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Advanced Cooling Therapy Receives FDA Clearance for Esophageal Cooling Device

Advanced Cooling Therapy Receives FDA Clearance for Esophageal Cooling Device

The product is designed to modulate and control patient temperature.

10.05.15

Advanced Cooling Therapy’s first product, the Esophageal Cooling Device, has secured U.S. Food and Drug Administration (FDA) de novo clearance. The Chicago, Ill.-based devicemaker said the product is the only temperature modulation device on the market that uses the esophageal space to cool or warm patients.

The device can be used in operating rooms, recovering rooms, emergency rooms or the intensive care unit.

The product won CE Mark certification last year, and is available in Canada and Australia. Advanced Cooling Therapy plans an imminent U.S. launch.

The FDA grants de novo clearance for novel or breakthrough Class I or II medical devices with low to moderate risk.

Advanced Cooling Therapy executives claim ECD shows 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 infections, 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 through the Surgical Care Improvement Project, and the American Society of Anesthesiologists. The ECD also is 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 healthcare professionals, in similar fashion to a standard gastric tube, and can be used to control patient temperature in various settings.

"We've been getting phenomenal feedback from clinicians using our device for both cooling and warming. Cooling patients is important for a number of clinical conditions in the emergency room and intensive care unit, but warming patients is equally important in the operating room, particularly during long surgeries,” said company President/Co-Founder, Erik Kulstad, M.D., M.S.

Watch a video demonstration of the ECD below:

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