Advanced Cooling Therapy (ACT) has received CE mark approval for use of their 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.
“This new CE mark clearance addresses a significant need in a growing market, in which temperature management is increasingly important for both warming and cooling patients when clinically indicated,“ commented Markus Tödtling, International Sales Manager for ACT. “The ECD’s compatibility with a new line of control units, or heat exchangers, now available on the market, enables us to meet the growing needs of hospitals across Europe that are utilizing the Altrix Precision Temperature Management System in emergency departments, intensive care units, and operating rooms for a wide range of cooling and warming needs.”
Robin Drassler, Vice President of Sales, North America, notes that FDA clearance for the ECD compatible with the Altrix Precision Temperature Management System is still pending, but says “Because our existing product line is compatible with the majority of existing control units, the ECD is already being deployed in a growing number of hospitals worldwide.”
The ECD received 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 is licensed for sale in Canada and Australia.