Pulse Biosciences has earned U.S. Food and Drug Administration (FDA) breakthrough device status for its cardiac surgery system for ablation of cardiac tissue to treat atrial fibrillation (AFib).

The company’s cardiac surgery system with surgical clamp produces durable, continuous, transmural ablation lesions during cardiac surgery to treat AFib. The bipolar clamp uses the company’s nanosecond pulsed field ablation (nsPFA).

Preclinical studies have shown one application of under two seconds with the surgical clamp creates a consistent, transmural ablation. The company said it needs about one-twentieth of the time compared to current thermal ablation technologies.

Further, because nsPFA is non-thermal, there’s no risk of thermal spread that could cause injury to collateral tissues.

“The science behind nanosecond pulse field ablation was immediately compelling to me. The theoretical benefits of short-duration, high-amplitude energy pulses with a nonthermal mechanism of action suggest the potential for a safer and more effective treatment,” said Dr. Niv Ad, chief science officer, cardiac surgery of Pulse Biosciences. “The preclinical data convinced me this technology could significantly advance the surgical treatment of atrial fibrillation. The FDA recognized Pulse’s Cardiac Surgery System as Breakthrough and we look forward to continuing our work to provide access to this technology to patients and surgeons as quickly as possible.”

Pulse Bio now plans to pursue premarket approval (PMA) for the nsPFA cardiac surgical system in the U.S. to treat AFib. The company expects to start its pivotal clinical trial for AFib in 2025 and will offer further details on the study and commercial implications later this year.

The company also completed the first U.S. procedures with its FDA-cleared CellFx nsPFA percutaneous electrode system earlier this year.

“The Breakthrough Device Designation granted by the FDA is an exciting milestone for Pulse. It emphasizes the unique potential benefits of nanosecond PFA,” said recently appointed Pulse Bio president and CEO Burke T. Barrett. “We plan to fully leverage the benefits of this designation and have chosen to seek PMA approval to achieve a specific indication for the treatment of atrial fibrillation. We look forward to aligning with the FDA on a pivotal clinical trial design in the near-term and towards initiating our planned first-in-human cases in the Netherlands soon.”