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(Stroke. 2005;36:1439.)
© 2005 American Heart Association, Inc.

Original Contributions

Editorial Comment—Mechanical Embolus Removal

A New Day Dawning

Thomas A. Tomsick, MD, FACR

Radiology Department, Section of Neuroradiology, University of Cincinnati Hospital, Cincinnati, Ohio

An extract of the first 250 words of the full text is provided, because this article has no abstract.

We must applaud the resourceful inventors, manufacturer, and investigators of the Merci Retriever device for completing the decade-long odyssey of directing the device through the design, development, study, and Food and Drug Administration (FDA) approval process. A number of devices have failed to climb that hill, falling back in pilot trials despite enthusiasm for their potential. However, previous editorials regarding approval of devices in general, and the potential Pandora’s box of approval of the Merci Retriever in particular,^1,2,3dictate that we evaluate the data that gained its approval as an embolectomy and revascularization device, as finally presented in this journal.

The device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.⁴ The manuscript gives no confirmation that flow restoration in this study is due to thrombus removal (embolectomy), as opposed to clot disruption with proximal revascularization and distal embolization. Aggressive clot manipulation more quickly opens primary occlusions with fibrinolytic agent.^5,6 No substantive data on wire-based clot manipulation without lytic therapy exists. An abstract from the February 2005 issue of Stroke suggested 50% subject clot removal with use of the Merci device.⁷ It was suggested that the 50% who might have a clot removed will be the same 50% that recanalize, and therefore that those who improve are among the 50% with clot removal. Nevertheless, even at that level of effectiveness, it is unclear that the device is doing what it is approved to do, which is to remove clots dependably. This embolectomy . . . [Full Text of this Article]

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