Dr. Gould is the Lead Author of a Landmark Study Published in the American Journal of Rhinology & Allergy - February 14, 2014
A new study published in the American Journal of Rhinology and Allergy demonstrates the benefits of in-office balloon dilation for sufferers of chronic sinusitis. Results reported in “In-office, multi-sinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial” show patients with disease in the maxillary, frontal and sphenoid sinuses can be successfully and comfortably treated in the physician’s office. Patients treated with the Entellus XprESS multi-sinus dilation device experienced significant sinus symptom relief and reduction in healthcare utilization throughout the 1 year period after treatment.
The study followed 81 patients for one year after undergoing treatment with the XprESS multi-sinus dilation device (Entellus Medical, Plymouth, MN) under local anesthesia in physician offices. Physicians used the XprESS device to remodel the sinus anatomy with a small high pressure balloon that opens blocked or narrowed sinus drainage pathways. XprESS has a malleable tip to help physicians achieve an optimal angle of access and ensure precise placement during the procedure. Overall, physicians successfully dilated 98.1% of all sinuses identified for treatment and patient comfort remained very high during the procedures.
"Multiple studies have shown the clinical effectiveness of balloon sinus dilation for the treatment of chronic rhinosinusitis. This study reinforces previous research and demonstrates that physicians can achieve a high technical rate of success and patient tolerance when using XprESS to dilate the maxillary, frontal and sphenoid sinuses in-office," said James Gould, M.D., FACS, lead author of the article. "The study also reflects the significant patient benefits of balloon dilation, from long-term symptom improvement to a significant reduction in post-treatment healthcare utilization."
In the year after treatment with balloon dilation, sinus symptoms improved by 69% on average. In the year prior to XprESS balloon treatment, patients on average experienced 3.0 sinus infections compared to just 0.7 infections in the year following treatment. As a result, patients also used significantly fewer antibiotics, and reduced the number of sinus-related physician visits from an average of 4.1 visits in the year prior to treatment to just 1.1 in the year after treatment. Patients treated with balloon sinus dilation also missed significantly less work or school due to their sinus issues.
"The results from this study of the Entellus XprESS device in all combinations of diseased sinuses extends and complement the results of our previously published REMODEL randomized trial which proved that Entellus balloon technology for the treatment of maxillary sinusitis relieves the symptoms of sinusitis as well as traditional sinus surgery while resulting in faster patient recovery and fewer post-operative debridements." said Brian Farley, CEO of Entellus Medical, Inc. "The excellent results from this latest study showing that patients are treated conveniently and comfortably in the physician office are particularly notable because treatment in the physician office is substantially less expensive to the patient and healthcare system than traditional sinus surgery performed in an operating room. Overall this study affirms that balloon dilation with XprESS in the office is an important element of the sinusitis treatment continuum.”
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