other material
confidence high
sentiment positive
materiality 0.65
Pulse Biosciences enrolls first patient in NANOCLAMP AF study for AF treatment using nPulse system
PULSE BIOSCIENCES, INC.
- First procedure completed at St. Helena Hospital in St. Helena, CA with nPulse Cardiac Surgical System using nanosecond PFA.
- NANOCLAMP AF is a single-arm, prospective multicenter study for safety/effectiveness of nPulse in concomitant AF procedures.
- nPulse system granted FDA Breakthrough Device Designation in July 2024 and enrolled in FDA's TAP program.
- Multiple U.S. and two international sites planned; study follows recent FDA IDE approval.