.
Dive Insight:
PFA has generated excitement among electrophysiologists who view it as an improvement over older thermal-based ablation approaches due to its potential for safer and faster procedures. The energy pulses form lesions in the cardiac tissue to disrupt the abnormal electrical signals that cause AFib’s irregular heartbeats.
New PFA devices have driven strong sales growth for Boston Scientific and Medtronic. Johnson & Johnson and Kardium have also introduced PFA systems in the U.S. market, while Abbott received Europe’s CE mark for its PFA system in March and expects FDA approval next year.
Pulse Biosciences looks to demonstrate its nPulse platform can further reduce injury to surrounding tissue, lower total energy delivery and improve freedom from atrial arrhythmias.
“Pulsed field ablation has already reshaped how we treat atrial fibrillation, but its full potential is just emerging,” David Kenigsberg, chief medical officer for electrophysiology, said in a statement. “This IDE represents a critical next step.”
Pulse Biosciences expects to share follow-up data from its study in 2026.
The company is also studying use of a PFA clamp to treat AFib during concomitant cardiac surgeries.
