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Two Abbott Studies Reaffirm Carotid Artery Stenting As A Safe And Effective Treatment To Reduce Risk Of Stroke
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Two Abbott Studies Reaffirm Carotid Artery Stenting As A Safe And Effective Treatment To Reduce Risk Of Stroke
"Two Abbott Studies Reaffirm Carotid Artery Stenting As A Safe And Effective Treatment To Reduce Risk Of Stroke"

"Positive 30-day results from two Abbott studies confirm that carotid stenting can be performed with positive results by physicians with a variety of background experience in real-world (non-clinical trial) settings in patients who are not favorable candidates for surgery. Interim results from the first 1,500 patients enrolled in EXACT (Emboshield and Xact Post Approval Carotid Stent Trial) and from the first 600 patients enrolled in CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) were presented today by William A. Gray, M.D., FACC, of Columbia University Medical Center in New York, in a late-breaking clinical trial session at the 56th Annual American College of Cardiology Scientific Session in New Orleans."

" "The results from these two studies reaffirm that carotid stenting is a safe, effective minimally invasive treatment option for patients with carotid artery disease who may be at risk of experiencing adverse events from surgery," said Dr. Gray. "The results also suggest that patient outcomes are improving over time as the practice of carotid stenting increases.""

" The primary endpoint of death, stroke and heart attack at 30 days was 4.6 percent in EXACT and 5.2 percent in CAPTURE 2. Further, results from EXACT and CAPTURE 2 demonstrated a low rate of 30-day major stroke and/or death in patients treated with Abbott's carotid stent systems (1.8 percent in EXACT, 1.3 percent in CAPTURE 2). The EXACT post-approval study utilizes Abbott's Xact(R) Rapid Exchange Carotid Stent System and Emboshield BareWire(TM) Rapid Exchange Embolic Protection System. CAPTURE 2 utilizes the company's ACCULINK(TM) Carotid Stent System and ACCUNET(TM) Embolic Protection System."

" "The results of our most recent post market studies are very encouraging, and suggest continued progress in improving carotid stenting outcomes," said Chuck Foltz, vice president, Abbott Vascular. "We are proud of our leadership in carotid stenting trials, with more than 10,000 patients enrolled in Abbott trials in the United States. These studies demonstrate that carotid stenting is making a difference in the lives of patients.""

" Abbott's next-generation Emboshield PRO(TM) Embolic Protection System, currently available in Europe, is under safety and effectiveness evaluation in PROTECT, a new U.S. clinical trial which recently began enrolling patients. The study will include 320 high surgical risk patients at 50 U.S. clinical sites. Patients will be evaluated at 30 days following stent placement to gather safety and efficacy data to support a 510(k) application to the U.S. Food and Drug Administration (FDA) for Emboshield PRO."

" 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 in the neck can cause ischemic stroke, the most common type. More than 700,000 Americans will have new (500,000) or recurrent (200,000) strokes each year, and more than 150,000 will die."

" Carotid artery stenting is a minimally invasive treatment option for patients who require intervention and who are at high risk for complications from carotid endarterectomy, an invasive surgical procedure. Carotid artery stenting is performed by delivering a stent on a catheter through the femoral artery in the groin. The catheter is maneuvered
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