Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: Final Results at 12 Months

Abstract

Background

Safety and efficacy endpoints for the single-arm, multicenter, open-label pivotal study, CONtrolled Focal Fibrous Band Release Method (CONFFIRM) [NCT04743635] assessing targeted verifiable subcision (TVS) for the treatment of cellulite were met at 3 months postprocedure and have been published. Final, 12-month data describing durability of treatment effect and safety are presented here for the first time.

Objectives

The authors sought to evaluate safety and efficacy out to 12 months of initial treatment for a single TVS procedure performed employing the Avéli device (Revelle Aesthetics, Inc.; Mountain View, CA) to treat cellulite on the buttock and thigh areas of adult females.

Methods

Effectiveness was determined by 3 independent physicians employing the Cellulite Severity Scale and Global Aesthetic Improvement Scale to assess improvement of baseline photographs when compared with 3-, 6- and 12-month posttreatment photographs. Blinded participant-reported outcomes and safety evaluations were also performed at all postprocedure time points.

Results

Clinically significant improvement in primary endpoint Cellulite Severity Scale scores were sustained out to 1 year, improving by 1.50 (P < .0001) at 3 months, 1.54 points at 6 months, and 1.48 points at 12 months. Adverse events were mild and mostly resolved by the 12-month visit.

Conclusions

A single TVS treatment has durable efficacy and safety in reducing cellulite on the buttocks and thighs of women with moderate to severe cellulite out to 12 months posttreatment.

Level of Evidence: 2

See the Commentary on this article here.

Occurring primarily in the buttocks and thighs, cellulite affects 80%to 90% of post-pubertal women across all races and ethnicities and, for some, can cause embarrassment and emotional distress, negatively impacting quality of life.^1–5 Females are more prone to cellulite due to the hormone-driven differences in septal arrangement in men and women, which are thought to arise in utero.^6,7 Although the prevalence and severity of cellulite is influenced by sex-based anatomical differences, cellulite is a multifactorial condition also influenced by weight, hormones, age-based changes in skin, genetic influences, and lifestyle factors.¹ The multifactorial nature is reflected in findings from histological studies that show that changes in septa, dermis, and adipose are each associated with the presence of visible cellulite.⁸ However, although the skin and subcutaneous fat certainly contribute to the appearance of cellulite, the force imposed on the dermis by fibrous septal bands appears to be both sufficient and necessary to cause the skin dimpling characteristic of cellulite.^9–14 In support of this concept, a comprehensive review of clinical data revealed that durable efficacy was achieved only with strategies targeting septa, further implicating the focal tension imposed on the dermis by this fibrous tissue as the primary cause of cellulite.⁸

Thus, subcision has emerged as the most effective strategy for management of cellulite. Subcision involves treating individual cellulite depressions by severing thickened fibrous septal bands, thereby releasing the tension on the overlying dermis. Mechanical subcision can be achieved through various methods that access the superficial layer between the dermis and superficial fascia: existing techniques include the insertion of a hypodermic needle under the cellulite depression to cut the septa, a laser-based treatment accessing the septa through cannula insertion, and a vacuum-assisted guided device with a motorized reciprocating cutting blade that is moved through the superficial layer.^15–17 The efficacy and durability demonstrated by these techniques reinforce the central role of septa in causing cellulite. However, these approaches are somewhat invasive, requiring at least 1 incision for each cellulite depression, which, along with the need for cumbersome or time-consuming devices, has limited uptake in clinical practice, leaving an unmet need for efficient, minimally invasive targeting of the culprit septa. More recently, enzymatic dissolution of type I and III collagen in the area of individual cellulite depressions has emerged as a possible modality for management of cellulite.^18,19 Although the minimally invasive nature of an injection is appealing, degradation of collagen in the fibrous septal network is not restricted to the septal band, which causes the cellulite depression, heightening the risk of inadvertent action on the septal network.

