Clinical Papers

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Clinical papers


Clinical paper search

Aesthetic Surgery Journal — Soft Tissue Contraction in Body Contouring With Radiofrequency-Assisted Liposuction: A Treatment Gap Solution

Abstract: Radiofrequency-assisted liposuction is a relatively new concept in energy-assisted body contouring techniques and has received instrument approval. This supplemental article reviews the clinical application of electromagnetic energy via the BodyTite (InMode Corporation, Toronto, Canada) device on soft tissues during suction lipectomy, its effect on soft tissue contraction, and its use in aesthetic body contouring in various clinical scenarios.

There is a large number of these “in between” patients in this “gap” category that their clinical picture presents as “not bad enough for an excisional procedure and not good enough for liposuction.” Specifically, areas of the body described as zones of nonadherence such as the arms, neck, and medial thighs may be amenable to radiofrequency-assisted liposuction (RFAL) for satisfactory contouring who otherwise would be turned away with liposuction alone by the judicious surgeon. The RFAL technology, being more effective and directed at fat resection, can be achieved with an increased margin of safety since the skin can be anticipated to retract more than with manual suction-assisted lipectomy (SAL) alone.

Author: Spero J. Theodorou, MD; Daniel Del Vecchio, MD; and Christopher T. Chia, MD

Technology: BodyTite

Published Date: January 2018

Publication: Aesthetic Surgery Journal

Radiofrequency-Assisted Liposuction Device for Body Contouring: 97 Patients under Local Anesthesia

Abstract
Background Radiofrequency-assisted liposuction involves the delivery of a controlled amount of energy to treated tissue resulting in fat liquefaction, accompanying hemostasis, and skin tightening. The purpose of this study is to report experience with a larger sample size using the BodyTiteTM radiofrequency-assisted liposuction (RFAL) platform, and its first use with local tumescent anesthesia. The BodyTiteTM device is currently awaiting FDA approval.

Author: Spero J. Theodorou, Robert J. Paresi, Christopher T. Chia

Technology: FormaV

Published Date: 2/06/2011

SCARLESS SCALPEL FREE BREAST LIFTING ADVANTAGES AND LIMITATIONS

ABSTRACT

Although all body parts age as we grow older, the decline of beauty in the breast region can be sudden and severe. While this type of change is usually due to childbearing, it also can be influenced by weight loss and hormonal change. While most efforts have been directed towards the skin envelope in the past, new data shows that the framework of the breast — the gland and soft tissue — is the scaffold upon which the breast is shaped. The case studies presented show a new approach to breast lifting: restoration of the collagen framework within the soft tissue plus heat mediated soft tissue contraction. With this approach, no skin is excised. Bipolar radiofrequency based energy was applied in the subcutaneous plane of the breast following infusion of tumescent fluid in six patients. Indications included a simple breast lift for grade II ptosis, a scarless breast lift plus subpectoral implants, and reduction of the soft tissue and skin envelope when exchanging large implants for a smaller size. Limitations include the need for post-treatment support for 2–3 months, and a mild to moderate improvement only. If the skin envelope needs to be reduced by more than 25%, a surgical excisional approach would be indicated.

Author: Diane Irvine Duncan, M.D., FACS, Plastic Surgical Associates of Fort Collins, CO, USA

Technology: BodyTite FaceTite

Published Date: 09/2017

Split-face histological and biochemical evaluation of tightening efficacy using temperature- and impedance-controlled continuous non-invasive radiofrequency energy

Bipolar radiofrequency (RF) is capable of heating dermal collagen fibers and inducing skin tightening by collagen remodeling.

Objective: To substantiate safety and improvement of skin laxity following skin heating with a novel temperature- and impedance-controlled non-invasive radiofrequency (RF) device by histological and biochemical evaluations.

Methods: A split-face study was performed on 4 subjects who underwent 8 weekly RF sessions on one side of their face, leaving the other side an untreated control and then underwent facelift procedure. Clinical evaluation by photographs was done prior to the surgical procedure. Ex vivo fragments were harvested from both sides and compared. Morphometric analysis of dermal collagen fibers, collagen synthesis, and elastin synthesis evaluations were compared in triplicates.

Results: Facial skin tightening was apparent in split-face photographs. A significant increase of 7.9% in dermal collagen content, and a significant increase of 34.7% in collagen synthesis were demonstrated in the treated samples. No statistically significant effect on elastin synthesis was detected.

Conclusions: Skin tightening following treatment with non-invasive RF has proven histologically and biochemically to derive from increase in dermal collagen synthesis and content.

Author: Sylvie Boisnica, Marc Divarisb, Marie-Christine Branchetc, and Andrew A. Nelsond

Technology: Forma

Published Date: 6/1/2015

Publication: Journal of Cosmetic and Laser Surgery

Radio-Frequency Assisted Liposuction (RFAL)

Introduction:

The increased prevalence of obesity worldwide has grown the body contouring market, as patients demand more solutions. One of the most popular body contouring methods is liposuction. Pioneered in Europe in the early 1980’s as a simple fat aspirating technique, liposuction has quickly expanded its breadth to incorporate a variety of energy sources and modus operandi.

Many types of energies have been combined with standard liposuction techniques in an attempt to improve and optimize treatment outcomes. The current chapter is dedicated to the authors’ experience with the most recent addition to the liposuction family, Radio-Frequency Assisted Liposuction (RFAL). RFAL delivers RF energy for a thermal effect to the adipose tissue, skin and sub-dermal matrix in a minimally invasive manner. Enhancing the standard lipoplasty experience with a safe and consistent thermal influence provides the following key benefits:

  • Blood vessel coagulation to reduce patient downtime through less bleeding and bruising.
  • Tissue tightening to expand the range of patients to now include individuals who are obese and/or have compromised skin conditions (lax skin).
  • Increased patient comfort and safety will increase consumer acceptance.
  • Reduced procedure time and ease of treatment will increase physician acceptance.

Author: G. Blugerman, M. Paul, D. Schavelzon, S. Mulholland, M. Sandhoffer, P. Lisborg, A. Rusciani, M. Divaris, M. Kreindel

Technology: BodyTite FaceTite

Published Date: 09/12/2011

Publication: Advanced Techniques in Liposuction and Fat Transfer

Three Dimensional Radiofrequency Tissue Tightening: A Proposed Mechanism and Applications for Body Contouring

Excerpt:
“Linear contraction observed at 3 months follow-up were much more significant than reported with any other technology and varied from 12.7% up to 47% depending on patient and treatment variables.”

