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ev3 humanitarian device

This article was originally published in The Gray Sheet

Executive Summary

FDA grants ev3 a humanitarian device exemption April 16 for its Onyx HD 500 liquid embolic system to treat wide-necked brain aneurysms. Launch to a small group of neurovascular specialists will follow a lengthy training period. The device is more viscous than ev3's Onyx 18 and 34 products, approved via PMA in 2005 for pre-surgical treatment of brain arteriovenous malformations (1"The Gray Sheet" July 25, 2005, In Brief). The HDE, which allows for treatment of up to 4,000 patients each year, was based on U.S. and European studies of more than 200 patients that would be less effectively treated with embolic coils...

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