CHICAGO--(BUSINESS WIRE)--Chicago-based medical device firm Attune Medical announced the presentation of clinical results from the largest device study to date designed to evaluate the performance of its ensoETM patient temperature management device as an aid in the reduction of esophageal injury during cardiac ablation, a common treatment for atrial fibrillation. The ensoETM is being evaluated in this and other studies to investigate the device’s ability to reduce esophageal injury related to common ablation techniques. (The ensoETM device is FDA cleared for whole body temperature management using the esophageal space, but it has not been cleared by the FDA for reduction of thermal injury to the esophagus.)
Dr. Mark Gallagher (St. George’s University Hospital, London UK) presented the completed study results of his Improving Oesophageal Protection During Catheter Ablation for Atrial Fibrillation (IMPACT) - A Double Blind Randomised Controlled Trial which investigated whether ensoETM could effectively reduce the incidence and severity of thermal injuries to the esophagus during cardiac ablation. The randomized trial included 120 patients and compared the use of the current safety standard, a temperature monitoring probe inserted into the esophagus, to ensoETM during ablation procedures to evaluate protection of the esophagus from thermal injury as measured by post-procedure endoscopy. This study is the first randomized clinical trial to be presented and includes endoscopy-proven injury assessment to investigate the ensoETM to mitigate the risk of thermal injury complications.
In addition, Dr. Jason Zagrodzky (St. David’s South Austin Medical Center, Austin Texas) presented a poster, Fluoroscopy reduction during left atrial ablation after implementation of an esophageal cooling protocol, investigating the ensoETM as a potential strategy to reduce the use of fluoroscopy during ablation procedures. The study compared fluoroscopy time required for 91 patients using standard luminal esophageal temperature monitoring to 189 patients treated with the ensoETM.
“We are thrilled to support these key studies evaluating the ensoETM as a method for decreasing risk of esophageal injury in cardiac ablation. As with all the applications of the ensoETM, we are driven to improve patient care in everything we do, and Attune Medical is proud to advance the potential of innovative new possibilities in cardiac ablation,” commented Attune Medical CEO Keith Warner. “We believe mitigating potential injury, whether from radiofrequency or cryoablation energy, is of increasing patient and practitioner interest.”
The AF Symposium is a major scientific forum that brings together the world’s leading medical scientists and health care providers to share the most recent advances in the field of atrial fibrillation, sharing thorough and practical insight into the current state of the art in the field.
Attune Medical has developed proprietary 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 whole-body temperature management. 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. 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.