IMPACT II trial expands to USA following FDA exemption approval


The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to Attune Medical to evaluate the company’s ensoETM in the reduction of oesophageal thermal injury during cardiac radiofrequency (RF) ablation procedures.

The study—Improving oesophageal protection during catheter ablation for atrial fibrillation (IMPACT II)—is underway in Europe and has already enrolled nearly 20 patients in the global evaluation.

IMPACT II is a multi-national, multicentre randomised controlled trial (RCT) evaluating the ensoETM to ascertain whether using the oesophageal space for temperature management can decrease collateral thermal injury in the oesophagus from RF ablation for the treatment of atrial fibrillation (AF). Its predecessor, the IMPACT single-centre study, was published in Europace last year.

The principal investigators in the USA, Pasquale Santangeli and Cory Tschabrunn) are currently with the Hospital of the University of Pennsylvania (Philadelphia, USA) and will soon begin to enrol patients in support of the study. Santangeli and Tschabrunn previously evaluated the ensoETM in the pilot eCOOL-AF study.

“Thermal injury during RF ablation procedures is a major concern in electrophysiology,” commented 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.”

The data from this study will be used to expand the ensoETM’s intended use in the USA to include reduction of oesophageal thermal injury during cardiac radiofrequency ablation procedures.

The US component of the study is supported by a US$3.8 million Small Business Innovation Research (SBIR) award from the National Heart, Lung, and Blood Institute of the National Institutes of Health.

Attune Medical’s ensoETM is a single use thermal regulating device that is placed in the oesophagus (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. Its placement in the oesophagus, with proximity to blood flow from the heart and great vessels, allows highly efficient heat transfer. Unlike surface warming devices, ensoETM‘s internal placement does not impede patient access during surgery and allows gastric decompression and administration of fluids and medications.

Attune Medical has developed a novel medical device technology that simplifies access to the patient’s core to efficiently control temperature and is the only device FDA-cleared for use in the oesophagus for patient temperature management. The ensoETM device is used in critical care units, operating rooms, and emergency departments for the intentional modulation of patient core temperature and can be rapidly placed by most trained healthcare professionals.

The ensoETM has been cleared by the FDA to control patient temperature. The ensoETM has NOT been approved or cleared by the FDA to reduce thermal injury to the oesophagus during radiofrequency cardiac ablation procedures.


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