Attune Medical wins FDA IDE nod to evaluate ensoETM in radiofrequency ablation procedures

[Image from Attune Medical]Attune Medical announced today that the FDA granted investigational device exemption (IDE) to study the company’s ensoETM.

Chicago-based Attune designed ensoETM to reduce esophageal thermal injury during cardiac radiofrequency (RF) ablation procedures. The IMPACT II study is underway in Europe and already enrolled nearly 20 patients.

Attune said in a news release that the single-use thermal regulating device is placed in the esophagus and connected to an external heat exchange unit. This creates a closed-loop system for heat transfer to increase or decrease patient temperature. Placement in the esophagus allows for highly efficient heat transfer due to proximity to blood flow from the heart and vessels.

The company said ensoETM’s internal placement doesn’t impede patient access during surgery. It also allows for gastric decompression and the administration of fluids and medications.  Attune designed it to simplif…

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