Syneron, a Yokneam, Israel company, is announcing it has received FDA’s 510(k) pre-marketing clearance and EU’s CE Mark certification for the temporary reduction of thigh circumference for its Vela™ device. We reported on the approval of the same device for the treatment of cellulite back in 2005.
From the Press Release:
The clearance is based on a multi-center, blinded and randomized clinical study performed in the US and Canada. The study included 66 patients. Each patient in the study was treated on only one thigh, while the other thigh was used as a control. The choice of the thigh to be treated was randomized at each site and the person who performed the circumferential measurements did not know which thigh was treated. All study participants were women between the ages of 21 to 62, with a wide range of body mass indexes (BMIs) corresponding to underweight, normal, overweight and obese. Seventy-three percent of the participants had normal BMIs.
The average circumferential reduction in the treated thigh was 1.9 cm (0.75 inch) with a range of 0.3 to 7.2 cm (0.12 to 2.8 inches). The average circumferential reduction in the untreated thigh was 0.3 cm (0.12 inch) with a range of -2 cm (-0.78 inch), an increase in circumference, to 1.7 cm (0.67 inch). Measurements were taken three to four weeks post final treatment. The differences in the circumference change levels of the treated and control thighs were found statistically significant (p < 0.001, t-test for unpaired data). The study demonstrated the effectiveness of the Vela platform devices in thigh circumferential reduction.