Attune Medical has been granted de novo marketing authorisation from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related oesophageal injury resulting from radiofrequency cardiac ablation procedures.
The FDA based its decision on pre-clinical studies, computer models, three randomised controlled studies, and data on tens of thousands of patients treated in real-world uses.
Published studies that have examined the use of ensoETM for this purpose include the pilot eCOOL-AF study, the IMPACT study and a large multicentre analysis of over 25,000 patients. These studies have found up to an 83% reduction in oesophageal injuries, and a significant reduction in risk of atrioesophageal fistula (AEF), the company said in a press release.
“Historically, there have been no proven strategies to prevent oesophageal injury during ablation procedures, and injury rates have not declined despite the use of temperature probes,” commented Jason Zagrodzky (Texas Cardiac Arrhythmia, Austin, USA). “This de novo authorisation gives electrophysiologists a solution to proactively cool the oesophageal wall during ablation procedures and is a great leap forward in best practice standards and patient care. We have found a 35% reduction in fluoroscopy requirements with cooling, as well as a reduced staff workload which results in significant cost savings to hospital systems.”
“Our lab has published studies showing a 30% reduction in procedure time and a 14% improvement in long-term efficacy when using ensoETM,” noted Mark Metzl (NorthShore University Health System, Chicago, USA). “These findings have in turn been shown to result in a quicker return home for patients and a cost savings of up to US$2,135 per procedure.”
“Over the last 20 years, significant resources have been committed to mitigating serious oesophageal complications, with no meaningful results. This de novo marketing authorisation opens the door to a new standard. 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,” commented Jay Istvan, Attune Medical’s CEO.
Attune Medical’s ensoETM is a single use thermal regulating device that is placed in the oesophagus and connected to an external heat exchange unit, creating a closed-loop system for proactive controlled temperature management.