Prof. David Luria (left), Director of Electrophysiology at Hadassah Medical Center, and Ziv Menshes (right), CEO of CardioVia
April 7, 2025 — CardioVia, a medical device company specializing in advanced cardiac care solutions, has received U.S. Food and Drug Administration (FDA) clearance for its ViaOne system. This device is designed to enable safe and precise access to the heart’s surface (pericardial space) for both diagnostic and therapeutic interventions — without using an exposed needle. By eliminating the need for an uncontrolled sharp needle, ViaOne mitigates the risk of heart perforation, a well-recognized complication associated with current percutaneous techniques.
ViaOne is a minimally invasive cardiac procedure that offers an alternative to conventional catheter-based methods.
FDA Breakthrough Medical Device Designation
Prior to this FDA clearance, ViaOne had already received and was taking part in the FDA’s prestigious Breakthrough Device Designation (BDD) program, recognizing its potential to deliver more effective treatments for patients with complex cardiac arrhythmias.
"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."
"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."
The FDA clearance is supported by compelling clinical evidence, including a recent study published in a leading medical journal — JACC: Clinical Electrophysiology, demonstrating ViaOne’s safety profile and effectiveness.
CardioVia is now preparing for the initial commercial launch of ViaOne at leading cardiac centers across the United States, with plans to integrate the technology into major healthcare networks and expand its availability to a broader patient population.
For more information, visit www.cardiovia.com
December 01, 2025 
