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 simplify access to the patient’s core, allowing for the efficient control of temperature. It is used in critical care units, operating rooms, and emergency departments for the intentional modulation of patient core temperature.
IMPACT II will evaluate ensoETM to determine whether using the esophageal space for temperature management can decrease collateral thermal injury in the esophagus from RF ablation for the treatment of AFib. Dr. Pasquale Santangeli and Cory Tschabrunn of the University of Pennsylvania will soon begin to enroll patients. The duo previously evaluated ensoETM in the pilot eCOOL-AF study.
“Thermal injury during RF ablation procedures is a major concern in electrophysiology,” said Santangeli. “We are optimistic based on our past experience with ensoETM that this study could validate the efficacy of this tool in reducing severe thermal injury and supporting improved outcomes for patients.”
Data from the IMPACT II study will be used to expand ensoETM’s intended use in the U.S. Attune plans to expand it to include the reduction of esophageal thermal injury during cardiac RF ablation. The U.S. component of the study is supported by a $3.8 million award from the National Heart, Lung, and Blood Institute of the National Institutes of Health.
Attune said ensoETM has FDA clearance for controlling patient temperature. It does not hold approval from the FDA for reducing thermal injury in the esophagus during RF cardiac ablation.