The FDA has classified the Alsius Thermogard™ heat exchange catheter as a Class II devices under 21 C.F.R §§ 870.5900. It is used in various clinical applications for cooling patients but it has not been FDA-approved for use in warming burn patients. The Thermogard™ is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling catheter that is placed percutaneously in the patient. The catheter can be placed in the femoral vein (larger catheter with three heat exchange balloons) or the subclavian or jugular vein (smaller catheter with two heat exchange balloons).