ZOLL Medical, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced that its Japanese subsidiary, Asahi Kasei ZOLL Medical (AZM), has obtained approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to market the company’s Thermogard (TGXP) Temperature Management System for sudden cardiac arrest in Japan.
AZM conducted a clinical trial 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 PMDA.
AZM also obtained new device approval for its Quattro® and ICY® heat exchange catheters to be used for therapeutic hypothermia sales in Japan will begin soon. 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, AZM seeks to advance resuscitation therapy technology available in Japan," said 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."
The Thermogard XP (TGXP) Temperature Management System offers healthcare providers the precision and speed to safely and effectively manage the core body temperature of critically ill or surgery patients. TGXP offers tremendous clinical efficiency in reaching and maintaining target temperature virtually all of the time.
A family of heat exchange catheters and TGXP’s unmatched control — regardless of target temperature — enable clinicians to tailor the treatment to the individual.