FDA Issues De Novo Marketing Authorization for Attune Medical's ensoETM™ to Mitigate Ablation-Related Esophageal Injury during Radiofrequency Cardiac Ablation Procedures
Friday, September 15, 2023
Attune Medical has received De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device, aimed at reducing the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.
The FDA's decision was based on extensive research, including pre-clinical studies, computer models, three randomized controlled studies, and data from tens of thousands of real-world patients. Published research, such as the eCOOL-AF pilot study, the IMPACT study, and a large multi-center analysis involving over 25,000 patients (awaiting publication in the Journal of the American College of Cardiology: Clinical Electrophysiology), has demonstrated a significant reduction in esophageal injuries, with reported reductions of up to 83%, along with a notable decrease in the risk of atrioesophageal fistula (AEF), a severe complication of ablation procedures.
Radiofrequency cardiac ablation is a common procedure used to restore normal heart rhythm in patients with atrial fibrillation, with over 300,000 of these procedures performed annually in the US alone.
Despite the use of available technologies, the risk of serious esophageal injuries has not seen a decrease for over two decades. This De Novo marketing authorization expands the approved uses of ensoETM to include reducing the likelihood of esophageal injury during radiofrequency cardiac ablation procedures. ensoETM, which has been cleared for patient temperature management since 2015, utilizes the esophageal space for temperature management and has treated over 50,000 patients in various medical settings.
Dr. Jason Zagrodzky, an Electrophysiologist at Texas Cardiac Arrhythmia, highlighted the historical lack of effective strategies to prevent esophageal injury during ablation procedures and praised the authorization as a significant advancement in patient care.
Dr. Mark Metzl, Section Chief of Cardiac Electrophysiology at NorthShore University Health System, mentioned studies showing reduced procedure times and improved long-term efficacy with ensoETM, resulting in quicker patient recovery and substantial cost savings for hospitals.
Jay Istvan, CEO of Attune Medical, expressed the importance of this De Novo marketing authorization, noting that it represents a new standard in patient safety and efficiency, with improved outcomes for patients and cost savings for hospitals.
The ensoETM is a single-use thermal regulating device inserted into the esophagus, similar to a standard orogastric tube, and connected to an external heat exchange unit, creating a closed-loop system for proactive temperature management."