FDA puts Acclarent’s Aera Eustachian tube balloon in Class II

 

The FDA today said it reclassified Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent’s Aera Eustachian tube balloon to a Class II device.

The Irvine, Calif.-based company’s Aera system consists of a balloon catheter designed to be inserted through the patient’s nose into the Eustachian tube. After insertion, the balloon is inflated to open up a pathway for mucus and air to flow through to restore proper function and reduce pressure, pain or clogged or muffled sensations in the ear, Acclarent said.

The company submitted a request for reclassification on December 17 last year, according to an FDA release.

The federal watchdog said it reviewed the request and determined the device viable to be classified as a Class II device with the establishment of “special controls,” which in addition to general controls will “provide reasonable assurance of the safety and effectiveness of the device.”

The federal agency said it will require certain mitigation measures to control risks associated with eustachian tube balloon. Specific non-clinical performance testing, simulated use testing, training and labeling will be required to avoid the introduction of false passages, rupturing or damage to the carotid artery. Non-clinical performance testing, simulated use testing, training and labeling will also be required to avoid injuring mucosal tissue.

Biocompatibility evaluations, sterilization validations, shelf life validations and labeling measures will be required to mitigate the risk of adverse tissue reactions and infections, the federal watchdog said.

Acclarent won de novo clearance from the FDA for its Aera Eustachian tube balloon dilation system last month.

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