Pulse Biosciences Enrolls 1st Patient in NANOCLAMP AF Study

Pulse Biosciences enrolled the first patient in its NANOCLAMP AF study for treatment of atrial fibrillation (AFib).

The successful first procedure was completed in St. Helena, California, with the nPulse cardiac surgical system following its recent FDA IDE approval.

NANOCLAMP AF is a single-arm, prospective multicenter study designed to show the safety and effectiveness of nPulse to treat AFib in concomitant surgical procedures. Multiple site, including two outside the U.S., are planned to enroll patients.

nPulse is a next-gen, bipolar surgical device that creates continuous, full-thickness ablation lines during concomitant surgical procedures. The system uses a nonthermal energy modality that’s expected to offer advantages over conventional thermal ablation methods.

The nsPFA (nanosecond pulsed field ablation) Cardiac Surgical System was awarded U.S. Food and Drug Administration (FDA) breakthrough device status in July 2024 and is enrolled in the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP).

“While I have seen this technology used in the European clinical experience, my team was impressed by the nPulse Cardiac Clamp’s ease of use, and the speed of treatment exceeded their expectations,” said Dr. Gan Dunnington, cardiothoracic surgeon for Adventist Health.

“Treating our first patient so quickly following the IDE approval demonstrates the excitement about nanosecond PFA among cardiovascular surgeons,” said Dr. Niv Ad, chief scientific officer, Cardiac Surgery at Pulse Biosciences. “Proving the benefits of nsPFA in this study could drive significant future adoption of surgical cardiac ablation. We are grateful to all the clinicians who continue to support our clinical work. Together we are poised to advance the standard of care for AF and increase the number of patients being treated.”