Absorbable Implant to Treat Nasal Valve Collapse

Abstract

Objective To 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.
Methods 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 12 months postprocedure.
Results 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 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.
Conclusion This study demonstrates safety and effectiveness of an absorbable implant for lateral cartilage support in subjects with NVC at 12 months postprocedure.

Full text

Absorbable Implant to Treat Nasal Valve
Collapse
Marion San Nicoló, MD1Klaus Stelter, MD2Haneen Sadick, MD3Murat Bas, MD4
Alexander Berghaus, MD1
1Department of Otorhinolar yngology, Head and Neck Surgery,
Ludwig Maximilian University of Munich, Munich, Germany
2HNO Zentrum Mangfall-Inn, Rosenheim, Germany
3Division of Facial Plastic Surgery, Department of
Otorhinolaryngology, University of Mannh eim, Mannheim, Germany
4Department of Otorhinolaryngology, Head and Neck Surgery, Klinikum
rechts der Isar, Technical University Munich, Munich, Germany
Facial Plast Surg 2017;32:233–240.
Address for correspondence Marion San Nicoló, MD, Department of
Otorhinolaryngology, Head and Neck Surgery, Ludwig Maximilian
University of Munich, Marchioninistr. 15, Munich 81377, Germany
(e-mail: marion.sannicolo@med.uni-muenchen.de).
The nasal valve, first described in the early 20th century by
Mink,1is a complex, three-dimensional, dynamically alter-
nating structure that controls nasal airflow resistance. A
dysfunction of the nasal valve can lead to nasal obstruction
and a significant drop in the qualit yof life (QOL) for patients.2
As defined by the Hagen–Poiseuille law, the flow through a
tube is proportional to the fourth power of the radius of the
tube and inversely proportional to the pressure difference
across the tube. Thus, even a small decrease in the valve area
can contribute to severe nasal obstruction.
Thenasal valvecollapse(NVC)canbe staticordynamic.Static
NVC consists of an anatomically narrowed nasal valve region,
which causes obstruction. Dynamic NVC is caused by insuffi-
cient cartilaginous support of the lateral nasal wall, leading to
lateral wall insufficiency.3,4 Common causes of NVC are prior
rhinoplasty, aging, nasaltrauma, and congenital abnormalities.
Therapies to correct NVC include invasive surgical procedures
and nonsurgical solutionsto temporarily dilate the nasalvalve,
such as Breathe Right strips or nasal cones. Surgical strategies
that involve septoplasty5or inferior turbinate reduction6may
reduce negative inspiratory pressure by enlarging the airway,
but these procedures do not directly address weakness in the
lateralwall.Proceduresintendedto addressthe weaknessof the
lateral wall include cartilaginous grafts, typically harvested
from the nasal septum,7ear8or rib cartilage9that can be placed
as lateral crural strut grafts,10 alar batten grafts,11 or butterfly
Keywords
►nasal valve
►implant
►rhinoplasty
►lateral wall
insufficiency
Abstract Objective To 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.
Methods 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 12 months postprocedure.
Results Fifty-six implants were placed in 30 subjects. The meanpreoperative 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.
Conclusion This study demonstrates safety and effectiveness of an absorbable
implant for lateral cartilage support in subjects with NVC at 12 months postprocedure.
DOI http://dx.doi.org/
10.1055/s-0037-1598655.
ISSN 0736-6825.
Copyright © 2018 by Thieme Medical
Publishers, Inc., 333 Seventh Avenue,
New York, NY 10001, USA.
Tel: +1(212) 584-4662.
THIEME
Rapid Communication 233

