WALDWICK, NJ, Sept. 27, 2010 – Life Recovery Systems (LRS) is pleased to announce that the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has increased the funding for the ongoing study of the use of the ThermoSuit System in patients with acute myocardial infarction (AMI). The IDE-cleared study is seeking to demonstrate the feasibility of rapidly cooling AMI patients in the emergency department prior to percutaneous coronary intervention (PCI).
Previous research has suggested that cooling prior to coronary reperfusion may reduce myocardial injury. Providing the fastest noninvasive cooling available, the ThermoSuit System likely is the only noninvasive approach eligible to succeed in this application. Following the current ThermoSuit Study, LRS intends to conduct a second study to demonstrate statistically significant treatment benefits of ThermoSuit-induced cooling for AMI patients.
A previous clinical study of the ThermoSuit System published earlier this year in the peer-reviewed journal Resuscitation demonstrated that LRS' patented cooling device cooled patients to a therapeutic level in a median time of 37 minutes. This was approximately five times faster than the median cooling time reported in a similar study of other hypothermia devices previously published by Resuscitation.
The goal of the current study is to demonstrate the ease of completing the patient cooling process within the 90-minute door-to-balloon window targeted for AMI patients. The ThermoSuit System is the only product that utilizes the highly efficient approach of direct contact liquid convection to cool patients. The device features a lower blanket with a soft porous lining that minimizes pressure points on the skin and enables free flow of coolant beneath the patient. A top sheet cools from above, and this includes a Velcro® closure that enables easy access to the patient during the cooling process.
The computer-controlled pumping and temperature monitoring system includes a touch-screen user interface with a message panel to guide the user though the feedback-controlled cooling process. The system can be set up in less than 10 minutes by nurses and does not require catheterization. The ease of setup, rapid cooling, and safety of the ThermoSuit System are making it the cooling device of choice in a growing number of hospitals in the U.S.
The ThermoSuit System is cleared by the FDA for temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients and for temperature monitoring. It is CE marked and licensed by Health Canada. In 2009 the ThermoSuit earned a Medical Design Excellence Award in a design competition sponsored by Canon Communications, and it was named as one of “2009’s Top Five Innovative Devices” by medicaldevice-network.com. Life Recovery Systems will be exhibiting the ThermoSuit System at the Scientific Sessions (Booth 2117) of the American College of American Physicians (ACEP) in Las Vegas, September 28th – 30th, 2010.
For additional information about Life Recovery Systems and the ThermoSuit System, go to www.life-recovery.com.
1. Howes D et al, “Rapid Induction of Therapeutic Hypothermia using Convective-Immersion Surface Cooling: Safety, Efficacy, and Outcomes”, Resuscitation 2010 Vol. 81, no .4, 388-392.
2. Heard KJ et al, “A randomized controlled trial comparing the Arctic Sun to standard cooling for induction of hypothermia after cardiac arrest”, Resuscitation 2010 Vol 81, No. 1, 9-14.