New Version of Devices to Treat Clogged Neck Arteries Approved by U.S. Food and Drug Administration
Leader in Peripheral Vascular Disease Market to Conduct 10,000 Patient Study at 275 Clinical Sites Worldwide
SCOTTSDALE, Ariz., Feb. 15 (HSMN NewsFeed) -- The Cordis Endovascular Division of Cordis Corporation, today announced U.S. Food and Drug Administration (FDA) approval to market its PRECISEŽ RX Nitinol Self-Expanding Stent and ANGIOGUARDŽ RX Emboli Capture Guidewire System to treat clogged neck arteries. Approval of the Cordis carotid system was announced today at the Arizona Heart Institute's International Congress on Endovascular Interventions in Scottsdale, Arizona.
The PRECISEŽ RX Nitinol Self-Expanding Stent and ANGIOGUARDŽ RX Emboli Capture Guidewire System are different from Cordis' over-the-wire carotid system approved last year. The RX, or rapid exchange, version facilitates single operator use and more efficient manipulation of the catheter and guidewire during stenting procedures.
Cordis Endovascular also announced the initiation of SAPPHIRE Worldwide, a 10,000 patient global registry to assess the 30-day rate of major adverse events (death, stroke or myocardial infarction) following the placement of a stent in high surgical risk patients with carotid artery disease. The stent procedure includes use of an emboli distal protection system -- designed to contain and remove plaque or debris from the artery during the procedure. The registry will include up to 275 centers with low, medium and high annual carotid stent implant volumes, from both academic and private hospitals.
Anil Chhabra, MD, Willis Knighton Medical Center in Shreveport, LA performed the first carotid case with the PRECISEŽ RX Nitinol Self-Expanding Stent and ANGIOGUARDŽ RX Emboli Capture Guidewire System in the United States. Dr. Chhabra said, "It's great to get the same devices on the rapid exchange delivery system. The ANGIOGUARDŽ RX Emboli Capture Guidewire System was very easy to advance through a very tight lesion and the auto tapering of the PRECISEŽ RX Nitinol Self-Expanding Stent was apparent in the excellent wall apposition across the different sized internal and common carotid arteries."
Carotid arteries are the main blood vessels leading to the brain. The PRECISEŽ RX Nitinol Self-Expanding Stent and ANGIOGUARDŽ RX Emboli Capture Guidewire System 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 Cordis devices are 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.
"No other carotid artery stent and embolic protection system has been studied as extensively in as wide a range of high-risk patients as the PRECISEŽ RX Nitinol Self-Expanding Stent and ANGIOGUARDŽ RX Emboli Capture Guidewire System and we intend to continue building upon this important body of clinical evidence," said Dr. Dennis Donohoe, Vice President, Worldwide Clinical and Medical Affairs, Cordis Corporation.
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 minimally 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.
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