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
In his session at 21st Cloud Expo, Raju Shreewastava, founder of Big Data Trunk, provided a fun and simple way to introduce Machine Leaning to anyone and everyone. He solved a machine learning problem and demonstrated an easy way to be able to do machine learning without even coding. Raju Shreewastava is the founder of Big Data Trunk (www.BigDataTrunk.com), a Big Data Training and consulting firm with offices in the United States. He previously led the data warehouse/business intelligence and B...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across business networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost as well as advance trade. Are you curious about how Blockchain is built for business? In her session at 21st Cloud Expo, René Bostic, Technical VP of the IBM Cloud Unit in North America, discussed the b...
The past few years have brought a sea change in the way applications are architected, developed, and consumed—increasing both the complexity of testing and the business impact of software failures. How can software testing professionals keep pace with modern application delivery, given the trends that impact both architectures (cloud, microservices, and APIs) and processes (DevOps, agile, and continuous delivery)? This is where continuous testing comes in. D
SYS-CON Events announced today that Synametrics Technologies will exhibit at SYS-CON's 22nd International Cloud Expo®, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Synametrics Technologies is a privately held company based in Plainsboro, New Jersey that has been providing solutions for the developer community since 1997. Based on the success of its initial product offerings such as WinSQL, Xeams, SynaMan and Syncrify, Synametrics continues to create and hone in...
With tough new regulations coming to Europe on data privacy in May 2018, Calligo will explain why in reality the effect is global and transforms how you consider critical data. EU GDPR fundamentally rewrites the rules for cloud, Big Data and IoT. In his session at 21st Cloud Expo, Adam Ryan, Vice President and General Manager EMEA at Calligo, examined the regulations and provided insight on how it affects technology, challenges the established rules and will usher in new levels of diligence arou...
Nordstrom is transforming the way that they do business and the cloud is the key to enabling speed and hyper personalized customer experiences. In his session at 21st Cloud Expo, Ken Schow, VP of Engineering at Nordstrom, discussed some of the key learnings and common pitfalls of large enterprises moving to the cloud. This includes strategies around choosing a cloud provider(s), architecture, and lessons learned. In addition, he covered some of the best practices for structured team migration an...
As you move to the cloud, your network should be efficient, secure, and easy to manage. An enterprise adopting a hybrid or public cloud needs systems and tools that provide: Agility: ability to deliver applications and services faster, even in complex hybrid environments Easier manageability: enable reliable connectivity with complete oversight as the data center network evolves Greater efficiency: eliminate wasted effort while reducing errors and optimize asset utilization Security: imple...
Mobile device usage has increased exponentially during the past several years, as consumers rely on handhelds for everything from news and weather to banking and purchases. What can we expect in the next few years? The way in which we interact with our devices will fundamentally change, as businesses leverage Artificial Intelligence. We already see this taking shape as businesses leverage AI for cost savings and customer responsiveness. This trend will continue, as AI is used for more sophistica...
No hype cycles or predictions of a gazillion things here. IoT is here. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, an Associate Partner of Analytics, IoT & Cybersecurity at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He also discussed the evaluation of communication standards and IoT messaging protocols, data...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
The 22nd International Cloud Expo | 1st DXWorld Expo has announced that its Call for Papers is open. Cloud Expo | DXWorld Expo, to be held June 5-7, 2018, at the Javits Center in New York, NY, brings together Cloud Computing, Digital Transformation, Big Data, Internet of Things, DevOps, Machine Learning and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding busin...
Modern software design has fundamentally changed how we manage applications, causing many to turn to containers as the new virtual machine for resource management. As container adoption grows beyond stateless applications to stateful workloads, the need for persistent storage is foundational - something customers routinely cite as a top pain point. In his session at @DevOpsSummit at 21st Cloud Expo, Bill Borsari, Head of Systems Engineering at Datera, explored how organizations can reap the bene...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
In his session at 21st Cloud Expo, Michael Burley, a Senior Business Development Executive in IT Services at NetApp, described how NetApp designed a three-year program of work to migrate 25PB of a major telco's enterprise data to a new STaaS platform, and then secured a long-term contract to manage and operate the platform. This significant program blended the best of NetApp’s solutions and services capabilities to enable this telco’s successful adoption of private cloud storage and launching ...
Kubernetes is an open source system for automating deployment, scaling, and management of containerized applications. Kubernetes was originally built by Google, leveraging years of experience with managing container workloads, and is now a Cloud Native Compute Foundation (CNCF) project. Kubernetes has been widely adopted by the community, supported on all major public and private cloud providers, and is gaining rapid adoption in enterprises. However, Kubernetes may seem intimidating and complex ...