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    Posted April 6, 2014 by
    Chicago, Illinois

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    Security Exchange Commission Annual 10k Filings and the Confirm the Myxo and the IMR rings are on Voluntary recall from 2008-2009

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    "From the outset, McCarthy and Northwestern have insisted they had assurances from Edwards that the device was FDA cleared and commercially available at the time it was used and thus did not need patients to provide informed consent or involve the university's institutional review board (IRB). Edwards, for its part, has said that the device was legally on the market because it incorporated only minor changes to a previously 510(k)-cleared device, the GeoForm Ring 4200, cleared August 26, 2003, and that the justification to market the device without first going the 510(k) process was based on the FDA's own guidance document, "Deciding when to submit a 510(k) for a change to an existing device."

    But as heartwire reported in October 2008, another cardiologist at Northwestern, Dr Nalini Rajamannan, has long believed that the device was investigational at the time it was used in her patient, Antonitsa Vlahoulis--the one now suing. When heartwire first reported on the controversy, the FDA acknowledged that the device had never been cleared or approved by the agency and launched its own investigation. Shortly thereafter, Edwards recalled all US inventory and suspended sales."

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