CHICAGO--(BUSINESS WIRE)--A clinical study published in the journal Resuscitation has demonstrated the efficacy and safety of Attune Medical’s EnsoETM in cooling and rewarming patients after out-of-hospital cardiac arrest (OHCA). The article, “Targeted Temperature Management Using The Esophageal Cooling Device After Cardiac Arrest (The COOL Study)”, assessed the performance and safety of the EnsoETM (previously named the Esophageal Cooling Device, or ECD) during a Targeted Temperature Management (TTM) protocol.
TTM is a therapeutic protocol that is associated with improved outcomes in patients successfully resuscitated after OHCA. The therapy is optimized by reaching and strictly maintaining a target temperature between 32-36°C for 24 hours, then slowly rewarming at a controlled rate to return to normal body temperature. In this study, all 17 patients reached 34°C and the device demonstrated an “excellent ability” to accurately maintain target temperature (on average within 0.1°C), and to rewarm at a controlled rate of 0.2°C/hr. Endoscopic evaluations to assess EnsoETM safety found no injuries attributable to the device. The authors note that other temperature management methods, such as endovascular or intraperitoneal cooling, can be expensive and invasive with a higher rate of side-effects.
- All patients (100%) reached the target temperature range.
- The cooling rate was similar to invasive technologies previously evaluated by the institution.
- Goal temperature maintenance was superior to the best advanced cooling devices.
- No adverse effects were caused by the device.
The study authors comment that the ETM could be “an interesting device to implement a 36°C protocol, because this internal device seems very efficient to correctly maintain the target temperature without the need for supplemental devices generating potential complications.”
Senior author of the article, Dr. Nicolas Deye, Researcher in Medicine and Toxicology who specializes in the field of cardiac arrest in the Intensive Care Unit of Lariboisiere University Hospital, Inserm U-942, Paris, France, commented, "The ECD is an interesting new tool to safely and easily provide precise targeted temperature management after cardiac arrest, using an alternative and semi-invasive approach."
Dr. Erik Kulstad, Attune’s CEO, Founder and inventor of the EnsoETM, remarked, “This study further validates the use of esophageal temperature management as a simple, safe and effective approach to control patient temperature, both for cooling or warming. Accurate targeted temperature management is becoming increasingly vital in a wide range of conditions, and the EnsoETM provides a clinically differentiated, cost effective solution to meet the needs of clinicians.”
Formerly known as Advanced Cooling Therapy, Attune Medical’s proprietary technology simplifies access to the patient’s core to efficiently control core temperature, whether warming or cooling. Attune Medical’s primary device, 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, or intensive care unit. No other products on the market are approved to use 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®. It 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.