The U.S. FDA awarded Pulse Biosciences, with a Breakthrough Device Designation for its Cardiac Surgery System intended to ablate cardiac tissue in patients suffering from atrial fibrillation (AF).
This designation is intended to speed up the development and approval process for devices that offer significant improvements over current treatments for severe or chronic conditions.
Pulse Biosciences’ nsPFA™ (Nanosecond Pulsed Field Ablation™) technology is found in the Cardiac Surgery System. It has an accompanying surgical clamp that is designed to deliver consistent and long-lasting transmural ablation lesions during heart surgeries.
Unlike the conventional thermal ablation method, the technique is non-thermal therefore preventing unintentional damages to adjacent tissues.
The Breakthrough Devices Program is intended to accelerate access to devices that are much better than the current therapies.
Nevertheless, even though it bears this title, Cardiac Surgical System must still satisfy the FDA’s strict requirements for safety and efficacy prior to being released into the market.
Pulse Biosciences plans premarket approval (PMA) and is preparing to start a major clinical trial for AF in 2025. The firm is also making arrangements for its first clinical procedures in Netherlands.
If PMA approval is obtained, it would mean that Pulse Biosciences can advertise Cardiac Surgical System as an option specifically indicated for patients suffering from atrial fibrillation.
Additional information on this clinical trial as well as progress on regulatory aspects will be provided by the company later in the year.
Source: https://investors.pulsebiosciences.com/news-releases/news-release-details/pulse-biosciences-inc-announces-receipt-fda-breakthrough-device
