FDA Grants Nanosecond PFA System Breakthrough Device Status

Pulse Biosciences, a Florida-based healthcare technology company, has received breakthrough device designation from the FDA for its new CellFX nanosecond pulsed field ablation (PFA) technology.

According to Pulse Biosciences, their proprietary Nanosecond PFA system is designed to treat patients with atrial fibrillation (AFib) in a single application lasting less than two seconds. As with other PFA systems, its use is associated with a reduced risk of adverse events due to its ability to destroy heart cells that cause arrhythmias without the use of extreme heat or cold.

“The FDA’s breakthrough device designation is an exciting milestone for Pulse. It highlights the unique potential benefits of nanosecond PFA,” said Burke T. Barrett, president and CEO of Pulse Biosciences, in a statement announcing the news. “We plan to fully leverage the benefits of this designation and have elected to seek premarket approval for a specific indication for the treatment of AFib. We look forward to working with the FDA on a pivotal clinical trial design in the near future and initiating our planned first-in-human cases in the Netherlands.”

“The science behind nanosecond PFA was immediately compelling to me,” added Niv Ad, MD, chief scientific officer of cardiac surgery at the company. “The theoretical benefits of short-duration, high-amplitude energy pulses with a nonthermal mechanism of action suggest the potential for safer, more effective treatment. Preclinical data convinced me that this technology could significantly accelerate the surgical treatment of AFib.”