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CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

US Commercial Launch On Horizon

 
• By Natasha Barrow

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.

Cardiology
(Shutterstock)

Israel-based startup CardioVia has secured US Food and Drug Administration clearance for its breakthrough device, ViaOne. This concealed blunt-tip needle can be used to access the heart’s pericardial space to treat cardiac arrhythmias.

Unlike conventional methods, the device does not use a sharp needle, which causes complications such as heart perforation in up to 30% of cases. Access with a sharp needle requires...

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