Acclarent, Inc. announced the U.S. availability of the Acclarent Aera Eustachian tube balloon dilation system, the first balloon dilation intervention approved by the U.S. Food and Drug Administration (FDA) for Eustachian tube dysfunction (ETD). Acclarent Aera is the only balloon dilation device that offers a minimally-invasive option to treat the source of ETD, a condition often marked by ear pain, pressure and dulled hearing.
“Health care providers treating ETD frequently see ear infections, pressure or blockage, or complaints such as hearing loss and pain,” said Dr. Dennis S. Poe, professor of otolaryngology at Harvard Medical School and Boston Children’s Hospital. “As discussed at the recent American Academy of Otolaryngology annual meeting, doctors do their best to treat these conditions, but until now—with the launch of Acclarent Aera—options did not address the root of the problem with the Eustachian tube itself.”
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See related story … FDA Permits Marketing Balloon Device to Treat Persistent Eustachian Tube Dysfunction
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ETD is a condition that affects approximately 1 percent of adults.1 Eustachian tubes are typically responsible for equalizing pressure in the middle ear, but when the tube is not functioning properly, patients may feel pain, pressure, or a sense of fullness or clogging. People with ETD may also experience hearing loss or ringing in the ear. Previously, ETD was treated with medications or surgery with ear tubes, one of the most commonly performed of all operations. However, failure to correct the underlying problem could lead patients to develop chronic symptoms, persistent complaints or more serious conditions such as middle ear effusion, infections and related long-term complications.
Acclarent Aera leverages the company’s innovative balloon catheter technology to dilate dysfunctional Eustachian tubes by inserting a small balloon into the tube and inflating the balloon. The device also offers the necessary flexibility to adapt to Eustachian tube anatomy to help ear, nose and throat (ENT) surgeons minimize trauma through precise access and positioning.
Results from clinical studies demonstrated a 99.7 percent technical success rate in Eustachian tubes dilated. Studies also found a greater rate of tympanogram normalization than control subjects treated with medical management alone (51.8 vs. 13.9 percent), as well as a greater improvement in quality of life measures. Additionally, there were zero reported serious device- or procedure-related adverse events.2
“We are excited to be first to launch an FDA-approved device in the United States that will help otolaryngologists directly restore physiologic Eustachian tube function and middle ear ventilation,” said Dr. William Kane, medical director at Acclarent. “The device is built on Acclarent’s pioneering technologies and provides physicians with a minimally-invasive and clinically-superior option for treating ETD that goes beyond managing the symptoms.”
About Acclarent, Inc.
Acclarent, Inc., part of Johnson & Johnson Medical Devices Companies, is located in Irvine, CA. Its singular focus is to free patients to live better lives by designing, developing and commercializing medical devices that address conditions affecting the ear, nose and throat. For more than a decade, Acclarent has led the field in delivering innovative technologies to ENT surgeons. For more information: www.acclarent.com.
Caution: Federal (U.S.) law restricts the sale, distribution or use of the Acclarent Aera by or on the order of a physician who is trained in the use of Acclarent technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices.
For Physicians: Acclarent Aera is intended for use by physicians who are trained on Acclarent technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices.
For Patients: Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices. Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you.
1 Browning G, et al. The prevalence of middle ear disease in the adult British population. Clin Otolarvngol. 17, 317-321, 1992.
2 Acclarent Aera Instructions For Use.
(Source: PR Newswire)
