CardioVia has received FDA clearance for ViaOne, a minimally invasive epicardial access system designed to safely reach the heart’s outer surface without the use of an exposed needle.
Key Highlights:
- Blunt-tip, concealed needle minimizes the risk of heart perforation.
- Sensor-guided navigation supports safe, controlled access to the pericardial space.
- Leverages tissue differentiation between pericardium and heart muscle to guide entry.
- Breakthrough Device Designation previously awarded by the FDA.
ViaOne enables both diagnostic and therapeutic interventions, offering a safer alternative to conventional needle-based methods for electrophysiologists and interventional cardiologists. Initial rollout will focus on leading U.S. cardiac centers before scaling across major healthcare networks.
“This is a pivotal milestone,” said Ziv Menshes, CEO of CardioVia. “ViaOne is a platform that opens the door to a new era of heart-surface therapies.”
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