Advanced Cooling Therapy’s first product, the Esophageal Cooling Device (ECD), is showing benefits in the conduction of heat for warming of patients in a controlled manner in new clinical settings. A site in the European Union has used the ECD to keep challenging patients, such as burn patients, warm while undergoing complex skin procedures in the operating room, which allows clinicians to accomplish more in one setting than they ordinarily could without the ECD. Clinical studies reporting these results are in progress.
Warming patients in the operating room is important to prevent infection, wound complications, excessive blood loss, and prolonged recovery time. Guidelines developed by the Surgical Care Improvement Project (SCIP) specifically focus on maintaining optimal temperature in patients during surgery. In addition, preventing inadvertent perioperative hypothermia is recommended by major organizations, including the Centers for Medicare and Medicaid Services via the Surgical Care Improvement Project, and the American Society of Anesthesiologists. The ECD is also being used to effectively control temperature in challenging patients with central fever and ischemic injuries.
The ECD is designed to modulate and control patient temperature when clinically indicated through a single use, fully enclosed triple lumen system that is inserted into the esophagus. Two lumens attach to existing temperature modulation equipment while a third lumen simultaneously allows gastric decompression and drainage. The ECD can be rapidly inserted by most trained health care 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 ICU.
The ECD is CE marked; Health Canada approved; sold in Europe and Canada; and cleared for marketing in Australia. The device is pending clearance from the FDA for use in the U.S. •