ensoETM (RF ablation device)

2023: Product Announcement

On September 14, 2023, Attune Medical announced an ensoETM device designed to reduce the risk of esophageal damage during radiofrequency cardiac catheter ablation procedures.

Ablation using radiofrequency energy is a minimally invasive method of treating heart rhythm disorders. The procedure is performed with a thin flexible catheter, which is inserted through a blood vessel and brought to the source of the pathological rhythm. Next, a radio frequency pulse is applied that destroys the tissue site that provokes arrhythmia. However, there is a possibility of thermal damage to the esophagus. The ensoETM system is designed to solve the problem.

Attune Medical ensoETM

EnsoETM is a disposable thermal control device that fits into the esophagus similar to a standard orogastric probe. The product is connected to an external heat exchange unit, creating a closed loop system for proactive controlled temperature control. As a result, the risk of esophageal damage is reduced by 83%. This makes it possible to increase the efficiency of radiofrequency cardiac catheter ablation procedures and speed up the recovery of patients.

Over the past 20 years [by 2023], significant resources have been devoted to mitigating the effects of ablation on the esophagus, but there have been no significant results. The ensoETM solution makes a difference. Studies have shown improved safety and efficacy for patients, "said Jay Istvan, CEO of Attune Medical.

The EnsoETM product has received approval from the U.S. Food and Drug Administration (FDA). The device will help tens of thousands of patients with arrhythmia.^[1]

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