Abstract: The use of radiofrequency energy to produce collagen matrix contraction is presented. Controlling the depth of energy delivery, the power applied, the target skin temperature, and the duration of application of energy at various soft tissue levels produces soft tissue contraction, which is measurable. This technology allows precise soft tissue modelling at multiple levels to enhance the result achieved over traditional suction-assisted lipectomy as well as other forms of energy such as ultrasonic and laser-generated lipolysis.

Conclusion: We believe the study results confirm the hypothesis of Kenkel [17], i.e., skin tightening and elasticity changes following thermal lipoplasty are mostly a result of subdermal tissue contraction but not dermal, which experiences lower heating during the treatment. It is clear that 40–42°C on the skin surface cannot result in an immediate contraction effect. Deep dermal remodeling may account for some horizontal contraction over time. It is possible that the dermal-fat junction experiences higher temperatures, but this process requires future investigation. We believe that the mechanism of subcutaneous collagen contraction during RF-assisted liposuction is similar to that witnessed in other types of collagen in that the contraction process has thermal contraction thresholds in the range of 60–70°C.
It is likely more accurate to talk about tissue contraction rather than skin tightening because significant area contraction is a result of the strong contribution of deeper adipose fascial layers. Further studies with accurate 3D area measurements will tell us more about the RF-mediated area contraction in this RFAL technology. This RFAL thermal process and contraction can be effectively applied during a liposuction treatment in selected cases, improving patient satisfaction and extending liposuction procedures to higher-weight patients and patients with compromised skin conditions.

Author: M. Paul, G. Blugerman, M. Kreindel, S. Mulholland

Technology: BodyTite FaceTite

Published Date: 09/11/2010

Publication: Aesthetic Plastic Surgery Journal

Improving Outcomes in Upper Arm Liposuction: Adding Radiofrequency-Assisted Liposuction to Induce Skin Contraction

Background: Brachioplasty is frequently recommended for patients with more skin laxity than subcutaneous fat. However, many patients are reluctant to accept a visible scar that will affect the activity of the upper arm or clothing choices. Traditional liposuction is effective when minimal skin laxity is present, but the dual problems of postoperative residual skin laxity and unsatisfactory contour irregularities are common when upper arm skin laxity is the chief complaint.

Objectives: The author investigates the degree of skin contraction resulting from treatment with radiofrequency-assisted liposuction (RFAL) and attempts to determine whether, after long-term follow-up, the classification of upper arm deformities and their corresponding treatment protocols can be refined to offer patients with prominent skin laxity an alternative to traditional brachioplasty.

Results: One year after treatment with RFAL, the mean surface area reduction in the volar upper arm region was 33.5% bilaterally. The mean degree of pendulous vertical “hang” shortening was 50%bilaterally. Statistical analysis showed a P value of >.001 for both measurements.

Conclusion: Treatment with RFAL achieved statistically significant skin contraction in the upper arm region. Patients in categories 2b and 4 were successfully treated with RFAL instead of traditional brachioplasty (which is recommended by the current classification system). Category 3 patients, however, did require a short-scar brachioplasty procedure to obtain satisfactory results.

Author: D. Duncan

Technology: BodyTite FaceTite

Published Date: 01/2012

Publication: Aesthetic Surgery Journal

Non-Excisional Face and Neck Tightening Using a Novel Subdermal Radiofrequency Thermo-Coaugulative Device

Abstract:

42 patients with broad age and ethnic demographics where treated with a novel, non-excisional, minimally invasive device to coagulate a very thin layer of sub-dermal septo-fascial fat, denature the deep reticular dermis and tighten the skin and sub-dermal matrix of connective tissue. The detailed treatment protocol and results are presented. Patients were observed for up to 6 month following the procedure. No major side effects were observed. The aesthetic outcome of this non-excisional procedure includes improvement of the position and shape of the cheek, lower lid-cheek junction, jawline and neck. The overall aesthetic results deliver a noticeable and impressive tightening of the soft-tissue and may be compared with a conservative, small excisional procedure. The authors propose this versatile device and treatment as a non-excisional, moderate facial rejuvenation procedure on its own, or as an adjunct to open procedures performed simultaneously, or as a simplified treatment for secondary skin laxity in combination with a lift procedure.

Author: D. Ahn, R. Mulholland, D. Duncan, M. Paul

Technology: BodyTite FaceTite

Published Date: 12/01/2011

Publication: Journal of Cosmetics, Dermatological Sciences and Applications

A New Approach for Adipose Tissue Treatment and Body Contouring Using RFAL

Excerpt:
“Radiofrequency-assisted liposuction is a promising technology for body contouring with the following apparent advantages:

  • Ability to heat a significant volume of tissue quickly and uniformly
  • Ability to control tissue heating through direct monitoring of temperature and tissue impedance.
  • Defragmentation of fat cells and coagulation of blood vessels in the treated zone, reducing bleeding and bruising
  • Obvious collagen denaturation after RFAL treatment
  • Significant contraction and retraction of adipose and dermal tissue after treatment.”

Abstract:
A new liposuction technology for adipocyte lipolysis and uniform three-dimensional tissue heating and contraction is presented. The technology is based on bipolar radiofrequency energy applied to the subcutaneous adipose tissue and subdermal skin surface. Preliminary clinical results, thermal monitoring, and histologic biopsies of the treated tissue demonstrate rapid preaspiration liquefaction of adipose tissue, coagulation of subcutaneous blood vessels, and uniform sustained heating of tissue.

Author: M. Paul, S. Mulholland

Technology: BodyTite FaceTite

Published Date: 06/19/2009

Publication: Aesthetic Plastic Surgery Journal

A Safety and Feasibility Study of a Novel Radiofrequency-Assisted Liposuction Technique

Excerpt:
“Body contour improvement was observed postoperatively in all patients and there were no severe systemic or local complications, although postoperative pain was minimal in all patients. Weight and circumference reductions were significant at both 6-week and 3-month follow-up. Skin tightening was judged optimal by the surgeon in all patients. “

Abstract:

Background: The feasibility, safety, and efficacy of a novel radiofrequency device for radiofrequency-assisted liposuction were evaluated in various body areas.

