heter-based Celsius Control System has received
FDA 510(k) clearance for use in inducing, maintaining and reversing mild
hypothermia in neurosurgical patients, both in surgery and in recovery or
intensive care. The system has also received FDA clearance for use in
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, acute ischemic
stroke and myocardial infarction (heart attack).
InnerCool's next-generation RapidBlue(TM) system for high-performance
endovascular temperature modulation is expected to receive FDA clearance in
the second quarter 2008, and to initially have the same clearance as the
Celsius Control System. The RapidBlue system includes a programmable
console with an enhanced user interface and a catheter designed to quickly
modulate patient temperature in association with surgery or other medical
procedures. The RapidBlue system powers InnerCool's Accutrol(TM) catheter,
which has a flexible metallic temperature control element and a built-in
temperature feedback sensor to provide fast and precise patient temperature
control.
About Cardium
Cardium Therapeutics, Inc. and its subsidiaries, InnerCool Therapies,
Inc. and the Tissue Repair Company, are medical technology companies
primarily focused on the development, manufacture and sale of innovative
therapeutic products and devices for cardiovascular, ischemic and related
indications. Cardium's lead product candidate, Generx(TM) (alferminogene
tadenovec, Ad5FGF4), is a DNA-based growth factor therapeutic being
developed for potential use by interventional cardiologists as a one-time
treatment to promote and stimulate the growth of collateral circulation in
the hearts of patients with ischemic conditions su
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SOURCE Cardium Therapeutics, Inc. Copyright©2008 PR Newswire. All rights reserved | |
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