Cardium Announces FDA 510(K) Clearance of InnerCool's RapidBlue(TM) Endovascu... (ol is establishing with the RapidBlueSys...)

Cardium Announces FDA 510(K) Clearance of InnerCool's RapidBlue(TM) Endovascular System

Date:10/20/2008

ol is establishing with the RapidBlue System.

InnerCool's RapidBlue(TM) and CoolBlue(TM) Temperature Modulation Systems

InnerCool's RapidBlue system for high-performance endovascular temperature modulation includes a programmable console with an enhanced user-friendly interface and touch panel screen and powers the low profile flexible Accutrol(R) catheter to quickly modulate patient temperature at cooling rates of 4-5 degrees Celsius per hour or warming rates of 2-3 degrees Celsius per hour. The Accutrol catheter, which has a flexible metallic temperature control element (TCE(R)) and a built-in temperature feedback sensor to provide fast and precise patient temperature control, can accurately measure core body temperature within 0.1 degree Celsius. Its novel software control algorithm provides automated and precise body temperature control, eliminating the use of peripheral temperature probes which are generally slow in responding to core temperature changes.

The RapidBlue console and Accutrol catheter can quickly and accurately modulate whole body temperature without introducing or exchanging any fluid within the body. The system functions by programmably circulating cold or warm saline in a closed circuit within the catheter to either cool or warm its outer metallic surface, which effectively conducts heat out of or into the surrounding bloodstream. The unique design of InnerCool's TCE(R), which is both thermally conductive and includes alternating surface helices to promote mixing around the TCE, further enhances heat transfer and enables rapid patient temperature modulation, even in obese patients. The catheter and TCE have a covalently-bonded heparin coating for hemo-compatibility and the catheter can be readily inserted intravenously while the patient is in an operating room or intensive care setting without the need for continuous fluoroscopy. The integrated temperature sensor allows for automated temperature management, and also elimina
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Cardium Announces FDA 510(K) Clearance of InnerCool's RapidBlue(TM) Endovascu...(ol is establishing with the RapidBlueSys...)