Methods: From July to December of 2008, 23 subjects underwent radiofrequency-assisted liposuction using the BodyTite system. Information regarding aesthetic results and local and systemic complications was collected immediately after the procedure and at 6- and 12-week follow-up.

Results: The mean age of the patients was 38.8 ± 12.4 years, and 87 percent were women. Radiofrequency-assisted liposuction was performed successfully in all cases; volume aspirated per patient was 2404 ± 1290 ml, whereas operative time was 158 ± 44 minutes. All patients underwent liposuction at the hip and low abdominal areas, laterally. Body contour improvement was observed postoperatively in all patients and there were no severe systemic or local complications, although postoperative pain was minimal in all
patients. Weight and circumference reductions were significant at both 6-week and 3-month follow-up. Skin tightening was judged optimal by the surgeon in all patients.

Conclusions: The authors’ study suggests that the removal of moderate volumes of fat with concurrent subdermal tissue contraction can be performed safely and effectively with radiofrequency-assisted liposuction. Additional benefits of this technique are excellent patient tolerance and fast recovery time. Nonetheless, a larger sample is required to confirm the authors’ results and guarantee the efficacy and safety of the procedure. Direct comparison with traditional liposuction or energy-assisted liposuction techniques may provide some insights to tailor future indications of this novel technique.

Author: G. Blugerman, D. Schalvezon, M. Paul

Technology: BodyTite FaceTite

Published Date: March 2010

Publication: Plastic and Reconstructive Surgery

Gynecomastia Treatment Using Radiofrequency-Assisted Liposuction (RFAL)

Background: Male gynecomastia is a commonly occurring aesthetic concern. Traditional liposuction, laser and ultrasound-assisted liposuction have many limitations, and excisional gynecomastia procedures can leave undesirable scars in the treatment of the enlarged male breast.

Methods: In this study, the authors report the use of radiofrequency-assisted liposuction (RFAL) in the treatmentof male gynecomastia. A total of 59 males had their gynecomastia treated by RFAL technology, 47/59 by closed RFAL alone, and an additional 12 patients with RFAL combined with our personal technique of trans-mammillary glandular reduction. The RFAL device afforded strong RF current and thermal energy for glandular and adipose coagulation and liquefaction, together with strong soft tissue contraction forces.

Results: All patients were followed for more than 12 months, and all reported good to excellent breast contour results. There was one seroma and over 90 % of patients report being very happy with their contour, and no secondary surgical procedures were necessary. The authors report RFAL as new and potentially powerful option in the treatment of male gynecomastia, having the advantages of strong coagulation, liquefaction and aspiration of glandular tissue, simultaneous coagulation and aspiration with constant thermal monitoring, and very strong soft tissue contraction, eliminating the need for skin resection in the majority of cases. In minority of cases where there may be remnant glandular structures following RFAL, a simple, minimally intrusive trans-mammillary glandular extraction technique can be deployed that leaves minimal scarring.

Conclusions: The mixed technique presented in this study appears to be safe and effective. The RFAL mixed technique has proven to be superior to ultrasonic and power-assisted liposuction due to the skin contraction, having no limitation dependent on the quality of the patient’s skin.

Author: G. Blugerman, D. Schalvezon, S. Mulholland, J. A. Soto, M. Siguen

Technology: BodyTite FaceTite

Published Date: 10/12/2012

Publication: European Journal of Plastic Surgery

Radiofrequency-assisted Liposuction for Arm Contouring: Technique under Local Anesthesia

Background:
Contouring of the arms that does not involve skin excision remains a difficult challenge due to the dependent nature and quality of the skin. Although brachioplasty remains effective, it requires lengthy incision. Radiofrequency-assisted liposuction (RFAL) may improve skin retraction with a satisfactory aesthetic result without skin resection and the resultant scar. The purpose of this study is to present our experience of RFAL arm contouring under local anesthesia, detailing safety guidelines, the marking technique, operative technique, complications, third party surgeon appraisal, and patient satisfaction survey

Methods:
Forty patients underwent RFAL under local tumescent anesthesia for aesthetic arm contouring. Postoperative patient satisfaction surveys were conducted and independent third-party surgeons were surveyed to assess improvements in contour and skin quality with preoperative and postoperative photographs

Conclusion:
In appropriately selected patients, RFAL arm contouring under local anesthesia represents and alternative procedure with acceptably low morbidity and high patient satisfaction. To achieve consistent results while minimizing complication, consideration to anatomic details, infiltration of the local anesthetic, and application of the radiofrequency energy must be given.

Author: S. Theodorou, MD & C. Chia, MD

Technology: BodyTite FaceTite

Published Date: 09/10/2013

Publication: PRS

Face expressive lifting (FEL): an original surgical concept combined with bipolar radiofrequency

Abstract:
Background Aging can lead to changes in facial expressions, transforming the positive youth expression of happiness to negative expressions as sadness, tiredness, and disgust. Local skin distension is another consequence of aging, which can be difficult to treat with rejuvenation procedures. The “face expressive lifting” (FEL) is an original concept in facial rejuvenation surgery. On the one hand, FEL integrates established convergent surgical techniques aiming to correct the agerelated negative facial expressions. On the other hand, FEL incorporates novel bipolar RF technology aiming to correct local skin distension. Methods One hundred twenty-six patients underwent FEL procedure. Facial expression and local skin distension were assessed with 2 years follow-up. Results There was a correction of negative facial expression for 96 patients (76 %) and a tightening of local skin distension in 100 % of cases. Conclusions FEL is an effective procedure taking into account and able to correct both age-related negative changes in facial expression and local skin distension using radiofrequency. Level of Evidence: Level IV, therapeutic study.

Introduction:
The recent years have seen a better understanding of the physiopathogenesis and manifestations of facial aging such as sagging due to gravity, fat loss and redistribution, and loss of bone volume [1–5]. However, aging can also lead to changes in facial expressions, transforming the positive youth expressions (happiness) to negative expressions (sadness, tiredness, and disgust) overtime [6, 7]. These projected “negative emotions” can impact other’s views of us and social interaction. This might explain that a high number of patients ask not only for cosmetic improvement but also for improvement of unattractive facial expression. Almost no studies have clearly analyzed and shown how to correct the age-related changes on facial expression. The FEL concept was developed upon the convergence of effects of rejuvenation surgical procedures on different levels of the face with priority given to the re-establishment of “vitality” in both the eyes and the smile, which are the key of emotions expressions. The present study aimed to address the question of wether the FEL could correct negative facial expressions of the aging face. Secondly, the skin of the face loses its tonicity over time. Although a lift can eliminate remaining folds after musculocutaneous tightening, simple redraping is not always sufficient in cases of local distension. The application of bipolar radiofrequency (RF), using FaceTite™ (Invasix Ltd., Yokneam, Israel) makes it possible to obtain stable quantitative and qualitative effects on the skin over time through the regeneration of the deep dermis and superficial subdermal septo-fascial fat [12]. The second question addressed was whether we could correct local skin distension on zones of weak facial skin (malar crescent, labio-jugal, and submental) using radiofrequency.

