Published online before print January 6, 2005, doi: 10.1161/01.STR.0000153057.07181.94
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(Stroke. 2005;36:398.)
© 2005 American Heart Association, Inc.
Emerging Therapies |
Devices, Drugs, and the Food and Drug Administration
Increasing Implications for Ischemic Stroke
From the Department of Neurology (M.F.), University of Massachusetts Medical School, Worcester, Mass; and the Head Section of Stroke and Neurocritical Care (A.J.F.), Department of Neurology, Cleveland Clinic, Cleveland, Ohio.
Correspondence to Dr Marc Fisher, Department of Neurology, University of Massachusetts Medical School, 19 Belmont St, Worcester, MA 01605-2982. E-mail fisherm@ummhc.org
Section Editors:: Marc Fisher MD Antoni Dávalos MD
Key Words: acute care • stroke, ischemic
An extract of the first 250 words of the full text is provided, because this article has no abstract. |
The approval process at the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has been of little interest previously to stroke neurologists, but an increasing number of devices are being approved for stroke prevention (carotid stents, patent foramen ovale closure) and now also for acute ischemic stroke intervention. Felten et al provide a review of the CDRH approval process and give their perspective concerning the recent approval of the Concentric Merci Retriever in acute ischemic stroke. Drs Becker and Brott were members of the FDA advisory panel that reviewed the MERCI (Mechanical Embolus Removal in Cerebral Ischemia) Trial and approval application. Despite concerns raised by the advisory panel, the Merci device was ultimately approved by CDRH. It is not our purpose to arbitrate the specific concerns raised by the advisory panel or to question the CDRH decision; readers can judge the strength of the evidence for themselves. However, we do wish to consider some of the implications of this decision for patient care and stroke clinical research.
The Merci Retriever was approved for clot removal in brain arteries and not as a therapeutic modality for acute ischemic stroke. This distinction is critically important. The MERCI Trial relied on historical controls (mostly data from PRolyse in Acute Cerebral Thromboembolism [PROACT] II) for demonstration of safety, recanalization efficacy, and clinical outcome.1 Although not the primary end point, it is useful to summarize clinical outcomes in the MERCI Trial. The median baseline National Institutes of Health (NIH)
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