Advanced Cooling Therapy (ACT) has obtained de novo clearance from the US Food and Drug Administration (FDA) for its new Esophageal Cooling Device (ECD).
The approval will allow the company to sell and distribute ECD in the US which will be used to modulate and control patient temperature in the operating room, recovery room, emergency room, or ICU.
The system will work when clinically indicated through a single use, fully-enclosed triple lumen system that is inserted into the esophagus.
The triple lumen system has two lumens attached to existing temperature modulation equipment while a third lumen simultaneously allows gastric decompression and drainage.
ACT president and co-founder Erik Kulstad said: "ACT pioneered the field of core temperature management through the esophagus. With this regulatory milestone, we are looking forward to bringing the ECD to the US, offering advanced patient temperature management in an efficient, easy-to-use device that can be quickly placed by a range of healthcare providers in the ER, OR and ICU.
"Our feedback from clinicians in Canada, Europe, and Australia using the ECD to both cool and warm patients has been impressive, and we anticipate strong adoption in the US."
Last year, the ECD received its CE Mark in Europe for sale in Canada and Australia.