Esophageal Cooling Device (ECD) developed by Advanced Cooling Therapy; a company based in Chicago has received FDA clearance, in effect creating a new category of regulated medical devices.
The ECD is used to cool patient body temperature via the esophagus. It is a disposable, single use device that has three channels, two of which are for running fluids and the third one for drainage and decompression.
AdvertisementThe ECD is inserted in a similar fashion to a standard orogastric tube, and can be used to control patient temperature from within. Two lumens attach to existing temperature modulation equipment while a third lumen simultaneously allows gastric decompression and drainage.
This is the first device the FDA has green lit to do such a trick, though the technology has already been used clinically in Europe, Canada, and Australia for about a year now.
"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," commented Dr.Erik Kulstad, ACT's President and Co-Founder.