In contrast, targeted verifiable subcision (TVS; Avéli [Revelle Aesthetics, Inc.; Mountain View, CA] employs a controlled, minimally invasive mechanical method of focal fibrous septal release where multiple septa can be accessed through a small skin incision. The device includes a deployable hook that is advanced in the subcutaneous layer, with an integrated light source to allow for trackable movement towards the septa. Once the depression is reached, a deployable hook allows for engagement of the septa and visualization of the recreated depression followed by the release of the culprit septa with the blade. The distal end is 15 cm long, allowing for a wide field of treatment and management of multiple cellulite depressions with a single small skin entry site (approximately 3.5 mm). The tactile and visual feedback afforded by this design offers a significant advantage in that it permits an assessment of septal involvement beyond the center of the depression through mechanical engagement and verification of the depression contributing to the cellulite. Given that fibrous strands can originate in various locations and be oriented in various directions relative to the center of the cellulite depression, visual confirmation is important for precise treatment. Further, multiple fibrous septa can be responsible for tethering an individual depression, highlighting the need for not only precise, but complete treatment.

TVS has demonstrated safety, efficacy, and feasibility in earlier studies, including a small open-label multicenter study.^20,21 A single-arm, multicenter, open-label pivotal study, CONtrolled Focal Fibrous Band Release Method (CONFFIRM) [NCT04743635], was initiated to assess TVS (Avéli) efficacy, safety, and response durability when employed in a single procedure to reduce cellulite in the buttock and thigh areas of adult females. Safety and efficacy endpoints were met for postprocedure follow-up at 3 months and have been published.²² Herein, we present 6-month and 12-month data assessing durability of response, electronic patient-reported outcomes (ePRO), and extended safety data.

METHODS

Study Enrollment

A total of 9 study sites in the United States and Australia, including 6 plastic surgeons and 3 dermatologists, enrolled study participants between January and February 2021. Enrollment criteria are detailed in the publication of the 3-month data.²² Key criteria were female aged 21 to 55 years with moderate to severe cellulite on thighs and/or buttocks, a Cellulite Severity Scale (CSS) score ≥ 3 (Supplemental Table 1, available online at www.aestheticsurgeryjournal.com), and a BMI < 30.0. Key exclusion criteria were severe skin laxity, having undergone a cellulite procedure in the last 12 months on the target area, >10% change in body weight within the last 6 months, history of significant weight loss (> 60 kg), or having previous liposuction on the thigh and/or buttocks.

The study protocol and related materials were approved by an IRB/ethics committee (WCG IRB in the US:20203855 and Bellberry Limited in Australia: 2020-11-1122-A-11). The CONFFIRM study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki. Each participant provided written informed consent prior to the procedure and was advised they could voluntarily withdraw from the study at any time.

Efficacy Assessment and Study Endpoints

Two components of the validated CSS, including the number of depressions (Part A) and depth of depressions (Part B), were employed to assess cellulite severity in this study. Based on FDA precedent, data for these endpoinds were collected at 3, 6, and 12 months (30 d/mo) postprocedure. For the 3-month time point, the primary efficacy endpoint was considered reached with a mean ≥1 point reduction in the total CSS score (Part A + Part B − 1) at month 3 (Supplemental Table 1). To determine efficacy, 3 independent, blinded physicians scored participant images from baseline and 3 months employing the CSS scoring system. The primary safety endpoint was evaluated based on device-related serious adverse events (SAEs) at 30 days.²²

Secondary inferential efficacy endpoints included improvement on the Global Aesthetic Improvement Scale (GAIS) (Supplemental Table 2, available online at www.aestheticsurgeryjournal.com) at 3 months, based on evaluation of baseline and postprocedure photographs by independent physician evaluators. A patient is considered improved if the GAIS assessment is improved (1), much improved (2), or very much improved (3). Secondary efficacy descriptive endpoints evaluated at 6 and 12 months described herein include longer-term mean CSS score change from baseline, proportion of responders as defined by ≥1 CSS point improvement, and GAIS improvement proportions.

Electronic Patient-Reported Outcomes

Multiple site-blinded ePROs were utilized in the study to collect participant satisfaction and safety information. For these patient-reported outcomes, patients utilized online, site blinded questionnaires to minimize potential bias in reporting. The ePROs included a 5-point satisfaction rating questionnaire collected at 3, 6, and 12 months (Supplemental Table 3, available online at www.aestheticsurgeryjournal.com) as well as a 3-point scale assessing whether the procedure experience met patient expectations at 3 months. Patient pain, discomfort, and soreness ePROs were also provided daily for 7 days after the procedure and again at 30 days and 3 months. The discomfort/soreness/pain assessments were only repeated by individual patients at 6 and 12 months if the participant reported related symptoms.

