Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent said today that it won de novo clearance from the FDA for its Aera Eustachian tube balloon dilation system, designed to treat persistent Eustachian tube dysfunction.
The Irvine, Calif.-based company’s Aera system consists of a balloon catheter designed to be inserted through the patient’s nose into the Eustachian tube. After insertion, the balloon is inflated to open up a pathway for mucus and air to flow through to restore proper function and reduce pressure, pain or clogged or muffled sensations in the ear, Acclarent said.
“The Eustachian tube supports hearing by maintaining pressure inside the ear. Restoring function to this important part of the middle ear may provide relief from the pain, discomfort and sensation of ear fullness or blockage associated with ETD. The Aera Eustachian tube balloon dilation system is a new treatment option for patients with ETD symptoms,” said Dr. Malvina Eydelman, director of the FDA’s Ophthalmic & Ear, Nose & Throat device division at the Center for Devices & Radiological Health.
The clearance was based on data from a 299-subject clinical trial in patients with chronic ETD. Results from the trial indicated 52% of patients treated with the Aera had a normal functioning range as measured by a tympanogram, a method used to measure mobility of the ear drum and pressure inside the ear.
Results from patients treated with the Aera system were 38% higher than the 14% of patients in the normal functioning range who were treated with conventional medical management using nasal sprays.
The most common adverse events reported with the Aera system are small tears in the lining of the Eustachian tube, minor bleeding and worsening of ETD.
In July, Acclarent said it launched the Relieva Scout multi-sinus dilation system in the U.S.