CardioVia announced today that it received FDA clearance for its minimally invasive ViaOne epicardial access system.
The company designed its device to enable safe, precise access to the heart’s surface (pericardial space). It serves both diagnostic and therapeutic interventions without the use of an exposed needle. Eliminating the need for an uncontrolled sharp needle mitigates the risk of heart perforation, according to a news release.
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CardioVia designed its system to provide controlled access to the heart’s outer surface, while avoiding the risk of puncturing heart muscle or surrounding structures. The system integrates a concealed, blunt-tip needle with a unique geometric structure. It leverages the natural differences between pericardial tissue and heart muscle.
According to the company’s website, integrated sensors continuously monitor the device’s position, too. This supports safe navigation into the pericardial space.
CardioVia says ViaOne sits poised to establish a new standard for minimally invasive cardiac procedures. It could offer electrophysiologists and interventional cardiologists an advanced alternative to conventional, catheter-based methods.
ViaOne already had FDA breakthrough device designation. The company earned the clearance based off of a clinical study, recently published in JACC: Clinical Electrophysiology, demonstrating safety and effectiveness.
CardioVia plans to initially launch ViaOne across leading cardiac centers in the U.S. It aims to integrate the technology into major healthcare networks and expand availability to a broader patient population.
“This FDA clearance represents a pivotal milestone in our mission to redefine how cardiac interventions are performed,” said Ziv Menshes, CEO of CardioVia. “ViaOne is not just a product — it’s a platform that opens the door to a new era of heart-surface therapies, improving safety and outcomes for patients worldwide.”
