CHICAGO--(BUSINESS WIRE)--Chicago-based medical device firm Attune Medical has received notification from the US Food and Drug Administration (FDA) that it has cleared the EnsoETM esophageal temperature management device for an extended duration of use for up to 72 hours. The EnsoETM is the only patient temperature management system cleared for use in the esophageal environment for whole-body temperature modulation, including both warming and cooling.
“As awareness of the importance of effective targeted temperature management increases, the EnsoETM delivers a simple and innovative solution for a complex therapy. Recent studies have shown the EnsoETM to have substantial benefits, including temperature maintenance capabilities that exceed those of competitors, and significant cost savings; this extended dwell time is a strong step forward in patient care that will help clinicians in the US in a multitude of clinical settings,” commented Maria Gray, Attune’s VP of Clinical Services.
Formerly known as Advanced Cooling Therapy, Attune Medical has developed proprietary medical device technology that simplifies access to the patient’s core to efficiently control core temperature. Whether warming or cooling, the company’s technology platform optimizes, or “tunes,” patient temperature safely and effectively. Attune’s initial product, the EnsoETM (formerly Esophageal Cooling Device or ECD), is designed to modulate and control patient temperature through a single-use, fully-enclosed system that is inserted into the esophagus. Two lumens attach to an external heat exchange unit while a third, independent, lumen simultaneously allows gastric decompression and drainage. The EnsoETM can be rapidly placed by most trained healthcare 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, and/or intensive care unit. No other products on the market are cleared for use in the esophageal environment for whole-body temperature modulation.
Attune Medical (as Advanced Cooling Therapy) received US FDA de novo clearance for the EnsoETM (Esophageal Cooling Device or ECD) in 2015 for use with the Medi-Therm III by Stryker®. The company received FDA 510(k) clearance in 2016 for use with the Blanketrol® II and III Hyper-Hypothermia systems made by Cincinnati Sub-Zero, a Gentherm Company, and FDA 510(k) clearance for use with the Altrix System by Stryker® in 2017. 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 2017. It is also licensed for sale in Canada and Australia.