ACT Receives 510(k) Clearance for Use with New Control Unit


Advanced Cooling Therapy (ACT) has received 510(k) clearance from the U.S. Food and Drug Administration for use of its Esophageal Cooling Device (ECD) with the Altrix Precision Temperature Management System by Stryker.

ACT’s technology platform provides a novel method to control patient temperature using the esophageal environment. The ECD is designed to modulate and control patient temperature when clinically indicated through a single use, fully enclosed triple lumen system that is inserted into the esophagus. Two lumens attach to existing temperature modulation equipment while a third lumen simultaneously allows gastric decompression and drainage. The ECD can be rapidly inserted by most trained health care professionals, in similar fashion to a standard gastric tube, and can be used to control patient temperature in the operating room, recovery room, emergency room, or ICU. No other products on the market are approved to use the esophageal environment for whole-body temperature modulation.

"The ECD is being adopted across the U.S., and globally, in an increasing number of hospitals to warm or cool patients when clinically indicated, and this clearance for use with the Altrix Precision Temperature Management System will further support that growth,” commented Robin Drassler, Vice President of Sales, North America. “The ECD is easy to use, doesn’t require additional capital purchase, and is compatible with the majority of available control units. We are addressing a significant demand in emergency departments, intensive care units and operating rooms for a wide range of temperature management needs.”

ACT’s ECD received U.S. FDA de novo clearance in June of 2015 for use with the Medi-Therm III by Stryker and received FDA 510(k) clearance in January 2016 for use with the Blanketrol II and III Hyper-Hypothermia systems made by Cincinnati Sub-Zero, a Gentherm Company. It received its CE Mark in Europe in 2014, with an expanded indication for use up to 120 hours in 2016 and a CE Mark for use with the Altrix System by Stryker in January 2017.  It is also licensed for sale in Canada and Australia.