Gore Acquires Next-Generation Embolic Protection Technology.

FLAGSTAFF, Ariz. -- W. L. Gore & Associates, Inc. (Gore), today announced that it has acquired substantially all of the assets of ArteriA Medical Science Inc. (ArteriA), a privately held San Francisco-based company and the manufacturer of the Parodi Anti-Emboli System(1) (PAES and PAES II) and other related devices. The PAES employs patented flow reversal technology for use during carotid revascularization to minimize the risk of stroke as a potential complication.

Together with Juan C. Parodi, MD, ArteriA developed the PAES for use during carotid angioplasty and stenting, minimally invasive alternatives to open surgery to reopen arteries delivering blood to the brain. The PAES temporarily reverses the direction of blood flow in the artery being treated to permit the capture and removal of small plaque particles released during the procedure (known as emboli) rather than allowing them to travel upstream in the direction of the patient's brain. If emboli reach the brain, they can cut off blood flow, potentially causing a stroke or even death.

With the addition of the PAES, Gore expands its product portfolio of endovascular/interventional products into neuro-interventional clinical applications.

The PAES consists of a guiding catheter with an elastomeric balloon that is inflated in the common carotid artery (CCA) below (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). During active flow reversal, embolization to the brain can be avoided.

Doctor Juan C. Parodi states, "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. Between 24 and 49% of the treated carotid stenoses have thrombus lining them as demonstrated in recent publications in the Journal of Vascular Surgery." He continues, "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."

Gore Product Specialist, Nitin Salunke, PhD, indicates that the PAES may allow physicians to treat patients with carotid artery disease who previously were unsuitable for endovascular therapy. He said, "The PAES is expected to be the first device to provide total embolic protection during percutaneous intervention. Unlike traditional procedures in which the filter placement step is conducted without protection, the PAES provides embolic protection throughout the endovascular procedure--minimizing possible clinical complications."

Nitin added, "Gore believes this exciting flow reversal technology will be the new benchmark for cerebral protection, and paired with our innovative endovascular products, will allow us to offer a total solution for stroke therapy."

(1) The PAES is commercially available to physicians in Europe and elsewhere outside the United States. It is an investigational device in the United States, limited by U.S. law to investigational use only. A U.S. clinical study under a Food & Drug Administration (FDA) IDE is currently in progress.

ABOUT W. L. GORE & ASSOCIATES, INC.

Gore is a leading manufacturer of thousands of advanced technology products for the electronics, industrial, fabrics and medical markets. The Gore Medical Products Division provides creative healing solutions to complex medical problems. Gore Medical provides such products as synthetic vascular grafts, interventional devices, surgical meshes for hernia repair, and sutures for use in vascular, cardiac, general surgery and orthopedic procedures. With more than 10 million implants, these devices have been saving and improving the quality of lives worldwide for nearly 30 years.

GORE is a trademark of W. L. Gore & Associates.

Arteria and PAES are trademarks of ArteriA Medical Sciences, Inc.