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NEW YORK, Mar 21 (Reuters Health) - The Health Care Financing Administration (HCFA) announced on Tuesday that Medicare would, under certain conditions, cover a new procedure for unblocking the artery that supplies blood to the head, for preventing strokes.
Medicare's decision provides an alternative to carotid endarterectomy, where surgeons open the carotid artery in the neck and manually remove accumulated plaque. Studies show endarterectomy poses a small but measurable risk of causing death.
The new procedure, angioplasty, involves inflating a balloon-like device in the narrowed section of the carotid artery. A small, mesh-like device, called a stent, is then placed in the vessel to prevent it from closing.
HCFA's decision allows payment for angioplasty of the carotid artery with stent in clinical trials that receive a Category B investigational device exemption designation from the US Food and Drug Administration.
"This is a promising new technology that may eventually be proven to prevent stroke in certain high-risk patients who would not be amenable to surgical removal of plaque from an obstructed carotid artery," noted Dr. Jeffrey Kang, director of HCFA's Office of Clinical Standards and Quality, and the agency's chief clinical officer.
"What we learn from this coverage decision also will help us consider this therapy as an alternative for other patients at risk for stroke," he said.
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