Medical device firm Attune Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) 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 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, 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, RN, 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 OR 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.“