The ensoETM is a single-use thermal regulating device placed in the oesophagus and connected to an external heat exchange unit to reduce the chances of ablation-related oesophageal injury due to cardiac ablation procedures
The ensoETM is a single-use thermal regulating device. (Credit: Business Wire)
US-based medical device company Attune Medical has secured the US Food and Drug Administration (FDA) De Novo marketing authorisation for its ensoETM device.
The ensoETM is a single-use thermal regulating device intended to reduce the chances of ablation-related oesophageal injury due to radiofrequency cardiac ablation procedures.
It is placed in the oesophagus and is connected to an external heat exchange unit to create a closed-loop system that facilitates proactive controlled temperature management.
Last year, the medical device company secured the FDA investigational device exemption (IDE) for the ensoETM device, in this indication.
Attune Medical CEO Jay Istvan said: “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.”
According to Attune, in the last two decades, commonly available technologies for mitigating complications have failed to reduce the risk of severe oesophageal injuries.
Its ensoETM has been approved since 2015, for controlling patient temperature, and more than 50,000 patients have been treated with the device, said the medical device company.
The FDA authorisation is based on pre-clinical studies, computer models, three randomised controlled studies, and data from thousands of patients treated in real-world uses.
The clinical trials, including the eCOOL-AF pilot study, the IMPACT study, and a large multi-centre analysis of more than 25,000 patients, have examined the use of ensoETM.
In the studies, the device showed up to an 83% reduction in oesophageal injuries, and a significant reduction in the risk of atrio-oesophageal fistula, a serious complication of ablation.
Texas Cardiac Arrhythmia electrophysiologist Jason Zagrodzky said: “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.
“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.”