A Study of a Novel Controlled Focal Septa Release Method for Improving Cellulite

Abstract

Background: Cellulite is a common and often emotionally distressing condition among affected individuals. The dimpled appearance is caused by fibrous connective tissue, or septa, which tether the dermis to underlying fascia. A novel, minimally invasive, controlled focal septa release method was developed to selectively identify, target and manually release the tethers in a precise manner from a single insertion point (Revelle Aesthetics). The following pilot study evaluated the safety and feasibility of this method for treating subjects with moderate-to-severe cellulite. Methods: Female subjects (N = 10), 21–55 years old underwent unilateral controlled, focal fibrous septa release on the buttocks and thighs. Local anesthesia was administered using standard techniques. Cellulite depressions were marked with the subject standing at rest. Target septa were identified in the marked areas by applying tension with the device to reproduce the dimple appearance on the skin. Once identified, the contributing septa were severed with the device. For eight subjects, access was achieved with one small incision in the gluteal crease. Study assessments occurred on posttreatment days 1, 3, 14, 30, and 90. Results: All procedures were successfully completed with no serious or unexpected adverse events and the procedure was well tolerated. Mild adverse events were transient bruising and soreness. Target septa can be visualized on the skin by applying tension with the device. Multiple depressions can be treated from a single entry point. Conclusion: These results confirm the safety and feasibility of the controlled focal fibrous septa release method to treat moderate and severe cellulite. Additional trials are ongoing.

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

“…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 …”

“…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 of cellulite and this study confirms the importance of targeting the bands which create the depression.…”

“…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.…”

Cellulite: Clinical Challenges and Future Perspectives

“…5 The newest technology in manual subcision is a controlled focal septa release method (Avéli; Revelle Aesthetics, Inc, Mountain View, CA) that has been shown to be effective for cellulite in the buttocks and thighs. 7,8 This technique has also been associated with ecchymosis, as shown in a study of 20 women, in whom this AE persisted for a mean duration of 17.6 days after treatment. AEs that were reported in $10% of treated women included ecchymosis (100%); edema (45%); soreness, pain, or tenderness (45%); and nodules (10%).…”

Cellulite: Current Treatments, New Technology, and Clinical Management

“…The newest minimally invasive subcision method—controlled focal septa release—can selectively identify, target, and manually release tethers with precision (Avéli; Revelle Aesthetics, Inc., Mountain View, CA). 10 This device enables visualization of target septa on the skin, and multiple depression sites can be treated from a single insertion site. After anesthesia, the device is inserted through the skin and advanced to a depression site guided by a light indicating the end of the device under the skin.…”