New Feeding and Warming Device Gains FDA Clearance

A new model of the EnsoETM, capable of enteral fluid administration while also managing body temperature through a patient’s core, was granted 510(K) clearance from the FDA, according to a release from Attune Medical.

The new model will provide food, medication, and warming or cooling to a patient through the esophagus in conjunction with the ENFit connector, another product available from the company. The device will allow physicians to administer food without the need for a separate feeding tube while managing the body temperature of the patient.

“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,” said Keith Warner, CEO of Attune Medical—formerly known as Advanced Cooling Therapy.

The original model of the EnsoETM, which was called the Esophageal Cooling Device, received FDA clearance in 2015. The new model is the only device on the market cleared for body temperature management through the esophagus, according to a company press release.

Daniel I. Sessler, MD, the Michael Cudahy Professor and Chair of the Department of Outcomes Research at the Cleveland Clinic, in Ohio, and the senior author of the study that tested the effectiveness of the device, said in a company press release, “Our study found that an advantage of esophageal heat exchange is that heat is transferred directly into the core, and thus rapidly warming or cooling the patient.”