First-in-Human study with nano-PFA cardiac surgery system by Pulse Biosciences

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Pulse Biosciences, a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology, announced treatment of the first two patients in the first-in-human feasibility study using its novel Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation. This first-in-human feasibility study is a multicenter study of up to 30 patients that will include an endocardial catheter-based remapping to confirm chronic isolation at approximately three months post treatment.

Pulse’s Cardiac Surgery System with Surgical Clamp is designed to produce durable, continuous, transmural, ablation lesions during cardiac surgery procedures for the treatment of atrial fibrillation. The bipolar clamp utilizes the Company’s proprietary nanosecond PFA technology. Based on pre-clinical studies, a single application of less than two seconds with the Surgical Clamp creates a consistent, transmural, durable ablation, which is significantly faster, requiring approximately one-twentieth the time of currently available thermal ablation technologies. The non-thermal mechanism of action of nano-PFA prevents thermal spread that may cause undesired injury to collateral tissues, which compares favorably to thermal radiofrequency ablation.

The nano-PFA Cardiac Surgical System received FDA Breakthrough Device Designation in early July 2024. Recently the device was enrolled in the FDA’s TAP program, launched by the FDA’s Center for Devices and Radiological Health (CDRH) to help generate more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health.