grafts.12 Implants made from nonabsorbable alloplastic mate-
rials have also been used for treatment of NVC including
expanded polytetrafluoroethylene13 and high-density porous
polyethylene.14,15 These nonabsorbable materials have not
gained wide use as they require invasive surgical procedures
and are associated with increased risks of infection, extrusion,
and the potentialneed for revision procedures.
While surgery to strengthen the lateral wall has been
shown to significantly improve the QOL for subjects suffering
from nasal airway obstruction, current procedures can be
invasive and have the potential to permanently alter the
patient’s appearance.16 In this study, a minimally invasive
technique to address NVC by supporting the weakened nasal
lateral wall cartilage with an absorbable implant is described.
Methods
Study Design
This prospective, single cohort, nonrandomized study eval-
uating the safety and effectiveness of an absorbable nasal
implant (Spirox Inc., Menlo Park, CA) enrolled 30 subjects at
three investigational sites in Germany.
Consecutive subjects at each site were screened for po-
tential enrollment. Eligible subjects were invited to partici-
pate in the study. The baseline visit included a medical
history review, an evaluation of symptoms, an assessment
of nasal airway obstruction, and photodocumentation of
nasal appearance. Demographic information, such as age,
gender, and date of onset of nasal obstruction, was collected.
History of any prior nasal traum a, surgery, and other medical
conditions were noted. Physical examination including an-
terior rhinoscopy and nasal endoscopy were performed to
determine the degree to which NVC contributed to the
overall nasal airway obstruction. The degree of nasal ob-
struction was rated by investigators on a severity scale as
none, mild, moderate, or severe.
Subjects were treated under general or local anesthesia. No
concomitant nasal procedures were performed. Follow-upvisits
tookplaceatweek1andmonths1,3,6,and12postprocedure.
Internalandexternal nasal examinations wereperformedat each
visit, as well as Nasal Obstruction Symptom Evaluation (NOSE)
score collection,17 pain assessments, presence of a foreign body
sensation, and assessment of cosmetic changes. Physical exami-
nations included an evaluation of nasal skin and nasal mucosa
appearance, and the presence of any implant extrusions, frac-
tures, or migration. Cosmetic changes were assessed using four
photographicviewsobtainedunderbothstaticandfullinhalation
conditions (frontal view, left side, right side, and chin up). An
independent physician assessedcosmetic changes by comparing
baseline images to the follow-up images and categorizing the
comparisons as no change, significantly better, or significantly
worse. For example, significantly better changes included struc-
tural changes such as widening of the nasal vault, whereas
significantly worse included a narrowing of the nasal vault.
Subjects
Eligible subjects were adults with NVC identified as the
primary contributor to nasal obstruction with a NOSE score
55 at baseline. Subjects were ineligible if they had septo-
plasty or turbinate reduction procedures within 6 months or
rhinoplasty procedures within 12 months prior to the
planned index procedure. Additional exclusion criteria
were recurrent nasal infections, intranasal steroid treatment
2 weeks prior or planned for 2 weeks postindex procedure,
permanent nasal implants or dilators, a history of (pre)
cancerous or cancerous lesions, and/or radiation exposure
or chemotherapy within 24 months of the study. Subjects
with bleeding disorders, those with significant systemic
diseases, or those requiring nasal oxygen or continuous
positive airway pressure (CPAP) were not eligible to
participate.
Implant and Delivery Tool
The absorbable nasal implant comprises a 70:30 blend of
poly(L-lactide) and poly(D-lactide). It is introduced through
an endonasal insertion technique using a delivery tool. The
implant is primarily a ribbed cylindrical structure with an
apical forked end. The implant is designed to provide supp ort
to the upper and lower lateral nasal cartilages. The geometry
of the forked end is flexible and collapses to fitwithinthe16-
gauge cannula portion of the delivery tool prior to place-
ment. The forked end first exits the delivery tool cannula and
expands open as the implant is deployed into the tissue. This
fork deployment is designed to anchor the implant in place
during the acute implantation step.
Once delivered, the apical, forked end of the implant is
positioned over and adjacent to the frontal process of the
maxilla while the main body extends caudally toward the
alar region. The implant is flexible and therefore has the
ability to conform to the natural curvature of the lateral wall
plane. In this location, the implant is adjacent to the upper
and lower lateral cartilages to provide support and strength-
en the lateral wall.
Implantation Technique
Implantation steps are illus trated in ►Fig. 1. Preprocedure, in
each subject, the nasal anatomy as well as the area of
maximum lateral wall collapse during inspiration were
examined and marked to identify the target implant location
and cannula insertion trajectory. The area of maximum
collapse was evaluated using the modified Cottle maneuver.
The target implant location was established to position the
forked tip of the implant adjacent and across the maxilla
bone to provide cantilever support, and the main cylindrical
body of the implant was positioned along a trajectory to
support the upper and lower lateral cartilages crossing the
area of maximum collapse. In cases where the collapse was
too lateral for placement of the implant, the implant was
positioned as close as possible to the area of collapse
(►Fig. 1A). Although this positioning does not directly cross
over the area of the collapse, the implant should provide
sufficient lateral wall support.
After subject marking, the implant was loaded into the
deliverytoolcannulaand wasintroducedthroughthevestibular
skin using an intranasal entry point close to the alar rim
(►Fig. 1B). Care was taken to ensure that the cannula at the
Facial Plastic Surgery Vol. 32 No. 2/2017
Absorbable Implant to Treat NVC San Nicoló et al.234

