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FDA accepts ev3's PMA filing

This article was originally published in Clinica

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Executive Summary

The US FDA has accepted ev3's premarket approval (PMA) application for its Pipeline Embolization Device, intended for the treatment of large, giant and wide-necked cerebral aneurysms. The PMA application will receive expedited review and processing. The filing is supported by data from the 108-patient PUFS (Pipeline for Uncoilable or Failed AneurysmS) study. Plymouth, Minnesota-based ev3 estimates that the potential market for the device could reach $350m in 2013.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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