|[February 06, 2013]
ZOLL Receives Shonin Approval from Japanese Ministry of Health, Labour and Welfare to Market Intravascular Temperature Management Technology
CHELMSFORD, Mass. --(Business Wire)--
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
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 o 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 recommendation3
from both the American Heart Association (AHA) and the Japan
Resuscitation Council (JRC).
Other ZOLL products sold in Japan:
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.
Non-invasive Cardiac Support Pump-a unique mechanical CPR system
that employs a load-distributing band to provide consistent,
uninterrupted, high-quality chest compressions.
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
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 Diringer MN, et al. Crit Care Med (2004) 32,
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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