Clinical Papers, References and Certificates
This page includes a selection of reference materials related to our treatment devices and products. We are a full service nutrition, lifestyle and aesthetic clinic, therefore not all claims or relate to therapeutic devices or products.
VelaShape FDA (United States Food and Drug Administration) Submission and Clearance Certificate - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. VELASHAPE Download PDF
VelaShape Australian Register of Therapeutic Goods Device entry -
ARTG Entry: 159412 & 159711
Sponsor Name: Innovative Medical Technologies Pty Ltd
Intended purpose: Non-ablative treatment of the skin surface (smoothing treatments)
SS Australian Register of Therapeutic Goods Device entry -
ARTG Entry: 151808
Sponsor Name: MM Beauty Equipment Services Pty Ltd
Intended purpose: Non ablative therapy (skin rejuvenation)
VelaShape Press Releases
Syneron's Vela™ Platform First to Receive FDA Clearance and CE Mark for Circumferential Reduction Download PDF
Syneron Launches High Power VelaShape™ for Faster Cellulite Treatment and Circumferential Reduction Download PDF
Syneron's VelaShape(TM) Proven Effective in Helping Women Achieve 'Before-Baby Body' -- Post-Pregnancy Study Finds VelaShape Reduces Circumference of Buttocks by More Than Two Inches Download PDF
VelaShape elōs™ TechnologyAll of our reported results for VelaShape are quoted from published worldwide clinical studies. Note that this represents a selection of key studies only. The terms elos, VelaShape and VelaSmooth represent the same technology, however VelaShape represents a 100% increase in power levels versus VelaSmooth (and therefore delivers more intensive results).
Adipocyte Membrane Lysis Observed After Cellulite Treatment Is Performed with Radiofrequency. Trelles M Æ , Mordon SR, Aesth Plast Surg (2009) 33:125–128 [Download]
METHOD: Treatment was given to ten (10) patients at the highest intensity with the VelaSmooth device on one buttock with the other serving as a control. The purpose was to check the histologic condition of cellulite in the buttock before and 2 hours after a single treatment via a 2-mm-deep skin biopsy.
RESULTS: In the subcutaneous tissue of the treated side, adipocytes showed signs of membrane rupture. Fat cells showed alteration in physical integrity with various forms of cell membrane rupture. Besides membrane lysis, adipocytes without rupture showed thickening of their membrane as a sort of stiffness, with pronounced deletion and reduction of fat tissue mass. Comparatively, no particular changes were noticeable in adiposites in the nontreated contralateral buttock in samples taken 2hrs after treatment of the other buttock, which were identical to those before-treatment samples
CONCLUSION: The heating skin by non-invasive RF permits impact in the subcutaneous fat layer, showing membrame lysis of adipocytes and/or reduction of fat tissue mass.
Improvement in arm and post-partum abdominal and flank subcutaneous fat deposits and skin laxity using a bipolar radiofrequency, infrared, vacuum and mechanical massage device. Brightman L, Weiss E, Chapas AM, Karen J, Hale E, Bernstein L, Geronemus RG. Lasers in Surgery and Medicine, Volume 41, Issue 10, pp. 791 – 798 [Download]
METHOD: This study was designed to evaluate the efficacy and safety of VelaShape on additional body sites and more rigorously examine the technology's impact on upper arm as well as abdominal and flank circumference. Twenty-nine (29) subjects underwent weekly treatments of the upper arms, abdomen and flanks. Treatments were performed using VelaShape. Circumference measurements, photographs, and subject weights were performed prior to treatment and at 1- and 3-month follow-ups. Subjects were asked to record their treatment satisfaction level.
RESULTS: Change in arm circumference, at the 5th treatment was statistically significant with a mean loss of 0.625 cm. At 1- and 3-month follow-ups, mean loss was 0.71 and 0.597 cm respectively. Reduction of abdominal circumference at 3rd treatment was statistically significant with a 1.25 cm mean loss. At 1- and 3-month follow-ups, average loss was 1.43 and 1.82 cm respectively.
CONCLUSIONS: This study demonstrates with statistical significance, sustainable reduction in circumference and improvement in appearance of arms and abdomen following treatment with VelaShape.
Bipolar Radiofrequncy, infrared heat and pulsatile suction in the non-surgical treatment of focal lipodystrophy and cellulite. Mulholland, RS, Australian Cosmetic Surgery, 2004; 26: 101–3. [Download]
METHODS: Fifteen (15) study patients, all female, with an average age of 46 years were treated with the ELOS VelaSmooth device.
