ABBOTT PARK, Ill., March 26 /PRNewswire-FirstCall/ -- 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.”
New Study Evaluates Next-Generation Embolic Protection Device
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.
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 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.
About Carotid Stenting
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 through the patient’s vasculature to the carotid artery. The stent, which is designed to prevent arterial plaque and debris from breaking off and blocking blood flow to the brain, is then expanded at the site of the blockage. The embolic protection filter captures and removes any debris that has become dislodged during the carotid stenting procedure.
Currently, carotid artery stenting in the United States is approved by the FDA for treating patients who are at high risk for experiencing adverse events from surgery. Abbott’s carotid stenting devices are also being investigated in a much broader group of patients who are not at high risk for surgery through two randomized clinical trials, CREST and ACT I, which compare stenting to surgery. Results from CREST and ACT I are expected to become available within three years.
Clinical evidence from Abbott’s studies supported Abbott’s request to the Centers for Medicare and Medicaid Services (CMS) to reconsider its carotid stenting coverage policy. As a result, CMS last month proposed expanding carotid stenting coverage, whereby certain high surgical risk Medicare patients who have a severe carotid blockage and have not yet experienced stroke or a transient ischemic attack would, for the first time, have access to carotid artery stenting.
To date, more than 60,000 patients worldwide have undergone carotid stenting with Abbott’s carotid stent systems.
For images of Abbott’s carotid stent and embolic protection systems and other information, please visit the company’s online ACC newsroom at http://www.abbottvascular.com/ACCpresskit .
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world’s leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety and effectiveness in treating patients with vascular disease.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott’s news releases and other information are available on the company’s Web site at http://www.abbott.com .
Abbott
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