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ZOLL files with Japan’s PMDA for new indication for Intravascular Temperature Management technology

ZOLL Medical, a manufacturer of medical devices and related software solutions, announced that its Japanese subsidiary, Asahi Kasei ZOLL Medical (AZM), has filed an application with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for approval for the company’s Intravascular Temperature Management (IVTM) System to be used for sudden cardiac arrest.

AZM conducted a clinical study in Japan from January 2013 to February 2014 for the indication of temperature management after resuscitation from cardiac arrest.

The application for the new indication was filed based on the results of this study following consultation and advice from the PMDA. The application also includes approval for ZOLL’s Quattro and Icy as new catheters for use in temperature management. Currently, only the Cool Line catheter has approval.

"Use of temperature management for sudden cardiac arrest is recommended in numerous national guidelines including the Japan Resuscitation Council Guidelines 2010, which we think will be informative in the PMDA’s consideration of our application," said James A. Palazzolo, President of ZOLL.

"In treating resuscitated patients, there is a need for easy-to-use equipment that enables precise cooling and rewarming of core body temperature. By expanding indications for IVTM in Japan, AZM seeks to contribute to advance technology for resuscitation therapy."

ZOLL’s IVTM system provides cooling and warming through a balloon catheter inserted into the venous system. This provides precise 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.