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ZOLL Receives Approval to Market Intravascular Temperature Management Technology for Sudden Cardiac Arrest in JapanZOLL® Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced today that its Japanese subsidiary, Asahi Kasei ZOLL Medical Corp. (AZM), has obtained approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) to market the company's Thermogard XP™ (TGXP) Temperature Management System for sudden cardiac arrest in Japan. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160328005482/en/ ![]() ZOLL Thermogard XP Temperature Management System (Photo: Business Wire) 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 temperatre 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."
About the Thermogard XP Temperature Management System
About ZOLL Medical Corporation
About Asahi Kasei
1Mayer SA, et al. Critical Care Medicine.
2004;(3)212:2508-2515. ©2016 ZOLL Medical Corporation. All rights reserved. COOL LINE, ICY, Quattro, Thermogard XP, and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All trademarks are the property of their respective owners.
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