Jul 31 2015
PLYMOUTH, Minnesota—Entellus Medical, Inc. (NASDAQ: ENTL), a medical technology company focused on products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, today announced positive data from its REMODEL study, the first prospective, multicenter, randomized controlled trial with sufficient statistical power to compare standalone balloon sinus dilation to traditional functional endoscopic sinus surgery (FESS) for the treatment of chronic or recurrent sinusitis. The article, published in The Laryngoscope, includes data from a larger cohort of patients than previous publications and reports for the first time follow-up results out to 24 months. The article also reports the results of a meta-analysis of standalone balloon dilation studies.
Highlights from the REMODEL larger cohort data:
135 patients treated, 130 followed to 12 months, 66 followed to 18 months, and 25 followed to 24 months;
Long-term follow-up results are consistent with previously reported 6-month and 12-month outcomes. At all-time points, both balloon sinus dilation and FESS delivered a comparable level of significant and clinically meaningful symptom improvements over baseline
Larger cohort of patients affirmed benefits of balloon sinus dilation reported in earlier REMODEL publications including faster recovery, shorter duration of prescription pain medication use, and fewer postoperative debridements
There were no significant differences between balloon sinus dilation and FESS with regard to ostial patency, revision surgery rates, and acute exacerbations of sinusitis
There were no complications related to the device or procedure for either treatment
Dr. Rakesh Chandra, the lead author, notes “Our group was able to observe significant, durable benefits of balloon dilation in selected patients with medically refractory chronic rhinosinusitis. This was seen for nasal-specific symptoms as well as other measures of general well-being and occupational functioning.” Dr. Chandra is an Otolaryngologist and Chief of Rhinology, Department of Otolaryngology at the Vanderbilt University Medical Center in Nashville, TN.
The article also compares patient-level data from six key standalone balloon sinus dilation studies sponsored by Entellus Medical, including 358 patients (846 sinuses) from 38 distinct centers with six months to two years of follow-up.
Meta-analysis demonstrated that outcomes from standalone balloon sinus dilation studies are consistent. These results included:
A 97.5% overall success rate across all 6 studies
Significant, clinically meaningful, and durable symptom improvement
Quick recovery time of 1.4 days on average
Procedural pain averaged 2.6 out of 10 (0 equals no pain)
Patients experienced significant improvements in work/social activities and healthcare utilization
Outcomes are consistent across a wide range of patients—both CRS and RARS patients, and patients with and without ethmoid disease all experienced similar improvements in outcomes
Comparisons of the pooled balloon dilation studies with the REMODEL FESS arm showed that there were no significant differences between balloon dilation and FESS for improvement in sinus symptoms out to 2 years follow-up or in 1-year revision surgery rates.
“This article provides the most comprehensive analysis of clinical outcomes for balloon sinus dilation reported to date. We are delighted with the outcome of this study as it brought together our balloon sinus dilation patients into one data set, and demonstrated remarkable consistency in positive, long-term outcomes,” said Robert White, President and Chief Executive Officer.
The full article is available through OnlineOpen and can be downloaded from The Laryngoscope website by clicking in the Early View tab.
About Entellus Medical, Inc.
Entellus Medical is a medical technology company focused on the design, development and commercialization of products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room. Its XprESS family of products is used by ENT physicians to open narrowed or obstructed sinus drainage pathways using balloon sinus dilation. 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. Patients treated with Entellus Medical’s products in this trial in the ENT physician’s office also experienced faster recovery, less bleeding at discharge, less use of prescription pain medication and fewer post-procedure debridements than patients receiving FESS. Entellus Medical currently markets its products in the United States, Europe and Canada and sells its products through a direct sales force in the United States and the UK.
Contact: Leigh Salvo
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