Advanced Cooling Gets Hot News From the FDA

Advanced Cooling Therapy has scored a win at the FDA, garnering 510(k) clearance for its second product, the Esophageal Cooling Device, or ECD-02.

The device is used to cool or warm a patient through a system that is inserted into the esophagus.  It is ready to use in a range of environments, from the operating room to the recovery room.  According to the company, it is designed to be used with Cincinnati Sub-Zero’s Blanketrol II and III hyper-hypothermia systems.

Last June, the company received de novo clearance for its first product, the ECD-01, also used to modulate patients’ temperatures through the esophagus. ECD-01 may be used with Stryker’s Medi-Therm III hyper/hypothermia system. — Elizabeth Hollis