Medical device firm Attune Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new EnsoETM model capable of administering tube feeds and/or medication while simultaneously cooling or warming patients using the esophageal space.
The newly-cleared model of EnsoETM, which manages patient temperature through the esophagus, allows for enteral fluid administration with the ENFit connector while managing the important task of temperature management through the patient’s core. With this new extension of the EnsoETM product line, the need for a separate feeding tube is eliminated, and clinicians can leverage the EnsoETM for comprehensive temperature management as well as gain compliance with an increasingly accepted standard of care using the ENFit connector.
“Attune Medical is focused on developing innovative targeted temperature management products with increasingly useful clinical features such as this new capability to administer tube feeds and medication through our device, all while delivering a safe, cost-effective and now more comprehensive alternative to other targeted temperature management options,” commented Attune Medical’s Chief Executive Officer Keith Warner.
