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Ev3's Pipeline

This article was originally published in The Gray Sheet

Executive Summary

FDA formally accepts ev3's PMA application for its Pipeline embolization device to treat "large, giant and wide-necked" cerebral aneurysms, the firm announces June 21. The PMA, submitted May 18, also has been granted expedited review by FDA, ev3 said. The agency grants expedited review - placing the PMA at the head of the pre-market review queue - if the device treats or diagnoses a life-threatening or irreversibly debilitating condition, and addresses an unmet medical need, according to FDA. "Safe and effective treatment of large and giant, wide-neck or non-saccular aneurysms remains a significant unmet clinical need," according to the company. Ev3 previously said it anticipates an FDA advisory panel review later this year and U.S. approval in 2011 (1"The Gray Sheet" May 24, 2010). Covidien will acquire ev3 for $2.6 billion under a June 1 agreement (2"The Gray Sheet" June 7, 2010)

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