News | October 20, 2008

FDA Gives 510(K) Clearance to InnerCool's RapidBlue Endovascular System

October 21, 2008 - Cardium Therapeutics and its operating unit InnerCool Therapies Inc. said the FDA gave 510(k) clearance to market the RapidBlue System, an endovascular temperature modulation device.

InnerCool’s RapidBlue System is a thermal regulating system designed to manage and control patient body temperature. This new system automatically cools or warms patients, as necessary, to quickly and controllably achieve and then maintain a desired body temperature. RapidBlue provides rapid or gradual temperature control for all patient sizes. Its closed loop catheter-based system modulates whole body temperature, without fluid introduction or exchange, by circulating cool or warm saline within the interior of the catheter. RapidBlue is reportedly powerful enough to quickly cool awake patients and may eliminate the need to use paralytic agents. The system reportedly combines a high-performance programmable console with an enhanced user-friendly interface.

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