Abbott Statement Regarding CMS' Proposed Expansion of Coverage for Carotid Artery Stenting
ABBOTT PARK, Ill., February 06, 2007 /PRNewswire-FirstCall/ -- Abbott today expressed support for the proposed National Coverage Determination (NCD) put forth by the Centers for Medicare & Medicaid Services (CMS) to expand its coverage policy for carotid artery stenting (CAS). Under the proposed policy, certain Medicare patients who have a severe carotid blockage and have not yet experienced stroke or a transient ischemic attack (TIA) and are at risk for surgery would, for the first time, have access to carotid artery stenting, a new, innovative technology for patients at risk of stroke.
Previously, a subset of high surgical risk patients was covered by Medicare for carotid stenting, specifically those who had already experienced symptoms of TIA or stroke and whose blockages were severe. Carotid stenting is approved by the U.S. Food and Drug Administration (FDA) for high surgical risk patients, both for those who have experienced symptoms and for those who have not.
In March 2006, Abbott formally requested that CMS reopen its coverage decision. The proposed new coverage reflects the large accumulated body of evidence on stenting for high surgical risk patients, including data from four Abbott studies that were presented to CMS.
"Abbott is pleased that CMS is proposing expanded reimbursement coverage for the majority of FDA-approved patients with severe carotid artery disease who are at high risk for surgery and who do not exhibit symptoms of stroke," said John M. Capek, Ph.D., president, Abbott Vascular. "This proposal reflects the growing consensus in the medical community that carotid artery stenting is an important treatment option for these patients. Abbott is committed to working with the medical community, the FDA and CMS to gather additional evidence to support broader patient access to carotid stenting."
Stroke is the third leading cause of death in the United States and the leading cause of serious, long-term disability. Approximately 70 percent of all strokes occur in people 65 and older, and approximately one-fourth of all strokes are caused by carotid artery disease.
Abbott is the worldwide leader in carotid stenting and related clinical research, with nearly 10,000 high surgical risk patients participating in Abbott's studies. In addition, Abbott is sponsoring two randomized trials designed to understand the benefits of carotid stenting in a broader population of standard surgical risk patients.
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, effectiveness and ease of use in treating patients with vascular disease.
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 .
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Posted: February 2007