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 granted the device de novo clearance earlier this month for use in RF ablation procedures.
The study, published in the Journal of the American College of Cardiology: Clinical Electrophysiology (JACC-EP), compared ensoETM to luminal esophageal temperature monitoring. It found a significant reduction in the rate of atrioesophageal fistulas (AEFs) during cardiac ablation of the left atrium when using ensoETM. AEF, the most severe form of esophageal injury that occurs during ablation procedures, often leads to death, Attune says.
The results of the Attune Medical study
According to a news release, the study incorporated data from more than 25,000 patients across 30 U.S. hospitals.
It found that, in 10,962 patients receiving luminal esophageal temperature monitoring, 16 developed an AEF. In 14,224 patients receiving ensoETM, none presented an AEF.
Attune Medical said the authors concluded that active esophageal cooling during RF ablation of the left atriam for treating AFib offered a significant AEF rate reduction. Dr. Javier Sanchez, a cardiac electrophysiologist in Texas, called ensoETM “remarkably effective.” He said he considers it the standard of care for esophagus protection.
More than 50,000 patients received ensoETM treatments since it first became available in 2015.
“Because the ensoETM is visible on intracardiac echocardiography, we’re able to perform our procedures without fluoroscopy, offering further benefits to patients and staff by reducing radiation exposure and eliminating the need to wear heavy lead protective shields throughout the case,” said co-author Dr. Christopher Woods, Jim & Carol White Chair in Cardiovascular Research, Sutter Health.
