FDA clears new device for enabling access to the heart’s surface without an exposed needle
CardioVia, an Israeli MedTech company, has gained U.S. Food and Drug Administration (FDA) clearance for its ViaOne technology designed to help clinicians reach the surface of the heart without the use of an exposed needle.
ViaOne pulls the pericardium away from the heart so that a concealed, blunt-tip needle can provide access to the pericardial space. This is designed to help interventional cardiologists and electrophysiologists alike treat cardiac arrhythmias with a reduced risk of perforation or any other complications. Also, sensors track the device’s position to make managing it as straightforward as possible.
“This FDA clearance represents a pivotal milestone in our mission to redefine how cardiac interventions are performed,” Ziv Menshes, CEO of CardioVia, said in a statement. “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.”
"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,” added David Luria, MD, director or electrophysiology at Hadassah Medical Center in Jerusalem, Israel.
(A) Preparation of the channel for the ViaOne device entry using the tunneling tool inserted through the peel-away sheath under the guidance of fluoroscopy, with slow deliberate and guided direction toward the cardiac silhouette coaxial to the sternum. (B,C) Insertion of the ViaOne device from the operator’s perspective (B) and as seen in fluoroscopy. (D) When the leading channel of the ViaOne device is outside the sheath, the inner tube and engagement element are pushed outward. (E,F) visualization of pericardial sac capture with the engagement element (E) and needle puncture of the grasped tissue (F). (G) Guidewire (arrows) insertion into the pericardial sac. Of note, on D, the tip of the device is advanced much further into the chest compared with G. This is because of the technique of the epicardial access with the ViaOne device (see text and videos for explanation). On the right-hand panels, peel-away sheath (H) and tunneling tool (I) used during the procedure are presented. All fluoroscopic projections are presented in left lateral view. Images and captions courtesy of Derejko et al. and JACC: Clinical Electrophysiology.
Luria was a co-author on a 2022 analysis in JACC: Clinical Electrophysiology focused on the safety and efficacy of the ViaOne technology.[1] The group tested the system on a total of 11 patients.
“Epicardial access with a novel concealed-needle blunt-tip device appears to be feasible and safe in this early human experience,” the group wrote at the time, highlighting this technology’s potential value to clinicians.
CardioVia is now preparing an initial U.S. launch of this newly cleared technology.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.