SAN DIEGO –
A non-invasive treatment, rapid acoustic pulse (RAP) technology (RESONIC), was approved by the Food and Drug Administration in 2021 for short-term improvement in the appearance of cellulite. The device emits rapid acoustic pulses (shock waves) that are transmitted through the skin to break or shear the fibrous septa. the release of diaphragms results in the smoothing of skin pits, Arisa E. Ortiz, MD, director of laser and cosmetic dermatology at the University of California, San Diego, said at the annual Masters of Aesthetics Symposium. RAP, however, was “temporarily withdrawn from the market to refine the design.”
According to Dr. Ortiz, the repetition rate and short rise time of RAP provide microscopic mechanical disruption to targeted structures and cell-level vacuoles, while the high peak pressure and fast repetition rate take advantage of the viscoelastic nature of the tissue. Compressed pulses from electronic filtering and reflector shape eliminate cavitation, heat and pain. Researchers have assumed that the process stimulates collagen and angiogenesis.
“There is no heat in it. it just uses sound,” explained Dr. Ortiz. “It also depends on the time. The longer you do the treatment, the more disruption of the diaphragms you see. The procedure takes 20-30 minutes. Unlike other treatments, it’s not just for subtle dimples. You can treat entire areas like the buttock or the rear leg,” said Dr. Ortiz, who has not used the RAP device in her practice.
Another device, the Targeted Verifiable Subsection (TVS, marketed as Avéli), is FDA-approved to temporarily reduce the appearance of cellulite on the buttocks and thighs of adult women. “But studies show lasting results, at least for a year,” Dr. Ortiz said. The device has a photo-guided sensor and a hook. The light allows clinicians to navigate under the skin, while the hook releases a tiny blade that cuts the septa. “Once you find the diaphragms, you activate the blade and release the diaphragms. Go right to left because the direction of the blade is to the left of the probe. Then you go back to verify that you have everything that created that dimple.”
Previous devices, he said, “were blindly scanning the area, so you would find the dimple and cut blindly, so there was no way to verify that you had the target dimple. The results were sometimes mediocre because you didn’t really know if you were effectively dealing with the area.”
He pointed out that TVS is only useful for subtle dimples. “Many patients who come in asking for cellulite treatment have a lot of looseness and wavy texture,” said Dr. Ortiz, who is also president-elect of the American Society for Laser Medicine and Surgery. “This will not be appropriate for these cases. Setting expectations is important. If patients have looseness and subtle dimples and it’s only the dimples that bother them, that’s fine. They just need to know the difference,” she said, noting that this is “safe for all skin types.”
General anesthesia is used to control pain during the procedure. The most common side effects are bruising and pain. Results from one nodal test showed that clinically meaningful improvements in the primary endpoint, Cellulite Severity Scale scores, were maintained 1 year after treatment. “Hemosiderin staining can occur, but it eventually goes away on its own,” added Dr. Ortiz. “You can use lasers to speed up healing, but sometimes that can make it worse, so you want to be careful with that. Most of the time I have patients waiting for it. it goes away by itself.”
One year after a single RAP treatment, patients give the results high marks
He noted that the development of RAP and TVS helped clinicians better understand the composition of septa. “We used to think of septa as single bands that are perpendicular to the cellulite, but what we’ve realized is that it’s more like a network of septa,” he said.
Another non-invasive technology, synchronous parallel beam ultrasound technology from Sofwave (marketed as SUPERB), was FDA cleared in December 2022 for short-term improvement in the appearance of cellulite. The device has seven parallel beam transducers that raise the tissue temperatures of the treatment area to 60-70°C, causing collagen remodeling and collagen denaturation, he said..
In the pivotal study of 68 women, two blinded reviewers reported an 89% improvement rate for both cellulite and skin sagging after two treatments 2-4 weeks apart, according to data she presented at the meeting. The average pain score during treatment was 4.55 on a scale of 1-10. No safety concerns were observed and immediate responses were limited to erythema and edema.
Dr. Ortiz disclosed that he has financial relationships with several pharmaceutical and device companies, including receiving speaker fees and royalties from Sofwave. He is also co-chair of MOAS.