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RapidBlue endovascular temperature modulation system receives CE Mark

Cardium Therapeutics : 14 July, 2008  (New Product)
Cardium Therapeutics and its operating unit InnerCool Therapies has declared that InnerCool's RapidBlue endovascular temperature modulation system conforms to the European Union’s CE Mark requirements for use in inducing, maintaining and reversing mild hypothermia in a variety of clinical indications.
The indications include cardiac arrest, neurosurgery, fever, cardiovascular re-warming, trauma re-warming, and potential additional applications including acute ischemic stroke and myocardial infarction (heart attack).

The CE Mark will allow the company to begin marketing the RapidBlue system in Europe and many other countries that recognize the certification. The company expects to begin selling the RapidBlue System through its established distribution network next quarter. As previously reported, InnerCool's RapidBlue System is currently under review for FDA 510(k) clearance.

'We believe our RapidBlue System is truly the most dynamic and best-in-class temperature modulation system on the market and receiving CE Mark and UL certification demonstrates that the company has established and operates a world class quality system. Based on our three year development effort, InnerCool's RapidBlue System establishes new performance standards by which all other endovascular and surface systems on a worldwide basis will now be judged,' stated Christopher J Reinhard, chairman and chief executive officer of Cardium Therapeutics and InnerCool Therapies. 'This is the first UL global certification for an endovascular thermal regulating system and further confirms the technology leadership position that InnerCool is establishing with the RapidBlue System. With commercialization agreements in place with leading distributors in the European Union, we look forward to expanding our distribution activities to include our RapidBlue System.'

InnerCool's RapidBlue System is a thermal regulating system designed to manage and control patient body temperature. The system automatically cools or warms patients, as necessary, to maintain desired body temperature. RapidBlue provides rapid or gradual temperature control for all patient sizes and 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. Unlike various other systems, RapidBlue is powerful enough to quickly cool awake patients and can eliminate the need to use paralytic agents. The system includes a programmable console with an enhanced user-friendly interface and touch-panel screen.

The RapidBlue System powers InnerCool's low-profile flexible Accutrol Catheter which can quickly modulate patient temperature at cooling rates of 4 to5 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.

The company also announced that Underwriters Laboratories (UL) completed a national and international conformity assessment for the RapidBlue System and concluded that it meets all of the applicable requirements of the US (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.
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