101 Study
Prospective, multicenter OR and office studies assessing 6-month outcomes with the LATERA® absorbable nasal implant as a treatment for nasal valve collapse (NVC).
Study
Overview
Results show that patients treated with LATERA absorbable nasal implant had statistically significant improvements in symptom burden at 1, 3 and 6 months post procedure, as measured by validated scales, including NOSE Scores.
Outcomes and
results
- The results of this study affirm earlier First In Human study results with significant reduction in symptoms at all time points (1/3/6 months in this study).
- Results show a significant improvement in symptom burden for the LATERA implant as a standalone therapy and in conjunction with other standard NAO procedures. For these 101 patients, symptom reduction of the LATERA implant alone and the LATERA implant plus additional procedures to correct septal deviation and/or turbinate hypertrophy is within the range of other nasal obstruction techniques, including traditional grafting techniques.
- Patients did well in this broader application of the LATERA implant, with 89.7% positive responder rates at 6 months.
Conclusion
These positive, prospective clinical trial results add to the growing body of data that support the clinical utility and favorable safety profile of the LATERA implant. The data show that the LATERA implant provides both short- and mid-term symptom relief and demonstrate that this novel implant is an important advance for patients suffering from symptoms of NVC.
Featured publication
Stolovitzky P, Sidle DM, Ow RA, Nachlas NE, Most SP. A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: outcomes using a bioabsorbable implant. Laryngoscope. 2018 May 14.
Nasal airway obstruction
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