LOUISVILLE, Colo., Jan. 5 /PRNewswire/ -- The European Resuscitation Council (ERC) and Elsevier's journal Resuscitation chose a randomized controlled study demonstrating a trend toward faster cooling and better control with Medivance's Arctic Sun® Temperature Management System as its featured "Article of the Month." The article chosen for December 2009 and published in the January 2010 edition is entitled, "A randomized controlled trial comparing the Arctic Sun to standard cooling for induction of hypothermia after cardiac arrest."
The study was conducted at five hospitals in the U.S. in 2004-2007 that were among the first to implement the joint AHA/ERC guidelines for the treatment of comatose patients after cardiac arrest. Sixty-four patients were enrolled in the study and treated with post arrest cooling; approximately half with standard methods supplemented with ice and the other half with the Arctic Sun Temperature Management System alone.
"The article is a good source of information about the issues and challenges often encountered by hospitals that are just beginning the process of implementing a cooling program for post arrest patients," said Dr. Kennon Heard, principal investigator and Associate Professor of Surgery and Medicine at the University of Colorado School of Medicine. "Despite the steep learning curve associated with new cooling procedures and the small sample size of the study, the Arctic Sun was easy to use and showed a trend of faster cooling and more precise temperature control than cooling blankets supplemented with ice."
In addition, although the study was not powered for clinical outcomes, the high proportion of patients with good neurological outcomes (CPC 1 or 2) is similar to or better than other studies of controlled hypothermia," he added.
"It is an honor for this study conducted with the Arctic Sun to be featured by the journal Resuscitation," stated Robert Kline, President and CEO of Medivance. "At the time the study was undertaken, Targeted Temperature Management(TM) was not as widely implemented as today and the lessons learned provide a good starting point for hospitals looking to start or improve their own cooling programs."
Cooling a standard of care
Since 2005, when the American Heart Association (AHA) issued recommendations and guidelines for inducing mild hypothermia in comatose survivors of cardiac arrest, adoption of therapeutic cooling has been on the rise. A rapidly growing body of medical literature suggests it may also reduce damage resulting from refractory fevers and other critical illnesses such as stroke and traumatic brain injury.
The noninvasive Arctic Sun Temperature Management System precisely monitors and maintains core body temperature in a therapeutic range, between 32 degrees and 38.5 degrees Celsius (approximately 89.6 degrees 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(TM) Pads enables the transfer of 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 has received 510(k) FDA clearance in the U.S., the European Union's CE Mark, and marketing approval in Japan and other global markets. Medivance develops and manufacturers proprietary Targeted Temperature Management solutions.