FDA Clears Therapeutic Temperature Management System


September 15, 2010

September 15, 2010 – The U.S. Food and Drug Administration (FDA) granted 510(k) market approval for the Medivance noninvasive Arctic Sun 5000 therapeutic temperature management device. The new patient cooling device offers fast initiation of treatment, simple programming capabilities and easy access to treatment.

"We beta tested the new device for six months and it's an incredible machine for both therapeutic hypothermia and normothermia indications," said Mary Kay Bader, RN, MSN, CCNS, FAHA of California's Mission Hospital, a nationally renowned cooling expert. "It's so easy to use and has new functions we find very valuable."

Bader and others cite the Arctic Sun's preprogrammed protocols and new trend analysis and data collection capabilities as key enhancements that optimize patient care.

"The entire staff loved the Arctic Sun 5000," Bader said.

The newest Arctic Sun also features:
• Embedded training
• The ability to preprogram hospital protocols for rapid induction of temperature control with the push of a button
• Comprehensive help screen with pop-up explanations for all alerts
• Voice and visual prompts for added safety
• Data storage during patient transfers, with ability to continue current patient case for up to six hours
• More efficient cooling
• Touch screen
• Ability to download up to 10 cases from device memory for research or analysis purposes
• Automatic initiation of rewarming

The noninvasive Arctic Sun 5000 precisely monitors and maintains core body temperature in a therapeutic range, between 32 and 38.5 degrees Celsius (approximately 89.6 to 101.3 degrees Fahrenheit) with the potential to minimize damage to the heart and brain. The patented design of the Arctic Sun and ArcticGel Pads enables them to transfer up to five times more thermal energy than conventional products such as water blankets, wraps or ice packs, resulting in more efficient temperature management. The system's precision also enables the slow rewarming thought to be critical for therapeutic benefit. The Arctic Sun 5000 has received 510(k) FDA clearance in the United States and the European Union's CE mark.

For more information: www.medivance.com