Pulse Biosciences, Inc. (Nasdaq: PLSE) has announced that it successfully treated the first two patients in its initial human feasibility study using its innovative Cardiac Surgery System. This study, which employs the company’s proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, aims to ablate cardiac tissue for treating atrial fibrillation.
Dr. Bart Van Putte, a cardiothoracic surgeon at St. Antonius Hospital in Nieuwegein, The Netherlands, successfully used Pulse Biosciences’ Cardiac Surgery System to treat two patients with atrial fibrillation. The procedure was supported by Dr. Gan Dunnington, Pulse Biosciences’ Chief Medical Officer for Cardiac Surgery, and Dr. Niv Ad, Chief Science Officer for Cardiac Surgery. This marks the beginning of a multicenter, first-in-human feasibility study that will include up to 30 patients and assess the system’s effectiveness through endocardial catheter-based remapping around three months post-treatment.
Dr. Van Putte noted, “We are proud to be the first to use this advanced nano-PFA technology for atrial fibrillation treatment. The initial results demonstrated effective pulmonary vein and ‘box’ isolation with Pulse’s Cardiac Surgery System. We were impressed by how quickly and efficiently we achieved linear ablations compared to traditional thermal methods like radiofrequency or cryoablation.”
Dr. Dunnington added, “These early results align with our preclinical findings. The patients handled the procedure well, and the device’s design allowed for quick and precise lesion creation. We look forward to continuing this study to confirm the system’s safety, effectiveness, and durability.”
Pulse’s Cardiac Surgery System, featuring a Surgical Clamp using nanosecond PFA technology, aims to deliver durable and continuous ablation lesions for atrial fibrillation treatment. The system offers a faster and more controlled approach than traditional thermal methods, minimizing the risk of collateral tissue damage.
The nano-PFA Cardiac Surgical System received FDA Breakthrough Device Designation in July 2024 and is now part of the FDA’s TAP program, which supports rapid development of innovative medical devices. The TAP program facilitates early and strategic communication with the FDA to expedite patient access to crucial medical devices. The FDA has enrolled 46 devices in the TAP program, with over 900 Breakthrough Device Designations granted.
President and CEO Burke T. Barrett remarked, “We are making significant progress with our nano-PFA devices, and we appreciate the support of key opinion leaders who are advancing this technology. The promising results from this study will guide our clinical and regulatory strategies. We are excited to proceed with our momentum following the Breakthrough Device Designation and TAP enrollment, with plans to submit for IDE approval to begin U.S. clinical trials.”
Pulse Biosciences aims to pursue FDA premarket approval (PMA) for the nano-PFA Cardiac Surgical System to treat atrial fibrillation in the U.S. They plan to initiate a pivotal clinical study in early 2025 and will provide more details on the study and its implications later this year.