Safety Evaluation

Participants were evaluated by phone 24 hours following the procedure for adverse events (AEs) and to ensure there was no immediate need for follow-up care. In-person safety assessments by the investigator were performed at 7 days (if in office) and at 1, 3, 6, and 12 months postprocedure, at which time patients were assessed for any new or ongoing adverse events. All AEs were evaluated for severity using the Common Terminology Criteria for Adverse Events.²³

Study Photography and Image Evaluation

As primary and secondary study efficacy endpoints relied on consistent, high-quality imaging, images were taken under strict, standardized environments by qualified photographers who were trained by a chief photographer. A training manual outlined the standardized set-up including equipment, lighting, participant angles, and camera positioning. During study photography visits, each participant was photographed per the study photography manual to generate a minimum of 3 images from a minimum of 3 different angles.

Efficacy outcomes were specific to treated regions only, which were disclosed to the evaluators. For the CSS assessment, independent evaluators were blinded and the treated areas were outlined. Before and after images were assigned a unique identifier and were randomized by ABio Clinical Research Partners, LLC, an independent, third party so that the evaluators did not know which images were before or after the procedure. Once the CSS image evaluations were completed, the corresponding baseline and follow-up images for each participant were provided for the GAIS unblinded assessment.

Procedure

Following baseline photography, the investigator identified and marked cellulite depressions to be treated using a surgical marker, with the participant in a standing position. First, the edge of the depression was marked, creating either a line, oval, or circle. Then, an 8-mm (width of a ballpoint pen) margin was drawn outside of the first marking to enable identification of the relevant septa, including branching and angled septa. Anesthesia was delivered subcutaneously from the skin entry site, generally in the gluteal crease, to the marked cellulite depressions and at least 35 mm past the marked targets to prevent discomfort when positioning the device at the marked cellulite depressions.

The procedure was conducted employing a minimally-invasive TVS device. The device consists of a handle housing the slider, home button, and active button, as well as an integrated light source that allows for depth control and trackable advancement to the procedure location. As shown in the Supplemental Video, available online at www.aestheticsurgeryjournal.com, the investigators advanced the device through a small transdermal entry site (approximately 3.5 mm) to the procedure location while keeping the device close to the dermis in the superficial plane, with the light visible. With the light positioned under the marked procedure location, the hook was deployed to engage septa within the superficial layer of fat. If tensioning the engaged septa resulted in the appearance of a depression in the marked target area, the device was employed to release the septa. Release of the contributing septa was verified by passing the hook through the area again with the hook deployed. These steps were repeated until the depression could no longer be recreated on the skin surface. The length of the device permits treatment of multiple cellulite depressions on the buttock and thigh from a single skin insertion site: the procedure was repeated until all marked depression areas were treated. Following the procedure, the entry site(s) was bandaged. Descriptive analyses of CSS and AEs were performed to explore the potential for learning curve effects on sequential patients using sites with at least 5 participants enrolled.

Statistical Analysis

Descriptive statistics were used to summarize the 6- and 12-month secondary endpoints, including mean, standard deviation, median, range for continuous data and frequency, and percentage for category values. The 2-sided 95% confidence interval (CI) for the mean reduction in CSS and GAIS improvement rate were calculated for the 6- and 12-month visits to provide support for the longer-term performance of these endpoints.

