FDA approves ThermoSuit(R) System for clinical study
The U.S. Food and Drug Administration has approved Life Recovery Systems‘ ThermoSuit(R) System, a rapid patient cooling device for use in a clinical study of patients suffering from traumatic brain injury. Till now, the system has been in use to induce rapid cooling of heart patients only.The study which will be conducted at the University of Texas Health Science Center in Houston will investigate whether the induction of hypothermia will result in higher number of patients coming up with good outcomes at six months and 12 months after injury as compared to patients who were randomized to normothermia.
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