Initial Patients Enrolled in EMPiRE Study of GORE Neuro Protection System.

FLAGSTAFF, Ariz. -- W. L. Gore & Associates (Gore) announced today that site initiation and enrollment has begun in the EMPiRE (Embolic Protection with flow Reversal) Clinical Study. This investigational clinical study is designed to demonstrate the safety and efficacy of the GORE Neuro Protection System 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. The patients all recovered from their procedure without incident, and have been discharged from the hospital.

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."

The GORE Neuro Protection System is a unique embolic protection system developed by Juan Parodi, M.D. 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.

Nitin Salunke, Ph.D., product specialist for the GORE Neuro Protection System, stated, "The GORE Neuro Protection System is the first in a portfolio of products that will help treat and prevent strokes. Gore is very pleased to be able to work with the pre-eminent physicians in the field of stroke."

About W. L. Gore & Associates

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than three decades. During that time, more than 18 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, and sutures for use in vascular, cardiac and general surgery. Gore was recently named the fifth best company to work for by Fortune Magazine.

Products listed may not be available in all markets pending regulatory clearance. GORE is a trademark of W. L. Gore & Associates.