Pulse Biosciences has been granted U.S. Food and Drug Administration (FDA) approval for its investigational device exemption (IDE) study of its nsPFA (nanosecond pulsed field ablation) Cardiac Surgery System, NANOCLAMP AF, to treat atrial fibrillation (AFib).

The single-arm, prospective study aims to demonstrate the nsPFA Cardiac Surgery System’s primary effectiveness in AFib treatment in concomitant surgical procedures. Up to 136 patients will be enrolled at up to twenty sites, including two outside the U.S.

The nsPFA Cardiac Clamp delivers continuous, linear, transmural ablations during concomitant cardiac surgeries. The bipolar device uses the company’s proprietary nonthermal nsPFA tech, which early clinical data suggests may provide safety and performance advantages over thermal ablation methods.

Unlike thermal approaches, nsPFA energy minimizes risk of collateral tissue damage because of its nonthermal mechanism of action. The system earned FDA breakthrough device status in July 2024 and is enrolled in the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP).

“We believe nsPFA’s novel and proprietary nonthermal mechanism of cardiac ablation offers significant safety, effectiveness and speed improvements over current thermal modalities, such as radiofrequency ablation,” said Dr. Niv Ad, Chief Science Officer, Cardiac Surgery at Pulse Biosciences. “The first-in-human feasibility data we are generating in Europe gives us confidence in our ability to successfully execute the IDE study, and we look forward to enrolling our first patients.”

The company’s first-in-human feasibility study has been underway in the EU since August 2024, with over 40 patients treated in three sites in the Netherlands. Surgeons reported ablation times as short as 2.5 seconds along with consistent, contiguous, and fully transmural lesions.

Pulse Biosciences expects to add additional sites to this study throughout the year.

“This FDA IDE approval is a major milestone for Pulse Biosciences,” said Pulse Biosciences co-chairman and CEO Paul LaViolette. “The study approval is a testament to the quality of the preclinical and human clinical data that has been generated in support of this breakthrough technology. Pulse Biosciences is the first company to advance PFA into the cardiac surgical field for the treatment of AF.”