CardioVia Wins FDA Nod for ViaOne Epicardial Access System

CardioVia, a company specializing in advanced cardiac care solutions, has obtained U.S. Food and Drug Administration (FDA) clearance for its ViaOne system.

ViaOne is a breakthrough device to allow safe, precise access to the pericardial space for diagnostic and therapeutic interventions without using an exposed needle. By removing the need for an uncontrolled sharp needle, ViaOne can mitigate the risk of heart perforation, a complication related to current percutaneous techniques.

The device received and took part in the FDA’s breakthrough device designation (BDD) program, which recognized ViaOne’s potential to provide more effective treatments for complex cardiac arrhythmias. The FDA clearance was supported by clinical evidence, including a recent study published in JACC: Clinical Electrophysiology that showed ViaOne’s safety profile and effectiveness.

“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.”

The company is preparing for the initial launch of ViaOne at leading U.S. cardiac centers. There are plans to integrate the technology into major healthcare networks and broaden its availability to a larger patient population.

“According to expert estimates, millions of people in the U.S. and the EU suffer from cardiac arrhythmias. A significant portion of them could benefit from innovative treatments delivered on the heart surface,” said Prof. David Luria, Director of Electrophysiology at Hadassah Medical Center, Jerusalem, Israel. “CardioVia’s device simplifies access to the heart surface, paving the way for a major shift in the field. It allows more physicians to perform these procedures with greater efficiency, while reducing the risk of complications that hold serious health and economic consequences.”