Covidien today announced that it received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the Pipeline Embolization Device.
The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
Pipeline is a new class of embolization device designed to divert blood flow away from the aneurysm in order to provide a complete and durable aneurysm embolization while maintaining patency of the parent vessel.
"The Pipeline Embolization Device is a breakthrough and life-saving endovascular treatment for large or giant wide-neck brain aneurysms." said Joe Woody, President, Vascular Therapies, Covidien.
The Pipeline Embolization Device PMA application was based on the results of the PUFS (Pipeline for Uncoilable or Failed Aneurysms) clinical study, a single-arm study of large and giant, wide-neck or fusiform aneurysms that included safety and efficacy data on 108 patients.
The Pipeline Embolization Device has received CE Mark approval in Europe and has been sold outside the United States since July 2009. The Pipeline device will be available at the existing clinical sites in the U.S. beginning this quarter.
