September 2013 The Effect of Exilis on Bra Fat S Soin, A Sarkar, S Yadav, N Anand New Delhi, India Abstract The aim of this study was to evaluate the effect of Exilis treatments on the overall improvement of bra fat through the reduction of subcutaneous fat and collagen remodeling. The study was conducted on 26 female patients between 36 and 67 years of age. Two patients did not complete the study. After completion of four sessions of treatment, subjective patient satisfaction was assessed using a written questionnaire. Ten patients (42 %) reported excellent improvement in bra fat after treatment, six patients (25 %) reported moderate improvement and five patients (21 %) reported mild improvement. Three patients reported no change. Keywords: Exilis, fat, collagen, ultrasound, radiofrequency, bra fat I. Introduction ody contouring, body sculpting and shaping modalities are a growing trend in the field of medical aesthetics. Globalization and the impact of media have contributed to growing body consciousness among people. This is especially true for women and teenagers and psychologists report weight and body image to be major concerns amongst women today. Surgical methods of body contouring are associated with potential risks and downtime, which has led to a growing demand for non-surgical aesthetic treatments. Several devices are currently available for non-surgical contouring, each utilizing different energies and technology, with variable results. The Exilis device by BTL offers a unique combination of two modes of energy delivery with built-in safety features and cooling. The efficacy of the Exilis device for skin tightening and body contouring has been investigated in several clinical studies; however none of these have B specifically evaluated the effect of Exilis treatments on bra fat. II. The Exilis Device The Exilis device combines radio-frequency (RF) and ultrasound, along with a cooling system, in a single applicator head which can be used for a wide range of body applications. It also includes a separate applicator which is specially designed for facial treatments. We have treated a large number of patients with the Exilis device since July 2012, for a variety of indications including treatment of wrinkles over the face, turkey neck, sagging jowls and double chin and rejuvenation of skin over the hands; contouring and skin tightening over the abdomen, flanks, bra fat, buttocks, thighs and calves; upper arms and décolleté for nonsurgical breast lift. In our experience, the Exilis device by BTL is a sound, safe and effective non-surgical technology for facial and neck skin tightening as well as body contouring. In this study, we specifically evaluated the effect S Soin, A Sarkar, S Yadav, N Anand : The Effect of Exilis on Bra Fat , Page 1 September 2013 of Exilis treatments over bra fat. III. Materials and Methods The study has been conducted on 26 women from 36 to 67 years of age. Exclusion criteria for the study were BMI over 30 and contraindications for Exilis treatments such as metal implants or pacemakers. The study consisted of 4 sessions, each twenty minutes long. The temperature of the treated area was allowed to reach and was then maintained at the clinical endpoint of 42 ◦ C. The treatments were performed 10-15 days apart. Patients were asked to drink three liters of water the day before and on the day of the treatment. Post treatment patients were asked to avoid contact of the treated area with cold water for 24 hours and thereafter to maintain good hydration and continue their usual routine including light exercise and a balanced diet, to facilitate lymphatic drainage for good results. Two patients did not finish study. The result of treatment was evaluated after the last session, through a subjective questionnaire, filled in just after the last therapy of the study. The questionnaire was designed in the following format: "How do you evaluate the appearance change after the set of therapies with Exilis device on bra fat? Choose one of the options on 4-level scale". The options given were as follows: 1- "Significant -excellent", 2"Significant- moderate", 3 - "Significant - mild", 4 - "None". IV. Results From the study group of women who completed 4 sessions of the therapy, 10 women (42 %) rated the improvement in the appearance of bra fat as excellent. Six women (25 %) rated their improvement as moderate while 5 women (21 %) rated their appearance improvement as mild. Only 3 women reported no difference in the appearance of bra fat