FDA Clears Medivance's Arctic Sun 5000 for Fastest, Easiest Therapeutic Temperature Management
LOUISVILLE, Colo., Sept. 15 /PRNewswire/ -- Medivance today announced the introduction of its next-generation therapeutic temperature management device, the non-invasive Arctic Sun® 5000. The new patient cooling device has received FDA 510 (k) clearance and offers the fastest initiation of treatment, simplest programming capabilities and easiest access to treatment data on the market.
"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."
Ms. Bader and others cite the Arctic Sun's pre-programmed 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.
Favored by hospitals worldwide for its safety, simplicity and precision, the newest Arctic Sun also features:
- Embedded training
- The ability to pre-program 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 6 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 Arctic Sun 5000 brings precision Targeted Temperature Management™ to the highest level of performance available today," said Medivance CEO Robert Kline. "With the Arctic Sun 5000 we have made it as effortless as possible to initiate this promising non-invasive therapy that may spare many more critically ill patients from devastating brain damage."
About Medivance's Arctic Sun 5000
The non-invasive 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 U.S. and the European Union's CE Mark. Medivance develops and manufactures non-invasive, proprietary therapeutic temperature management solutions. http://www.medivance.com.