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January 30, 2011

Multisociety Guidelines Issued on Management of Extracranial Carotid and Vertebral Artery Disease

January 31, 2011—New multisociety practice guidelines on the management of patients with extracranial carotid and vertebral artery disease have been issued that reinforce the safety and efficacy of carotid artery stenting (CAS) as an option for patients in need of revascularization. The guidelines are sponsored by 14 medical organizations involved in interventional and surgical treatment of these diseases.

The guidelines are currently available at the Web sites of the Journal of the American College of Cardiology, Circulation: Journal of the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI).

SCAI noted that support for broadened access to CAS continues to gain momentum after a recommendation on January 26 by the US Food and Drug Administration (FDA) Circulatory System Devices Advisory Panel to expand the availability of CAS to patients at standard risk for surgical complications. The CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) findings published last July by Thomas G. Brott, MD, et al in the New England Journal of Medicine offer the latest scientific evidence in support of CAS (2010;363:11–23).


According to SCAI, the new guidelines state that CAS is a safe and effective alternative option in symptomatic (transient ischemic attack or nondisabling stroke within 6 months) patients with > 50% blockages in their carotid arteries, and that CAS could be considered for asymptomatic patients with ≥ 60% blockages. The guidelines also recommend against widespread screening for blocked carotid arteries, stating that ultrasound should be used to detect the condition only in people with symptoms or other stroke risk factors.

These guidelines, in conjunction with the FDA Panel recommendation and CREST data, demonstrate mounting support for CAS across physician specialties. Further support for CAS is shown in the recently updated guidelines for secondary stroke prevention by the American Heart Association/American Stroke Association, which are consistent with the new guidelines in recommending CAS be considered in a broader population of patients than those currently covered by Medicare. 
SCAI stated that it hopes the recent developments will encourage the Centers for Medicare & Medicaid Services to widen its current “highly restrictive” coverage policy on CAS and allow patients and physicians to decide what is the best form of treatment for individuals.

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January 31, 2011

FDA Approves Boston Scientific's Renegade Hi-Flo Fathom Preloaded System

January 31, 2011

FDA Approves Boston Scientific's Renegade Hi-Flo Fathom Preloaded System


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