Welcome!

News Feed Item

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

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 recommendation3 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.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that DXWorldExpo has been named “Global Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Digital Transformation is the key issue driving the global enterprise IT business. Digital Transformation is most prominent among Global 2000 enterprises and government institutions.
One of the biggest challenges with adopting a DevOps mentality is: new applications are easily adapted to cloud-native, microservice-based, or containerized architectures - they can be built for them - but old applications need complex refactoring. On the other hand, these new technologies can require relearning or adapting new, oftentimes more complex, methodologies and tools to be ready for production. In his general session at @DevOpsSummit at 20th Cloud Expo, Chris Brown, Solutions Marketi...
SYS-CON Events announced today that Nihon Micron will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Nihon Micron Co., Ltd. strives for technological innovation to establish high-density, high-precision processing technology for providing printed circuit board and metal mount RFID tags used for communication devices. For more inf...
SYS-CON Events announced today that Ryobi Systems will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Ryobi Systems Co., Ltd., as an information service company, specialized in business support for local governments and medical industry. We are challenging to achive the precision farming with AI. For more information, visit http:...
SYS-CON Events announced today that mruby Forum will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. mruby is the lightweight implementation of the Ruby language. We introduce mruby and the mruby IoT framework that enhances development productivity. For more information, visit http://forum.mruby.org/.
SYS-CON Events announced today that Mobile Create USA will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Mobile Create USA Inc. is an MVNO-based business model that uses portable communication devices and cellular-based infrastructure in the development, sales, operation and mobile communications systems incorporating GPS capabi...
SYS-CON Events announced today that Keisoku Research Consultant Co. will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Keisoku Research Consultant, Co. offers research and consulting in a wide range of civil engineering-related fields from information construction to preservation of cultural properties. For more information, vi...
SYS-CON Events announced today that MIRAI Inc. will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MIRAI Inc. are IT consultants from the public sector whose mission is to solve social issues by technology and innovation and to create a meaningful future for people.
SYS-CON Events announced today that Daiya Industry will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Daiya Industry specializes in orthotic support systems and assistive devices with pneumatic artificial muscles in order to contribute to an extended healthy life expectancy. For more information, please visit https://www.daiyak...
SYS-CON Events announced today that Fusic will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Fusic Co. provides mocks as virtual IoT devices. You can customize mocks, and get any amount of data at any time in your test. For more information, visit https://fusic.co.jp/english/.
SYS-CON Events announced today that Interface Corporation will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Interface Corporation is a company developing, manufacturing and marketing high quality and wide variety of industrial computers and interface modules such as PCIs and PCI express. For more information, visit http://www.i...
Today companies are looking to achieve cloud-first digital agility to reduce time-to-market, optimize utilization of resources, and rapidly deliver disruptive business solutions. However, leveraging the benefits of cloud deployments can be complicated for companies with extensive legacy computing environments. In his session at 21st Cloud Expo, Craig Sproule, founder and CEO of Metavine, will outline the challenges enterprises face in migrating legacy solutions to the cloud. He will also prese...
Elon Musk is among the notable industry figures who worries about the power of AI to destroy rather than help society. Mark Zuckerberg, on the other hand, embraces all that is going on. AI is most powerful when deployed across the vast networks being built for Internets of Things in the manufacturing, transportation and logistics, retail, healthcare, government and other sectors. Is AI transforming IoT for the good or the bad? Do we need to worry about its potential destructive power? Or will we...
SYS-CON Events announced today that Enroute Lab will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Enroute Lab is an industrial design, research and development company of unmanned robotic vehicle system. For more information, please visit http://elab.co.jp/.
In his session at @ThingsExpo, Greg Gorman is the Director, IoT Developer Ecosystem, Watson IoT, will provide a short tutorial on Node-RED, a Node.js-based programming tool for wiring together hardware devices, APIs and online services in new and interesting ways. It provides a browser-based editor that makes it easy to wire together flows using a wide range of nodes in the palette that can be deployed to its runtime in a single-click. There is a large library of contributed nodes that help so...