Author: M. Divaris, G. Blugerman, and M. Paul

Technology: BodyTite FaceTite

Published Date: 12/06/2013

Publication: European Journal of Plastic Surgery

Nonexcisional, Minimally Invasive Rejuvenation of the Neck

Introduction:
Western civilization is experiencing a “boom in boomers,” an aging population, with population
decline. The aging population in Western Europe, North America, and Asia has disposable income
and the mantra of “youth and vitality” has this generation increasingly presenting for aesthetic treatments, specifically noninvasive or nonexcisional procedures. The neck aesthetic subunit often ages early and more noticeably than other head and neck regions and is one of the most common motivations for patients to present to aesthetic physicians for rejuvenation options. The neck undergoes extrinsic and intrinsic aging changes in all anatomic layers and the aesthetic physician must be well equipped to deal with aging cervical concerns, both surgically and nonsurgically. For the surgeon, being skilled in nonsurgical cervical rejuvenation is critical, as many patients may opt or nonexcisional cervical enhancements, alone, or in combination with other facial cosmetic surgical procedures. For the cervical surgeon, a familiarity and expertise with nonsurgical management of the neck, as “stand-alone” therapy or as postoperative “protect your investment” treatments, may help extend and prolong the achievements achieved surgically.

A youthful neck is most often characterized by an acute cervicomental angle and a firm, well-defined jawline (Fig. 1). The skin in a youthful neck is smooth and devoid of horizontal or vertical neck lines; has no platysmal bands; no visible submandibular glands; small, nonhypertrophic masseter muscles; and skin that is bright and even in color, with minimal melanin or vascular lesions. For the nonexcisional cervical physician, aesthetic rejuvenation of the neck with a multimodal, nonexcisional, minimally invasive approach will be a very common and popular component of the facial aesthetic practice. For all aesthetic physicians, familiarity with the aging tissue changes of the neck, its anatomy and the possible minimally invasive, nonexcisional interventions, including laser, light, radio frequency, high-intensity focused ultrasound (HIFU) energy-based therapy, both transepidermal and subdermal approaches, injectable soft tissue fillers, neuromodulators, and ablative and nonablative technologies for skin rejuvenation, as well as suture-based suspensory techniques, all used alone or in combination, will be a valuable asset to the global aesthetic head and neck cosmetic physician.

This article brings together the “tried-and-true” nonexcisional neck rejuvenation methodologies, which have had long-term, peer-reviewed success in the literature, together with procedures and technologies that have emerged in the past few years that have proven to be successful and complementary. It is my hope that this information assists aesthetic physicians in enhancing their global approach to nonexcisional rejuvenation of the neck.

Author: S. Mulholland

Technology: BodyTite FaceTite

Published Date: 01/2014

Publication: Clinics in Plastic Surgery

RADIOFREQUENCY-ASSISTED LIPOSUCTION FOR NECK AND LOWER FACE ADIPODERMAL REMODELING AND CONTOURING

Background: The purpose of this study is to report our experience using radio-frequency-assisted liposuction (RFAL) for neck and face contouring. This article details the operative technique, selection, complications, third-party surgeon appraisal, and patient satisfaction survey.

Methods: From November 2009 to November 2013, 55 patients who underwent RFAL treatment were enrolled in the study. Postoperative patient satisfaction surveys were conducted, and 2 independent plastic surgeons evaluated contour and skin quality with randomized preoperative and postoperative photographs at 6 months post operatively. The different parameters recorded involved age, sex, weight, body mass index, operative time, amount of fat aspirated and energy delivered, complications, and aesthetic outcome in 1 and 4 weeks and 3 and 6 months. Our longest follow-up was 4 years. Patients were asked 6 months post operatively to grade their satisfaction as poor, no change, moderate, good, and excellent.

Results: The mean age was 51 years (range, 35–61 years), and the mean amount of fat aspirated was 30 mL (range, 10–200 mL). Five out of 55 patients (9.1%) developed tissue hardness that resolved with massage. All patients were followed up for a minimum of 6 months. Eighty-five percent of patients were satisfied with their contouring result and degree of skin tightening (48/55 patients). Two independent plastic surgeons considered the improvement in contouring and degree of skin tightening good to excellent in 52 of 55 cases.

Conclusions: In appropriately selected patients, RFAL neck and face contouring represent a safe procedure to achieve significant improvement of the skin laxity and fat deposits of the cervicomental zone and jowls.

Conclusions: Radiofrequency-assisted tissue tightening, when applied in conjunction with SAL, is effective in achieving greater skin surface area
reduction.

Author: Evangelos Keramidas, MD, EBOPRAS, Stavroula Rodopoulou, MD, EBOPRAS

Technology: BodyTite FaceTite

Published Date: 08/24/2016

Publication: PRS Global Open

Clinical Evaluation of Hair Removal Using an 810 nm Diode Laser With a Novel Scanning Device

Objective:
To evaluate the safety and efficacy of hair removal with an 810nm novel scanning diode laser, up to six months after last treatment.

Methods:
A scanning 810nm diode laser was used for axillary hair removal of 14 female patients who received 3 treatments, 4-6 weeks apart. Follow-up on hair count was conducted 3 and 6 months after last treatment and compared to baseline hair count.

Results:
No unexpected or significant adverse events were recorded. An average hair count reduction of 72.8% after 3 months and 67.6% 6 months after the last treatment is demonstrated.

Conclusion:
The examined 810nm diode laser was proven to be safe and effective for hair removal. Results were sustained for 6 months after last treatment.

