FDA Grants IDE to Attune Medical’s ensoETM

The FDA has granted an Investigational Device Exemption (IDE) to Attune Medical for the evaluation of its ensoETM in the reduction of esophageal thermal injury during cardiac radiofrequency ablation procedures.

The device is a single use thermal regulating device that is placed in the esophagus — similar to a standard orogastric tube — and connected to an external heat exchange unit, creating a closed-loop system for heat transfer to increase or decrease patient temperature, the company said.

Some of the highlights surrounding this tool include its internal placement not impeding patient access during surgery and allows gastric decompression and administration of fluids and medications, according to Attune Medical.

The ensoETM device has been cleared by the FDA to control patient temperature. However, it has not been approved or cleared by the FDA to reduce thermal injury to the esophagus during radiofrequency cardiac ablation procedures.