RESULTS

Study Disposition

The demographics and baseline characteristics of enrolled participants are included in Table 1. The modified intent-to-treat (mITT) group (excludes the first 6 participants, 2 per investigator, for the 3 investigators who had not performed a TVS procedure in the earlier safety and feasibility studies) had a mean BMI of 24.8 ± 2.7 (range, 19-29.8) and age of 41.4 ± 7.4 years (range, 26-54 years). All Fitzpatrick skin types were represented, with types II to IV being the most common. Most participants (88.2%, 60/68) were treated in both the buttocks and the thigh, whereas the remaining 11.8% (8/68) were treated in the buttocks only. The mean number of depressions treated was 20 ± 8.1, ranging from 6 to 45, with a mean of 2.9 access sites per participant. Among the participants treated, 94.1% were grade 3 (severe) on the CSS Part A category at baseline (Table 2). Learning curve analyses were performed on the ITT group (74 participants, 9 sites, 9 treating investigators, including the 6 roll-in participants enrolled at 3 sites) and there was no statistical difference between new investigators and experienced investigators, demonstrating no clear learning curve for the TVS procedure. At 12 months, the mean patient follow up was 353 days (range, 271-392 days).

Table 1.

Demographics and Baseline Characteristics for the CONFFIRM Study

Characteristic	N = 68
Age (y)
Mean (SD)	41.4 (7.4)
Median	41.5
Minimum, maximum	26, 54
Height (in)
Mean (SD)	64.9 (2.2)
Median	65.0
Minimum, maximum	60, 69
Weight (lb)
Mean (SD)	148.4 (18.4)
Median	150.0
Minimum, maximum	105, 185
BMI (kg/m2)
Mean (SD)	24.8 (2.7)
Median	25.0
Minimum, maximum	19, 29.8
Ethnicity, no. (%)
Hispanic or Latino	19 (27.9)
Not Hispanic or Latino	49 (72.1)
Race, no. (%)
Asian	1 (1.5)
Black or African American	6 (8.8)
Native Hawaiian or Other Pacific Islander	1 (1.5)
White	54 (79.4)
More than 1 race reported	3 (4.4)
Unknown or not reported	3 (4.4)
Fitzpatrick skin type, no. (%)
Type I	1 (1.5)
Type II	19 (27.9)
Type III	24 (35.3)
Type IV	15 (22.1)
Type V	6 (8.8)
Type VI	3 (4.4)

Table 2.

Range of Depressions Treated for the CONFFIRM Study

Range of depressions	No. (%)	Cellulite Severity Score, depressions (CSS part A)
5-9	4 (5.8)	Moderate CSS Part A 4 (5.8%)
10-15	18 (26.5)	Severe CSS Part A 64 (94.1%)
16-20	18 (26.5)
21-25	13 (19.1)
26-30	6 (8.8)
31-35	7 (10.3)
35-45	2 (2.9)

Abbreviation: CSS, cellulite severity score.

Efficacy and Durability

The primary efficacy endpoint was surpassed with a mean improvement in CSS of 1.50 ± 0.9 (P < .0001) at 3 months. At 6 and 12 months, CSS outcomes remained stable with mean improvement of 1.54 ± 0.8 and 1.48 ± 0.9, respectively (Table 3, Figure 1). Of these, 78.5% (51/65) and 73.8% (48/65) of patients improved by at least 1 point from the baseline CSS score, similar to the 3-month responder rate (83.8% [57/68] [P < .0001]) (Figure 2). At 6 months, 26.2% (17/65) of patients improved by 2 points and 6.2% (4/65) improved by 3 points. At 12 months, 35.4% (23/65) of patients improved by 2 points and 4.6% (3/65) improved by 3 points.

Table 3.

CSS Score Improvement From Baseline for the CONFFIRM Study

CSS score improvement from baseline
Visit	N	Mean ± SD	95% CI
3 mo	68	1.50 ± 0.87	1.28-1.71
6 mo	65	1.54 ± 0.82	1.34-1.75
12 mo	65	1.48 ± 0.87	1.27-1.70

Abbreviation: CSS, cellulite severity score.

Figure 1.

The Cellulite Severity Scale score improvement was determined by blinded evaluators using photography at 3, 6, and 12 months and plotted with 95% confidence intervals.

Figure 2.

The Cellulite Severity Scale responder rate was determined by blinded evaluators using photography at 3, 6, and 12 months and plotted as the percentage of patients with 1-point, 2-point, or 3-point improvements.