Author: Erin Courtney RN BSN and David J. Goldberg MD JD

Technology: DiolazeXL

Published Date: 12/6/2016

Publication: Journal of Drugs in Dermatology

Radiofrequency-Assisted Liposuction Compared with Aggressive Superficial, Subdermal Liposuction of the Arms: A Bilateral Quantitative Comparison

Background:
Liposuction of the arms alone may be inadequate for aesthet- ic improvement because of skin laxity. Radiofrequency-assisted liposuction (RFAL) and aggressive super cial liposuction (SupL) have been described to stimulate soft tissue retraction to improve results. We compare the tech- niques and describe a classi cation scheme that factors skin laxity, skin quality, and Fitzpatrick type to provide treatment recommendations.

Methods:
Ten consecutive female patients underwent RFAL of 1 arm and SupL on the contralateral arm. All patients had Fitzpatrick skin types of III, IV, or V with an average body mass index of 26.0. Using uorescent tattooing, key points on the arm skin were measured preoperatively and postoperatively to indicate changes in surface area.

Results:
There were no complications in the group, and all patients re- ported satisfaction with the aesthetic results. All patients showed reduc- tion of measured skin surface areas and skin distances postoperatively. At 1 year, the measured surface area reductions on the anterior arms averaged 15.0% for RFAL and 10.9% for SupL on the anterior arm skin. Posteriorly, RFAL showed 13.1% reduction and SupL 8.1% reduction in the surface areas at 1 year. Linear reduction for RFAL averaged 22.6% and 17.8% for SupL 1 year postoperatively anteriorly.

Conclusion:
Both RFAL and SupL of the arms showed quanti able and sustained reductions in skin surface. Good contour and soft tissue contrac- tion were achieved with both techniques but RFAL with its safety features presents an alternative to SupL, which has a higher complication rate, risk for contour deformities, and steeper learning curve.

Author: Christopher T. Chia, MD., Spero J. Theodorou, MD., Alfredo E. Hoyos, MD., & Gerald H. Pitman

Technology: BodyTite FaceTite

Published Date: 08/10/2015

Publication: PRS Global Open

RF Microneedling Applications

With many products targeted to treat acne over the last few years, many dermatologists are finding high success rates using radiofrequency (RF) microneedling devices, specifically Fractora.
This new technology has shown a great improvement not only on patients’ acne, but additionally acne scarring, axillary hyperhidrosis, neck tightening, stretch marks and treatment of the vertical lines women can develop on their chest area. A unique feature to Fractora is that the technology allows users of the 24-pin needles to choose between regular tips and tips with silicone coating to protect the epidermis and the top layers of the dermis from heat injury. With Fractora, an additional benefit is all skin types can be treated, up to the darkest type VI skin without risk of pigmentation changes. With such technology, acne scarring is improved up to 75-80% in patients with downtime as low as 24 hours over the course of one treatment.

Author: Judith Hellman

Technology: Fractora

Published Date: 2/5/2014

Publication: Dermatology Times

Evidence-Based Medicine: Liposuction

WHAT IS MAINTENANCE OF CERTIFICATE?

Developed by the ABMS and the Member Boards, including the American Board of Plastic Surgery, the Maintenance of Certification® requirement is a response to the rapid pace of research and technological changes in the medical field and the drive toward improving the overall care and safety of patients. Maintenance of Certification® in Plastic Surgery (MOC-PS®) involves continuous professional development to measure a physician’s continued competency in his or her certified specialty and/or subspecialty.

About Plastic and Reconstructive Surgery Journal:

For more than 70 years Plastic and Reconstructive Surgery® has been the one consistently excellent reference for every specialist who uses plastic surgery techniques or works in conjunction with a plastic surgeon. Plastic and Reconstructive Surgery® , the official journal of the American Society of Plastic Surgeons, is a benefit of Society membership, and is also available on a subscription basis.

The purpose of the Journal serves in cooperation with the overall mission of the American Society of Plastic Surgeons,® which is to support its members in their efforts to provide the highest quality patient care and maintain professional and ethical standards through education, research and advocacy of socioeconomic and other professional activities.
Official Journal of the American Society of Plastic Surgeons, Inc.

Excerpt of Article:

Using the BodyTite (Invasix Ltd., Yokneam, Israel) device in an industry-sponsored in vivo study, linear contraction observed at 6-month follow-up was much more significant than reported with any other technology and varied from 12.7 percent up to 47 percent, depending on patient and treatment variables.

Author: Christopher T. Chia, M.D., Ryan M. Neinstein, M.D., Spero J. Theodorou, M.D.

Technology: BodyTite FaceTite

Published Date: 8/18/2016

Publication: PRS Journal

Sicherheits- und Machbarkeitsstudie einer neuen radiofrequenzassistiertenm Fettabsaugungstechnik

Introduction
Die Liposuktion ist derzeit die meist angewandte Technik zur Entfernung ?bersch?ssiger und dysmorpher Fettdepots. Aufgrund ihrer derzeitigen Sicherheit und der relativ leichten Durchf?hrbarkeit wird sie weltweit eingesetzt. Im Lauf der Jahre wurden durch verschiedene Innovationen verbesserte Ergebnisse erzielt. Anf?nglich gab es lediglich die trockene Fettabsaugungstechnik [2] mit all ihren Komplikationen, welche durch die Einf?hrung der Tumeszenz-Fettabsaugung abgel?st wurde, die deutlich weniger Komplikationen zur Folge hatte und bessere ?sthetische Ergebnisse erzielte. Neuere Methoden wie der Gebrauch von Vibrationskan?len [5] oder die ultraschallassistierte Fettabsaugung [6, 7, 8] haben zwar Verbesserungen in der Prozedur gebracht, zeigten jedoch keine wesentlichen Ergebnisse in der Straffung der Haut. Auch durch die laserassistierte Fettabsaugung wurden gelegentlich gute Straffungsergebnisse [10, 11, 18, 19] erzielt. Diese Methode ist jedoch sehr zeitaufwendig und eine pr?zise Anwendung hinsichtlich W?rmeentwicklung und Bindegewebsspezifit?t ist nicht m?glich. In letzter Zeit haben nicht-invasive Radiofrequenztechniken Hautstraffungsergebnisse im Rahmen der w?rmeinduzierten Hautbehandlung gezeigt [11, 12]. Die Anwendung von au?en erbrachte jedoch nur moderate Straffungsergebnisse. Das Body-Tite™-System (Invasix Ltd.) ist bis dato die einzige bipolare Anwendung, die genug Radiofrequenzenergie w?hrend der Fettabsaugung erzeugt, um kontrollierte Energie von innen an die Haut und das subdermale Bindegewebe abzugeben und zwar in pr?ziser Tiefe, wobei sowohl eine Lipolyse als auch eine Gef??koagulation stattfindet und zugleich auch eine Straffung der Haut erzielt wird. Die Pilotstudie diente dem Zweck, die Anwendungsm?glichkeit und Sicherheit dieser radiofrequenzassistierten Fettabsaugungstechnik zu pr?fen.

