Evaluation of absorbable PLA nasal implants in an ovine model

Rippy, Marian K.; Baron, Scott; Rosenthal, Mike; Senior, Brent A.

doi:10.1002/lio2.166

Cited by 16 publications

(16 citation statements)

References 21 publications

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“…The outcomes at 24 months should be representative of long-term improvement since the implant is absorbed by the body over a period of approximately 18 months. 13,14 The lack of a control group is the limitation of this study. Although these were single-arm studies comparing pretreatment with post-treatment outcomes within patient, a recent randomized control trial has demonstrated the superiority of the implant over a sham procedure for the treatment of NVC.…”

Section: Discussionmentioning

confidence: 94%

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Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures

et al. 2021

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The aim of the study is to report outcomes after treatment of nasal valve collapse with a bioabsorbable nasal implant. It involves two prospective, multicenter, post-market studies evaluating long-term effectiveness of the LATERA implant for severe to extreme nasal obstruction. Participants underwent implant alone or with concomitant inferior turbinate reduction (ITR) and/or septoplasty. Outcome measures included the change from baseline Nasal Obstruction Symptom Evaluation (NOSE) scores, NOSE responder rates, visual analog scale (VAS) scores, and adverse events. A total cohort of 277 participants (109 implants only, 67 implants + ITR, 101 implants + septoplasty + ITR) enrolled at 19 U.S. centers was available for analysis with 177 participants (69 implants only, 39 implants + ITR, 69 implants + septoplasty + ITR) available at 2 years. The mean changes from baseline in NOSE scores and VAS scores were statistically significant (p < 0.001) at all follow-up periods. The baseline NOSE score of 77.8 ± 13.6 was improved to 24.2 ± 23.6 at 24 months. Greater than 90% of participants were NOSE responders across all follow-up periods, 6.1% withdrew for lack of treatment effect. The baseline VAS score of 66.7 ± 18.8 was improved to 21.1 ± 23.9 at 24 months. There were no serious adverse events related to the device or implant procedure. Implant retrieval rate was 4.0% (22/543 implants). Nonserious adverse events were mild to moderate in severity, typically occurred within 6 months of implant, and resolved or were stable. Significant reductions in NOSE and VAS scores and high responder rates from our large population of patients with nasal obstruction who had nasal valve implants confirm sustained effectiveness at 24 months after treatment. The studies are registered on www.clinicaltrials.gov (NCT02952313 and NCT02964312).

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Section: Discussionmentioning

confidence: 94%

“…The outcomes at 24 months should be representative of long-term improvement since the implant is absorbed by the body over a period of approximately 18 months. 13 14…”

Section: Discussionmentioning

confidence: 99%

Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures

et al. 2021

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“…Follow‐up for this study was limited to 12 months postprocedure. Previously, animal histology studies have shown that an implant of the same composition is absorbed over 18 to 24 months after implantation and that, upon complete absorption, the implant is replaced with nodular bundles of mature collagenized fibrous tissue that may provide mechanical strength at the lateral wall . Therefore, additional follow‐up out to 24 months would be beneficial.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, a bioabsorbable implant (Latera, Spirox Inc., Redwood City, CA) comprised of 70:30 copolymer of poly(l‐lactide) and poly(d‐lactide), which can be placed under local anesthesia in the physician's office or under general anesthesia in the operating room (OR), was used to address dynamic NVC by supporting the nasal lateral wall . Animal studies showed that the implant material was biocompatible and was absorbed over 18 to 24 months postoperatively . Combined interim 6‐month safety and effectiveness results of two studies using this bioabsorbable implant have been reported in a mix of patients who received the implant in an OR or office setting .…”

Section: Introductionmentioning

confidence: 99%

Twelve‐month outcomes of a bioabsorbable implant for in‐office treatment of dynamic nasal valve collapse

Sidle

Stolovitzky

et al. 2019

The Laryngoscope

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Objectives: To examine 12-month outcomes for in-office treatment of dynamic nasal valve collapse (NVC) with a bioabsorbable implant.Study Design: Prospective, multicenter, nonrandomized study. Methods: One hundred sixty-six patients with severe-to-extreme class of Nasal Obstruction Symptom Evaluation (NOSE) scores were enrolled at 16 U.S. clinics (November 2016-July 2017). Patients were treated with a bioabsorbable implant (Latera, Spirox Inc., Redwood City, CA) to support the lateral wall, with or without concurrent inferior turbinate reduction (ITR), in an office setting. NOSE scores and Visual Analog Scale (VAS) were measured at baseline and 1, 3, 6, and 12 months postoperatively. The Lateral Wall Insufficiency (LWI) score was determined by independent physicians observing the lateral wall motion video.Results: One hundred five patients were treated with implant alone, whereas 61 had implant + ITR. Thirty-one patients reported 41 adverse events, all of which resolved with no clinical sequelae. Patients showed significant reduction in NOSE scores throughout 12 months postoperatively (77.4 AE 13.4 baseline vs. 36.2 AE 22.7 at 1 month postoperatively, 33.0 AE 23.4 at 3 months, 32.1 AE 24.6 at 6 months, and 30.3 AE 24.3 at 12 months; P < 0.001). They also showed significant reduction in VAS scores postoperatively (69.7 AE 18.1 baseline vs. 31.3 AE 27.1 at 12 months postoperatively, P < 0.001). These results were similar in patients treated with implant alone and those treated with the implant + ITR. Consistent with patient-reported outcomes, postoperative LWI scores were demonstrably lower (1.42 AE 0.09 and 0.93 AE 0.08 pre-and postoperatively, P < 0.001).Conclusion: In-office treatment of dynamic NVC with a bioabsorbable implant improves clinical evidence of LWI at 6 months and improves nasal obstructive symptoms in a majority of patients up to 12 months.

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“…From an animal study, the implant material had structural degradation and active absorption at 18 months postimplantation. 21 Once completed absorbed around 24 months, the implant was replaced by mature collagenized fibrous tissue. 21 From these results, the authors hypothesize that the fibrocollagenous scar tissue may provide support to the lateral wall over time, resulting in a prolonged improvement that outlasts the mechanical integrity of the absorbable implant.…”

Section: Discussionmentioning

confidence: 99%

A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse

Nicoló

Stelter²,

Sadick

et al. 2018

Facial plast Surg

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The safety and effectiveness of an absorbable implant for lateral cartilage support have been recently demonstrated in subjects with nasal valve collapse (NVC) at 12 months postprocedure. This follow-up study aimed to assess whether the safety and effectiveness of the implant persist in these patients for 24 months after the procedure. Thirty 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 24 months postprocedure. Fifty-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 24 months, the mean score was 32.0 ± 29.3, reflecting an average within-patient reduction of -44.0 ± 31.1 points. There were no device-related adverse events in the 12 to 24 months period. There were five subjects who exited the study prior to the 24-month follow-up. Four of the five subjects who exited were elected for further intervention and one subject was lost to follow-up. This study demonstrates safety of an absorbable implant for lateral nasal wall support and symptom improvement in some subjects with NVC at 24 months postprocedure.

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Evaluation of absorbable PLA nasal implants in an ovine model

Cited by 16 publications

References 21 publications

Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures

Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures

Twelve‐month outcomes of a bioabsorbable implant for in‐office treatment of dynamic nasal valve collapse

A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse

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