Advanced Cooling Therapy LLC (ACT), has received a license for commercial sale of its first product, the Esophageal Cooling Device (ECD), from Health Canada. The device is used to control patient temperature where clinically indicated.
Health Canada is the federal department in Canada that reviews medical devices to assess their safety and effectiveness before being authorized for sale. The ECD received CE mark for European sale in April and is awaiting regulatory clearance in the United States.
The ECD is a single use, fully enclosed triple-lumen system that is inserted into the esophagus to modulate and control patient temperature. 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 the operating room, recovery room, emergency room or intensive-care unit, according to the company.
Officials for the Chicago, Ill.-based startup claim that no other product on the market is approved to use the esophagus for whole-body temperature modulation.
ACT’s President and Co-Founder Erik Kulstad, M.D., MS, said: "Monitoring and controlling a patient's temperature is an increasingly important component of patient care for a growing number of clinical conditions. As an emergency room physician, I often face the challenges associated with traditional temperature management – bulky blankets, expensive machines, and invasive catheter procedures. The ECD is safe, easy to use, and cost-effective, and we look forward to commercialization in Canada."