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

Covidien

, 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. 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 <.0001) without the use of an alternative treatment. Importantly, the occlusion rate in these patients also improved over time, reaching 86.8% complete occlusion at one-year follow-up. These occlusion rates are significant, especially for this challenging patient population. Investigators compared the Pipeline device to historical controls because no other blood flow diverting devices are available in the U.S. Effectiveness of stents has not been proven to FDA standards; and outcomes for surgical or other endovascular treatments have been suboptimal. Investigators measured safety of the device by the number of patients who suffered an ipsilateral stroke or neurologic death in the 180 days following the procedure. In the study, six of 107 (5.6%) patients (p-value <.0001) suffered one of these events, significantly less than the predefined safety threshold of 20%. The 20% threshold was based on a literature review of adverse events rates associated with other current procedures and therapies.