other material
confidence high
sentiment positive
materiality 0.60
Pulse Biosciences treats first two patients in first-in-human study of nano-PFA Cardiac Surgery System for AFib
PULSE BIOSCIENCES, INC.
- Successfully treated first two AFib patients using nano-PFA Cardiac Surgery System at St. Antonius Hospital, Netherlands.
- Feasibility study is multicenter, up to 30 patients, with chronic isolation confirmed at ~3 months via catheter remapping.
- Cardiac Surgery System enrolled in FDA's TAP program and holds Breakthrough Device Designation (granted July 2024).
- Plans to submit IDE for U.S. clinical work and begin pivotal study in early 2025, pursuing PMA for commercialization.