Esophageal Cooling Device to Cool and Warm Patients Receives Regulatory Approval

by Julia Samuel on  June 25, 2015 at 6:24 PM Medical Gadgets
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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.
Esophageal Cooling Device to Cool and Warm Patients Receives Regulatory Approval
Esophageal Cooling Device to Cool and Warm Patients Receives Regulatory Approval

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.

The 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.

Source: Medindia

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