what do you mean "the safety standard wasn't reached"??? the 3 deaths during the course of INSPIRE had absolutely NOTHING to do with the scaffold/implantation--any acute spinal cord injured patient has a multitude of other injuries at the time of their accident and these 3 cases were no different-I know at least one of these deaths was due to a massive pulmonary embolism-again a common event that happens even with anticoagulation?? this company/scaffold hasn't advanced ("treading water" is more like it)-is because of gross mismanagement-especially Perrin who thankfully is long gone
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