This article was originally published in The Gray Sheet
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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Covidien says its large international operations will further accelerate ev3's fast-growing neurovascular and peripheral vascular businesses following its planned $2.6 billion acquisition of the endovascular firm
Ev3's Pipeline: Firm completes modular PMA application for its Pipeline embolization device to treat uncoilable or failed aneurysms, announced May 18. Ev3 says it anticipates an FDA advisory panel review of the endovascular treatment "sometime later in the year" and U.S. approval in 2011. Ev3 acquired the self-expanding cylindrical mesh implant through its purchase of Chestnut Medical Technologies in 2009 (1"The Gray Sheet" June 8, 2009)
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