Stroke2prevent announced that it has received FDA 510(k) approval for A-View® a unique medical device, used in cardiac interventions. A-View® balloon catheter visualizes the aortic arch with Transesophageal Echocardiography (TEE). “Receiving US FDA 510(k) clearance for A-View® is a major milestone to make this technology available to clinicians and contribute to improved outcomes for cardiac patients” said Maarten Nibbelke, CEO of Stroke2prevent.
Stroke2prevent & A-View
Stroke2prevent B.V. develops, manufactures and distributes medical devices. Our product A-View® is used to resolve the so called ‘blind-spot’ caused by interposition of the trachea in Transoesophageal Echocardiography (TEE). A-View® provides images of the images of the entire thoracic aortic arch allowing detection of atherosclerosis, diagnosing aortic diseases and to permits monitoring of vascular flow. The additional information obtained by A-View® supports physicians to ensure the best patient outcomes.