Author: M. Sandhofer, P. Schauer, G. Blugerman, D. Schavelzon, M. Paul

Technology: BodyTite FaceTite

Published Date: 8/19/2016

Publication: Journal f?r ?sthetische Chirurgie

Noninvasive Body Contouring with Radiofrequency, Ultrasound, Cryolipolysis, and Low-Level LaserTherapy.

Abstract:

Noninvasive body contouring is perhaps one of the most alluring areas of esthetic surgery today. This article discusses current noninvasive body-contouring modalities, including suction massage devices, radiofrequency energy, high-frequency focused ultrasound, cryolipolysis, and low-level light laser therapy devices. It also discusses imminent technologies awaiting approval by the Food and Drug Administration, reviews the basic science and clinical effects behind each of these existing and emerging technologies, addresses patient selection and clinical applications of each modality, and discusses the applicability and economics of providing noninvasive lipolysis services in office.

Author: S. Mulholand, M.Paul, C. Chalfoun

Technology: BodyTite FaceTite

Published Date: 07/2011

Publication: Clinics in Plastic Surgery

Late to the Party? Pyroptosis Becomes a New Mechanism of Cell Death for Adipocytes

Background
For many years, medical practitioners have thought that cells die in one of only two ways: Either necrotic cells die violently when their outer membrane ruptures, or cells undergo programmed silent cell death through a mechanism called apoptosis. In 2001 Cookson and Brennan1 published an article in Trends in Microbiology describing a new means of cell death that occurs usually within the context of an infectious process called pyroptosis.

Objective
An investigation for a device that causes an intermediate reaction—a fractional response, permanent adipocyte demise, and a ild to moderate inflammatory response in the treatment region

Results
The best responders to this RFbased tissue treatment type are older patients with little fibrous content in their fatty layer. A thick fibroseptal network can act as insulation, creating a protective covering for the adipocytes, which are then less affected by the heat and electroporation effect.

Conclusions
Although early evidence shows that irreversible electroporation causes a pyroptotictype response in treated adipocytes, the mechanism of action seen with SEM varies somewhat from the process seen with infectioncaused pyroptosis. The recent emergence of similar but distinct mechanisms of cell death such as anoikis, pyronecrosis, paraptosis, and entosis shows that there are probably many undiscovered cell death pathways, each with unique characteristics.12 More study is needed to better define the stepbystep mechanism of action of irreversible electroporation on adipocytes. As the nuances of response to increases and decreases in power, duration, optimal treatment temperature, wave oscillation patterns, and subject tissue type are studied, we will be better able to predict and control treatment outcomes.

Author: Diane Irvine Duncan, MD, FACS

Technology: BodyFX

Published Date: 5/15/2015

Publication: QMP's Plastic Surgery Pulse News

A novel non-invasive radiofrequency dermal heating device for skin tightening of the face and neck

Background
Loose, lax skin is a common cosmetic complaint. Previous non-invasive skin tightening devices had modest efficacy and were associated with pain or downtime. New technologies may allow for effective skin tightening with a series of no downtime, radiofrequency treatments.

Objective
To evaluate the efficacy and safety of a novel bipolar radiofrequency device for skin tightening.

Methods
15 consecutive female patients were enrolled in the case series; 14 completed the study and were included in the analysis. The device under investigation is a novel, bipolar radiofrequency device allowing for achievement and maintenance of optimal dermal temperatures to stimulate collagen remodeling and skin tightening. Patients underwent a series of 4-6 weekly treatments. Three blinded, experienced cosmetic physicians evaluated paired blinded pre-treatment and post-treatment photographs and determined the associated improvement, if any.

Results
All patients (14/14) were determined to have a clinical improvement, as the pre-treatment and post-treatment photos were correctly identified by the evaluators. 21% (3/14) patients were observed to have significant improvement, 50% (7/14) observed to have moderate improvement, and 29% (4/14) had mild improvement. No pain, side effects or adverse events were observed.

Conclusions
This novel bipolar radiofrequency device represents a safe, effective treatment option for non-invasive skin tightening.

Author: Andrew A. Nelson, David Beynet, Gary P. Lask

Technology: Forma

Published Date: 5/15/2015

Publication: Journal of Cosmetic and Laser Therapy

A Clinical and Biological Evaluation of a Novel, Noninvasive Radiofrequency Device for the Long-Term Reduction of Adipose Tissue

Background and Objective
A novel, noninvasive technology, utilizing suction-coupled radiofrequency (RF) heating and ultra-short pulse duration, high-voltage electrical pulses was studied for its efficacy and safety on adipose tissue reduction.

Method
Twenty-one subjects underwent treatment of their abdominal fat once weekly for 6 weeks. Clinical outcomes including abdominal circumference, adipose tissue thickness (measured by ultrasound), adipose tissue weight, body weight, and clinical photographs were obtained at visits 1 and 3 months after last treatment. Adverse events were recorded. Three subjects, who were undergoing a future elective abdominoplasty, were treated with the same protocol, but on only one side of the abdomen before abdominoplasty. Biopsies from the RF-treated and untreated sides were harvested during abdominoplasty and cultured; measurements of adipocyte size and shape, rate of apoptosis, collagen production, and dermal thickness were determined.

Results
Significant clinical improvements (P  < 0.05) were observed for the reduction of abdominal circumference (113.4–110.7 cm). Within the adipose tissue of the treated areas, increased levels of adipocyte apoptosis were observed immediately following the treatment series, with approximately 20% of all adipocyte cells staining positive for APAF-1, a validated marker of apoptosis. In contrast, the control untreated skin only rarely had adipocytes undergoing apoptosis, with less than 1% of adipocytes staining positive for APAF-1. At day 14 of culture, fat cell apoptosis had further increased (30% of adipocytes staining positive for APAF-1) within the RF-treated adipose tissue. Additionally, a significant increase in collagen synthesis (neocollagenesis) representing an average increase of 13.7% was observed after treatment by the RF device, with a mean collagen level of 57.6 mg/mg in the treated zone versus 49.7 mg/mg in the non-treated zone, as determined by the spectrocolorimetric method. Only minor, transient side effects were reported.

