Next Generation New Devices to Treat Clogged Neck Arteries Launched in U.S. and Europe
Washington, D.C.– Cordis Corporation today announced the U.S. and European launch of Cordis’ next generation carotid stent system, the PRECISE® PRO RX™ Nitinol Self-Expanding Stent, to treat clogged neck arteries. The worldwide launch of the Cordis carotid system was announced today at the Transcatheter Cardiovascular Therapeutics 2007 meeting (TCT 2007).
The PRECISE® PRO RX™ Stent provides physicians with a broader range of treatment options for patients with carotid artery disease. It is the lowest profile system approved in the U.S. and among the lowest available in Europe. The PRECISE® Stent is a small, wire-mesh tube that props open the blocked artery and may be used in conjunction with Cordis’ ANGIOGUARD® Rx Emboli Capture Guidewire System – a tiny, basket-like device designed to trap particles of plaque, blood clot, or other material that may be dislodged in the carotid artery during stent placement.
James Joye, DO, FACC, Director of Research and Education, The Heart & Vascular Institute, El Camino Hospital, Mountain View, CA said, “The PRECISE® PRO RX™ provides interventionalists with a lower profile carotid stent system that makes it easier to use and enables improved crossing of the lesion. The new delivery system enables more efficient manipulation of the catheter and guidewire during stenting procedures, and better crossability especially in challenging lesions. This new carotid stent system is a significant enhancement – which is important for physicians and patients.” Dr. Joye successfully treated the first patient with the PRECISE® PRO RX™ Stent in the U.S.
Carotid arteries are the main blood vessels leading to the brain. The PRECISE® PRO RX™ Stent System is FDA and CE Mark 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 PRECISE® Stent 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 PRECISE® Stent has been studied extensively in a wide range of high-risk patients and we intend to continue building upon this important body of clinical evidence,” said Dr. Dennis Donohoe, Vice President, Worldwide Clinical 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 or at high-risk 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. According to the World Health Organization, annually 15 million people worldwide suffer a stroke. Of these, five million die and another five million are left permanently disabled1.
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