Long term safety and effectiveness of a novel absorbable implant in patients with nasal valve collapse

Outcome Objectives: Nasal valve collapse (NVC) is an important contributor to nasal obstruction. The objective of this study was to evaluate the safety and effectiveness of a novel absorbable implant for supporting lateral cartilage in the nasal valve through 24 months post implantation.

Methods:

A prospective study was conducted in three centers in Germany between 2014 and 2017. The implant, composed of a polylactic acid copolymer, was placed with a minimally invasive delivery tool into the lateral nasal wall of patients with isolated NVC. Patient assessments include physical examination, NOSE (Nasal Obstruction Symptom Evaluation) score, digital photographs, and adverse events at 1 week (N = 30), 1 month (N = 30), 3 months (N = 29), 6 months (N = 30), 12 months (N = 30), 18 months (N = 26) and 24 months (N = 25).

Results:

56 implants were placed in 30 patients. The average baseline NOSE score was 76 ± 15 (SD). 53% of cases were completed under local anesthesia. The LS mean NOSE score improvements over baseline were: 1 week (67%), 1 month (65%), 3 months (63%), 6 months (56%), 12 months (52%), 18 months (52%) and 24 months (58%.) Three implants were easily retrieved within the 30 day follow-up period without the need for anesthesia. No additional serious device-related adverse events were reported through 24 months.

Conclusions. This first-in-man study provides evidence for the safety and effectiveness of the device in supporting the lateral cartilage wall through 24 months post-implantation.

Publication History

Publication Date:
18 April 2018 (online)