The secondary GAIS endpoint was met with an overall improvement rate of 95.6% (P < .0001) at 3 months. GAIS improvement was sustained through 1 year posttreatment at 89.2% at 6 months and 93.9% at 12 months, respectively (Figure 3). Improvement from baseline to 12 months is demonstrated in sample participant images in Figures 4 to 7. Patient satisfaction was 72.1% (49/68) at 3 months, 72.7% at 6 months and 69.2% (45/65) at 12 months (Figure 8; Table 4). When the roll-in participants (n = 74) were included, satisfaction improved to 73% (54/74) at 3 months, 73.6% (53/72) at 6 months, and 70.4% at 12 months. Sites did not administer the questionnaires, and participants directly entered their data online, maintaining site and sponsor blinding and increasing the stringency of ratings. The sponsor was only unblinded after the data analyses was performed by the statistician. An exit interview was conducted by a third party, independent of the sponsor with a subset (n = 18) of exited CONFFIRM study participants to understand participant satisfaction responses. Of particular importance for both future clinical studies and real-world use of cellulite treatments is that most interviewed participants indicated they expected that the procedure would get rid of their cellulite completely. Thus, even when participants demonstrated an improvement on the CSS scale and were rated as improved on the GAIS scale, some were not satisfied. In addition, several patients indicated that the area they cared the most about was not treated, further highlighting the need to educate patients on the specificity of treatment aimed at disrupting septa and treating individual cellulite depressions.

Figure 3.

The Global Aesthetic Improvement Scale (GAIS) responder rate was determined by unblinded evaluators using photography at 3, 6, and 12 months and plotted as the percentage of patients considered improved, much improved, and very much improved.

Figure 4.

Sample participant photos of this 39-year-old female patient with a BMI of 19.9 (A, C, E) before and (B, D, F) after treatment.

Figure 5.

Sample participant photos of this 38-year-old female patient with a BMI of 25.1 (A, C, E) before and (B, D, F) 12 months after treatment.

Figure 6.

Sample participant photos of this 34-year-old female patient with a BMI of 29 (A, C, E) before and (B, D, F) 12 months after treatment.

Figure 7.

Sample participant photos of this 37-year-old female patient with a BMI of 28.8 (A, C, E) before and (B, D, F) 12 months after treatment.

Figure 8.

Patient satisfaction was measured using a blinded electronic patient-reported outcomes questionnaire at 3, 6, and 12 months.

Table 4.

Patient Satisfaction ePRO Responses for the CONFFIRM Study

Patient response	3 mo	6 mo	12 mo
Very satisfied	26.5% (18/68)	34.8% (23/66)	33.8% (22/65)
Satisfied	45.6% (31/68)	37.9% (25/66)	35.4% (23/65)
Neutral	17.6% (12/68)	21.2% (14/66)	18.5% (12/65)
Patient satisfaction (combined categories)
Any satisfaction	72.1% (49/68)	72.7% (48/66)	69.2% (45/65)
Neutral	17.6% (12/68)	21.2% (14/66)	18.5% (12/65)

Importantly, at 3 months, participants completed an online ePRO questionnaire to assess whether their procedure experience met their expectations, and most participants (82.4%, 56/68) had a procedure experience that met or exceeded their expectations.

Safety

The primary safety endpoint was met with an absence of device-related SAEs at 30 days.¹ Importantly, the definition of AEs in CONFFIRM is defined as any undesirable medical occurrence, a broad definition which permits a comprehensive, real-world safety profile. Throughout the entire follow-up, no related SAEs, serious adverse device effects, or unanticipated adverse device effects were observed in the ITT cohort (n = 74).

A total of 2 related, grade 1 AEs (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated) were reported in the 68 mITT participants starting after the 3-month follow-up visit. All related AEs reported throughout the 12-month study were mild (Grade 1, 90.3%) or moderate (Grade 2, 9.7%) on the 5-grade Common Terminology Criteria for Adverse Events scale. Only 6% (13/217) of AEs were ongoing at study exit and were all evaluated as grade 1 by the Investigators. The related AEs experienced by >3% of participants are presented in Table 5 and are typical and expected for this type of procedure. The most common AEs were ecchymosis, occurring in 59 participants (86.8%, mean duration 37.4 days, median 27.0 days), followed by tenderness (35, 51.5%, mean duration 38.5 days, median 21.0 days), pain (26, 38.2%, mean duration 19.9 days, median 9.0 days), and induration (25, 36.8%, mean duration 175.9 days, median 172.0 days). The median duration of all resolved events was 25 days, with all pain and tenderness AEs resolving by the 6-month visit. There were 2 ongoing cases of induration (Grade 1) at study completion, defined as small areas of firmness, not visible or painful, and not associated with the incision site.

