ZOLL Receives Shonin Approval from Japanese Ministry of Health, Labour and Welfare to Market Intravascular Temperature

  ZOLL Receives Shonin Approval from Japanese Ministry of Health, Labour and
  Welfare to Market Intravascular Temperature Management Technology

          First Intravascular Temperature Management System in Japan

Business Wire

CHELMSFORD, Mass. -- February 6, 2013

ZOLL Medical Corporation, a manufacturer of medical devices and related
software solutions, has received Shonin approval from the Japanese Ministry of
Health, Labour and Welfare (MHLW) to enter the Japanese market with its
Intravascular Temperature Management (IVTM^™) technology—the first
intravascular temperature management system to receive Shonin approval in
Japan.

ZOLL Thermogard XP (Photo: Business Wire)

ZOLL Thermogard XP (Photo: Business Wire)

ZOLL’s IVTM solution will be marketed and sold by Asahi Kasei ZOLL Medical
(AZM), a ZOLL company established in August 2012 to pursue the regulatory
approval, sale, and marketing of ZOLL products in Japan.

ZOLL’s IVTM technology was approved in Japan for fever control in
neurologically injured patients. The intravascular system offers superior
temperature control when compared to other cooling methods. Fever is commonly
found in both neurologically injured and neurosurgical patients and is
associated with poor outcomes.^1 Specifically, moderate fever has been
reported to almost double patient mortality, while extremely high fever can
triple mortality.^2 Management of the body’s core temperature is key to proper
neurological function, especially for patients in neurointensive care.

ZOLL’s IVTM system provides cooling and warming through a balloon catheter
inserted into the venous system. This provides better control of the core body
temperature over surface methods by directly cooling or warming the patient’s
blood as it flows through the body. This catheter is connected to the
Thermogard XP^® console, which circulates cold saline solution inside the
catheter. Since the saline flows only within the catheter, no fluid is infused
into the patient. ZOLL offers a variety of triple-lumen catheters with
placement options to handle specific patient challenges. The ZOLL IVTM system
is efficient, precise, and easy to use, and frees up clinical staff to attend
to other patient needs.

“We are very excited to begin commercialization of IVTM in Japan and to
continue to offer innovative technologies and devices for critical care to
this high-growth market,” said James Palazzolo, President of ZOLL Sunnyvale
(Calif.) operations. “We are now preparing for a clinical trial for
therapeutic hypothermia following cardiopulmonary resuscitation, a treatment
having a Class 1 recommendation^3 from both the American Heart Association
(AHA) and the Japan Resuscitation Council (JRC).

Other ZOLL products sold in Japan:

  *The AED Plus^®—an automated external defibrillator (AED) that incorporates
    ZOLL’s real-time CPR feedback technology, Real CPR Help^®, which assists
    rescuers in delivering high-quality CPR to sudden cardiac arrest victims.
    The AED Plus is the only AED with CPR feedback capability available in the
    Japanese market.
  *The AutoPulse^® Non-invasive Cardiac Support Pump—a unique mechanical CPR
    system that employs a load-distributing band to provide consistent,
    uninterrupted, high-quality chest compressions.
  *Pocket CPR^®—an easy-to-use portable device that uses Real CPR Help to
    provide real-time audible and visual feedback on the depth and rate of
    chest compressions, guiding rescuers to meet current guidelines.

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
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 critical care,
dialysis, therapeutic apheresis, transfusion, and manufacture of
biotherapeutics, as well as pharmaceuticals, diagnostic reagents, and
nutritional products. With more than 25,000 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, Pocket CPR, IVTM, Real CPR Help, Thermogard, 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 trademarks are the property of their respective owners.

^1 Diringer MN, et al. Crit Care Med (2004) 32, 2:559–564.

^2 Diringer MN, et al. Crit Care Med (2004) 32, 7:1489–1495.

^3 2010 AHA Guidelines for Cardiopulmonary Resuscitation and Emergency
Cardiovascular Care and JRC 2010 Guidelines. Class I: Procedure/treatment
should be performed/administered, Class IIa: It is reasonable to perform
procedure/administer treatment, Class IIb: Procedure/treatment may be
considered, Class III: Procedure/treatment should not be
performed/administered since it is not helpful and may be harmful.

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Contact:

ZOLL Medical Corporation
Diane Egan, +1-978-421-9637
degan@zoll.com
 
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