MicroTherapeutics, Inc.
This article was originally published in The Gray Sheet
Executive Summary
Pivotal trial of the Onyx liquid embolic system for treatment of brain aneurysms is expected to include 15 sites and 138 patients following FDA go-ahead, announced March 28. The study will be the first randomized, direct comparison of Oynx against detachable coils, currently the only option available for aneurysm intervention, the firm says. The market potential for the device is estimated to exceed $800 mil. by 2006. A premarket approval application is anticipated in the second half of 2002, and approval in 2003