FIM

Absorbable implant to treat nasal valve collapse.

Study overview

Nasal valve collapse (NVC) attributed to weak lateral cartilage is a common cause of nasal airway obstruction. However, due to complex surgical techniques for correcting NVC and associated cosmetic consequences, NVC frequently remains untreated.17 This study presents a first-in-human experience using the LATERA® absorbable nasal implant to support the lateral nasal cartilage. The ability of the implant to provide sufficient lateral cartilage support is demonstrated by a significant reduction in NOSE scores through 18 months of follow-up with an acceptable safety profile.


Methods

Study design and overview

  • Assessed quality of life for nasal airway obstruction (NAO) patients using the validated NOSE score16,19
  • Prospective, multi-center, single cohort study in Germany
  • 30 subjects with Nasal Valve Collapse, treated only with the LATERA implant (56 implants)
  • Majority of patients had previous nasal surgeries
  • Subjects were treated under general or local anesthesia

Demographics and Procedure Background

Baseline NOSE score 76.7 ± 14.8 Nasal surgical history  
All Subjects   Yes 19 (63.3%)
    No 11 (36.7%)
       
Age (year) 51.1 ± 14.5 Sides treated  
    Bilateral 26 (86.7%)
    Unilateral 4 (13.3%)
       
Gender   Anesthesia type  
Female 12 (40.0%) OP/ITN 14 (46.7%)
Male 18 (60.0%) Office/LA 16 (53.3%)

Key Results

This study demonstrated the safety and effectiveness of an absorbable implant for lateral cartilage support in subjects with NVC at 18 months post procedure.

1. Durable results16 within the range of other nasal obstruction techniques.18

Latera Patient Experience

2. Effective in severely or extremely symptomatic patients.

FIM Latera Severity chart

3. Well-tolerated with an acceptable safety profile and without adverse cosmetic impact at 6, 12 and 18 months.

FIM Latera safety profile

 

a Study follow-up is ongoing for 27 patients. Three patients exited the study early.

b One subject did not record a pain assessment at 6 mos.

c Device-related AE’s includes 3 device retrievals, 1 hematoma, and 1 inflammation.

d Independent reviewer noted alar retraction in 1 patient, which was not observed subsequently at 6, 12 or 18 months.

Risks included mild bruising and inflammation, awareness of the implant, mild pain or irritation, discomfort, infection, reaction to material and device retrieval. The limitations of this study included a modest sample size, nonrandomized study design and a heterogeneous subject population with respect to prior history of nasal surgery.


Featured publication

San Nicolo, et al. 2017. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg, 32:233-240.

Browse clinical data:

Sinusitis

Eustachian tube dysfunction

Nasal airway obstruction

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