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.
According to the company, 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.
Christopher Reinhard, chairman and CEO of Cardium Therapeutics and InnerCool Therapies, said: “The FDA’s 510(k) clearance of our new RapidBlue endovascular system represents a key milestone in completing Cardium’s turnaround and strategic repositioning of our InnerCool investment.
“We believe that the new RapidBlue system is the most powerful and easiest to use endovascular-based system in the world and is the only endovascular temperature modulation system that has obtained both FDA and European CE Mark regulatory clearances as well as UL certification, providing InnerCool with one of many competitive advantages.”