Zoll Medical has announced that its Japanese subsidiary, Asahi Kasei Zoll Medical, has obtained approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to market the company’s Thermogard XP temperature management system for sudden cardiac arrest in Japan.
Asahi Kasei Zoll Medical conducted a clinical trial in Japan from January 2013 to February 2014 for the indication of therapeutic hypothermia after resuscitation from cardiac arrest, which was sued as a basis for approval was obtained following examination by Japan’s PMDA. The company also obtained new device approval for its Quattro and ICY heat exchange catheters to be used for therapeutic hypothermia, which will be commercialised shortly in Japan. Previously, only the Cool Line catheter, which lowers the temperature of neuro-fever patients, had approval.
“For the treatment of resuscitated patients, there is a need for easy-to-use equipment that enables precise cooling and rewarming of the core body temperature with greater speed. By expanding indications for TGXP in Japan, Asahi Kasei Zoll Medical seeks to advance resuscitation therapy technology available in Japan,” says James A Palazzolo, president of ZOLL temperature management solutions. “Use of temperature management for sudden cardiac arrest is recommended in the 2015 Guidelines issued by the American Heart Association and the European and Japan Resuscitation Councils,” he says.