Johnson & Johnson announces FDA clearance to expand indication for Acclarent AERA device

Procedures May Now Be Performed on Patients as Young as 18, New Data on Local Anesthesia Also Recognized

Johnson & Johnson Medical Devices Companies today announced that Acclarent, Inc., a leader in developing minimally-invasive Ear, Nose & Throat (ENT) technologies, has received clearance from the U.S. Food and Drug Administration (FDA) to expand the indication for the Acclarent AERA® Eustachian Tube Balloon Dilation System to include its use in patients as young as 18. The device was previously cleared only for adults aged 22 and older.

In addition, recent evidence shows the procedure may be performed with local and/or topical anesthesia – before, only general anesthesia had been studied. The use of local anesthesia may provide benefits including cost savings and time efficiencies for suitable patients.

Eustachian Tube Dysfunction (ETD) is a blockage of the narrow tube that connects the throat to the middle ear, and helps the ears drain fluid and equalize pressure. The condition, which affects up to 5 percent of adults, is often marked by ear pain, pressure in the ears, and dulled or loss of hearing. Previously, ETD was treated with medication, or surgery with ear tubes. However, failure to correct the underlying problem may lead some patients to develop chronic symptoms, persistent complaints or more serious conditions such as middle ear effusion, infections and related long-term complications.

Acclarent AERA® is the first and only device specifically designed to help treat patients with persistent ETD. The device leverages flexible technology to adapt to variations in ear anatomy to help ear, nose and throat surgeons minimize trauma through precise access and positioning. More than 9,000 patients have been treated with the Acclarent AERA® since it was first granted clearance by the FDA in 2016.

"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," said Dr. Marc Dean, a board-certified otolaryngologist in private practice and the cofounder and chairman of the Vitruvio Institute for Medical Advancement in Fort Worth, Texas. "The device provides a minimally invasive option for ear, nose and throat surgeons to treat persistent ETD at its source."

Results from a recent clinical study demonstrated a 99.7 percent technical success rate in Eustachian tubes dilated with the Acclarent AERA® device. Additionally, there were zero reported serious device- or procedure-related adverse events, and patients reported greater improvement in quality of life measures.

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