There is a huge need for this procedure, and it will greatly reduce the need for all those ear tubes” and other related surgeries. “Every time the tubes come out, they need the tubes in again. “There are people who need tubes 13 or 14 times,” he said. Acclarent Balloon Inflation Device, Entellus FinESS Endoscope, Entellus FinESS Sinus Treatment Kit, Entellus XprESS Pro Multi-Sinus Dilation System. Still, Kaylie believes it will be a significant advance for millions of people who require ear tube surgery. During the clinical trial for the Aera system, some common problems included small tears in the lining of the eustachian tube, minor bleeding, and sometimes, worsening of their eustachian tube dysfunction. While Kaylie believes the device will prove useful to many people who currently require ear tube surgery due to eustachian tube dysfunction, fluid in their ears, or chronic ear infections, he also cautions that there are some people for whom it will not be appropriate. Once the tube is open, the balloon is deflated and removed. The balloon is inflated, which opens the eustachian tube and allows air to flow through. Studies of the device showed “long-term normal eustachian function after the procedure.”ĭuring the minimally invasive procedure, a catheter is used to insert a small balloon through the nose and into the eustachian tube. “This new device has been shown to return the middle ear to normal and greatly eliminate middle ear pressure in properly selected patients,” he said. With the FDA-approved Aera system, children and adults with chronic eustachian tube dysfunction can opt for a simple, 10-minute procedure instead, Kaylie said. Recurrent eustachian tube dysfunction requires the surgical placement of tubes in the eardrum, which allows pressure to equalize in the middle ear. When used as a stand-alone therapy, Entellus Medical's balloon sinus dilation products are the only devices proven in a sufficiently powered prospective, multicenter, randomized, controlled trial to be as effective as functional endoscopic sinus surgery, or FESS. Stuffy ears and noses, hearing loss, ear pain and pressure, as well as ringing in the ears (tinnitus) can result.īlocked eustachian tubes can be relieved by nasal sprays and antihistamine tablets, which reduce inflammation and congestion. When the tube is blocked from a cold, sinus or nose problems, or ear infections, air can no longer pass through. “This allows you to equalize pressure” on either side of the eardrum, explained David Kaylie, MD, a Duke otolaryngologist. Normally, the tube is filled with air and opens when yawning or chewing. When used as a stand-alone therapy, the company’s balloon sinus dilation products are the only devices proven in a sufficiently powered prospective, multicentre, randomised, controlled trial to be as effective as functional endoscopic sinus surgery (FESS).The eustachian tube is the main connection between the back of the throat and the middle of the ear. The company is focused on the design, development and commercialisation of products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room. Products from the XprESS family are used by ear, nose and throat (ENT) physicians for treatment of patients with symptomatic inflammation of the nasal sinuses, and open narrowed or obstructed sinus drainage pathways using balloon sinus dilation.Įntellus Medical president Robert White said: "The addition of XprESS Ultra to the XprESS family of devices highlights our ongoing commitment to making it even easier for ENT specialists to offer the benefits of balloon sinus dilation to patients suffering from sinusitis." XprESS Ultra provides additional features to address patient needs and meet physician preferences. "The profile device provides smooth movement through tight nasal passages and easy endoscopic viewing of the treatment area, while the malleable tip can be reshaped to meet challenges of patients with extremely narrow sinus drainage pathways."
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