If as I think SSH has been implanting the desperate (not a cross section of Class 3 but the end of life people [ 1/2 the heart gone, sleeping on knees etc], often with co morbidities known and unknown), it must put pressure on the FDA. 80% short term benefit, relief from symptoms, 50% long term benefit (including 25% cure) v miserable existence relieved only by imminent death. 20% deaths from other causes but C-Pulse did no harm.
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A gentlemanly dispute, page-9
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