FDA approves Acclarent AERA Eustachian Tube Balloon Dilation System for OETD
22 Dec 2023
Drug Approval
Acclarent AERA is said to have been designed to suit the anatomy of the Eustachian tube for offering flexibility to address the root problem in a minimally invasive manner without the need for an incision in the eardrum
Acclarent AERA Eustachian Tube Balloon Dilation System gets FDA clearance for the treatment of OETD. (Credit: The U.S. Food and Drug Administration/Wikimedia Commons)
Acclarent has obtained approval from the US Food and Drug Administration (FDA) for the use of the Acclarent AERA Eustachian Tube Balloon Dilation System in treating persistent obstructive Eustachian tube dysfunction (OETD) in children aged 8-17.
The approval broadens the range of treatment options for paediatric patients with OETD, which was previously limited to adults.
Acclarent, a division of Johnson & Johnson MedTech, is now the first and only company to secure FDA clearance for Eustachian tube balloon dilation in children.
According to Johnson & Johnson MedTech, prior to the approval, available treatments for children with persistent OETD were restricted to procedures such as tympanostomy (ear) tubes, adenoidectomy (removal of the adenoids), and oral therapies aimed at combating infection and inflammation.
However, these options may not always address the root cause of the problem, said the medical technology company.
Acclarent president Jeff Hopkins said: “The expanded indication of the Acclarent AERA Eustachian Tube Balloon Dilation System is a transformational moment for families and children suffering with chronic ear issues.
“Today’s milestone is an example of how Acclarent collaborates with surgeons to pioneer innovation, driving better outcomes for patients with ENT conditions.”
Johnson & Johnson MedTech revealed that the Acclarent AERA was designed precisely to accommodate the anatomy of the Eustachian tube, providing flexibility to target the underlying issue in a minimally invasive manner without necessitating an incision in the eardrum.
Extensive and growing evidence from Eustachian tube balloon dilation in adults has demonstrated notable short-term improvement, long-term durability, a favourable safety profile, and superior performance when compared to medical management, said the company.
Johnson & Johnson MedTech stated that analysis of real-world evidence was conducted to assess the safety and effectiveness of Acclarent AERA in patients aged 8-17 with OETD. The findings support that Eustachian tube balloon dilation is comparable, if not superior, to tympanostomy tube placement alone.
Earlier this month, Johnson & Johnson MedTech’s subsidiary Ethicon signed a $275m deal to divest Acclarent to Integra LifeSciences.
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