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Cardium Announces FDA 510(K) Clearance of InnerCool's RapidBlue(TM) Endovascular System
Date:10/20/2008

ristopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and InnerCool Therapies. "We are continuing to develop new and innovative best-of-class medical devices based on our important technology position and expertise in the growing field of temperature modulation. With both RapidBlue and CoolBlue now completed and cleared, and other potential products in development, we intend to leverage InnerCool's technology portfolio and broaden access to its products through potential strategic alignments and sales and distribution-related transactions with established companies having larger existing sales forces with a need for new products capable of providing innovative solutions for this emerging market."

The RapidBlue System powers InnerCool's low-profile, flexible Accutrol(R) catheter which can quickly modulate patient core body temperature at cooling rates of 4-5 degrees Celsius per hour or warming rates of 2-3 degrees Celsius per hour. The Accutrol catheter contains an integrated temperature sensor capable of accurately measuring core body temperature to within 0.1 degree Celsius of pulmonary artery temperature. Its novel software control algorithm provides automated and precise body temperature control, eliminating the use of peripheral temperature probes which are generally slow to respond to changes in core body temperature.

Underwriters Laboratories, Inc. (UL) completed a national and international conformity assessment for the RapidBlue System and concluded that it meets all of the applicable requirements of the U.S. (UL 60601-1), Canadian (CSA C22.2 No. 601.1-M90), and European Union (EN60601-1) medical electrical safety standards. In addition, the RapidBlue console passed the stringent UL 471 Standard for commercial refrigerators and freezers. This is believed to be the first and only UL global certification for an endovascular thermal regulating system and further confirms the technology leadership position that InnerCo
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SOURCE Cardium Therapeutics
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