Medtronic Launches Manually Controlled Balloon Catheter System to Treat Eustachian Tube Dysfunction

A new single-use device that treats Eustachian tube dysfunction features a flexible balloon section that allows customized placement based on patient anatomy and enables surgeons to deliver treatment in an outpatient or office setting.

Medtronic plc (Dublin, Ireland) has launched the NuVent Eustachian tube dilation balloon, which has been cleared by the US FDA for the treatment of chronic, obstructive Eustachian tube dysfunction that occurs when the Eustachian tube, which links the back of the nose to the middle ear, fails to open or close properly. As a result, the tube is unable to perform its primary functions, which are protecting the middle ear from pathogens, equalizing air pressure on either side of the eardrum, and helping drain secretions from the middle ear cleft. This may result in pain, hearing difficulty, and/or a feeling of fullness in the ears. If not treated, patients may also suffer damage to the middle ear and eardrum.

The NuVent eustachian tube dilation balloon is a manually controlled balloon catheter system that expands and dilates the eustachian tube canal. The shape of the balloon handpiece enables easy access and entry into the eustachian tube from the nasal opening with the aid of endoscopic guidance. An atraumatic tip at the distal end of the flexible balloon section is meant to reduce the potential for risk of injury to the eustachian tube and surrounding tissues. The rigid shaft and handle extending to the balloon provide stability and tactile feedback when moving the balloon through the nasal passages and into the eustachian tube canal. The 6 x 16 mm long rigid balloon is located near the distal tip of the device where it expands the eustachian tube canal tissue and cartilage.

"Patients who suffer from Eustachian Tube Dysfunction often experience pain, pressure, and hearing difficulties, so it's important to address their illness quickly," said Dr. Boris Karanfilov, a rhinologist and head of the Ohio Sinus Institute. "Balloon dilation restores proper Eustachian tube function and reduces these symptoms, plus the ability to perform the procedure in the office makes it both convenient and efficient."

"Patients with persistent Eustachian Tube Dysfunction – especially those who experience frequent pressure changes, like airline travelers and divers – often require more than nasal sprays and oral medication to treat the condition," said Dr. Sina Joorabchi, an otolaryngologist at South Florida Ear, Nose, and Throat Associates. "The NuVent balloon provides an effective, minimally invasive treatment option that can be administered in the office."

"As office-based procedures for ENT conditions increase, we look forward to introducing more innovative technologies designed specifically for this setting," said Vince Racano, president of the Ear, Nose, and Throat business, which is part of the Neuroscience Portfolio at Medtronic. "The NuVent balloon is another important product within this expanding portfolio."

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