Article preview from Medtech Insight - May 1, 2011
The neurointerventional device market is one of the most dynamic areas in the field of neurology. Over the next four years, US neurointerventional procedures are expected to grow at a rate of nearly 18% compounded annually, reaching more than 197,000 procedures by 2015.
Article preview from Medtech Insight - May 1, 2011
These impressive growth rates have spawned a number of recent deals in this space, which is shifting from a market controlled by small and mid-level competitors to one dominated by large, diversified device companies. Large device companies involved in recent acquisitions in this space include Covidien Ltd., Stryker Corp. and Johnson & Johnson (J&J).
One area that could see significant growth in the years ahead is CAS. But much of that growth will depend on recent efforts to expand covered indications to lower-risk patients in the US. CAS initially was approved by the US Food & Drug Administration (FDA) for use only in patients at high risk for surgery with at least a 50% stenosis if symptomatic or an 80% stenosis if asymptomatic. Last year, Abbott Laboratories Inc.,the leading CAS device competitor, requested expanded labeling to include
standard-risk patients, and in February of this year, an FDA advisory panel voted 7-3 in favor of extending indications to standard-risk patients with a stenosis of at least 50% if symptomatic and at least 70% if asymptomatic .Early in May, FDA followed the panel's advice and granted final approval for expanded use of Abbott's RX Acculink Carotid Stent System to include patients who are at standard surgical risk. As a condition of the expanded approval, Abbott will conduct a post-approval study, which will start later this year, to assess clinical outcomes in standard surgical risk patients, with follow-up at 30 days and annually for three years. The company also says it intends to seek expanded Medicare coverage for CAS from the US Centers for Medicare and Medicaid Services (CMS) now that it has FDA approval. According to Abbott, the new indication could have a "significant impact" on patient care, as more than 60% of US carotid artery disease patients fall into the standard-risk category.
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