Marketing Of Medical Balloon Device Gets FDA’s Nod

The U.S. Food and Drug Administration has approved the  marketing of a device that uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear.

fda-bldg The Eustachian tube connects the middle ear to the back of the throat. It is normally filled with air and helps maintain equal pressure inside the ear with the surrounding environment by periodically opening and closing, like a valve.

If this function is impaired, as is the case with ETD, it results in discomfort, impaired hearing, persistent ear infections, ringing in the ears (tinnitus) or other symptoms.

“The Eustachian tube supports hearing by maintaining pressure inside the ear,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic and Ear, Nose, and Throat devices in the FDA’s Center for Devices and Radiological Health.

“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,” added Eydelman.

The agency noted that with the Aera system a doctor uses a catheter to insert a small balloon through the patient’s nose and into the Eustachian tube. Once inflated, the balloon opens up a pathway for mucus and air to flow through the Eustachian tube, which may help restore proper function. After the Eustachian tube is dilated, a doctor deflates and removes the balloon.

The FDA expressed satisfaction after the reviewed of the data on the Aera system from a randomized clinical trial of 299 patients with chronic ETD.

It noted that the most common adverse events associated with the Aera system are small tears in the lining of the Eustachian tube, minor bleeding and worsening of ETD.

The agency also advised that patients under the age of 22, patients who have a carotid artery that protrudes through a gap in the bone surrounding the Eustachian tube or patients whose Eustachian tube is always open (patulous Eustachian tube) should not use the Aera system.

The Aera Eustachian Tube Balloon Dilation System is manufactured by Acclarent, Inc., a company located in Irvine, California.

Nigel Belle, Readers Bureau, Fellow

Edited by Jesus Chan

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