A Medical Device Daily

InnerCool Therapies (San Diego), a unit of Cardium Therapeutics (San Diego), reported receiving FDA clearance for its RapidBlue system, an endovascular temperature modulation device.

RapidBlue is designed to control patient body temperature, automatically cooling or warming, as necessary, to quickly achieve and maintain a desired body temperature. It is a closed-loop catheter-based system which modulates whole body temperature, without fluid introduction or exchange, by circulating cool or warm saline within the catheter's interior.

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

Cardium and its subsidiaries develop therapeutic products for cardiovascular, ischemic and related indications.