Healthcare Industry News:  hypothermia 

Devices FDA

 News Release - July 30, 2007

Medcool Inc. Receives FDA Clearance for Its RapidCool (TM) System

Medical Device Provides Rapid Non-Invasive hypothermia Therapy

WELLESLEY, MA--(Healthcare Sales & Marketing Network)--Jul 30, 2007 -- Medcool Inc. of Wellesley, MA, an emerging provider of non-invasive systems for therapeutic hypothermia and temperature management, announced today that its RapidCool(TM) System has received 510(K) clearance by the FDA to be marketed in U.S. for temperature reduction therapy.

The RapidCool System is indicated for use for "temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients, and for monitoring of patient temperature."

The RapidCool System uses an innovative and patented disposable helmet that directs agitated cold water to the scalp, plus more standard body and neck pads, to rapidly cool the head and body of patients for whom cooling is indicated. The system rapidly reduces head and body temperature to a set point in the range of 32-37 degrees C, is non-invasive and does not interfere with cardiac catheterization and other hospital procedures.

A growing body of research indicates that mild hypothermia, in the range of 32-34 degrees C, could potentially have a protective effect, reducing damage from cardiac arrest, stroke, brain injury, and other traumatic events. Rapid cooling is believed to be important in reducing injury to the brain following these events. The recent cover article in Newsweek describes the evolving use of hypothermia following cardiac arrest (http://www.msnbc.msn.com/id/19751440/site/newsweek/).

"We are very pleased to be cleared for marketing in the U.S.," said Joe Caruso, Medcool CEO, "and are actively looking for strategic and distribution partners for this unique technology."

The Company's helmet design makes use of the fact that the body responds to decreasing temperature by increasing blood flow to the scalp while reducing blood flow to the periphery. As a result, the RapidCool System is capable of high rates of cooling compared to standard non-invasive cooling systems -- and directs most of its cooling to the head where it is most needed.

About Medcool

Medcool, Inc. is a medical products company based in Wellesley, Massachusetts, that develops and manufactures non-invasive, proprietary therapeutic temperature reduction solutions for emergency medicine and intensive care applications including potentially following brain injury, cardiac arrest or stroke.


Source: MedCool

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