Healthcare Industry News:  hypothermia 

Devices FDA

 News Release - January 19, 2016

Medical Device Firm Advanced Cooling Therapy Receives 510(k) Clearance from FDA for Second Esophageal Cooling Device to Cool and Warm Patients

CHICAGO--(Healthcare Sales & Marketing Network)--Emerging medical device firm Advanced Cooling Therapy (ACT) has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its second product, the Esophageal Cooling Device (ECD-02), in the United States. The Esophageal Cooling Device (ECD) technology platform, which includes ACT’s ECD-01 and ECD-02, is the only temperature modulation device available that uses the esophageal space to cool or warm patients. This new version of the ECD is designed for use with the Blanketrol® II and III Hyper-hypothermia systems made by Cincinnati Sub-Zero.

The ECD-02, along with Advanced Cooling Therapy’s first product, the ECD-01, is designed to modulate and control patient temperature when clinically indicated through a single use, fully-enclosed triple lumen system that is inserted into the esophagus. 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 health care 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 ICU. No other products on the market are approved to use the esophageal environment for whole-body temperature modulation.

The ECD-01 received FDA de novo clearance in June of 2015 for use with the Medi-Therm III by Stryker®. It also received its CE Mark in Europe in 2014, and is licensed for sale in Canada and Australia.

"Hundreds of clinicians continue to report great satisfaction with the ECD from a growing number of important clinical sites across the globe, noting that they are able to obtain core temperature control without the risks, complexities, and higher costs of traditional products," commented Maria Gray, Director of Clinical Services. “This clearance expands the ability of clinicians across the US to use the ECD product with temperature modulation equipment already in their possession.”

Advanced Cooling Therapy’s technology platform provides a novel method to control patient temperature where clinically indicated using the esophageal environment.


Source: Advanced Cooling Therapy

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