Medical Device Network

Pulse Biosciences launches first-in-human pulsed field ablation trial

Pulse Biosciences plans to pursue FDA premarket approval and begin a pivotal study next year for the system.

US-based Pulse Biosciences has treated the first two patients with atrial fibrillation (AF) in the first-in-human feasibility study using its novel cardiac surgery system.

The two patients were treated at St Antonius Hospital in the Netherlands, initiating the first-in-human feasibility study. The patients tolerated the procedure well, said Pulse’s chief medical officer of cardiac surgery Gan Dunnington.

The multi-centre study will enrol up to 30 patients, featuring an endocardial catheter-based remapping to confirm chronic isolation at approximately three months post-treatment.

The company’s Cardiac Surgery System received US Food and Drug Administration (FDA) breakthrough device designation last month.

The system uses Pulse’s CellFX nanosecond pulsed field ablation (nsPFA) technology and percutaneous electrode system, which secured FDA clearance in March 2024. It facilitates the ablation of soft tissue in both percutaneous and intraoperative surgical procedures. The system comes equipped with a surgical clamp which enables durable continuous transmural ablation lesions during cardiac surgery.

Pulse said it plans to use the clinical data from this study to inform the next steps of its clinical and regulatory strategy. It is set to pursue FDA premarket approval (PMA) for the system and to begin a pivotal study early next year.

Pulse CEO Burke Barrett said: “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 enrolment into the prestigious TAP programme. Moving forward, we intend to submit for IDE approval from the FDA to begin US clinical work.”

Pulsed-field ablation (PFA) uses short, intense bursts of electric pulses to selectively destroy abnormal tissue associated with AF. The technology is an advancement over the gold-standard thermal ablation, which uses heat to destroy the tissue instead.

There have been two recent high-profile approvals by the FDA. Medtronic’s PulseSelect became the first PFA device approved in the region, with Boston Scientific following less than two months later with its Farapulse system.