EMPiRE study to assess GORE Neuro Protection System

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Enrollment has begun in the EMPiRE (Embolic Protection with flow Reversal) clinical study, designed to demonstrate the safety and efficacy of the GORE Neuro Protection System (W L Gore & Associates) when used for embolic protection during carotid artery stenting procedures. The first patients were enrolled and successfully treated for narrowing of the carotid arteries at the University of Buffalo, NY. The patients all recovered from their procedure without incident, and have been discharged from the hospital.

The GORE Neuro Protection System was developed by Dr Juan Parodi and was formerly called the Parodi Anti-Emboli System (PAES). Gore purchased the system when the company acquired ArteriA Medical Science Inc. (ArteriA), in November 2004. Parodi commented, “Based on the prior experience of mechanical filters and distal balloon occlusion devices, we developed the technique of temporary blood flow reversal in the internal carotid artery. Using this technique, protection can start before interaction with the stenotic lesion, which can then be safely crossed with the physician’s preferred guidewire. This system is designed to be used in the patients with tortuous internal carotid arteries where filter devices cannot be used. Further, it is expected to facilitate retrieval of all the particles, irrespective of their size.”

The system consists of a guiding catheter with an elastomeric balloon that is inflated in the common carotid artery (CCA) proximal to the stenotic lesion being treated, and a hollow wire with an elastomeric balloon at its tip to occlude the external carotid artery (ECA). An outside connector with a filter creates an external arteriovenous (AV) fistula (by connecting sideport of the arterial and venous introducers). The system operates on the principle of reversing the flow of blood at the treatment site. Unlike available embolic protection devices, flow reversal enables physicians to perform carotid interventions with confidence knowing that liberated emboli will be safely directed away from the brain. Flow reversal is achieved at the treatment site by selectively occluding common carotid and external carotid artery blood flow. By establishing the shunt between the carotid artery and femoral vein, blood from the opposite side of the brain via the Circle of Willis and collateral vessels is redirected to the lower pressure venous return. Embolic particles are captured in a filter outside the body.

Dr L Nelson Hopkins of the University of Buffalo, national co-principal investigator for the EMPiRE study, said, “The GORE Neuro Protection System is an important advancement in protecting patients during carotid artery stenting procedures. The system eliminates the need for physicians to cross lesions unprotected and the associated risks of emboli going to the brain and causing a stroke. We believe it will allow us to treat a broader group of patients with greater confidence.”

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