Zoll Medical said today its Japanese Subsidiary Asahi Kasei Zoll Medical won approval from Japan’s Pharmaceuticals and Medical Devices Agency for its Thermogard XP temperature management system for patients in sudden cardiac arrest.
Approval was based on a clinical trial in Japan conducted between 2013 and 2014 as the company sought approval for an indication of therapeutic hypothermia after resuscitation from cardiac arrest.
“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. By expanding indications for TGXP in Japan, AZM seeks to advance resuscitation therapy technology available in 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,” Zoll temperature management solutions prez James Palazzolo said in a press release.
The Chelmsford, Mass.-based company said it also won device approval for its Quattro and ICY heat exchange catheters designed for treating therapeutic hypothermia.
In December, Zoll Medical said it won FDA premarket approval for its LifeVest wearable cardioverter defibrillator designed for children who are at risk for sudden cardiac arrest but aren’t candidates for an implantable defibrillator.
The LifeVest is the only wearable cardioverter defibrillator that monitors the heart continuously for abnormal heart arrhythmias and responds automatically, Zoll said.
The wearable device weighs less than 2 pounds and consists of an electrode belt and chest garment and a wrist-worn monitor. The LifeVest is intended for children that weigh at least 41 pounds with chest sizes of 26 inches or greater, which Zoll said is about the size of an average 8 year old.