RESULTS: There was a 100% response in circumferential reduction in lipodystrophic regions. Mean circumferential reductions of the thigh of 4.18cm, abdomen 5.73c and hips 5.86cm were achieved. The average pre-treatment weight was 76.73kgs and the post-treatment weight was 76.64. Patient based assessment of cellulite and skin texture improvement was 62% (range 20-80%) and blinded doctor based evaluation of improvement was 40%.
CONCLUSION: In the absence of weight loss or dietary manipulations it was concluded that the fat reduction contouring was a direct result of the energies delivered. It was concluded that the combination of bi-polar radiofrequency, infrared energy and vacuum suction device can achieve predictable, safe and clinically non-surgical reduction of focal lipodystrophic regions, smoothening of cellulitic skin and skin firming.
Cellulite treatment using a novel combination radiofrequency, infrared light, and mechanical tissue manipulation device: Tina S. Alster & Elizabeth L Tanzi. Journal of Cosmetic Laser Therapy 2005; 7: 81–5. [Download]
METHODS: Twenty (20) adult women with moderate bilateral thigh and buttock cellulite, received VelaSmooth treatments to a randomly selected side (the contralateral side serving as a non- treated control). Patients were evaluated using standardized digital photography and circumferential leg measurements at baseline, prior to each treatment session, and at one, three, and six months after the final treatment. Clinical improvement scores of comparable photographs using a quartile grading scale were made independently by two masked medical assessors after the series of treatments.
RESULTS: Ninety per cent (18/20) of patients noticed overall clinical improvement, and 17 of these 18 patients reported that they would pursue treatment of the contralateral thigh. Clinical improvement scores averaged 1.82 (corresponding to 50% improvement) after the series of treatments. Circumferential thigh measurements were reduced by 0.8 cm on the treatment side.
CONCLUSION: It was concluded that Cellulite can be significantly and safely reduced with the use of a noninvasive device that combines bipolar RF, infrared light, and mechanical massage. The effects of treatment appear to be prolonged, but maintenance treatments may be necessary to further enhance the clinical results achieved.
Treatment of cellulite with a bipolar radiofrequency,infrared heat, and pulsatile suction device: a pilot study. Rungsima Wanitphakdeedecha, MD & Woraphong Manuskiatti, MD. Journal of Cosmetic Dermatology, 5, 284–288 [Download]
METHODS: Twelve (12) subjects were treated with the RF-light-based device (VelaSmooth) and baseline weight and circumference measurements were taken, and standardized photographs that were judged independently by two non-treating dermatologists after the series of treatment..
RESULTS: The average body weights at baseline, immediately after the last treatment, and four weeks and one year after the complete treatment were 56.30, 56.05, 56.23, and 56.53 kg, respectively. The average circumferential reductions at the last treatment were 5.17cm from the abdomen, and 3.50cm from the thigh. These reductions were sustained 4 weeks later on the abdomen and thigh at 3.17cm and 3.50cm respectively, and one year later at 3.83cm and 3.13cm respectively. Average clinical improvement of 25% improvement in appearance of cellulite was observed.
CONCLUSION: It was concluded that a bipolar RF, IR heat and pulsatile suction device provides a beneficial effect on reduction of abdomen and thigh circumference, and smoothening of the cellulite.
METHODS: 16 subjects with cellulite were treated with the VelaSmooth system. One thigh was treated while the other served as a control. Treatment efficacy was measured through circumferential measurements of both thighs and by having the investigator and an independent evaluator grade visual improvement during follow-up visits.
RESULTS: The results were positive, showing overall thigh circumference decreased in 71.87% of the treated legs. The mean decrease was 0.44 cm of the lower thigh and 0.53 cm of the upper thigh. There was significant visual improvement in cellulite and skin texture. Visual improvement of greater than 51% was seen in 50% of the subjects at the final follow-up visit. While all patients noted some degree of improvement following the study protocol, the improvement continued to increase in 37.5% of subjects up to 8 weeks after the last treatment
CONCLUSION: This treatment showed positive results. Future studies employing higher energy levels and additional treatments will likely augment the results of the present study.
