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.

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

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  

Female   12 (40.0%)

Male   18 (60.0%)

Anesthesia type  

OP/ITN   14 (46.7%)

Office/LA   16 (53.3%)

Outcomes and
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.

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

 

Latera Patient Experience

 

Effective in severely or extremely symptomatic patients.

 

FIM Latera Severity chart

 

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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