entrypointdidnotpenetratethroughthelowerlateralcartilage.
The cannula was then advanced over the lateral surface of the
lowerlateral cartilageand over the upper lateral cartilage tothe
frontal processof the maxilla. From there, it was advanced over
the maxilla to a point where the apical portion of the implant
wouldbe positionedoverthe maxillawhilethe maincylindrical
portion is positioned in the lateralwall (►Fig. 1C). The implant
was then deployed, and the delivery tool was retracted and
removed,leaving the implant in place to support the upper and
lower lateral cartilages (►Fig. 1D).
Statistical Analysis
The NOSE scale is a validated disease-specificQOLinstru-
ment.17 It uses a 20-point scale to capture breathing symp-
toms, with higher scores indicating more severe symptoms
than lower scores. NOSE score results are converted to a 100-
point scale by multiplying the total score by 5. This analysis
includes the change in NOSE scores from baseline (preoper-
ative) to 3, 6, and 12 months. A paired t-test was used to
determine whether the mean at follow-up time points was
significantly different from the preoperative mean while
controlling for within-subject correlation. A sensitivity anal-
yses using a mixed model for repeated measures (MMRM)
including baseline score as a fixed covariate was performed
for comparison.
A NOSE score severity classification system was devel-
oped by Lipan and Most based on the data from 345 patients
with and without nasal airway obstruction.18 Their analysis
derived clinically relevant severity classes of NOSE scores:
mild (5–25 points), moderate (30–50 points), severe (55–75
points), or extreme (80–100 points). The analysis reported
herein used this classification system to report the percent-
age of subjects in each category at baseline, 3, 6, and 12
months as well as to classify subjects as responders or
nonresponders to the procedure. Responders are defined
as subjects that have at least one NOSE class improvement or
a NOSE score reduction of at least 20%.
Statistical analyses were performed by an independent
statistician (Axio Research, Seattle, WA) using SAS version 9.4
and R version 3.2.3.
Results
Subject demographics and baseline disease characteristics
are provided in ►Table 1. A significant percentage of the
subjects had previous surgeries (66%); all subjects had
confirmed NVC as the primary contributor to nasal airway
obstruction. A total of 56 implants were placed in 30 subjec ts.
Fourteen procedures took place in an operating suite under
general anesthesia, and 16 procedures were conducted in a
Fig. 1 Implantation technique. (A) Planned location of the implant relative to the area of collapse. (B) Placement of pierce point for delivery tool
placement. (C) Delivery tool placement. (D) Delivery tool removal.
Facial Plastic Surgery Vol. 32 No. 2/2017
Absorbable Implant to Treat NVC San Nicoló et al. 235

Table 1 Subject demographics and medical history
Attribute Result
(N¼30)
Gender Female 12 (40%)
Male 18 (60%)
Age (y) Mean SD 51.1 14.5
Minimum 24
Maximum 77
BMI (kg/m
2
)MeanSD 27.6 5.3
Minimum 22
Maximum 44
Race (n (%)) Asian 1 (3.3%)
White 28 (93.4%)
Black 1 (3.3%)
Baseline NOSE score Mean SD 76.7 14.8
Minimum 55
Maximum 100
Prior history Nasal trauma
Yes 8 (26.7%)
No 22 (73.3%)
Nasal surgery
Yes 19 (6 3.3 %)
No 11 (36.7%)
Years since most recent nasal surgery
<1y
a
3 (15.8%)
1–3 y 8 (42.1%)
3–5y 1(5.3%)
>5 y 7 (36.8%)
Nonsurgical nasal treatments
Yes 5 (16.7%)
No 25 (83.3%)
Medications
None 10 (33.3%)
Topical steroid use 1 (3.3%)
External nasal dilator 4 (13.3%)
Other medications 15 (50%)
Nasal endoscopy findings None 15 (50%)
Deviated septum 13 (43.3%)
Inferior turbinate hypertrophy 2 (6.7%)
Middle meatus pathology 0 (0.0%)
Choanae and nasopharynx pathology 0 (0.0%)
Degree of nasal obstruction Moderate 17 (56.7%)
Severe 13 (43.3%)
NVC primar y contributor to nasal
obstruction
Yes 30 (100%)
No 0 (0.0%)
Abbreviations: BMI, body mass index; NOSE, Nasal Obstruction Symptom Evaluation; NVC, nasal valve collapse; SD, standard deviation.
a
Does not include rhinoplasty or nasal valve surger y per protocol.
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Absorbable Implant to Treat NVC San Nicoló et al.236

