FOR IMMEDIATE RELEASE
Wednesday, July 9th, 2014
FDA APPROVES LIFE RECOVERY SYSTEMS TO CONDUCT CLINICAL STUDIES OF THERMOSUIT® COOLING OF HEART ATTACK AND STROKE PATIENTS
KINNELON, NJ – Life Recovery Systems announced today that the US Food and Drug Administration (FDA) has approved two investigational device exemptions (IDE’s) to study the use of the ThermoSuit® System in the treatment of heart attack and ischemic stroke.
According to Dr. Robert Schock, Vice President of R&D for the firm, “We are eager to see our rapid cooling treatment evaluated in victims of heart attack and stroke, as preliminary data predict that cooling will be most effective if it is provided close to the time of reperfusion.” Patients in both trials will be cooled while under sedation, with the intent of reaching a state of therapeutic hypothermia in approximately 30 minutes or less.
The ThermoSuit System uses direct liquid contact with the patient to reduce core body temperature. A thin film of ice water is circulated over the patient’s body until the temperature reaches a pre-set limit, at which point the water is automatically removed from the suit. The system is easily set up by nurses or technicians in minutes and cools to a therapeutic temperature of 33˚C in about 30 minutes. The patient is then removed from the suit and remains cold for hours without the need for further maintenance, allowing unencumbered access for imaging or treatment in the Cath. Lab.
About Life Recovery Systems
Founded in 2003, Life Recovery Systems focuses on ground breaking, innovative medical devices for the emergency medical care market. Its mission is to save and preserve the quality of lives. Its first product, the ThermoSuit System, was developed with the assistance of NIH NHLBI funding to provide physicians and nurses with a safe, convenient, and extremely rapid method for cooling patients. It has received FDA 510(k) clearance for “temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients.” It won a Medical Design Excellence Award in 2009, and multicenter clinical results were published in the Journal Resuscitation in 2010. Headquartered in Kinnelon, NJ, Life Recovery Systems also has offices in Alexandria, LA and Napa, CA. http://www.life-recovery.com.
Contact: Robert Schock
Life Recovery Systems enthusiastically welcomes Lewistown Hospital, a non profit, 123-bed acute care community hospital in Lewistown, PA, as one of our newest clients. Lewistown Hospital’s mission is to provide personal, high quality economical healthcare for their community, by providing direct access to specialty services through collaboration with advanced specialty centers. This vision is directly aligned with LRS, as we strive to save and preserve the quality of lives with our cutting edge medical devices for the emergency care market.
LRS is eager to provide our services to Lewistown Hospital and be a part of their contributions to the improvement of the health status of their communities, serving 80,000 residents of Mifflin and Juniata counties, and members of the contiguous counties Centre, Perry, Snyder & Hutingdon.–>