Normalization of the tympanic membrane position was experienced by 79.2% (19/24 p<0.001), positive Valsalva maneuver by 62.5% (20/32 p<0.0001), and improvement in tympanogram type by 55.0% (11/20 p=0.006). The participants with abnormal middle ear functional assessments at baseline experienced significant improvements in these assessments at 12 months. Significant symptom improvement was maintained through 3-, 6-, and 12-month follow-up ( p<0.0001). Participants in the balloon dilation arm reported a mean reduction (improvement) of 2.9 in overall ETDQ-7 score, versus 0.6 for those in the control arm of the study – a significant difference demonstrating balloon dilation’s superiority in reducing symptoms ( p<0.0001). A majority of study procedures (72%) were performed under local anesthesia in the office point-of-care. Long-term follow-up was conducted at 3, 6 and 12 months for all patients who underwent balloon dilation.
Control patients who had continuing symptoms at 6 weeks were offered treatment with balloon dilation. Follow-up was conducted and outcomes compared at 6 weeks for all randomized patients. Sixty qualified patients were randomized 1:1 to either balloon dilation with the XprESS ENT Dilation System or ongoing medical therapy (control). Patients were required to have moderate severe symptoms, as indicated by an overall Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Patients included in the study had to be 18 years and older, diagnosed with ETD for 12 months or more, have three or more ETD symptoms, and have failed medical therapy. “This study demonstrates our ongoing commitment to deliver technologies backed by clinical evidence to serve the needs of our ENT physician partners and their patients.”
#ENTELLUS ULTRA BALLOON SYSTEM TRIAL#
“The results of this randomized controlled trial are an important affirmation of balloon dilation as an effective treatment option for Eustachian tube dysfunction,” said Robert White, CEO of Entellus Medical, Inc. The results of this study offer new hope to appropriate patients that balloon dilation can provide durable symptom relief of their Eustachian tube dysfunction.” Ted Meyer, from the Medical University of South Carolina, “Traditional treatments for patients with Eustachian tube dysfunction do not address the underlying disease pathology and are considered temporary options. Statistically significant improvements in ETD symptoms and middle ear functional assessments were demonstrated at 1-year follow-up.Īccording to lead author Dr.
The results of “Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction with 1-Year Follow-Up” demonstrate that balloon dilation with XprESS ENT Dilation System is superior to ongoing medical management, and is safe and effective for the treatment of persistent ETD. Balloon dilation has recently emerged as a treatment option for ETD that has the potential to provide more durable relief than traditional alternatives. Over 7.3 million people have symptoms of Eustachian tube dysfunction, including ear pain and pressure, ear fullness, muffled hearing, and pain or discomfort with barometric changes.
PLYMOUTH, Minn., J(GLOBE NEWSWIRE) - Entellus Medical, Inc., now a part of Stryker, today announced Otology and Neurotology published results from a study that compares balloon dilation with ongoing medical therapy for the treatment of persistent Eustachian tube dysfunction (ETD).
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