clinic-based setting with local anesthesia. Bilateral, single
implants were placed in 26 subjects, and a unilateral, single
implant was placed in 4 subjects. Implants were successfully
delivered during the initial attempt in 91% of the cases. All
procedures resulted in successful placement of implant(s) to
the target location(s). No device-related adverse events were
reported during the index procedure.
►Table 2 summarizes cumulative internal and external
nasal examination results through 12 months of follow-up.
There was no evidence of transcutaneous extrusions. The
skin examination was normal with two exceptions: one
patient with a hematoma was noted at the 1 week follow-
up time point, and one patient with inflammation was noted
at the 1-month follow-up examination. Both observations
resolved prior to the subsequent follow-up examination.
Internal nasal examinations were normal across all time
points with the two exceptions: one report of nondevice-
related inflammation was noted at 1 week, and one non-
device-related infection was reported at 6-month follow-up
(rhinitis). There was no evidence of implant fracture and no
findings of implant migration based on internal and external
physical examination.
Three subjects required retrievals of a single implant
within the 1-month follow-up period. These events were
attributed to the implantation technique in two instances
and possible nasal manipulation by the subject in one
instance. The two retrievals related to the implantation
technique were attributed to an incomplete delivery, re-
sulting in the tip of the caudal end of the implant lying
very close to the cannula entry point causing subsequent
exposure. Using forceps, the investigator was able to
remove the entire implant without difficulty and without
the need for anesthesia. The third retrieval occurred when
a tip of the implant protruding through the implantation
site on one side was observed and retrieved by the
investigator. In this case, the subject reported to have
blown his nose forcibly, multiple times during the week
following the procedure. There was no erythema, bleeding,
swelling, or pain. The protruding portion of the implant
appeared to be mobile and was removed easily with
forceps and without anesthetic. During the nasal endo-
scopic examination, it was noted that there was no sign of
infection or a lesion due to the remaining upper part of the
implant on the lateral nasal wall. These three device-
related events resolved with no clinical sequelae.
Follow-up outcomes including pain assessments, evalua-
tion of foreign body sensation, the independent assessment
of cosmetic change, and adverse events at 1, 3, 6, and
12 months are summarized in ►Table 3. There were no
reports of moderate or severe pain at 1, 3, 6, or 12 months.
Four subjects reported a “mild”foreign body sensation at
month 1, and three subjects at month 12. Independent
physician photography review reported one subject with
an adverse cosmetic change at 3 months postprocedure that
subsequently resolved. At 6 and 12 months, there were no
adverse cosmetic changes identified, and three subjects were
classified as having significant cosmetic improvements at
12 months, where the independent reviewer observed less
alar retraction for 2 subjects, and 1 subject where the nasal
vaults were more open bilaterally. Approximately half of the
subjects wore eyeglasses throughout the follow-up period.
There were five adverse event related to the study device/
procedure that occurred within the 1-month postprocedure
follow-up. No subsequent device/procedure related adverse
event was observed.
Within-subject changes in NOSE score from baseline to
3, 6, and 12 months are summarized in ►Table 4.The
mean preoperative NOSE score was 76.7 14.8. Twelve
months postprocedure, the mean NOSE score was
35.2 29.2, reflecting an average within-subject reduc-
tion of –40.9 31.2 points. The paired t-test showed
significant differences between the mean baseline and
follow-up NOSE score at all three follow-up time-points
(p<0.001 for months 3, 6, and 12). MMRM results were
similar. ►Table 5 presents the response rates at 3, 6, and
12 months. The majority (76%) of subjects were classified
as responders at 12 months, demonstrating sustained
reductions in nasal obstruction symptoms. ►Fig. 2
presents NOSE score categories preprocedure and at
12 months in terms of the number of subjects in each
NOSE severity class. Preprocedure, all subjects were clas-
sified as extreme or severe. At 12 months, 66% of the
subjects were classified as mild or moderate, and the
number of subjects classified as extreme and severe was
reduced to 3 and 31%, respectively.
Table 2 Nasal examination cumulative observations through
12 months follow-up
Attribute (N¼30)
External nasal examination
Implant extrusion
No 30 (100%)
Skin appearance
Normal 28 (93.3%)
Hematoma 1 (3.3%)
Inflammation 1 (3.3%)
Internal nasal examination
Implant retrieval
Yes 3 (10%)
No 27 (90%)
Mucosal appearance
Normal 28 (93.3%)
Inflammation 1 (3.3%)
a
Infection 1 (3.3%)
a
Implant break/fracture
No 30 (100%)
Implant migration
No 30 (100%)
a
Not device procedure related.
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Absorbable Implant to Treat NVC San Nicoló et al. 237

