FDA approves Covidien's PMA application for Pipeline Embolization Device

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that it received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the Pipeline® Embolization Device, 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.

A cerebral aneurysm is a weak spot in the wall of a blood vessel within the brain, characterized by an abnormal "ballooning" or widening of the vessel. A brain aneurysm ruptures every 18 minutes and 40% of these cases are fatal. Of those who survive, about 66% suffer some permanent neurological deficit.¹

"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. "Pipeline now offers hope for those patients who have had no other options for treating this often debilitating and even fatal medical condition."

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.

"Brain aneurysms are a silent killer because most show no symptoms over time," said Christine Buckley, Executive Director, The Brain Aneurysm Foundation. "The Pipeline Embolization Device now provides patients with a safe and effective treatment of large or giant, wide-neck aneurysms, which remained an unmet clinical need until now."

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.