Medical device firm Advanced Cooling Therapy (ACT) has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its second Esophageal Cooling Device (ECD-02).
The ECD technology platform is comprised of ECD-01 and ECD-02 devices, which will use the esophageal space to cool or warm patients.
ACT has designed the new version of ECD for use with the Blanketrol II and III Hyper-Hypothermia systems, which are produced by Cincinnati Sub-Zero.
Both the devices will modulate and control patient temperature when clinically indicated through a single use and fully-enclosed triple lumen system, which is inserted into the esophagus.
Trained health care professionals will insert the ECD in patients similar to standard gastric tube, and will use the operating room, recovery room, emergency room and ICU to control patient temperature.
ACT clinical services director Maria Gray said: "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 US to use the ECD product with temperature modulation equipment already in their possession."
In June last year, the ECD-01 obtained FDA de novo clearance for use with the Medi-Therm III by Stryker.
The device also received CE mark approval in 2014 for distribution in Europe, as well as approved for sale in Canada and Australia.