Japan’s Ministry of Health, Labour and Welfare granted Shonin approval to Zoll Medical‘s intravascular temperature managment device for treating patients with high fevers and brain damage.
The Chelmsford, Mass.-based medical device company’s temperature regulating device is designed to control high fevers in patients with neurological impairment. It provides direct cooling and warming to the circulatory system via a ballon catheter.
Zoll is preparing a clinical trial for a hypothermia treatment and is seeking a recommendation from both the American Heart Assn. and the Japan Resuscitation Council, James Palazzolo, president of Zoll’s California operations, said in a prepared statement.