Approval of new indication for Thermogard™ System in Japan
Asahi Kasei Corp.
Asahi Kasei ZOLL Medical Corp.
Asahi Kasei ZOLL Medical Corp. (AZM), the Asahi Kasei Group company for acute critical care devices in Japan, obtained approval for the Thermogard™ System intravascular temperature management system to be used for the indication of therapeutic hypothermia after resuscitation from sudden cardiac arrest from Japan’s Ministry of Health, Labour and Welfare on February 15, 2016.
Thermogard™ System controls a patient’s body temperature from within blood vessels. It has been used in intensive care units in Japan together with antipyretic drugs and surface cooling methods to lower the temperature of patients with neurogenic fever. AZM performed a clinical study in Japan from January 2013 to February 2014 for the indication of therapeutic hypothermia after resuscitation from cardiac arrest. The application for the new indication was filed based on the results of this study, and approval was obtained following examination by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Furthermore, in addition to the COOL LINE™ catheters that lower the temperature of patients with head injury, heatstroke, and subarachnoid hemorrhage, AZM also obtained new device approval for Quattro™ and ICY™ catheters for use in therapeutic hypothermia, with sale in Japan to begin soon.
Therapeutic hypothermia after resuscitation from cardiac arrest is a therapeutic method to inhibit the progress of harmful reactions within the brain by lowering the metabolism with reduced temperature. Based on common evidence around the world, therapeutic hypothermia is recommended in guidelines in the US and Europe, and also in the Japan Resuscitation Council Guidelines 2015. In the treatment of resuscitated patients, there is a need for easy-to-use equipment that enables faster and more precise temperature control. With the newly expanded indications for Thermogard™ System, AZM seeks to contribute to improved technology for resuscitation therapy.