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Guidant Receives First U.S. Approval for New Therapy Designed to Reduce Risk of Stroke
New Carotid Stent System Offers Minimally Invasive Alternative to Open Surgery Indianapolis, Ind. and Santa Clara, Calif. — August 31, 2004 — Guidant Corporation (NYSE: GDT) today announced U.S. Food and Drug Administration (FDA) approval of a new carotid stent system designed to reduce the risk of stroke associated with carotid artery disease. The RX ACCULINK™ Carotid Stent System and RX ACCUNET™ Embolic Protection System will provide a minimally invasive treatment alternative to conventional open carotid artery surgery to patients who are at high surgical risk. Guidant’s carotid stent and embolic protection system are the first to receive FDA clearance. “Guidant is committed to reducing the risk of stroke, which has serious health and economic consequences for the 700,000 Americans who suffer a stroke each year,” said Beverly Huss, president, Endovascular Solutions, Guidant Corporation. “Stenting is an established therapy that has been used successfully for years to treat heart and peripheral vascular disease. The approval of a carotid stent represents a minimally invasive breakthrough therapy for patients at risk of stroke who are ineligible or at high risk for traditional surgery.” Carotid artery disease involves the buildup of plaque in one or both carotid arteries in the neck. The carotid arteries supply vital oxygen and glucose-rich blood to the parts of the brain where thinking, speech, personality, and sensory and motor functions reside. The traditional surgical treatment for carotid artery disease usually entails general anesthesia and involves an incision in the patient's neck and artery to remove plaque from inside the vessel wall. In contrast, during a carotid stenting procedure, the embolic protection system is positioned and a stent is deployed using a catheter inserted into a small puncture in the patient's groin. The patient usually remains conscious while the stent is implanted at the site of the blockage. The embolic protection system is designed to capture and remove particles of plaque that might be dislodged during the procedure, which could potentially lead to stroke and other complications. High-risk patients indicated for carotid stenting with Guidant’s devices include those with significant heart, kidney or lung disease, recurrence of a blockage following a prior carotid surgery, or with difficult-to-access neck anatomy. Guidant is pioneering the use of virtual reality simulators in its physician training program for the RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System. This innovative technology will be available at training centers nationwide this fall. The simulator displays images of the body’s circulatory system, allowing physicians to learn as the virtual reality implantation procedure is performed. Clinical trials of Guidant’s carotid stent and embolic protection system showed the therapy to be safe and effective. The risk of combined complications of death, stroke and heart attack at 30 days and/or any stroke in the area of the blockage at one year was about 10 percent for high-risk patients, compared to approximately 15 percent for complications seen in the literature from high-risk patients undergoing surgery. In addition, results for patients followed beyond one year demonstrated continued effectiveness of the stent procedure, with a low rate of repeat procedures due to re-narrowing. “Results from the clinical trials of the ACCULINK Stent demonstrated that high surgical-risk patients benefited from being treated with carotid artery stenting, and Guidant’s rapid-exchange technology gives physicians an easy-to-use platform for treating these patients,” said William Gray, M.D., director of Endovascular Care at the Swedish Medical Center in Seattle, Wash., and an Executive Committee member overseeing the clinical trials that gathered data used for FDA approval of the devices. Rapid-Exchange Technology Preferred By Most Doctors Performing Carotid Procedures Guidant’s RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System are available on rapid-exchange platforms. Rapid-exchange systems, which can be used by a single operator, are designed to offer improved device control and easier device exchanges in comparison with standard over-the-wire catheter systems. Most doctors performing carotid artery stenting procedures in Europe and the United States prefer to use rapid-exchange platforms. About Carotid Artery Disease and Stroke Stroke is the third leading cause of death in the United States and the number one cause of disability in adults, according to the American Heart Association. Approximately 25 percent of strokes are caused by carotid artery disease. Clogged carotid arteries can cause ischemic stroke, the most common type. An ischemic stroke can occur when carotid arteries become narrowed and when small particles of atherosclerotic plaque become dislodged from the diseased artery wall. This embolic material can travel through the bloodstream and block vessels in the brain. More than 700,000 Americans will have new (500,000) or recurrent (200,000) strokes each year, and 280,000 will die. The lifetime cost of stroke exceeds $90,000 per patient in the United States. For more information, please visit www.guidant.com/carotidmediakit. Source: Guidant CorporationContact: |
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