Conclusions
This novel, noninvasive RF device was effective for improving subcutaneous fat, reducing abdominal circumference and reducing subcutaneous fat layer thickness. Histologically, these improvements appear to be partly related to increased adipocyte apoptosis.

Author: Sylvie Boisnic- MD, Marc Divaris- MD, Andrew A. Nelson- MD, Nima M. Gharavi- MD, PhD and Gary P. Lask-MD

Technology: BodyFX

Published Date: 2/18/2014

Publication: Lasers in Surgery and Medicine

Non-Surgical Body Contouring: Introduction of a New Non-Invasive Device for Long-Term Localized Fat Reduction and Cellulite Improvement Using Controlled, Suction Coupled, Radiofrequency Heating and High Voltage Ultra-Short Electrical Pulses

Objective: To evaluate the safety and efficacy of a new and novel radiofrequency (RF) device used for focal fat reduction. 

Materials and methods: 24 female and 1 male patients were enrolled in the study. The age range of the patients was 28-62 years old and an average BMI was 26. All patients underwent focal shape correction, without anticipating any weight reduction and 14/24 patients also had posterior or anterior grade 2 or 3 thigh cellulite treated. The patients underwent a 6 treatment protocol where they were treated with a novel RF device on the abdominal and flank regions once a week over a period of 6 weeks. 14 patients also had cellulite on their posterior or anterior thigh treated with the same device and a 6-treatment, once weekly protocol. Therapeutic thermal end points for each treatment were established and achieved as outlined in the paper. The RF device emits both basic RF and ultra-short High Voltage Pulsing (HVP). All patients and zones were treated once per week for 6 weeks.

Results and conclusions: All patients were observed for 3 months following their last treatment to determine the long-term adipose tissue effects and body contour changes. Standard pre and post-operative photography, circumferential measurements were taken. 3 patients who were scheduled for future abdominoplasty surgery had Investigational Review Board compliant lower abdominal subcutaneous biopsies performed at 72 hours and 14 days following their initial RF treatment. The average circumferential reduction was 3.58 cm with range of 1.5 cm-4.4 cm. There were no non-responders observed in the study. Using the modified Nurnberger-Muller 7 stage cellulite grading system, the average cellulite score improved 2 sub-grades. Using the Vectra 3D imaging device and cellulite scoring software, the average starting pit depth was 4.1 mm (range 0.5 mm-7.3 mm). Average Vectra measured improvement in the pit depth or “smoothness score” was 2.9 mm or 60% (range 1.1 mm-6.3 mm). Biopsies revealed histological evidence of the death of proportion fat cells by apoptosis. There were no complications that required medical management. We conclude that the TiteFX appears to offer a safe and effective option for the non-invasive management of both focal fat excess and cellulite. The basic RF and High Voltage pulses appear to result in a long term, proportional death of fat tissue, presumably through adipocyte apoptosis.

Author: Dr. S. Mulholland

Technology: BodyFX

Published Date: 2/14/2014

Publication: Clinical & Experimental Dermatology Research

Fractional Ablative Radio-Frequency Resurfacing in Asian and Caucasian Skin: A Novel Method for Deep Radiofrequency Fractional Skin Rejuvenation

This paper reports the clinical experience of a multi-center, multiple physician trial with a novel fractional radio-frequency ablative skin resurfacing and rejuvenation device (Fractora, Invasix, Israel) deployed on both Caucasian skin types I – III and Asian skin type IV. Histological study demonstrated deep ablation and collagen restructuring in the papillary and reticular dermis. The Fractora device combines the more “cone shaped” ablation seen with CO2 and Erbium lasers with a deep non-ablative heating pattern, seen with other bipolar RF fractional needle resurfacing devices. Ablation, coagulation zones and healing dynamics are analyzed for different energy settings. Two different treatment protocols are suggested: one for light skin and then one for darker skin with a higher risk of post-inflammatory hyper-pigmentation. Treatment results show improvement in skin texture, pores, wrinkles and skin dyschromia.

Author: D. H. Ahn, S. Mulholland, M. Kreindel, M. Paul

Technology: Fractora

Published Date: 8/13/2013

Publication: Journal of Cosmetics, Dermatological Sciences and Applications

Fractora: A Novel Method for Deep Radio-Frequency Fractional Resurfacing and Total Skin Rejuvenation

Carbon Dioxide laser skin resurfacing (LSR) gained great popularity in the 1990’s because of impressive results seen with skin tightening, wrinkle reduction, improving skin texture and tone after a single treatment session. [1,2] One of the unique features of CO2 laser resurfacing is that it creates almost equal ablation, coagulation and residual sub-necrotic 50-100 micron thermal zones in the skin. [3] The main disadvantages of the procedure were relatively long downtimes with surface discharge followed by prolonged erythema and then long-term risks of hypopigmentation resulting from a poor reservoir of epidermal cells and melanocytes after deep skin ablation.

One of the significant advances in laser skin rejuvenation was the introduction of ablative fractional skin resurfacing [4-6], where small areas of skin, with depths in the range of 100-800 microns were treated with in a fractional fashion, leaving a proportion of the skin intact around the ablative thermal column, keeping this undamaged skin around for fast skin healing after the fractional ablative laser treatment. Over several years and multiple different lasers and wavelengths, the majority of laser manufactures have focused on Fractional CO2 resurfacing [7-8], either as a single aggressive treatment or in several more mild sessions, providing dramatic improvement in skin dyschromia, texture, wrinkles and acne scars, with relatively short downtime and a low rate of side effects that can be minimized by correct patient selection.

An alternative ablative technology is radio-frequency (RF) fractional skin resurfacing [8], which in published studies promotes more superficial ablation and is more focused on non-coagulative dermal residual heat. This relatively comfortable treatment demonstrates some level of improvement over a multiple treatment program. We believe that RF technology need not be limited by this superficial dermal heating.

The current study demonstrates the results with a new fractional RF ablative rejuvenation technology providing a complete single treatment solution for aging patients.