after four sessions of treatment Figure 1: Patient satisfaction ratio S Soin, A Sarkar, S Yadav, N Anand : The Effect of Exilis on Bra Fat , Page 2 September 2013 Figure 2: Before treatmnet - After treatment Figure 3: Before treatmnet - After treatment S Soin, A Sarkar, S Yadav, N Anand : The Effect of Exilis on Bra Fat , Page 3 September 2013 V. Conclusion This study evaluated the satisfaction level of patients with improvement in the appearance of bra fat after four sessions of treatment with the Exilis device by BTL. All patients tolerated the therapy well without any side effects or discomfort. The study shows that majority of patients (88 %) rated the improvement of the appearance of their bra fat as significant. We opine that the Exilis technology is a safe and effective non-surgical modality for the aesthetic improvement of bra fat VI. Discussion The unique body applicator of the Exilis device combines radio-frequency and ultrasound technologies which enable the treatment of skin laxity and irregularities of contour irregularities in the same treatment session. The energy is delivered in continuous motion in a format termed ’Dynamic Monopolar RF’. The device offers selectivity and specificity of treatment of target tissues in a safe manner. Controlled cooling through the Peltier system allows focused application of heat directed to a precise depth of penetration. It protects the skin surface while allowing sub-dermal fat layers to reach higher - and therefore more effective temperatures, thus yielding better results. The Exilis device uses a safety feature called the Energy Flow Control system or EFC which detects skin impedance (energy flow through tissue) and shuts off energy delivery on loss of contact of the applicator tip with the skin. The EFC virtually eliminates the risk of burns and provides enhanced safety and comfort with reduction in treatment time. The goal of treatment is to reach surface skin temperature of 40 to 43 ◦ C for 6-7 minutes over the treated area. At this temperature, the patient perceives a hot sensation. Energy levels were modulated using patient feedback and comfort along with the monitoring of skin temperatures displayed in the LCD monitor. Exilis treatments for body contouring can postpone or eliminate the need for elective surgery, es- pecially for patients with mild to moderate fat deposits and those who may not be good candidates for surgery. For additional treatment of skin laxity, the cooling system may be turned off to allow rapid heating of the skin surface, with minimal impact on the subcutaneous fat. Thus Exilis treatments may be used before and after invasive procedures such as liposuction, for enhancement of results, especially for the improvement of skin laxity and bumpiness. A word about BTL: BTL is a leading manufacturer of medical devices with a complete range of aesthetic products, including non-surgical aesthetic devices for body contouring, fat reduction, skin tightening and anti-wrinkle treatments. BTL’s devices are CE approved. The Exilis device has been approved by the US FDA and Health Canada. VII. Disclosures The authors have no commercial interest in BTL and received no compensation for this study. The study was independently conducted by Dr. Soin and her team at their clinic in New Delhi. References [1] Robert A. Weiss, MD, FAAD, Margaret A. Weiss, MD, FAAD. Dynamic Monopolar Radiofrequency for Successful NonInvasive Treatment of Skin Laxity and Body Contouring. [2] Peter B. Fodor, MD; Kathryn A. Stecco, MD, MA; Jody Johnson, BSEE The Precision of High-Intensity Focused Ultrasound (HIFU) for Non-Invasive Body Sculpting: In Situ Thermocouple Measurement of the HIFU Treatment Zone within Adipose Tissue. [3] Arnoczky SP, Aksan A. Laboratory for Comparative Orthopedic Research, Michigan State University, East Lansing, Michigan, USA. Thermal modification of connective tissues: basic science considerations and clinical implication. S Soin, A Sarkar, S Yadav, N Anand : The Effect of Exilis on Bra Fat , Page 4 September 2013 [4] Roustaei N, Masoumi Lari SJ, Chalian M, Chalian H, Bakhshandeh H. Safety of ultrasound-assisted liposuction: a survey of 660 operations Aesthetic Plast Surg. 2009 Mar;33(2):213-8. Epub 2008 Dec 18. [5] Rusciani, Antonio, et al., Nonsurgical tightening of skin laxity: A new radiofrequency approach J Drugs Dermatol. 2007, Vol. 6(4), pp. 377-382. S Soin, A Sarkar, S Yadav, N Anand : The Effect of Exilis on Bra Fat , Page 5
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