Attune Medical Receives FDA Clearance for Use of EnsoETM to Warm Patients

Attune Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for new models of its EnsoETM targeted temperature management device to raise or maintain patient temperature with Cincinnati Sub-Zero’s Norm-O-Temp Hyperthermia System. This is the company’s first clearance specifically focused on the warming application to combat patient hypothermia.
 
Two models of the EnsoETM, which manages patient temperature through the esophagus, are included in the clearance: EnsoETM with ENFit, which allows for enteral fluid administration through the device, and the original EnsoETM.
 
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, as well as the administration of enteral fluids such as tube feeds and medications in some models. 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’s Vice President of Clinical and Field Operations Maria Gray, MA, R.N., commented, “This new FDA clearance for use of our EnsoETM with the Norm-O-Temp will specifically serve to offer surgeons and anesthesiologists another option to counteract hypothermia in the O.R. for the longest and most complex cases. With a broadening interest in temperature management, and increased needs in the operating room, we are addressing the importance of warming patients to avoid complications like increased blood loss, post-operative infections, and prolonged length of stay.”
 
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 Medical (as Advanced Cooling Therapy) received FDA de novo clearance for the EnsoETM (Esophageal Cooling Device or ECD) in 2015 for use with the Medi-Therm III by Stryker Corp. 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. The EnsoETM model for use with enteral feeding was cleared by the FDA in January 2018. 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.