Pulse Biosciences receives FDA approval to launch atrial fibrillation study with nonthermal ablation system

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Pulse Biosciences has received approval from the U.S. Food and Drug Administration (FDA) to begin its first U.S.-based clinical study of the company’s nanosecond pulsed field ablation (nsPFA) Cardiac Surgery System for treating atrial fibrillation (AF).

The Investigational Device Exemption (IDE) approval allows the company to initiate the NANOCLAMP AF trial, a single-arm, prospective study. The trial plans to enroll up to 136 patients across as many as 20 sites, including two outside the U.S.

According to a company news release, the study is designed to evaluate the primary effectiveness of the nsPFA Cardiac Surgical System in patients undergoing concomitant surgical procedures.

A nonthermal approach to cardiac ablation

Pulse Biosciences says its nsPFA technology delivers ultrashort electrical pulses that ablate cardiac tissue without the heat typically generated by radiofrequency or other thermal ablation techniques.

The company’s cardiac clamp is designed to provide continuous, linear, transmural ablations in a matter of seconds while minimizing the risk of collateral tissue damage.

“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 Niv Ad, M.D., chief science officer for 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 device received FDA Breakthrough Device designation in July 2024 and is also participating in the agency’s Total Product Life Cycle (TPLC) Advisory Program.

An alternative to radiofrequency ablation?

Pulse Biosciences executives say early feasibility data from Europe — where more than 40 patients have been treated since August 2024 — suggest nsPFA can deliver consistent, contiguous lesions in as little as 2.5 seconds. Surgeons have reported rapid ablation times and fully transmural outcomes.

“This FDA IDE approval is a major milestone for Pulse Biosciences,” said Paul LaViolette, co-chairman and CEO of Pulse Biosciences. “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.”

The company expects to highlight its nsPFA Cardiac Clamp at the upcoming European Association for Cardio-Thoracic Surgery meeting in Copenhagen next month.

Building a broader portfolio

The FDA study follows Pulse Biosciences’ recent expansion into other therapeutic areas. Last week, the company announced the launch of its PRECISE-BTN trial evaluating nsPFA for the treatment of benign thyroid nodules, underscoring its ambitions to extend the technology beyond cardiology.

“We believe the benefits of nsPFA technology for cardiac ablation will increase the overall adoption of surgical cardiac ablation for AF well beyond what radiofrequency ablation has been able to do,” said Gan Dunnington, M.D., chief medical officer for cardiac surgery at Pulse Biosciences.

By advancing parallel studies in both cardiovascular and endocrine indications, Pulse Biosciences is positioning nsPFA as a versatile nonthermal ablation platform that could broaden treatment options across specialties.