Pulse Biosciences, Inc. 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. 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. 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. Also, due to the non-thermal mechanism of action of nano-PFA, there is no risk of 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. The FDA's Center for Devices and Radiological Health (CDRH) launched the TAP program to help generate more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health.
TAP's primary goal is to expedite patient access to innovative medical devices by providing early, frequent and strategic communications with the FDA and facilitating engagement with other key parties for developers of devices of public health importance. According to its website, the FDA has enrolled 46 devices in the TAP program to date, while there have been over 900 Breakthrough Device Designations granted. The Company plans to pursue FDA premarket approval (PMA) to commercialize its nano-PFA CardiacSurgical System in the United States as a treatment for atrial fibrillation.
If granted by the FDA, a specific treatment indication would permit direct marketing of the device's treatment benefits. The Company intends to begin its pivotal clinical study of its nano-PFA Cardac Surgical System as a treatment for atrial Fibrillation in early 2025 and will provide additional details on the study and its regulatory and commercial implications later this year.