Zoll wins Japanese OK for temperature management device

February 6, 2013 by MassDevice staff

Zoll Medical breaks into the Japanese market with its temperature regulating device, the first of its kind to win regulatory approval in the Land of the Rising Sun.


Japan's Ministry of Health, Labour and Welfare granted Shonin approval to Zoll Medical's intravascular temperature managment device for treating patients with high fevers and brain damage.

The Chelmsford, Mass.-based medical device company's temperature regulating device is designed to control high fevers in patients with neurological impairment. It provides direct cooling and warming to the circulatory system via a ballon catheter.

In March 2012, Asahi Kasei (TYO:3407) bought out Zoll for $2.2 billion in a move to increase its presence in the medical device market. Currently, Asahi Kasei operates mostly in chemical markets.

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Zoll is preparing a clinical trial for a hypothermia treatment and is seeking a recommendation from both the American Heart Assn. and the Japan Resuscitation Council, James Palazzolo, president of Zoll's California operations, said in a prepared statement.

Last month Zoll was the 1st company to announce a pledge to share data as part of a patient safety initiative spearheaded by Masimo (NSDQ:MASI) CEO Joe Kiani.