Attune Medical Receives US FDA’s clearance for new EnsoETM

Attune Medical has acquired 510 (k) clearance from the US Food and Drug Administration for new EnsoETM that administers tube feeds medication while cooling or warming patients at the same time using the esophageal space.

The new model regulates and conditions the temperature through the esophagus calling for enteral fluid administration with the ENFit connector thus eliminating the requirement for a separate feeding tube. The process includes two lumens attached to an external heat exchange unit while a third, independent, lumen simultaneously allowing gastric decompression, drainage, or the administration of enteral fluids such as tube feeds and medications. The EnsoETM can be rapidly placed by most trained healthcare professionals, in a 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. 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.

Attune Medical’s Chief Executive Officer Keith Warner said “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.”