Pipeline™ Embolization Device
Think Uutside the Sac
With over 800 patients treated worldwide, the Pipeline device is establishing a new standard of care for patients who suffer aneurysms. The Pipeline technology is a new class of embolization device that is 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. Early experience suggests that the Pipeline Embolization Device may benefit the large number of patients suffering from large and giant, wide-neck or non-saccular brain aneurysms that currently are not well treated with either surgical or endovascular techniques and address a potential market opportunity of approximately $350 million in 2013.
The Pipeline Embolization Device has the CE Mark and is available outside the U.S. We have finished enrolling patients in our PUFS (Pipeline for Uncoilable or Failed Aneurysms) U.S. IDE study and anticipate U.S. approval in 2011. A second U.S. IDE study, COCOA (Complete Occlusion of Coilable Aneurysms), is currently enrolling patients to compare Pipeline to coils in treating smaller aneurysms.
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. It is estimated that up to one in 15 people in the United States will develop a cerebral aneurysm during their lifetime. Left untreated, cerebral aneurysms can rupture and cause stroke or death.
The Pipeline Embolization Device is intended for endovascular embolization of aneurysms.
The Pipeline Embolization Device is for investigational use only in the United States.
Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.
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