CardioVia Announces FDA Clearance for ViaOne, Opening a New Frontier in Minimally Invasive Heart-Surface Treatments

TEL AVIV, Israel, April 8, 2025 /PRNewswire/ — CardioVia, an innovative medical device company specializing in advanced cardiac care solutions, announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its ViaOne system. This breakthrough device is designed to enable safe and precise access to the heart’s surface (pericardial space) for both diagnostic and therapeutic interventions — without the use of 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 poised to establish a new standard for minimally invasive cardiac procedures, offering electrophysiologists and interventional cardiologists an advanced alternative to conventional catheter-based methods.

Recognized as a Breakthrough Medical Device by the FDA

Prior to this FDA clearance, ViaOne had already attracted significant attention, by receiving and 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 — a condition for which curative options remain limited today.

“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.

About CardioVia

CardioVia is a privately held medical device company headquartered in Tel Aviv, Israel, dedicated to developing next-generation solutions for cardiac care. CardioVia enables safe and effective access to the heart’s surface — an area with unique therapeutic potential and a promising alternative to traditional catheter-based procedures.

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For media inquiries, please contact:
Ziv Menshes
CEO, CardioVia
Email: ziv@cardiovia.com

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SOURCE CardioVia