Advanced Cooling Therapy said today it won FDA 510(k) clearance for its ECD-02 esophageal cooling device, the company’s 2nd cleared product.
The ECD-02 is designed to modulate and control patient temperature through a triple lumen system inserted into the esophagus, with 2 lumens attached to temperature modulation equipment and a 3rd lumen to provide gastric decompression and drainage.
“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. This clearance expands the ability of clinicians across the U.S. to use the ECD product with temperature modulation equipment already in their possession,” clinical services director Maria Gray said in a press release.
The Chicago-based company said the device is designed to be “rapidly inserted” by trained healthcare professionals, similar to standard gastric tubes. ACT added that no other product on the market are approved for use in the esophagus for temperature modulation.
The ECD-02 is designed to be used with the Blanketrol II and III hyper-hypothermia systems from Cincinnati Sub-Zero.
Last June, Advanced Cooling Therapy won de novo clearance from the FDA for its esophageal cooling device, claiming it as the sole temperature modulation device to use the esophagus.
The ECD won CE Mark approval in the European Union last year and is on the market in Canada and Australia.
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