The FDA Neurological Devices Advisory Panel has voted to recommend approval for Covidien’s Pipeline Embolization Device, 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 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.
At its meeting on 18 March 2011, the FDA Advisory Panel discussed the premarket approval application for Pipeline. Following its review of the premarket approval data, the Panel voted unanimously to recommend approval. Although the FDA is not required to follow Panel recommendations, it often does.
The Pipeline’s premarket approval 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.
“Safe and effective treatment of large and giant, wide-neck or non-saccular aneurysms remains a significant unmet clinical need,” said Aaron Berez, general manager, Neurovascular, Covidien. “Clinical experience suggests that the Pipeline embolization device may represent a valuable alternative to current endovascular or surgical treatment options for these types of aneurysms.”
“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,” said Joe Woody, president, Vascular Therapies, Covidien. “We believe strongly that the premarket approval application data that was submitted from the PUFS clinical study supports the safety and efficacy of this device.”
The Pipeline Embolization Device has received CE mark approval and has been sold outside the United States since July 2009.