Application for new indication for Thermogard™

November 21, 2014
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, has filed an application with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for approval of a new indication for the Thermogard™ intravascular temperature management system.

Thermogard™ is a system to control a patient’s body temperature by cooling from within blood vessels. It has been used in intensive care units together with antipyretic drugs and cooling blankets to lower the temperature of patients with neurogenic fever using a central venous catheter. 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 following consultation and advice from the PMDA. Whereas Thermogard™ is currently used with COOL LINE™ catheters, AZM also filed an application for approval of Quattro™ and ICY™ as new catheters for use in therapeutic hypothermia.

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 2010. In the treatment of resuscitated patients, there is a need for easy-to-use equipment that enables more precise temperature control. By expanding indications for the Thermogard System™ AZM seeks to contribute to improved technology for resuscitation therapy.


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