March 28, 2016 - ZOLL Receives Approval to Market Intravascular Temperature Management Technology for Sudden Cardiac Arrest in Japan
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ZOLL RECEIVES APPROVAL TO MARKET INTRAVASCULAR TEMPERATURE MANAGEMENT TECHNOLOGY FOR SUDDEN CARDIAC ARREST IN JAPAN
March 28, 2016—CHELMSFORD, MASS.—ZOLL® 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.
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.”
About the Thermogard XP Temperature Management System
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.1-7 A family of heat exchange catheters and TGXP’s unmatched control—regardless of target temperature—enable clinicians to tailor the treatment to the individual.
About ZOLL Medical Corporation
ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com.
About Asahi Kasei
The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the chemicals and fibers, homes and construction materials, electronics, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals, diagnostic reagents, and nutritional products. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.
1Mayer SA, et al. Critical Care Medicine. 2004;(3)212:2508-2515.
2Diringer MN, et al. Critical Care Medicine. 2004;(32)2:559-564.
3Hoedemaekers CW, et al. Critical Care. 2007;11:R91.
4Heard KJ, et al. Resuscitation. 2010;81:9-14.
5Horn CM, et al. Journal of Neurointerventional Surgery. 2014 Mar;6(2):91-95.
6Knapik P, et al. Kardiologia Polska. 2011;69(11):1157-1163.
7COOL-ARREST JP: An Evaluation of Therapeutic Hypothermia by Means of Intravascular Cooling (Intravascular Temperature Management; {IVTM}) in Patients who Have Undergone Endogenous Cardiac Arrest and Return of Circulation – a Joint, Multicenter, Single-Arm, Prospective Interventional Study Trial.
Copyright © 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 other trademarks are the property of their respective owners.