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Zoll gains Japan's sign-off for intravascular temperature management device

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Zoll Medical won a coveted regulatory approval in Japan for its intravascular temperature management device--the first system of its kind to reach the commercial market in that country.

The approval allows doctors to use the intravascular system to help control fevers in patients with neurological injuries. Zoll's device is simple but effective, designed to get the job done by warming and cooling a patient's blood by way of a balloon catheter inserted into the venous system, which in turn is connected to a console that circulates cold saline solution inside the catheter.

Japan's Asahi Kasei snatched up Zoll last year for $2.2 billion, and plans to sell the product there through a subsidiary dubbed, oddly enough, Asahi Kasei Zoll Medical, which launched in October as a vehicle through which to beef up sales of Zoll's external defibrillators, monitoring equipment and other medical devices.

It's a major win for the company to gain product approvals in Japan--one of the world's largest markets for medical devices outside of the U.S. And Zoll has aggressively pursued this market; the company now has an automated external defibrillator, cardiac support pump and a portable diagnostic device available in Japan.

Zoll, meanwhile, is already at work pursuing an expanded indication for the device in Japan. The company is prepping a clinical trial to use its intravascular temperature management device for therapeutic hypothermia following cardiopulmonary resuscitation.

- read the release

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