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April 5, 2011
FDA Approves Covidien's Pipeline Embolization Device
April 6, 2011—Covidien (Mansfield, MA) announced that it has received premarket approval (PMA) from the US Food and Drug Administration for the Pipeline embolization device, which is intended for the endovascular treatment of adults (≥ 22 years of age) with large or giant wide-necked intracranial aneurysms of the internal carotid artery from the petrous to the superior hypophyseal segments.
According to Covidien, the Pipeline's PMA application was based on the results of the PUFS (Pipeline for Uncoilable or Failed Aneurysms) clinical study that included safety and efficacy data on 108 patients. PUFS is a single-arm study of large and giant wide-necked or fusiform aneurysms that are not typically coilable, with 6-month safety and effectiveness endpoints.
The company stated that Pipeline is a new class of embolization device that is designed to divert blood flow away from the aneurysm to provide complete and durable aneurysm embolization while maintaining patency of the parent vessel. The Pipeline embolization device has received CE Mark approval in Europe and has been sold outside the United States since July 2009. The Pipeline will be available at existing clinical sites in the United States beginning in the second quarter of this year.
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