INTRODUCTION
Body contouring with liposuction is consistently one of the two most popular aesthetic surgical procedures.1 More recently, a number of options for non-invasive body contouring have become available. These have been even more popular and show a double-digit growth of 18.7% in 2015 compared to the prior year.1 This demand is fueled by the growing desire to avoid invasive procedures where possible.Some non-invasive fat reduction options create immediate necrosis of adipocytes due to tissue coagulation.2 Others achieve a similar endpoint with cavitation.3 An alternative strategy creates adipocyte damage that is sub-lethal, resulting in apoptosis over time. This endpoint can be produced using tissue heating or tissue cooling. Laboratory studies have demonstrated the ability to produce apoptosis in a high percentage of the adipocyte population heating to temperatures of 42-47 C for a period of 15 minutes.4 A variety of energy sources can potentially be used to produce such heating. Preliminary laboratory and clinical studies demonstrated the ability to damage adipocytes using a 1060 nm diode laser device to target this endpoint.4,5This study reports the experience of using a non-invasive 1060 nm diode laser device in the pivotal clinical trial for safety and efficacy of fat layer reduction in the abdomen that has since been approved by FDA for this indication.
PATIENTS AND METHODS
Study DeviceThe device used in this study provided 1060 nm diode laser light exposure through a 4X6 cm optical window that was simultaneously cooled with circulating fluid to 15ºC (Cynosure, Westford, MA). The treatment head was held in contact with the skin overlying the targeted fat using straps passed around the subject’s waist. Energy densities ranging from 0.9-1.4 W/cm2 were used.Study DesignA prospective controlled study was conducted at two centers, with each enrolled patient receiving a single non-invasive treatment. Institutional review board approval of the protocol was obtained and patients signed an informed consent form.This study included subjects who had to be healthy males or females between 20 and 65 years of age with a BMI of 32 or under and with unwanted fat in the abdominal region. Subjects were excluded for a variety of conditions including skin hypersentivities, anti-coagulant, or anti-platelet therapies, previous surgery, or liposuction in the treatment area, pregnancy, or a history of