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Alsius Corp.
FDA clearance granted for thermal regulation system
September 10th, 2003
Alsius Corp., a pioneer in intravascular temperature management therapies, announced that it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) to market its Cool Line Catheter and CoolGard 3000 Thermal Regulation System. In a clinical study, the device was shown to effectively reduce fever, as an adjunct to other fever management therapies, in patients with cerebral infarction (CI) and intracerebral hemorrhage (ICH), two common forms of stroke, who require a central venous catheter and who are intubated and sedated. Alsius' technology features the Cool Line heat-exchange catheter and CoolGard 3000 Thermal Regulation...
Source: Biotech Week (2003-09-10)
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