Hayward, Calif.–based Pulse Biosciences’ study evaluates its novel Cardiac Surgery System for ablating cardiac tissue to treat AFib. The Cardiac Surgery System received FDA breakthrough device designation last month.
The technology utilizes Pulse Biosciences’ CellFX nanosecond pulsed field ablation (nsPFA) technology and percutaneous electrode system, which the FDA cleared earlier this year. It enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures.
This system, which features a surgical clamp, produces durable, continuous transmural ablation lesions during cardiac surgery. The bipolar clamp utilizes the proprietary nsPFA technology.
Dr. Bart Van Putte treated the first two patients with AFib at St. Antonius Hospital, Nieuwegein, The Netherlands. Pulse Biosciences plans for the multicenter study to enroll up to 30 patients. It features an endocardial catheter-based remapping as well to confirm chronic isolation at approximately three months post-treatment.
Pulse Biosciences Chief Medical Officer Dr. Gan Dunnington said the initial treatments produced well-tolerated procedures.
The company plans to pursue FDA premarket approval (PMA) for its system. It intends to begin a pivotal study 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,” said 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.”
Pulse Biosciences continues its progress in a hot space
Pulsed-field ablation continues to heat up following several recent milestones for a number of different companies. Boston Scientific followed less than two months later with its Farapulse system. Johnson & Johnson’s Biosense Webster submitted its Varipulse for FDA approval at the end of March.
Other companies, such as Volta Medical, Adagio Medical, Kardium and more have made recent progress on the PFA front. Abbott entered the fray as well with its Volt system.
Read all about pulsed-field ablation technology on MassDevice HERE.
