Pulse Bio Treats First-in-Human Patients with Nano-PFA Cardiac Surgery System

Pulse Biosciences announced treatment of the first two patients in the first-in-human feasibility study of its novel Cardiac Surgery System to ablate cardiac tissue to treat atrial fibrillation (AFib).
 
Dr. Bart Van Putte, Cardiothoracic Surgeon at St. Antonius Hospital, used the Company’s Cardiac Surgery System to successfully treat two patients with atrial fibrillation at St. Antonius Hospital, Nieuwegein, The Netherlands. Dr. Van Putte was joined by colleagues and Pulse Biosciences’ Chief Medical Officer, Cardiac Surgery, Dr. Gan Dunnington and Chief Science Officer, Cardiac Surgery, Dr. Niv Ad during the concomitant procedure.
 
The multicenter study of up to 30 patients will include an endocardial catheter-based remapping to confirm chronic isolation at about three months after treatment.
 
Pulse’s Cardiac Surgery System with Surgical Clamp aims to create durable, continuous, transmural ablation lesions during cardiac surgeries to treat AFib. The bipolar clamp uses the company’s proprietary nanosecond pulsed field ablation (nsPFA) technology.
 
Preclinical studies showed one application of less than two seconds with the Surgical Clamp created a consistent, transmural, durable ablation. It was also significantly faster, needing about one-twentieth of the time of current thermal ablation technologies. Because of nano-PFA’s non-thermal mechanism, there’s no risk of thermal spread that can cause injury to surrounding tissues.
 
The nano-PFA Cardiac Surgical System earned FDA breakthrough status in early July. Recently, the device was enrolled in the FDA’s TAP program.
 
Pulse plans to initiate a pivotal clinical study of the nano-PFA Cardiac Surgical System to treat AFib in early 2025.
 
“We continue to make great strides on the development of our current nano-PFA devices, three of which have now been used in patients with initial promising results. We are grateful for all the key opinion leader clinicians who have partnered with us to advance nano-PFA technology for the benefit of patients and clinicians worldwide,” said Pulse Bio’s president and CEO Burke T. Barrett. “These initial clinical results with the Cardiac Surgical System will inform the next steps of our clinical and regulatory strategy. We are excited to continue the momentum with the System following its Breakthrough Device Designation and recent enrollment into the prestigious TAP program. Moving forward, we intend to submit for IDE approval from the FDA to begin U.S. clinical work.”