Chicago-based Attune designed ensoETM to reduce the likelihood of ablation-related esophageal injury. These injuries occur as a result of radiofrequency (RF) cardiac ablation procedures. ensoETM received FDA investigational device exemption (IDE) for this indication just over one year ago.
The FDA nod came on the back of pre-clinical studies, computer models, three randomized controlled studies and data from tens of thousands of patients treated in real-world settings. Studies demonstrated up to an 83% reduction in esophageal injuries. Additionally, ensoETM reduced the risk of atrioesophageal fistula (AEF), a complication of ablation procedures.
De Novo authorization expands ensoETM’s indications for use to reduce the likelihood of esophageal injury in these procedures. Attune Medical received clearance for the device to control patient temperature in 2015. More than 50,000 patients received ensoETM treatments to date across a range of healthcare settings.
The single-use, thermal regulating device goes into the esophagus, similar to a standard orogastric tube. It connects to an external heat exchange unit, creating a closed-loop system for proactive controlled temperature management.
“Over the last 20 years, significant resources have been committed to mitigating serious esophageal complications, with no meaningful results. This De Novo marketing authorization opens the door to a new standard,” said Attune Medical CEO Jay Istvan. “Studies have shown improved safety and efficacy for patients while allowing improved efficiency for physicians and greater cost savings for the hospitals in which they operate.”
