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November 16, 1994

Compression-Decompression CPR: The Biomotor-Reply

Author Affiliations

University of Minnesota Minneapolis

JAMA. 1994;272(19):1477-1478. doi:10.1001/jama.1994.03520190019007

In Reply.  —Dr Lerman is correct that studies evaluating the addition of a suction phase to conventional CPR should not require consent as the patients are pulseless, without a palpable blood pressure, and essentially dead. We took that approach during our recent clinical trials to determine the efficacy of active compression-decompression CPR but were told (and continue to be told) by FDA officials that the handheld suction device is a "significant risk" device for this unconscious patient population. This is an absurd but not a trivial problem. When evaluating the risks of a new drug or device, the FDA still does not differentiate between the living and the nearly dead.Lerman is also correct that active chest decompression during CPR improves vital organ blood flow.1 However, he is incorrect about his description of the importance of the Eisenmenger Biomotor. The Biomotor is a large shell-like device that mechanically compresses

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