FDA Approves Investigational Device Exemptions for ThermoSuit Cooling System
Life Recovery Systems' ThermoSuit system uses direct liquid contact with the patient to reduce core body temperature. A thin film of ice water is circulated over the patient's body until the temperature reaches a preset limit, at which point the water is automatically removed from the suit. The system is easily set up by nurses or technicians in minutes and cools to a therapeutic temperature of 33˚C in about 30 minutes. The patient is then removed from the suit and remains cold for hours without the need for further maintenance, allowing unencumbered access for imaging or treatment in the cath lab.
Life Recovery Systems received two investigational device exemptions (IDEs) to study the system's use in July 2014.
For more information: www.life-recovery.com