Acclarent, Inc. announced today the launch of the ACCLARENT AERA™ Eustachian Tube Balloon Dilation System for the treatment of adult patients with Eustachian Tube Dysfunction (ETD), a condition marked by ear pain, pressure and dulled hearing. The ACCLARENT AERA™ is cleared for use in Europe and is now available in Nordic countries.
The ACCLARENT AERA™ leverages the company's innovative balloon catheter technology and expertise to help physicians treat patients suffering from ETD. The ACCLARENT AERA™ System dilates an obstructed Eustachian tube by inserting a small balloon into the Eustachian tube and inflating the balloon. The balloon is then deflated and removed.
"The ACCLARENT AERA™ offers a minimally-invasive and promising option for patients suffering from Eustachian Tube Dysfunction," said Dr. Juha Silvola, MD, PhD, Consultant in Otology-Otoneurology at Rikshospitalet, Oslo University Hospital, Oslo, Norway. "In my initial experiences with the ACCLARENT AERA™, the device enabled me to safely and successfully dilate my patients' Eustachian tubes."
ETD occurs when the Eustachian tube, a canal extending from the middle ear to the nasopharynx, cannot open properly. Patients with ETD often feel like their ears are perpetually clogged, deal with earaches, or experience impaired hearing. For many with ETD, this is a way of life and current treatment options may not resolve the problem, leaving patients and Ear, Nose and Throat (ENT) physicians frustrated. Current treatment options for ETD include medication and ear tubes, which may relieve symptoms. More invasive surgery may be necessary to address severe complications.
"Physicians and patients worldwide face many challenges in treating Eustachian Tube Dysfunction," said Dennis S. Poe, MD, associate professor of otology and laryngology at Boston Children's Hospital in Boston, Mass and co-primary investigator of the US-based clinical trial for the Eustachian Tube Balloon Dilation System. "ACCLARENT AERA™ may be a promising new option to fulfill an unmet need in the treatment of Eustachian Tube Dysfunction."
"Acclarent is excited to once again be at the forefront of enabling ENT surgeons to address patient needs by developing new and innovative technologies," said Bridget Ross, Worldwide President of Acclarent. "We are pleased to make the ACCLARENT AERA™ available to Nordic physicians, and are looking forward to expanding availability of the device to other regions in Europe and around the world."
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