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Intravascular Temperature Management
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INDICATIONS FOR USE

Please refer to the following information for market-specific Indications for Use of Alsius Catheters.

Alsius Quattro™, Icy® , and Fortius® Catheters

U.S. Indications for Use

The Alsius CoolGard 3000® Thermogard™ orThermogard XP™ Thermal Regulation System, using either the Icy, Fortius, or Quattro model catheter, is indicated for use:

  • in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care,
  • to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/ intensive care.

International Indications for Use

The Alsius Icy, Quattro and Fortius model catheters, in combination with the CoolGard 3000, Thermogard or Thermogard XP System, permits circulation of temperature controlled saline through a heat exchanger to cool/rewarm the patient's blood in patients for whom the risks of a central line are warranted.

Alsius Cool Line® Catheter

U.S. Indications for Use

The Alsius CoolGard 3000®, Thermogard™ or Thermogard XP™ Thermal Regulation System, using the Cool Line Catheter is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

Indications for Use

WARNING - Fever Reduction
The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage (SAH) or primary traumatic brain injury (PTBI). The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial, for the four patient cohorts enrolled, are presented in the table (Cl-cerebral infarction. ICH - intracerebral hemorrhage, PTBI - primary traumatic brain injury, SAH - subarachnoid hemorrhage). *Fischer's exact test. For more details on the results of this study please refer to "Physician's Manual-Fever Reduction for Patients with Cerebral Infarction and Intracranial Hemorrhage" #101418-001.

International Indications for Use

The Alsius Cool Line Catheter in combination with the CoolGard 3000, Thermogard or Thermogard XP System permits circulation of temperature controlled saline through a heat exchanger to cool/rewarm the patient's blood in patients for whom the risks of a central line are warranted.

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