ZOLL Receives Shonin Approval from Japanese Ministry of Health, Labour and Welfare to Market X Series Monitor/Defibrillator

CHELMSFORD, Mass.

ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that its Japanese subsidiary, Asahi Kasei ZOLL Medical (AZM), has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to enter the Japanese market with its X Series^® Monitor/Defibrillator.

AZM, a ZOLL company established in August 2012 to pursue the regulatory approval, sale, and marketing of ZOLL products in Japan, will begin the marketing and selling of the X Series in spring 2014. Designed primarily for EMS operations and critical care transport, the X Series is about half the size and half the weight of competitive full-featured monitor/defibrillators, yet much more powerful and built to the most extensive standards for ruggedness.

Weighing less than 12 pounds (6 kilograms), the X Series is compact without compromise in capability, performance, or display size. This monitor/defibrillator combines the clinically superior therapeutic capabilities of ZOLL defibrillation, pacing, and CPR assistance with advanced monitoring parameters.

Key among the X Series’ features is the unequaled ability to assist with improving CPR quality to keep oxygen-rich blood flowing. ZOLL’s proprietary See-Thru CPR^® minimizes the duration of pauses in CPR to enable rescuers to see the underlying rhythm. ZOLL’s Real CPR Help^® provides real-time CPR feedback, and a built-in sensor measures the depth, rate, and effectiveness of chest compressions.

The X Series also lets first responders assess the patient’s needs as soon as possible and wirelessly transmit critical information to a receiving hospital so clinicians are prepared when the ambulance arrives. Wireless transmission allows the EMS crew and hospital staff to work as a team and start treating the patient without delay.

“We are very excited to begin commercialization of the X Series in Japan and to continue to offer innovative technologies and devices for acute critical care to this high-growth market,” said Richard A. Packer, CEO of ZOLL. “The X Series not only helps rescuers save lives, but makes the lives of first responders a great deal easier by having so many life-saving capabilities in one unit.”

In addition, the X Series provides ECG monitoring, invasive and non-invasive blood pressure, pulse oximetry (including SpO₂, CO, etc.), end-tidal carbon dioxide concentration (EtCO₂), body temperature, and respiratory rate.

Other ZOLL products that received Shonin approval in Japan:

• The AED Plus^® is an automated external defibrillator (AED) that incorporates ZOLL’s real-time CPR feedback technology, Real CPR Help^®. The AED Plus is the only AED with CPR feedback capability available in the Japanese market.
• The AutoPulse^® Non-Invasive Cardiac Support Pump is an automated, portable chest compression device. It is the only mechanical CPR system to have shown improved survival in comparative clinical trials. The AutoPulse more than tripled survival compared to typical CPR during witnessed shockable arrests.¹
• ZOLL’s Intravascular Temperature Management (IVTM™) system offers health care providers the power and control they need to rapidly, safely, and effectively manage the core body temperature of critically ill or surgical patients. In Japan, IVTM is only approved for patients with high fever. The Thermogard XP® delivers accurate, easy-to-use and cost-effective control for both cooling and warming applications.

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, fluid resuscitation, and therapeutic temperature management, 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 29,000 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/.

Copyright © 2013 ZOLL Medical Corporation. All rights reserved. AED Plus, AutoPulse, IVTM, Real CPR Help, See-Thru CPR, X Series, Thermogard XP, X Series, and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All product names are the property of their respective owners.

¹Wik L, et al. The impact of CPR duration on survival to discharge between integrated AutoPulse-CPR and manual–CPR during out-of-hospital cardiac arrest of presumed cardiac origin. Resuscitation. 2012;83:e17