Johnson & Johnson MedTech unit Acclarent announced that it won a new FDA clearance for its Aera Eustachian tube balloon dilation system.
While Acclarent still belongs to Johnson & Johnson, Integra Lifesciences is set to buy it for $275 million next year. While the completion of that deal awaits, the company cleared a regulatory hurdle that expands the patient population for its Aera system.
The new FDA clearance expands access to children aged eight to 17 with persistent obstructive Eustachian tube dysfunction (OETD). Previously only indicated for adults, the system can now treat pediatric patients, making Acclarent the first and only company to achieve a pediatric indication for a Eustachian tube balloon dilation system, according to a news release.
Until now, according to Acclarent, children with persistent OETD only had a handful of options. Those included tympanostomy (ear) tubes, adenoidectomy (removal of the adenoids) and oral therapies to fight infection and inflammation. However, the company says those methods can fail to treat the source of the problem.
Acclarent specifically designed Aera for the Eustachian tube anatomy. It features flexibility to reach the source of the problem in a minimally invasive way without an incision on the ear drum. Data from adults demonstrated significant short-term improvements, long-term durability, favorable safety and superior performance.
The Eustachian tube anatomy of children aged eight and older closely matches that of adult patients. Real-world evidence in that patient population demonstrated comparable, if not superior, results compared ot tympanostomy tubes.
“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,” said Jeff Hopkins, president, Acclarent. “Today’s milestone is an example of how Acclarent collaborates with surgeons to pioneer innovation, driving better outcomes for patients with ENT conditions.”