DANA POINT, CALIF. – Of the 152 patients who have been treated with the Liposonix body sculpting system in controlled clinical trials to date, the average reduction in waist circumference reached 2.8 cm.
The system, cleared by the Food and Drug Administration in September 2011 for noninvasive fat removal, "has a good safety profile, no discernible effect on internal organs or adjacent structures, and minimal adverse events," Dr. Michael A.C. Kane said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF), where he reviewed the evidence on the device.
Solta Medical's Liposonix system uses high-intensity, focused ultrasound to destroy anterior abdominal subcutaneous adipose tissue in a single treatment without harming skin or surrounding tissue. The pattern generator of the device "allows for uniform delivery of ultrasonic energy, analogous to pattern generators used with aesthetic lasers," said Dr. Kane, a plastic surgeon in private practice in New York. The treatment area measures 21 cm2.
Liposonix's mechanism of action is necrosis by a thermal process. "An ultrasound beam that can focus at a specific depth beneath the dermis, combined with proprietary application techniques, results in the intended adipose tissue disruption," Dr. Kane explained. "The pattern generator moves the focus of the ultrasound to successive parts of the adipose tissue. The automated movement of the transducer creates a matrix of lesions produced by highly focused, high-intensity ultrasound."
Macrophage cells, he continued, "are attracted to the treated area to engulf and transport lipids and cellular debris. As the treated area is cleared, the lesion resolves naturally and results in an overall reduction in local adipose tissue volume."
According to data on the 152 patients treated with Liposonix, the most common post-treatment side effects were temporary erythema, mild ecchymosis, discomfort, and edema. The total energy dose ranged from 118 to 148 J/cm2, the treatment depth was 13 mm beneath the skin line, and the average change in waist circumference was a reduction of 2.8 cm, generally within 8-12 weeks post treatment. No significant changes in blood lipid levels, liver function tests, or other blood parameters were observed.
Patients expressed a high degree of satisfaction, Dr. Kane said, with 91.3% saying they were satisfied with the results of treatment and 87% saying they were likely or very likely to have a second treatment.
The bottom line, he concluded, "is that ... ultrasonic energy can be accurately used to kill fat cells."
Dr. Kane disclosed that he received compensation from Medicis, which originally developed the Liposonix system, as a consultant and research investigator.
SDEF and this news organization are owned by Elsevier.