Advanced Cooling Therapy Nabs CE Mark for its Temperature Control Technology

Advanced Cooling Therapy (ACT), received CE mark in the European Union for its first product, the Esophageal Cooling Device (ECD) to control patient temperature. The Chicago, Ill.-based firm is an emerging medical device company.

The ECD is a single use, fully enclosed triple-lumen system that is inserted into the esophagus to modulate and control patient temperature when clinically indicated. 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.

ACT officials claim that no other product on the market is approved to use the esophageal environment for whole-body temperature modulation.

“As an emergency room physician, I know intimately the challenges associated with traditional temperature management—bulky blankets, expensive machines, and invasive catheter procedures,” said ACT’s Erik Kulstad, M.D., president and co-founder. “ECD is safe, easy to use, and cost-effective, and we look forward to commercialization in Europe with the CE marking.”

The product is not yet cleared by the U.S. Food and Drug Administration in the United States.