The FDA expanded Johnson & Johnson's Acclarent Aera Eustachian Tube Balloon Dilation System's indication to now allow treatment in patients as young as 18 years old.
Here's what you should know.
1. The device was previously cleared for adults 22 years and older.
2. Recent evidence supports the use of local and/or topical anesthesia with the procedure as well. General anesthesia was previously studied.
3. The balloon system treats eustachian tube dysfunction. ETD blocks the narrow tube that connects the throat to the middle ear that helps the ear drain fluid and equalizes pressure.
4. Vitruvio Institute for Medical Advancement Co-Founder and Chairman Marc Dean, MD, said, "This expanded indication of Acclarent Aera, and the data regarding the procedure under local anesthesia, will help expand treatment options and bring relief to more patients with persistent ETD. The device provides a minimally invasive option for ear, nose and throat surgeons to treat persistent ETD at its source."