Medical Devices

U.S. FDA grants humanitarian use approval for balloon catheter.

Published in Medical Letter on the CDC and FDA, September 18th, 2005

Boston Scientific Corporation (BSX) announced that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) approval for the Wingspan Stent System with Gateway PTA Balloon Catheter.

The Wingspan Stent System is designed to treat atherosclerotic lesions or accumulated plaque in brain arteries. Designed for the brain's fragile vessels, the Wingspan Stent System is a self-expanding, nitinol stent sheathed in a delivery system that enables it to reach and to open narrowed arteries in the brain.

The Wingspan Stent System is currently the only device available in the U.S. for the treatment of intracranial...

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Source: Medical Letter on the CDC and FDA (2005-09-18)

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