FDA Grants IDE Approval to Evaluate Attune Medical’s ensoETM in Radiofrequency Ablation Procedures

US Arm of IMPACT II Study Will Ascertain Reduction of Esophageal Thermal Injury During Cardiac RF Ablation Procedures

CHICAGO--(BUSINESS WIRE)--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 esophageal thermal injury during cardiac radiofrequency 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, multi-center randomized controlled trial evaluating the ensoETM to ascertain whether using the esophageal space for temperature management can decrease collateral thermal injury in the esophagus from radiofrequency (RF) ablation for the treatment of atrial fibrillation. Its predecessor, the IMPACT single-center study, was published in Europace last year.

The principal investigators in the US, Pasquale Santangeli, M.D., Ph.D. (Associate Professor of Medicine and Co-Director, Penn Ventricular Tachycardia Center), and Cory Tschabrunn, PhD, (Research Assistant, Professor of Medicine and Director, Translational Cardiac Electrophysiology), are currently with the Hospital of the University of Pennsylvania and will soon begin to enroll patients in support of the study. Drs. 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 Dr. 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 US to include reduction of esophageal thermal injury during cardiac radiofrequency ablation procedures.

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

Attune Medical’s ensoETM 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. Its placement in the esophagus, with proximity to blood flow from the heart and great vessels, allows highly efficient heat transfer. Unlike surface warming devices, ensoETM‘s internal placement doesn‘t 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 esophagus 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 esophagus during radiofrequency cardiac ablation procedures.

ⁱResearch reported in this publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number R44HL158375. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.