Discussion
Nasal airway obstruction can be caused by a combination of
anatomical and structural abnormalities, including a weak-
ened lateral nasal wall that can result in NVC.
Data presented herein describe the first-in-human expe-
rience characterizing t he use of a novel absorbable impla nt to
support the upper and lower lateral cartilages in subjects
with NVC through 12 months. Subjects noted a significant
reduction in nasa l obstruction symptoms after the proced ure
through 12 months. The strengths of this study are of a
disease-specific instrument for treatment of nasal obstruc-
tion due to NVC, long-term follow-up, and prospective
patient evaluation.
Recently, a meta-analysis was conducted by Rhee et al19 of
studies covering conventional invasive surgical procedures
such as septoplasty, turbinate reduction, and functional
rhinoplasty, in combination or alone for treatment of nasal
airway obstruction. The analysis showed a weighted mean
pretreatment NOSE score of 65 points and a weighted mean
posttreatment NOSE score of 23 points, resulting in an
improvement from baseline of 42 points. In this study,
Table 3 Devicetolerability,cosmeticchanges,andadverseeventsat1,3,6,and12months
Attribute 1 mo postprocedure 3 mo postp rocedure 6 mo postprocedure 12 mo postprocedure
(N¼30) (N¼29) (N¼30) (N¼29)
Pain assessment
None/mild 30 (100%) 29 (100%) 29 (96.7%) 29 (100%)
Moderate/severe 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Not assessed 0 (0.0%) 0 (0.0%) 1 (3.3%) 0 (0.0%)
Foreign body sensation
None 26 (86.7%) 27 (93.1%) 27 (90.0%) 26 (89.7%)
Mild 4 (13.3%) 2 (6.9%) 3 (10%) 3 (10.3%)
Photography review (cosmetic change from baseline) (N¼30) (N¼29) (N¼27) (N¼27)
None 28 (93.3%) 25 (86.2%) 24 (88.9%) 24 (88.9%)
Yes–insignificant 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Yes–significant–worse 0 (0.0%) 1 (3.4%) 0 (0.0%) 0 (0.0%)
Yes–significant–better 2 (6.7%) 3 (10.3%) 3 (11.1%) 3 (11.1%)
Adverse events
Device related
a
5
Other
b
442
a
Device -related adverse e vents include th ree device retrievals, onehematoma, and one inflammation.
b
Other nondevice-/procedure-related adverse
events includes rhinitis, common colds, vertigo, rhinorrhea, acute hypertension, headache, hernia repair, and epistaxis.
Table 4 Pre- and postprocedure NOSE scores and change from baseline value
Statistics Baseline 3 mo postprocedure 6 mo postprocedure 12 mo postprocedure
NOSE score NOSE score Change from
baseline
NOSE score Change from
baseline
NOSE score Change from
baseline
N30 29 29 30 30 29 29
Mean 76.7 28.4 -48.4 33.3 -43.3 35.2 -40.9
SD 14.8 26.9 27.8 29.7 31.3 29.2 31.2
Median 75 20 -50 27.5 -45 35 -45
p-Value
a
<0.001 <0.001 <0.001
Abbreviations: NOSE, Nasal Obstruction Symptom Evaluation; SD, standard deviation.
a
p-Values are from paired t-tests comparing the mean preoperative NOSE score to the mean score at each follow-up time point.
Table 5 Response rate
a
at 3, 6, and 12 months after procedure
NResponders,
b
N(%)
3 mo postprocedure 29 25 (86.2%)
6 mo postprocedure 30 24 (80%)
12 mo postprocedure 29 22 (75.9%)
a
Response rate is based on the number of subjects with data at each
visit.
b
Responders are subjects with an improvement of at least one
NOSE score category or a 20% reduction in NOSE score.
Facial Plastic Surgery Vol. 32 No. 2/2017
Absorbable Implant to Treat NVC San Nicoló et al.238

