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(Stroke. 2005;36:400.)
© 2005 American Heart Association, Inc.

Emerging Therapies

Approval of the MERCI Clot Retriever

A Critical View

From the University of Washington School of Medicine (K.J.B.), Harborview Medical Center, Seattle, Wash; and the Mayo Clinic (T.G.B.), Jacksonville Fla.

Correspondence to Dr Kyra Becker, Box 359775, Harborview Medical Center, 325 9th Ave, Seattle, WA 98104-2499. E-mail kjb@u.washington.edu.

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 Food and Drug Administration (FDA) evaluates applications for new human drugs, biologics, and complex medical devices. Companies must obtain FDA approval to legally market these products. In August, the FDA gave Concentric Medical clearance to market its Merci Retriever system to "remove blood clots from the brain in patients experiencing an ischemic stroke." Given that the FDA is charged with "protecting the public health by assuring the safety, efficacy, and security of... biological products and medical devices..., " "advancing public health by helping to speed innovations that make medicines ... more effective, safer, and more affordable," and "helping the public get the accurate, science-based information they need to use medicines ... to improve their health,"¹ the FDA’s decision to approve the Merci Retriever system is of concern. The pathways to approval are reviewed by Felten et al in the accompanying article and are outlined in Figure 1.

View larger version (16K): [in this window] [in a new window]   Figure 1. Potential pathways for device approval.

The decision to approve the Merci Retriever was based on data from the MERCI (Mechanical Embolus Removal in Cerebral Ischemia) Trial; the approval was granted through the 510(k) process. The Merci Retriever system includes a flexible nickel titanium (nitinol) wire that obtains a helical shape once it is passed through the tip of the guidance catheter. In practice, the catheter/wire is passed distal to the thrombus, the catheter is removed, and the helical configuration assumed by the wire; the clot is then trapped in the helix and withdrawn from the vasculature (Figure 2. . . [Full Text of this Article]

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