Healthcare Industry News:  nitinol stent 

Devices Interventional FDA

 News Release - September 26, 2006

U.S. Food and Drug Administration Approves New Medical Devices to Treat Clogged Neck Arteries

Approval of PRECISE(R) nitinol stent and ANGIOGUARD (R) Emboli Capture Guidewire Announced at Vascular Interventional Advances (VIVA) Meeting

LAS VEGAS, Sept. 26 (HSMN NewsFeed) -- Cordis Endovascular, a division of Cordis Corporation, today announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its PRECISEŽ nitinol stent and ANGIOGUARDŽ Emboli Capture Guidewire to treat clogged neck arteries, known as carotid artery disease. FDA approval of the Cordis carotid system was announced today at the Vascular Interventional Advances (VIVA) meeting in Las Vegas. Carotid arteries are the main blood vessels leading to the brain. PRECISEŽ and ANGIOGUARDŽ are approved to treat carotid artery disease in patients at high risk for adverse events from carotid endarterectomy (CEA) -- a surgical treatment for removing arterial plaque from the carotid artery.

The PRECISEŽ and ANGIOGUARDŽ is the only carotid system backed by a large, randomized clinical trial -- the landmark SAPPHIRE study -- to support the potential benefits of carotid artery stenting (CAS) in patients who are ineligible, or considered high-risk, for carotid endarterectomy. The Cordis carotid system has been studied in over 3,000 patients across both SAPPHIRE and the Carotid Artery Stent Education System Post-Marketing Study (CASES(TM)- PMS) and demonstrated low stroke rates in both.

"No other carotid artery stent and embolic protection system has been studied as extensively in as wide a range of high-risk patients as PRECISEŽ and ANGIOGUARDŽ," said Dr. Dennis Donohoe, Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "Robust clinical evidence from the randomized, multi-center SAPPHIRE trial demonstrates that our carotid system is proven to be a less invasive treatment option when compared to carotid endarterectomy."

Carotid Artery Disease

Carotid artery disease is the buildup of atherosclerotic plaque in the major neck vessels delivering blood to the brain, a major cause of stroke. CAS is a non-invasive, non-surgical procedure intended to improve blood flow to the brain while helping prevent debris from entering cerebral circulation, and an important alternative for patients who are ineligible for CEA. Risk factors for carotid artery disease include advanced age, family history of stroke, plaque buildup in other areas of the body, high blood pressure, and diabetes.

The American Heart Association estimates that 20 to 30 percent of strokes are associated with carotid artery disease, caused by particles of atherosclerotic plaque traveling into the vessels that supply the brain with oxygen and vital nutrients. Stroke affects an estimated 700,000 Americans each year, making it the nation's third leading cause of death, and a leading cause of serious, long-term disability.

Cordis Endovascular

Cordis Endovascular is a recognized leader in endovascular research and development and is committed to serving the cardiology, radiology and vascular surgery communities through the development of groundbreaking technologies for the treatment of peripheral vascular disease. It constantly seeks solutions to the human anatomy's most challenging problems, such as carotid artery disease, superficial femoral artery disease, venous thrombotic disease, lower extremity disease and aortic aneurysm.

Cordis Corporation

Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease.

Source: Cordis

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