title: Absorbable Implant to Treat Nasal Valve Collapse.
abstract: ObjectiveTo evaluate the safety and effectiveness of an absorbable implant for lateral cartilage support in subjects with nasal valve collapse (NVC) with 12 months follow-up.MethodsThirty subjects with Nasal Obstruction Symptom Evaluation (NOSE) score ≥ 55 and isolated NVC were treated; 14 cases were performed in an operating suite under general anesthesia and 16 cases were performed in a clinic-based setting under local anesthesia. The implant, a polylactic acid copolymer, was placed with a delivery tool within the nasal wall to provide lateral cartilage support. Subjects were followed up through 12 months postprocedure.ResultsFifty-six implants were placed in 30 subjects. The mean preoperative NOSE score was 76.7 ± 14.8, with a range of 55 to 100. At 12 months, the mean score was 35.2 ± 29.2, reflecting an average within-patient reduction of -40.9 ± 31.2 points. The majority (76%) of the subjects were responders defined as having at least one NOSE class improvement or a NOSE score reduction of at least 20%. There were no adverse changes in cosmetic appearance at 12 months postprocedure. Three implants in three subjects required retrieval within 30 days postprocedure and resulted in no clinical sequelae.ConclusionThis study demonstrates safety and effectiveness of an absorbable implant for lateral cartilage support in subjects with NVC at 12 months postprocedure.
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Ludwig Maximilian University of Munich, Munich, Germany.
authors.forename: Marion
authors.initials: M
authors.lastname: San Nicoló
authors.affiliation: HNO Zentrum Mangfall-Inn, Rosenheim, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Stelter
authors.affiliation: Division of Facial Plastic Surgery, Department of Otorhinolaryngology, University of Mannheim, Mannheim, Germany.
authors.forename: Haneen
authors.initials: H
authors.lastname: Sadick
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.
authors.forename: Murat
authors.initials: M
authors.lastname: Bas
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Ludwig Maximilian University of Munich, Munich, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Berghaus
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects; D000328:Adult; D000368:Aged; D020878:Device Removal; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015508:Nasal Obstruction / Q000601:surgery*; D011091:Polyesters / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012225:Rhinoplasty / Q000295:instrumentation* / Q000379:methods; D055815:Young Adult
chemical_list: D011091:Polyesters; C033616:poly(lactide)