The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Shonin approval to Zoll Medical's intravascular temperature management (IVTM) system for use in neurologically injured patients to control fever.
Using a balloon catheter connected to the Thermogard XP console, the intravascular system circulates cold saline solution and provides better control of the core body temperature by directly cooling or warming the patient's venous blood as it flows through the body.
The system also offers various triple-lumen catheters with placement options to handle specific patient challenges.
The technology's automated features free up clinical staff to attend to other patient needs, according to the company.
Asahi Kasei ZOLL Medical (AZM), a Zoll company, will be responsible for the sale and marketing of the IVTM system.
Zoll Medical president James Palazzolo said with the Shonin approval, the company will market IVTM technology in Japan and continue to provide new technologies and devices for critical care to the high-growth market.
"We are now preparing for a clinical trial for therapeutic hypothermia following cardiopulmonary resuscitation, a treatment having a Class 1 recommendation from both the American Heart Association (AHA) and the Japan Resuscitation Council (JRC)," Palazzolo said.
Zoll Medical's products also include AED Plus, an automated external defibrillator (AED), AutoPulse Non-invasive Cardiac Support Pump and easy-to-use, portable Pocket CPR device.
Image: Zoll Medical's intravascular temperature management system controls fever in neurologically injured patients. Photo: Courtesy of Business Wire.