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The ECD01 model of ensoETM™ is indicated as follows: The ensoETM™ is a thermal regulating device, intended to: - 1. connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature. - 2. connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and - 3. provide gastric decompression and suctioning. The ECD02 model of ensoETM™ is indicated as follows: The ensoETM™ is a thermal regulating device, intended to: - 1. connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature. - 2. connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia Systemto reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and - 3. provide gastric decompression and suctioning.

The ensoETM is a multi-lumen silicone tube that is placed in the esophagus in a manner similar to a standard orogastric tube. The primary function of the ensoETM™ is to connect to an external heat exchanger to either (1) cool or warm a patient or (2) cool the esophagus to reduce the likelihood of thermal injurv after radiofrequency (RF) cardiac ablation procedures. The external heat exchanger circulates warmed or chilled water through the two outer lumens of the ensoETMTM. One outer lumen serves as the water inflow, while the other serves as the water outflow. The distal end of the ensoETM™ contains an opening between the two outer lumens, allowing the water to circulate back to the external heat exchanger without contacting the patient. The central lumen of the ensoETM™ is open to the stomach to allow for gastric decompression and suction. The ensoETM™ is primarily composed of standard medical-grade silicone. The ensoETMIM is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less.