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Micro Therapeutics

This article was originally published in The Gray Sheet

Executive Summary

Withdraws its 510(k) submission for its Embolyx liquid embolic system for the treatment of arteriovenous malformations (AVMs) and head and neck tumors. The San Clemente, California-based firm, which says it is in discussions with FDA regarding a study design, intends to submit an IDE for further clinical evaluations. Additional studies related to aneurysms and peripheral vascular applications are expected. More than 40 AVM treatment procedures have been performed to date at sites in Los Angeles, Mexico City and Buenos Aires. An additional 10-patient trial to evaluate Embolyx in the pre-operative treatment of hypervascular tumors was recently initiated at UCLA Medical Center
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