subjects with NVC as a primary contributor to their nasal
airway obstruction symptoms were treated in stand-alone
procedures. The results from this study are within the range
of the meta-analysis findings with a mean improvement in
NOSE score of 41 points at 12 months. In addition, this study
showed 76% of the subjects were classified as responders
defined as having at least one NOSE class improvement or a
NOSE score reduction of at least 20%.
The implant created no adverse cosmetic change as con-
firmed by the independent photographic review. Spreader
grafts and batten grafts may lead to changes in the external
appearance of the nose, including widening of the middle
third of the nose, blunting of the alar crease, and widening of
the nasal tip.16 However, many of these grafting procedures
are more extensive (i.e., require cartilage repair or replace-
ment) than the procedures indicated for the subject implant
(i.e., cartilage support only). The lack of significant cosmetic
changes in this study may be attributable to the design and
position of the implant; the low profile of the implant,
particularly in the region that aligns with the thinner skin
above the maxillary transition, allows for minimal change in
the external nasal appea rance. The presence of the implant in
the nasal wall was well-tolerated by the subjects as evi-
denced by minimal pain scores and minimal foreign body
sensation to the device’s presence in the nose. The implant
also did not interfere with the use of eye glasses.
There were a total of five device-related adverse events
reported in four subjects. These events included one case of
hematoma, one case of inflammation, and three of implant
retrievals. All events resolved with no clinical sequelae. Inves-
tigators concluded that the three implant retrievals were the
result of suboptimal implantation method during initial cases
or possibly significant patient nasal manipulation during the
first postoperative week. There was no evidence of adverse
physiological tissue rejection, infection, and/or significant
implant migrations in contrast with the extrusion events
reported in the literature for more invasive procedures involv-
ing permanent, nonabsorbable allografts.13,14
The efficacy of the implant in reducing nasal obstruction is
demonstrated by a significant reduction in NOSE scores
through 12 months of follow-up, the gold standard for
rhinoplasty studies. This current study represents a first-in-
man demonstration of a new technique, as it has a modest
sample size, a nonrandomized study design, and a heteroge-
neous subject population with respect to prior history of
surgery. Future studies with a lager patient population should
address this as well as to include comparisons of the efficacy,
morbidity, and cost-effectiveness of this technique to stan-
dard surgical techniques and placebo treatments.
The absorbable nasal implant used in this study comprised
70% poly(L-lactide) and 30% poly(D-lactide). This nontoxic,
biocompatible copolymer has an extensive history of use in a
variety of medical applications such as suture materials,
orthopedic, dental, ophthalmic, and craniofacial implants.
Once implanted in vivo, over time, the copolymer chains
degrade into water soluble fragments that are naturally found
in the body (i.e., lactic acid) and are metabolized and eliminat-
ed through normal physiologic pathways. Landes et al studied
70% poly(L-lactide) 30% poly(D-lactide) copolymer degrada-
tion in human subjects in the maxillofacial region applica-
tions.20 The copolymers decomposed reliably in patients
within 24 months on average, leaving only extremely small
granules that powder upon finger touch. Landes et al also
noted fibrous capsule formation at around 3 months postim-
plantation. For the current application for the support of the
nasal lateral wall, it is hypothesized that the eventual encap-
sulation of the implant and then replacement of the implant
substrate with fibrocollagenous scar tissue may provide sup-
port to the lateral wall over time; however, the strength and
quality of the scar, as well as the potential for a prolonged
improvement that outlasts the mechanical integrity of the
absorbable implant is yet to be determined.
Fig. 2 Nasal Obstruction Symptom Evaluation (NOSE) severity class at baseline and 12 months postprocedure.

One subject who was classified
as extreme at baseline did not complete the 12-month NOSE score assess ment.

Four subjects at 12-month follow-up h ad a NOSE score of 0 that
have been categorized as mild for this analysis.
Facial Plastic Surgery Vol. 32 No. 2/2017
Absorbable Implant to Treat NVC San Nicoló et al. 239

In summary, NVC attributed to a weak lateral cartilage is a
common cause of nasal obstruction. However, due to com-
plex surgical techniques for correcting NVC and associated
cosmetic consequences, NVC frequently remains untreated.2
Hence, in this study, we present a first-in-human experience
with a minimally invasive technique for supporting the
lateral nasal wall with low cosmetic risk and using a widely
used absorbable material with well-known safety profile.
Conflict of Interest
The authors declare no conflict of interests.
Funding
This study was supported with research funding from
Spirox Inc., MenloPark, CA. Dr. San Nicoló received research
funding by Spirox Inc., Menlo Park, CA, and is consultant to
Spirox. Prof. Sadick received and Dr. Bas received research
funding from Spirox Inc., Menlo Park, CA.
References
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Vogel; 1920
2Becker SS, Dobratz EJ, Stowell N, Barker D, Park SS. Revision
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