Velomedix nets IDE to study hypothermia in acute MI patients

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Velomedix, a clinical-stage medical device company, has received Investigational Device Exemption (IDE) approval from the FDA to evaluate the use of therapeutic hypothermia for the treatment of patients suffering an acute MI.

The conditional approval allows the company to initiate a clinical trial at select sites in the U.S. The IDE study will build upon limited data developed over the last eight years for the use of therapeutic hypothermia for MI patients, according to the Menlo Park, Calif.-based company.

It is anticipated the Velomedix IDE study will begin enrolling patients in the second half of 2012.