US FDA clears Stroke2prevent’s A-View balloon catheter

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The US Food and Drug Administration (FDA) has cleared Stroke2prevent’s A-view device for commercialisation on the US market. The A-view is a balloon catheter designed for visualisation of the aortic arch by transoesophageal echocardiography (TEE).

The A-Views is intended to resolve the so-called “blind spit” of TEE, caused by interposition of the trachea. It is used to provide imaging of the entire aortic arch and, according to a press release, it has been demonstrated to detect atherosclerosis, to diagnose aortic diseases and to monitor vascular flow.

A-View is currently marketed in Europe, and the company is organising distribution and clinical support channels for the product’s US market release.