Cardium Announces FDA 510(K) Clearance of InnerCool's RapidBlue(TM) Endovascu... (tes the need to place bladder orother pa...)

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

Date:10/20/2008

tes the need to place bladder or other patient temperature probes which can be slow to react to changes in core body temperature, and may be uncomfortable to the patient and time-consuming to place.

Other currently-marketed endovascular systems rely on plastic-based balloon catheters that are inflated after placement in the bloodstream. Although expansion of the balloons increases their overall surface area for heat transfer, it also tends to make the catheters fairly large and rigid. In addition, they do not contain integrated temperature feedback sensors and heat transfer is limited by the very poor conductive nature of plastic. In terms of performance, a medium-sized balloon-based catheter which inflates to about 8 mm (24 French) has been reported to cool anesthetized intubated (i.e. surgical) patients at a rate of around 1C per hour. In comparison, InnerCool's RapidBlue System combines an ultra-thin flexible metallic catheter of only 3.5 mm (10.7 French) or 4.6 mm (14 French) with the potential to achieve cooling rates that are approximately 4-fold faster, i.e. about 1C per 15 minutes. Rapid cooling is considered to be particularly important for preserving tissue and organ function under conditions of acute ischemia, which result from reduced blood flow to critical tissues and organs.

The RapidBlue System can be used in inducing, maintaining and reversing mild hypothermia in neurosurgical patients, both in surgery and in recovery or intensive care. The system can also be used for cardiac patients in order to achieve or maintain normal body temperatures during surgery and in recovery / intensive care, and as an adjunctive treatment for fever control in patients with cerebral infarction and intracerebral hemorrhage. Potential additional applications of the technology include endovascular cooling for cardiac arrest (resuscitation), acute ischemic stroke, myocardial infarction (heart attack) and trauma.

InnerCool's CoolBlue surface temperature
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Cardium Announces FDA 510(K) Clearance of InnerCool's RapidBlue(TM) Endovascu...(tes the need to place bladder orother pa...)