FDA grants de novo approval for device to reduce ablation-related esophageal injury
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Key takeaways:
- The FDA granted de novo authorization for a single-use silicone tube designed to reduce radiofrequency ablation-related esophageal injury.
- More than 50,000 patients have been treated with the device to date.
Attune Medical was granted de novo marketing authorization from the FDA for its single-use silicone tube designed to reduce the odds of radiofrequency ablation-related esophageal injury.
The tube (ensoETM) is a single-use thermal regulating device placed in the esophagus and connected to an external heat exchange unit designed for proactive temperature management during cardiac ablation procedures, according to a company press release.
The decision was based on preclinical studies, computer models, three randomized controlled studies, and real-world data that demonstrated an up to 83% reduction in esophageal injuries and a significant reduction in risk for atrioesophageal fistula, according to the release.
More than 50,000 patients have been treated with the device to date, the company stated in the release.
“Historically, there have been no proven strategies to prevent esophageal injury during ablation procedures, and injury rates have not declined despite the use of temperature probes,” Jason Zagrodzky, MD, FHRS, an electrophysiologist at Texas Cardiac Arrhythmia in Austin, Texas, said in the release. “This De Novo authorization gives electrophysiologists a solution to proactively cool the esophageal 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.”
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