Zoll Medical has gained Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its intravascular temperature management (IVTM) system, designed for use in neurologically injured patients to control fever.
The intravascular system uses a balloon catheter connected to the Thermogard XP console to circulate cold saline solution and provide better control of the core body temperature by directly cooling or warming the patient’s venous blood as it flows through the body.
The company said the system also offers various triple-lumen catheters with placement options to handle specific patient challenges.
Asahi Kasei ZOLL Medical (AZM), a Zoll company, will be responsible for the sale and marketing of 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 added.