Source: Siyu MedTech; Editor: Liu Xinyi
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On December 20, 2023, Acclarent, a subsidiary of Johnson & Johnson that focuses on ENT, announced that its company'sAERA® Balloon Dilation System for Eustachian TubeReceived FDA approval,Can be used to treat children aged 8-17 with long-term obstructive Eustachian tube dysfunction (OETD)。
AERA® Eustachian Tube Balloon Dilation System# About AERA® Balloon Dilation System for Eustachian Tube
Following this FDA expanded approval, Acclarent isThe first and only company with a regulatory system-approved balloon dilation system for children's Eustachian tubes. The system is from the United StatesThe first balloon dilation device specifically designed for patients with long-term ETD, previously only applicable to adults. The demonstration video of the system is as follows:Acclarent stated that the Eustachian tube anatomy in children aged 8 years and above is very similar to that of adult patients. Studies have shown that the effect of using this Eustachian tube dilation device for treatment is comparable to tympanostomy tubes, and may even be better.According to Acclarent, so far, there have been few treatment options for children with long-term OETD, including:Tympanostomy Tube Placement: The tube inserted is generally a miniature hollow tube made of plastic or metal. The surgeon places it in the eardrum through surgery to create an air passage, thereby preventing fluid from accumulating behind the eardrum.Adenoidectomy: That is, the removal of adenoids. Adenoids, also known as pharyngeal tonsils or vegetations, are located at the top of the nasopharynx and on the posterior pharyngeal wall, and belong to lymphatic tissue with an appearance resembling that of mandarin orange segments. Like the tonsils, adenoids gradually grow larger after birth as the child ages, showing vigorous growth between the ages of 2-6, and generally start to shrink after the age of 10. However, during their growth, adenoids can become excessively enlarged, compressing the Eustachian tube.Oral Therapy: Take medications to combat infections and inflammation.Acclarent stated that these therapiesMay address the symptoms but not the root cause.Jeff Hopkins, the president of the company, stated: "The expansion of indications for Acclarent's Eustachian Tube Balloon Dilation System brings new hope to families with chronic ear problems at home."# Eustachian Tube and Eustachian Tube Dysfunction
The Eustachian tube is a small conduit connecting the nasopharynx and the middle ear cavity in the human body. Although it is only 3-4 centimeters in length, it has very important functions. It canHelps ventilate and balance the pressure in our middle ear cavity, promotes the drainage of middle ear secretions through the nasal passage, maintains normal hearing function, and also has a certain immune function.。Normally, the Eustachian tube is closed., The Eustachian tube opens only when you open your mouth, swallow, or yawn. If it fails to close when it should, it is medically termed as"Abnormal Opening of the Eustachian Tube"; When it should be open but can't be opened, it's medically called"Eustachian Tube Obstruction". The condition where the Eustachian tube cannot open or close properly is collectively referred to as "Eustachian Tube Dysfunction." Eustachian Tube Dysfunction may cause the following problems:Ear Fullness、Tinnitus、Otitis Media、Spontaneous Otoacoustic Emissions。Acclarent, specifically, belongs to Ethicon under Johnson & Johnson. Its revenue in 2022 was $110 million, and its products are divided intoAirway Balloon Dilation System、Balloon Sinuplasty Instruments、Balloon Eustachian Tuboplasty System、Nasal Dilation System、Surgical NavigationAndNasal Sinus Surgery InstrumentsThese few categories.On December 13, Integra Lifesciences, a leader in tissue repair, announced that it had reached an agreement to acquire the company for $275 million (approximately 1.95 billion RMB) in cash.
