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WElkins Receives 510(K) Clearance From FDA for EMT/ICU


8/31/2012 8:04:16 AM

Thursday, 30 August 2012 -- WElkins, LLC today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EMT/ICU Temperature Management System. The EMT/ICU System provides hospitals and emergency care givers a means of reducing and controlling patient temperature in a safe, non-invasive, and effective way across the continuum of care—from the critical minutes after an injury thru to the ICU and recovery. The System includes a lightweight, portable cooling unit for pre-hospital induction of therapeutic cooling, i.e. immediately after return of spontaneous circulation (ROSC), which can be crucial to patient survival and recovery. Therapeutic cooling is one of the most critical interventions for hypoxic-ischemic injury, limiting tissue damage by reducing oxygen metabolism and inflammation, while maintaining cell membrane integrity.

“We are very pleased to receive FDA market clearance for the EMT/ICU System, which is the first in a series of new microenvironment cooling products WElkins will be introducing over the next year to our civilian and military clients,” said Christopher Blodgett, Chief Operating Officer of WElkins. “With these devices, WElkins will introduce a new standard in patient temperature management—one that extends active cooling technology to the pre-hospital setting for those critical moments after an injury, in the field and during transit, all the way through to the ICU and recovery. Therapeutic hypothermia has the potential to save lives and limit long-lasting neurological damage. We are very excited to see the EMT/ICU System on the market and this represents an important first-step in WElkins’ mission to transform human survival and quality life.”

WElkins plans to launch the EMT/ICU System in the U.S. immediately and will expand to global markets early next year.

About the EMT/ICU Temperature Management System

The EMT/ICU Temperature Management System is a family of non-invasive, liquid-cooled, thermoregulatory devices that control patient temperature within a range of 30°C (86°F) to 37°C (98.6°F), wherein the therapeutic effects of cooling have the potential to minimize damage to the brain, heart and other vital organs from hypoxia, ischemia and other injurious conditions. The System comprises both a field (EMT) and hospital (ICU) Conditioning Unit. The EMT Conditioning Unit is a lightweight, rugged, battery-powered device originally developed for the U.S. Department of Defense for battlefield cooling. It is the first active cooling device to extend patient temperature management to the pre-hospital setting, enabling ultra-early induction of therapeutic hypothermia in the field, at the point of injury. The ICU Conditioning Unit is an enhanced version of the EMT Conditioning Unit designed for use in the hospital setting This version features a touchscreen graphical user interface, microprocessor-driven automatic temperature control, and patient temperature monitoring. Both Conditioning Units utilize the same patent pending Cooling Headliner, an innovative head-neck pad with pneumatic over-pressure to improve patient contact and enhance cooling rate. The Headliner has an integrated universal cervical collar for streamlined deployment in the field and during emergency medical transport.

About Patient Temperature Management / Therapeutic Cooling

Temperature management is an essential component in modern healthcare, affecting a series of physiological factors from metabolic activity to glucose level. In use for centuries, temperature management is widely recognized as a key contributor to the maintenance of normal physiology and impacts recovery after an illness. In the case of hypoxic-ischemic brain injuries—a broad constellation of conditions ranging from cardiac and respiratory arrest to carbon monoxide and other poisonous gas exposure—induced mild hypothermia appears to limit tissue damage by reducing oxygen metabolism and inflammation, while maintaining cell membrane integrity. For heart attack survivors, hypothermia after cardiac arrest (HACA) is a cost-effective way to improve long-term quality of life. The cost-effectiveness of hypothermia treatment is less than the standard benchmark $100,000 per quality-adjusted life year, according to a report from the American Heart Association. In a study published in the New England Journal of Medicine, the HACA Study Group found that therapeutic hypothermia increases patients’ chances of survival by 31% and quality of survival by 41%. Today, major medical societies in the U.S. and E.U. recommend temperature management as the standard of care therapy for many critically ill or surgical patients.

About WElkins

WElkins, LLC is dedicated to transforming human survival, quality of life, and performance in life threatening and extreme conditions across the spectrum of human activity. Founded by Bill Elkins, a father of the modern spacesuit and pioneer in microenvironment temperature regulation, WElkins fields a diverse family of liquid cooling systems with myriad applications across medical, military, industrial, and athletic markets.

For more information, please e-mail Christopher Blodgett at christopher(at)welkinsmed(dot)com or visit http://www.welkinsmed.com




   

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