After securing regulatory clearance, Pulse Biosciences, Inc. (NASDAQ: PLSE) shares are on a significant uptick. As of the latest current market check, PLSE shares have surged by 26.97%, reaching $15.30.
Breakthrough Device Designation
Pulse Biosciences announced it has received the Breakthrough Device Designation from the U.S. FDA for its Cardiac Surgery System, designed for the ablation of cardiac tissue in the treatment of atrial fibrillation (AF). This designation underscores the potential impact of their technology on cardiac surgery.
The Cardiac Surgery System with Surgical Clamp aims to create durable, continuous transmural ablation lesions during cardiac procedures to treat AF. This system utilizes Pulse Biosciences’ proprietary nanosecond Pulsed Field Ablation (PFA) technology. Pre-clinical studies indicate that a single application of less than two seconds with the Surgical Clamp can produce a consistent transmural ablation.
This is significantly faster, approximately one-twentieth the time required by existing thermal ablation technologies. Moreover, the non-thermal mechanism of action of nano-PFA eliminates the risk of thermal spread, which can cause unintended injury to adjacent tissues, thereby presenting an advantage over traditional thermal radiofrequency ablation methods.
Relevance of the Program for Breakthrough Devices
The optional Breakthrough Devices Program is open to medical devices that have the potential to better effectively detect or treat conditions like atrial fibrillation, which can be fatal or chronically debilitating. Accelerating the premarket approval, 510(k) clearance, and De Novo marketing authorization development, evaluation, and review processes is the aim of this program.
Before being put on the market, devices with this classification still need to pass the FDA’s stringent safety and efficacy requirements. Pulse Biosciences has achieved a noteworthy milestone with the FDA’s Breakthrough Device Designation, which underscores the inventive capacity of its nanosecond PFA technology.
In order to get a particular indication for the treatment of atrial fibrillation, Pulse Biosciences is requesting PMA approval, and the company intends to take full advantage of this designation. The business plans to start its first-in-human cases in the Netherlands shortly and is getting ready to work with the FDA on a key clinical trial design.
