Covidien Announces Publication of Final Results of Pipeline?Embolization Device Pivotal Study

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that the final results of the PUFs (Pipeline for Uncoilable or Failed Aneurysms) clinical study of its Pipeline™ embolization device have been published in the June issue of Radiology.1 Radiology is the official peer-reviewed medical journal of the Radiological Society of North America.

Covidien´s Pipeline is an 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. (Photo: Business Wire)

The Pipeline device met the trial’s primary endpoints for both effectiveness and safety. Based on these data, the Pipeline device was approved by the U.S. Food and Drug Administration (FDA) on April 6, 2011.

“Patients with an unruptured large or giant wide-necked aneurysm in the internal carotid artery are at significant risk of death or a highly disabling stroke and other significant neurologic complications if the aneurysm bursts or pushes on surrounding nervous tissues,” said principal investigator Tibor Becske, MD, assistant professor, Departments of Radiology, Division of Neuro Interventional Radiology and Neurology at NYU Langone Medical Center in New York. “This study of highly complex aneurysms confirms that, for certain patients, there is a safe and effective minimally invasive procedure to address the underlying pathology of the aneurysm – allowing the vessel to heal over time.”

A brain aneurysm is a weak, bulging area on the wall of an artery in the brain. Over time, the blood flow and pressure within the artery gradually weaken the arterial wall, which can result in a rupture and the release of blood into the space around the brain.

“The Pipeline device offers hope for those patients who have had poor alternatives for treating this often debilitating and sometimes fatal medical condition,” said Christine Buckley, Executive Director of the Brain Aneurysm Foundation. “We’re pleased that Covidien dedicated itself to generating clinical evidence supporting new innovative devices that have helped many patients in our community overcome an incredibly frightening and serious diagnosis so they can go on to live normal lives.”

Traditional endovascular methods of treating these aneurysms have included a reconstructive approach of filling the aneurysm sac with an embolic material (usually detachable coils), or parent artery occlusion, where doctors attempt to close off the affected artery. However, neither of these approaches addresses the underlying pathology of the aneurysm.2 3 4 5

Overall, 108 patients were enrolled into the study. Of the 106 evaluable aneurysms that were treated with one or more Pipeline devices, 73.6% completely closed (p-value