Table 5.

Adverse Events Experienced By >3% of Participants Through 12 Months for the CONFFIRM Study, N = 68

Adverse events	≤3 mo	6 mo	12 mo
Ecchymosis	59 (86.8%)	0	0
Tenderness	35 (51.5%)	0	0
Pain	26 (38.2%)	0	0
Induration	25 (36.8%)	0	0
Numbness	12 (17.6%)	0	0
Incision-site bleeding	11 (16.2%)	0	0
Edema	8 (11.8%)	0	0
Fluid discharge	6 (8.8%)	0	0
Hemosiderin stain	5 (7.4%)	0	0
Hyperpigmentation skin	2 (2.9%)	1 (1.5%)	0
Burning sensation	3 (4.4%)	0	0
Swelling	3 (4.4%)	0	0
Tingling	3 (4.4%)	0	0

Most related AEs did not require any action (148/217, 68.2%). Where action was specified, it often involved over-the-counter pain medication and at-home recovery management with compression, massage, and icing. Only 4 events required minor intervention (1.8%), which included aspiration of seroma and hematoma, aeration for a small mass, and precautionary stitches on the access site. Additionally, there were no new or ongoing patient reports of soreness, discomfort, or pain at the 6-month and 12-month visits on the ePROs.

DISCUSSION

The minimally invasive TVS device was proven highly effective and safe in reducing cellulite on the buttocks and thighs of adult women having an average of 20 depressions (range, 6-45) when administered in a single TVS treatment session under local anesthesia.²² The TVS treatment effect is durable through 12 months. Improvement in CSS score remained consistent throughout the study, demonstrating a 1.50-point improvement at 3 months, 1.54 at 6 months, and 1.48 at 12 months (Figure 1; Table 3). Furthermore, the durability of the CSS response is demonstrated at 6 and 12 months, providing support for the longer-term performance of this endpoint (Figure 2). Improvement on the GAIS also remained high at 6 and 12 months (Figure 3).

Patients were satisfied throughout the study period, with most participants reporting satisfaction with their cellulite procedure results at 12 months at a similar rate to that observed for 3 months when asked on a blinded ePRO questionnaire (45/65, 69.2%, Figure 8). Given the pathophysiology of cellulite, and the durability of subcision based techniques, the persistent satisfaction may very well reflect a highly durable outcome. The procedure is a one-time treatment with real-time, tactile feedback of septa release. It is reasonable to assume that the results will be visible once swelling and bruising subside and can be expected to remain consistent out to at least 1 year. In clinical practice, patients often identify skin laxity or adiposity as “cellulite,” when in fact these surface irregularities have a different etiology. Thus, it is of critical importance that diligent patient education, expectation setting, and identification of areas for which the patient most wishes to see improvement occur prior to treatment. All ePROs were collected in a blinded fashion and patients reported their responses on their own device. Employing reporting procedures that remove the clinician from the process through blinded, written self-reporting is effective for controlling bias.²³

Safety remained high through the entire follow-up with related AEs being mild (Grade 1, 90.3%) or moderate (Grade 2, 9.7%) and expected for this type of procedure. As demonstrated herein and in the published 3-month data, the CONFFIRM trial demonstrated statistically significant, durable improvement in reducing the appearance of cellulite with a powered multi-center pivotal study, confirming the safety, efficacy, and feasibility of the procedure demonstrated in 2 pilot studies of the device.^20,21

The device for TVS is unique in that it provides tactile and visual feedback, allowing for the assessment of the contribution of septal fibers engaged by the deployable hook to an individual depression before the blade is employed to release the septa. It is already well established the role of fibrous bands in the formation of cellulite and this study confirms the importance of targeting the bands which create the depression.⁸ These bands may be oblique to the center of the depression, and visual confirmation of the culprit septa is critical for targeted treatment. For the treating physician, especially those familiar with liposuction, this procedure is intuitive and efficient with a favorable learning curve. The minimal number of incisions needed when compared with other subcision-based techniques is an important feature of TVS that allows for a less traumatic treatment. Although this study is limited to assessment of efficacy at 1 year, the effect of subcision has proven to be highly durable with numerous devices and approaches, making these data of particular interest.^15,24

