VelaSmooth™ System (Syneron Medical Ltd, Yokneam, Israel)

The next frontier in the non-invasive treatment of cellulite may be lasers. One of these systems, Velasmooth™ (Syneron Medical Ltd, Yokneam, Israel), was approved by the FDA in July 2007 for “temporary reduction of thigh circumference”. This system combines RF, 700 nm near-infrared light (IR), and negative tissue massage. The IR aspect of the device reduces the occurrence of adverse effects such as skin pigmentation and scarring, while the RF energy can penetrate deeper layers of the skin (a feature that IR alone does not pos­sess). In addition, the combination of the RF and the IR is thought to create heat that aids in the dissociation of oxygen from oxyHb, thereby increasing the amount of oxygen available in adipose tissue for fat metabolism. The negative tissue massage contributes to the process by aiding in the physical breakdown of fat clusters and in promoting lymphatic drainage [23] (Fig. 16.9).

Velasmooth is recommended for healthy women with a 20-30% BMI. The recommended treatment regimen includes bi-weekly treatments (45-60 minutes each) for a total of 8-12 sessions. With maintenance, the results of Velasmooth are expected to last several weeks to months. However, without maintenance, results have been found to fade after 6-8 weeks.

Prior to treatment with Velasmooth, the designated skin regions are first rinsed with soap and water to wash off any lotion or other debris. The skin is then hydrated with a conductive fluid. The Velasmooth device is programmed to the following settings: IR light of 20 W (700-1500 nm); RF power of 20 W (1 MHz); vacuum suction level of 200 mbar (750 mmHg negative pressure). The affected area is treated by moving the handpiece of the Velasmooth device in a backward and forward motion. The typical protocol calls for 4-6 passes of the device to be delivered to the area over a 30-minute period. Patients have reported a feeling of a mild regional heating sensation during the massage portion of the treatment.

In a study by Sadick and Mulholland, 35 female subjects received 8-16 bi-weekly treat­ments with the Velasmooth device. Circumferential thigh measurements were taken before treatment and four weeks after the initial treatment, and photographs for review by blinded physicians were also obtained. The results indicated that after 4 weeks of treatment, 70% of all patients experienced a reduction in thigh circumference, and after the full 8 weeks of treatment, all study patients showed a reduction in thigh circumference and cellulite appear­ance. Physician reviewers found that patients showed an average of 40% improvement in their cellulite, and 90% of the patients would highly recommend the treatment to other women. Finally, a histological assessment of the treated area noted no epithelial or mesen­chymal morphologic damage, indicating that Velasmooth does not significantly damage deeper skin structures [24].

Sadick and Magro treated 16 women with cellulite with the Velasmooth system bi­weekly for 6 weeks (12 total treatments). Thigh circumferential measurements of the treated leg and the contralateral control thigh were taken before and after treatment. Results demonstrated that the overall thigh circumference decreased in 71.87% of the treated legs, with a mean decrease of 0.53 cm in the upper thigh. Significant appearance of cellulite was noted [23]. In a similar study by Alster and Tanzi, 18 out of 20 adult women (90%) treated with Velasmooth for cellulite noticed overall clinical improvement. The mean reduction in circumferential thigh measurements was reported to be 0.8 cm [25].

In another clinical trial, the efficacy of a combination of multiple therapies was tested. Kulick evaluated a device that combined RF, infrared energy, and mechanical rollers (ELOS

technology). Treatment lasted for 15 minutes and machine settings were set as follows: RF (1 MHz-20W), IR light (700-1500 nm-12.5W) and suction (750 mmHg negative pressure/250 ms on-150 ms off). After treatment, compressive stockings were worn for 48 hours. Patients received two treatments per week for four weeks (eight treatments total). Patients were given follow-up self-assessments at 3 and 6 months, and blinded physicians evaluated photographs at these times as well. Patient self-evaluation revealed 75% percep­tion of improvement at 3 months, and 50% at 6 months. Physician evaluations disclosed a greater than 50% improvement at 3 months and 50% improvement at 6 months [26].

Ongoing clinical trials of the Accent RF system have demonstrated that the device has a high safety and efficacy. Del Pino et al. reported that erythema was a possible short-term side effect that resolved within 15-30 minutes posttreatment. Persistent erythema has been shown to resolve within 24 hours [21,26]. Patient self-perception of transient pain has also been noted during treatment or immediately following treatment. Kulick reported bruising, which resolved within one week post-treatment. After the first and second treatment ses­sions, it was observed that in subsequent treatment sessions, patients experienced a reduc­tion in the extent of bruising [26].

It is still unknown as to what extent clinical improvement in cellulite via Velasmooth is due to the combination of RF and IR versus mechanical massage. Endermologie, a device exerting a mechanical massage effect, has been shown in past studies to be an effective way of reducing the appearance of cellulite. The studies mentioned earlier demonstrated a reduction in cellulite with the Velasmooth system, which includes a mechanical manipula­tion component. There are no known studies to date, that have directly compared the effi­cacy of these two treatments. Perhaps future studies could determine to what extent the massage treatment versus the RF/light energy treatment contributes to cellulite reduction in Velasmooth (Fig. 16.10).

Like other treatment modalities, there are reported side affects of Velasmooth. A small number of the patients from Sadick and Mulholland’s study experienced temporary swell­ing and discomfort, and two patients reported local crusting that resolved after 72 hours. The authors speculated that these side effects may have been due to coupling of electrodes, or improper vacuum contact [24]. Less than half of Sadick and Magro’s subjects reported mild redness, discomfort, and mild bruising, edema, erythema, hyperpigmentation, and hypopigmentation within the first two weeks posttreatment. All these symptoms subsided on their own without any additional interventions [23]. Overall, although the clinical studies on the Velasmooth device are still ongoing, the results thus far appear to be efficacious.