FDA Clears Stroke2prevent's A-View Balloon Catheter for TEE
May 30, 2017—Stroke2prevent, a medical device company based in Zwolle, The Netherlands, announced that it has received US Food and Drug Administration 510(k) clearance for the company's A-View balloon catheter to visualize the aortic arch with transesophageal echocardiography (TEE).
The company stated that the A-View is designed to resolve a blind spot of TEE that is caused by the interposition of the trachea. The device provides imaging of the entire aortic arch to detect atherosclerosis, diagnose aortic diseases, and monitor vascular flow. The device is currently available in Europe and will be marketed in the United States, pending arrangements for distribution and clinical support.