TVS minimizes the risk of visible scarring with a mean number of 2.9 access sites per participant, generally within the gluteal crease, and small skin entry sites (approximately 3.5 mm). In particular for patients with skin of color, minimizing the number of incisions can also reduce the risk of post-inflammatory hyperpigmentation, which is an important feature of this treatment.

Importantly, the risk of hemosiderin staining with this device is minimal with resolution in the study by 90 days without any intervention, though ecchymosis occurs in 86.8% of participants, the mean duration is 37.4 days (median, 27.0 days). Nearly all ecchymosis was grade 1 (58/59 events), with only a single report of grade 2 ecchymosis that resolved by the 1-month visit. Because there is only a single treatment, the risk of ecchymosis is not compounded by the need for additional interventions. Patients should be encouraged to utilize sun protection in the treated area to prevent the risk of hemosiderin staining. Given the association of vessels with the sclerotic septa, bruising is somewhat of an inevitability; however, the specificity and local action of TVS reduce this risk.^6,11,13 For TVS, bruising is inherently minimized, as it is a result of septal disruption only without the need for transdermal openings at each site.

The fact that TVS allows for focal treatment of cellulite-causing septa while leaving the remaining supporting structure of the region intact makes it uniquely suited to treat patients for whom cellulite is bothersome. Mechanical confirmation of septal involvement in cellulite formation and the ability to confirm complete disruption of tethering assures targeted treatment, but perhaps more importantly, it reduces the potential for non-specific treatment. Leaving the remaining supporting structure of the buttocks intact is requisite for responsible treatment of cellulite. Excess disruption of the septal network, which supports buttock shape could potentially lead to flattening of the buttock, a poor outcome for patients. Further, the durability and potential permanence of septal disruption means that such an event would likely not be easily reversed.

Limitations of this study include the open-label study design and the lack of a comparator group. The minimally important difference was not estimated to interpret PRO measures in this study and will be considered for future studies. Future studies could evaluate older or higher BMI patients who were not included in the CONFIRRM study population. Future studies may also include longer-follow up, evaluation of TVS as an adjunct for other body contouring procedures including liposuction in combination with autologous fat grafting or to release tethered scars unrelated to cellulite and could also include basic studies of tissue changes (eg, septal morphology or collagen deposition) following treatment.

CONCLUSIONS

The durability of the primary and secondary endpoints of CONFFIRM was demonstrated through 12 months, reinforcing the safety and efficacy of reducing the appearance of moderate to severe cellulite on the buttocks and thighs of adult women under local anesthesia in a single procedure employing the minimally invasive device for TVS. The device for TVS provides tactile and visual feedback allowing for effective identification of the culprit septa, differentiating it from existing subcision techniques.

Supplemental Material

This article contains supplemental material located online at www.aestheticsurgeryjournal.com.

Disclosures

The authors are consultants to and/or shareholders of the study sponsor, Revelle Aesthetics, Inc. (Mountain View, CA). Dr Layt is a consultant and educator for Mentor Corporation (Irvine, CA). Dr Kaminer is a consultant for Allergan (Irvine, CA). Dr Wall is an investigator for Establishment Labs (Alajuela, San Jose, Costa Rica) and a shareholder at Establishment Labs, Ideal Implant (Dallas, TX), Patient Fi (Irvine, CA) and Brijit Medical (Marietta, GA) and is on the advisory board for Brijit Medical. Dr Fabi is a consultant and investigator for Endo (Malvern, PA) and Abbvie (North Chicago, IL). Dr Magnusson is an advisory board member for Allergan/AbbVie on breast surgery, an educator for Mentor Corporation on breast surgery, and a founding investor for Strathspey Crown (Newport Beach, CA). The other author(s) declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Funding

This study was sponsored by Revelle Aesthetics, Inc (Mountain View, CA).