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http://www.theheart.org/article/926729.do
Washington, DC - Sen Charles Grassley (R-IA) has launched an investigation to determine whether Edwards Lifesciences marketed the Myxo-ETlogix mitral-valve ring without first obtaining FDA approval and whether the device was being used without informed patient consent. In letters sent Wednesday to Edwards, Northwestern University, and the FDA, Grassley, the ranking member of the Senate Finance Committee, said he had "recently received troubling allegations that Edwards Lifesciences' Myxo ETlogix 5100 Ring . . . has not been approved and/or cleared for marketing by the Food and Drug Administration."
As previously reported by heartwire, the Myxo ring was invented by Northwestern surgeon Dr Patrick McCarthy. Both McCarthy and Northwestern have been fending off allegations from a patient that McCarthy used the device before it was formally approved and without first telling the patient that he might use it.
Most concerning:
Grassley's letter also asks Northwestern to explain actions taken against Rajamannan and specifically why she was asked to agree, in a letter sent July 24, 2008, "not to provide clinical care at Northwestern Medical Faculty Foundation and Northwestern Memorial Hospital."
Rajamannan has confirmed to heartwire that her clinical practice at Northwestern is "on hold" but that she is still a full faculty member at Northwestern and has continued work on her National Institutes of Health R01 grant work during the period in question.
Also, rumors are rampant that there is a reshuffling of leadership, but can't confirm that for myself as I am peon.
Washington, DC - Sen Charles Grassley (R-IA) has launched an investigation to determine whether Edwards Lifesciences marketed the Myxo-ETlogix mitral-valve ring without first obtaining FDA approval and whether the device was being used without informed patient consent. In letters sent Wednesday to Edwards, Northwestern University, and the FDA, Grassley, the ranking member of the Senate Finance Committee, said he had "recently received troubling allegations that Edwards Lifesciences' Myxo ETlogix 5100 Ring . . . has not been approved and/or cleared for marketing by the Food and Drug Administration."
As previously reported by heartwire, the Myxo ring was invented by Northwestern surgeon Dr Patrick McCarthy. Both McCarthy and Northwestern have been fending off allegations from a patient that McCarthy used the device before it was formally approved and without first telling the patient that he might use it.
Most concerning:
Grassley's letter also asks Northwestern to explain actions taken against Rajamannan and specifically why she was asked to agree, in a letter sent July 24, 2008, "not to provide clinical care at Northwestern Medical Faculty Foundation and Northwestern Memorial Hospital."
Rajamannan has confirmed to heartwire that her clinical practice at Northwestern is "on hold" but that she is still a full faculty member at Northwestern and has continued work on her National Institutes of Health R01 grant work during the period in question.
Also, rumors are rampant that there is a reshuffling of leadership, but can't confirm that for myself as I am peon.
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