CHICAGO--(BUSINESS WIRE)--A new clinical study has demonstrated that Attune Medical’s EnsoETM esophageal temperature management device reduced shivering and medication costs when compared to other methods of temperature management to achieve normothermia in patients with non-traumatic brain injury. The study, published in the journal Therapeutic Hypothermia and Temperature Management, compared the EnsoETM to both surface and endovascular temperature modulating devices in a total sample of 32 patients (8 EnsoETM recipients and 24 controls).
In patients with acute neurologic conditions affecting the brain, such as stroke, intracerebral hemorrhage, and trauma, fever can result in further harm. Advanced temperature management devices are often used to prevent or reverse fever in this patient population. However, actively cooled patients commonly experience shivering, which can be detrimental and reverse the benefit of targeted temperature management.
In this prospective study, authors evaluated EnsoETM performance, patient shivering burden, and shivering interventions. The authors then compared shivering medication administration in the EnsoETM group with 24 similar patients who were cooled using other methods.
The study found that the EnsoETM achieved and maintained normothermia in patients with subarachnoid and intracranial hemorrhage with similar efficacy, but was associated with less shivering and significantly lower pharmaceutical costs than other devices, largely driven by the decreased need for anti-shivering medications.
Mean daily cost with the EnsoETM was $124 and with controls was $233, and mean total cost (factoring in the multi-day treatment) was $497 for the EnsoETM and $1,157 for controls, resulting in a total cost savings of almost $700 over the course of treatment.
First author of the article, Imad Khan (University of Rochester School of Medicine and Dentistry, Division of Neurocritical Care, Department of Neurology), commented, "We found the requirement for medical interventions for shivering used by EnsoETM recipients to be significantly less than a matched cohort of patients, resulting in a significant cost savings compared to other devices."
Maria Gray, Attune’s VP Clinical Services, remarked, “Effective temperature management is a growing requirement for improved patient outcomes in a number of clinical arenas, including the ICU, ED and surgical suite. We are thrilled that this study shows the EnsoETM cools effectively, and does so for a lower cost than other accepted temperature management devices.“
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’s initial product, 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. 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 Medical (as Advanced Cooling Therapy) received US FDA de novo clearance for the EnsoETM (Esophageal Cooling Device or ECD) in 2015 for use with the Medi-Therm III by Stryker®. 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. 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.