A prospective clinical study to evaluate the efficacy and safety of cellulite treatment using the combination of optical and RF energies for subcutaneous tissue heating: Neil S. Sadick & R Stephen Mulholland. Journal of Cosmetic Laser Therapy 2004; 6: 187–190 [Download]
METHODS: This two-center study investigated the safety and effectiveness of combined energies for cellulite treatment using the VelaSmooth system. Thirty-five (35) female subjects with cellulite and/or skin irregularities on the thighs and/or buttocks were treated with the VelaSmooth device. All patients maintained their normal lifestyle, and diet and fluid consumption.
RESULTS: All study patients showed some level of reduction in thigh circumference after 8 weeks of treatment; indeed, 70% of all patients showed such a reduction after 4 weeks of treatment. Also, 100% of all patients showed some level of improvement in skin texture and cellulite. The mean decrease in circumference was 0.8 inches. Some patients demonstrated reductions of more than 2 inches. There were minimal complications associated with treatment.
CONCLUSION: This preliminary study demonstrates that the VelaSmooth system can have a beneficial effect on cellulite appearance.
ELOS Technology for Cellulite and Fat treatment: Combination of Conducted RF, Infrared and Vacuum. Shaoul, J. Australian Cosmetic Surgery Magazine, 32-3 [Download]
METHODS: Fifteen (15) female patients enrolled in this clinical study with a variety of body fat and cellulite conditions. Documentation of treatment results included before and after pictures with blinded evaluation, as well as circumference measurements of the hips and thighs before the first treatment and after the eighth.
RESULTS: Initial tissue reaction when treating with the Vela Smooth is an increase in local blood supply to the adipose tissue. All patients demonstrated improvement in cellulite appearance as well as reduction in the hip circumference. Average improvement for all patients on the appearance of cellulite was 65 per cent. Hip perimeters were reduced 3.2cm on average, and all patients reported feeling skin contraction as a result of the treatment. No complications were noted and there was no discomfort during and after the treatment. Indeed most of the patients enjoyed the treatments.
CONCLUSION: This preliminary study demonstrates promising results. An unequivocal smoothening of the skin surface was observed.
Evaluation of the combination of radio frequency, infrared energy and mechanical rollers with suction to improve skin surface irregularities (cellulite) in a limited treatment area. Kulick, M. Journal of Cosmetic and Laser Therapy. 2006; 8: 185–190 [Download]
METHOD: This IRB-approved (Institutional Review Board) study evaluated the efficacy of ELOS technology to reduce skin surface irregularities in a limited treatment zone. Sixteen (16) patients were enrolled and received treatments. Evaluations consisted of a patient questionnaire and photographic assessment of skin contour by three physicians at 3 and 6 months after the last session who were blind to the treatment each patient received.
RESULTS: Physician evaluators determined that all patients were improved at both post-treatment periods. The average improvement at 3 and 6 months was 62% and 50%, respectively. All patients felt they were improved. The patient assessment of improvement was an average of 75% at 3 months and 50% at 6 months. There was no significant change in the patients’ weight at the two evaluation periods.
CONCLUSION: This technology provided consistent improvement in all patients that lasted 6 months after their last treatment. Device settings and treatment technique may play a role in the results.
Post-pregnancy body contouring using a combined radiofrequency, infrared light and tissue manipulation device. Winter ML - J Cosmet Laser Therapy, 2009; 11(4): 229-35. [Download Summary]
METHOD: To evaluate the performance of a high-power RF device (VelaShape) for reshaping and improvement of skin texture/laxity in postpartum women. METHODS: Twenty women received five weekly treatments to the abdomen, buttocks and thighs with the VelaShape system. Each patient's weight and nutritional habits were followed. Outcome was assessed using reproducible circumference measurements, digital photography, the physician's scores of cellulite and improvement as well as patient satisfaction. Safety was evaluated by recording subjects' comfort and tolerance.
RESULTS: The overall mean circumferences reduction was 5.4 +/- 0.7 cm (p < 0.001). Significant (p < 0.02) improvement in skin laxity and tightening was noted by both the physician and patients. Treatments were well tolerated with no major safety concerns (one purpura, one mild burn).
CONCLUSIONS: The evaluated system enabled significant results. Data suggest that postpartum reshaping via circumferential reduction and skin laxity improvement can be effectively and safely achieved using a high-energy combination of radiofrequency, infrared and mechanical manipulation.
Website References and Credits
Model images copyright Dimitri, 2007, used under license.
Look Better Naked logo copyright Shrinc Clinic, 2010.
Gallery images courtesy of Syneron.com and Medic-Age.com.au
Syneron Medical Pty Ltd www.syneron.com