Life Recovery Systems gets FDA nod for ThermoSuit study
The FDA has approved Life Recovery Systems’ Investigational Device Exemption (IDE) application to investigate rapid hypothermia treatment in combination with primary angioplasty to treat heart attacks. The patients enrolled in the study will be given hypothermia along with Life Recovery Systems ThermoSuit(R) non-invasive cooling system. The patients will undergo cooling in the emergency room within one hour of their arrival and the door-to-balloon time will not extend beyond 90 minutes.
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