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New portable therapeutic cooling system gets FDA clearance

The EMT/ICU system includes lightweight, portable cooling unit for pre-hospital induction

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Image WElkins

Medical Industry Week

WElkins has secured 510(k) clearance for its EMT/ICU temperature management system, which provides hospitals and emergency care givers with a means of reducing and controlling patient temperature in a safe, non-invasive and effective way across the healthcare environment —from the critical minutes after an injury through to the ICU and recovery areas.

The EMT/ICU system includes a lightweight, portable cooling unit for pre-hospital induction of therapeutic cooling, the process 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-ischaemic injury, limiting tissue damage by reducing oxygen metabolism and inflammation, while maintaining cell membrane integrity. WElkins plans to launch the EMT/ICU system in the US immediately and will expand to global markets early in 2013.

The EMT/ICU range of non-invasive, liquid-cooled, thermoregulatory devices control patient temperature within a range of 30°C to 37°C, wherein the therapeutic effects of cooling have the potential to minimise damage to the brain, heart and other vital organs from hypoxia, ischaemia and other injurious conditions.

The system comprises both a field (EMT) and hospital (ICU) conditioning unit. The EMT conditioning unit is a battery-powered device originally developed for the US 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 features a touchscreen graphical user interface, microprocessor-driven automatic temperature control and patient temperature monitoring. Both units use the same patent pending Cooling Headliner, a 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.

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