FDA Approves Abbott’s Carotid Stent
Abbott Vascular Devices (Redwood City, CA) received FDA approval earlier this month for its Xact carotid stent and Emboshield embolic protection system. The device is intended to treat carotid artery disease, which results in an estimated 700,000 strokes and 280,000 deaths in the United States annually.
Carotid stents are a less-invasive alternative to the surgical procedure known as carotid endarterectomy. Carotid stents are used to prevent strokes by unclogging arteries in the neck that can become partially blocked with a buildup of fatty plaque and debris, a condition known as atherosclerosis. The Xact system, similar to other products on the market or in development, consists of two devices: the carotid stent and a mesh filter system designed to capture any emboli or debris material that may become dislodged during the stenting procedure. Abbott’s Xact stent and Emboshield embolic protection system were developed in cooperation with Mednova Ltd. (Galway, Ireland) and received the CE Mark for European distribution at the end of 2003.
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Illustration of Abbott’s Xact stent and Emboshield embolic protection system. |
Robert B. Hance, president of Abbott Vascular, a division of Abbott (Abbott Park, IL), hailed the launch of the carotid stent system as “further evidence of the innovative line of vascular products Abbott has built that is gaining momentum in the interventional community.” He added, “We are delighted to see the benefits of clinical and scientific advancement at Abbott result in an important new treatment for patients at risk of stroke.”
Although Abbott is generally recognized more for its pharmaceuticals than for its medical devices, the company has recently begun to focus increased attention on the development of advanced medical products. The company’s interest in the stent market gained speed in June 2003, when Abbott acquired the coronary and peripheral intervention product lines of Netherlands-based Jomed for $65 million.
Abbott is the second medtech company to market a carotid stent in the United States. Guidant Corp. (Indianapolis) received the go-ahead from FDA for its Rx Acculink carotid stent and Rx Accunet embolic protection system at the end of August 2004. Other players in the carotid stent market include Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company; EndoTex Interventional Systems Inc. (Cupertino, CA); and Medtronic Corp. (Minneapolis).
Cordis received a positive recommendation for its carotid stent from FDA’s circulatory devices panel, but full agency approval was held up due to concerns about manufacturing issues. Those problems have since been resolved, Cordis has been informed that its product is approvable, and the company expects to have its carotid stent on the U.S. market by early 2006. EndoTex, which will likely be acquired by equity partner Boston Scientific Corp. (Natick, MA), has received CE marking of its NexStent for distribution in Europe. Medtronic is developing the Exponent carotid stent and filter system, which is currently undergoing clinical trials.
Analysts believe that Abbott is well positioned to capture about 25% of the carotid stent market. But that share could increase, particularly if the Federal Trade Commission (Washington, DC) requires Johnson & Johnson Inc. (New Brunswick, NJ) to divest either the Guidant or Cordis carotid stent line as a condition of approval for J&J’s pending $25.4 billion acquisition of Guidant.
Carotid stents and filter system kits cost about $3000 each. Industry analysts estimate that sales of carotid stents will reach $100 million in 2006—and will likely generate annual revenue of $1 billion before the end of the decade.
It’s becoming a crowded sector, but growth of the carotid stent market will be greatly influenced by the coverage policies and payment rates adopted by third-party payers. Private insurers typically follow the reimbursement decisions of the Centers for Medicare and Medicaid Services (CMS; Baltimore), which reimburses about $8000 per carotid stenting procedure—roughly the equivalent cost of traditional surgery. However, CMS currently only approves carotid stenting for high-risk patients with actual symptoms of carotid artery disease. Clinicians and device manufacturers are seeking to have coverage expanded.
Canon Communications LLC
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