Japan approves ZOLL Medical Corps Temperature Management System


Medical device and software solutions manufacturer ZOLL Medical Corporation has announced its Japanese subsidiary, Asahi Kasei ZOLL Medical Corp (AZM), has obtained approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to market the company’s Thermogard XP™(TGXP) Temperature Management System for sudden cardiac arrest in Japan.

AZM conducted a clinical trial in Japan from January 2013 to February 2014 for the indication of therapeutic hypothermia after resuscitation from cardiac arrest. The application for the new indication was filed based on the results of this study, and approval was obtained following examination by Japan’s PMDA.

RELATED TOPIC: Royal Melbourne Hospital's bionic spine set to help paralyzed patients

AZM also obtained new device approval for its Quattro® and ICY® heat exchange catheters to be used for therapeutic hypothermia sales in Japan will begin soon. Previously, only the Cool Line® catheter, which lowers the temperature of neuro-fever patients, had approval.

“For the treatment of resuscitated patients, there is a need for easy-to-use equipment that enables precise cooling and rewarming of the core body temperature with greater speed,” said ZOLL Temperature Management Solutions president James A. Palazzolo. “By expanding indications for TGXP in Japan, AZM seeks to advance resuscitation therapy technology available in Japan.

RELATED TOPIC: Why Performance Horizon is expanding into Japan

“Use of temperature management for sudden cardiac arrest is recommended in the 2015 Guidelines issued by the American Heart Association and the European and Japan Resuscitation Councils.”

The Thermogard XP (TGXP) Temperature Management System offers healthcare providers the precision and speed to safely and effectively manage the core body temperature of critically ill or surgery patients.

RELATED TOPIC: How return of ANA flights will increase Japanese tourism

TGXP offers tremendous clinical efficiency in reaching and maintaining target temperature virtually all of the time.1-7 A family of heat exchange catheters and TGXP’s unmatched control —regardless of target temperature — enable clinicians to tailor the treatment to the individual.

Let's connect!  

Check out the latest edition of Business Review Australia!


Featured Articles

Exec interview: Brook Sims, COO, MAC Diversity Recruiters

Passionate about helping others find their voice, diversity leader and COO Brook Sims talks powerful leadership, diverse teams and being a change agent

Best new books that will make you a better leader

From inspiring CEO memoirs to strategic guides, these new books dish up plenty of principles, strategies, and anecdotes to help you become a better boss

5 Mins With: Jeff Li, founder and CEO of Shoplazza

Named in Fortune China’s 40 under 40 for 2022, former Baidu head Jeff Li is the entrepreneurial founder and CEO of ecommerce platform Shoplazza

Workplace special – the changing nature of the office

Leadership & Strategy

Meet Shanique Bonelli-Moore, DEI leader at Clorox


Forterro CEO Dean Forbes – inspirational leadership

Leadership & Strategy