Covidien has received the US Food and Drug Administration (FDA) Neurological Devices Advisory Panel vote to recommend approval for Pipeline Embolization Device.
Covidien Pipeline Embolization Device is intended for the endovascular treatment of large or giant wide-necked intracranial aneurysms in the cavernous and paraclinoid regions of the internal carotid artery.
Pipeline Embolization Device is a new class of embolization device designed to divert blood flow away from the aneurysm to provide a complete and durable aneurysm embolization while maintaining patency of the parent vessel.
The Pipeline Embolization Device PMA application is 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-neck or fusiform aneurysms typically not coilable, with six-month safety and effectiveness endpoints.
Covidien Vascular Therapies president Joe Woody said the Pipeline Embolization Device represents a breakthrough endovascular treatment for large, giant and wide-neck aneurysms that are very difficult or impossible to treat with existing therapies such as surgery or coiling.
"We believe strongly that the PMA data that was submitted from the PUFS clinical study supports the safety and efficacy of this device," Woody said.