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.


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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.