Author: S. Mulholland, M. Kreindel

Technology: Fractora

Published Date: 8/13/2013

Fractora RF Provides Excellent Results with Less Downtime

Fractora™ RF fractional rejuvenation by Invasix Ltd. (Yokneam, Israel) improves the appearance of aging skin while offering less downtime than previous technologies. According to the company, the Fractora achieves results that would normally require up to four different technologies. Benefits include stimulating collagen production, a smoother appearance of skin texture, evening of pigmented lesions and an improvement in fine lines and wrinkles.

For F. Richard Noodleman, M.D., a board certified dermatologist in Campbell, Calif. (in the Silicon Valley), Fractora is “a new and very popular technology.” In his practice Dr. Noodleman and his staff perform about 75 procedures a month with this machine. “Our Invasix device is being utilized all day every day,” he stated.

Author: A. Di Leo

Technology: Fractora

Published Date: 8/13/2013

Publication: Aesthetic Buyers Guide

FracTotal Facial Offers Complete Combination of Skin Resurfacing and Tightening

When radiofrequency (RF) fractional skin resurfacing meets thermal-based RF collagen remodeling in a single session, the result is a completely new facial treatment called FracTotal by Invasix (Yokneam, Israel). By performing Fractora Firm skin tightening and Fractora skin resurfacing in succession, aesthetic physicians are able to successfully address deterioration and descent – two of the three “D’s” (deterioration, descent and deflation) in the aging face.

Author: Sarah Franz Wheeler

Technology: Fractora

Published Date: 8/13/2013

Publication: The Aesthetic Guide

Peak Power Effect On Skin Rejuvenation Using Ipl: Lumecca Ipl Evaluation

Objective
This article is intended to demonstrate efficiency of the IPL device which is designed to provide the highest peak power and shorter pulse duration for treatment of vascular and pigmented lesions.

Methods and materials
The Lumecca IPL device (InMode Ltd.) was used in a pilot study for treatment of vascular and pigmented lesions. The Lumecca IPL device has a peak power of 3.3 kW/cm2 and 3 cm2 area. That combination allows for a fluence of 10 J/cm2 at a pulse duration of only 3 ms. Such pulse durations correspond to the TRT for vessels with diameters of 70 μm. For comparison, a pulse width of 20 msec corresponds to a TRT of a vessel with diameter of 18 μm. In patients a single treatment with fluence of 8-16 J/cm2 and filter of 515nm was performed and followed-up after four weeks.

Conclusion
Single treatment with Lumecca provides significant improvement for majority of patients. Exceptionally short pulses provide improvement even for some patients who had previous treatments with other IPL devices. The high peak power of Lumecca makes its effect on vascular lesions comparable to a pulse dye laser.

Author: E.V. Ross MD, M. Kreindel, Ph.D

Technology: Lumecca

Published Date: 9/24/2015

Retrospective Study of the Use of a Fractional Radio Frequency Ablative Device in the Treatment of Acne Vulgaris and Related Acne Scars

Acne vulgaris (AV) is a common disease that often results in disfiguring facial scarring that carries into adulthood. Here we report our experience with fractional radiofrequency (FRF) device in treatment of patients with acne and acne related scarring. Materials & Methods: We retrospectively reviewed the charts of all patients with acne scarring who completed a four treatment regimen in our clinic. Results: We identified eight patients who completed four treatments with median age of 20.5 years (range 17 — 41). All patients demonstrated significant improvement of acne lesions and acne scarring. Skin biopsies demonstrated reduction of scar depth and increased new collagen production, and repopulation of the scar tissue by elastic fibers and adnexal structures after the fourth treatment. Conclusion: FRF emerges as a safe and effective treatment modality for AV and acne related scars. Further randomized controlled studies are required to fully evaluate the magnitude of this positive effect and more basic science studies are needed in order to better characterize its mechanism of action on acne lesions.

Author: Judith Hellman

Technology: Fractora

Published Date: 8/12/2013

Publication: Journal of Cosmetics, Dermatological Sciences and Applications

Radio Frequency Energy for Non-invasive and Minimally Invasive Skin Tightening

Abstract:

This article reviews the non-invasive and minimally invasive options for skin tightening, focusing on peer-reviewed articles and presentations and those technologies with the most proven or promising RF non-excisional skin-tightening results for excisional surgeons. RF has been the mainstay of non-invasive skin tightening and has emerged as the «cutting edge» technology in the minimally invasive skin-tightening field. Because these RF skin-tightening technologies are capital equipment purchases with a significant cost associated, this article also discusses some business issues and models that have proven to work in the plastic surgeon’s office for non-invasive and minimally invasive skin-tightening technologies.

Author: S. Mulholland

Technology: FaceTite

Published Date: 07/2011

Publication: Clinics in Plastic Surgery

A Clinical and Histological Study of Radiofrequency-Assisted Liposuction (RFAL) Mediated Skin Tightening and Cellulite Improvement

Abstract:

Background: A novel Radiofrequency-Assisted Liposuction (RFAL) technology was evaluated clinically. Parallel original histological studies were conducted to substantiate the technology’s efficacy in skin tightening, and cellulite improvement.

Methods: BodyTiteTM system, utilizing the RFAL technology, was used for treating patients on abdomen, hips, flanks and arms. Clinical results were measured on 53 patients up to 6 months follow-up. Histological and biochemical studies were conducted on 10 donors by using a unique GREDECO model of skin fragments cultured under survival conditions. Fragments from RFAL treated and control areas were examined immediately and after 10 days in culture, representing long-term results. Skin fragments from patients with cellulite were also examined.

Results: Gradual improvement in circumference reduction (3.9 — 4.9 cm) and linear contraction (8% — 38%) was observed until the third month. These results stabilized at 6 months. No adverse events were recorded. Results were graded as excellent by most patients, including the satisfaction from minimal pain, bleeding, and downtime. Histological analysis of skin fragments immediately following RFAL treatment showed hypodermal coagulation of fat and blood vessels, and structural changes in dermal fibers. After 20 days in culture, fibroblast fibers metabolism was stimulated. Histological changes following cellulite treatment were also noted.

Conclusions: The novel RFAL technology offers immediate skin tightening effect that is stable over time. The histological results correlated with the clinical observations of circumference reduction and skin tightening, as expressed by tissue fibers modulation. Moreover, RFAL offers an effective treatment for cellulite by formation of a thick collagen band at the dermal-hypodermal junction.

Author: M. Divaris, S. Boisnic, M. Branchet, M. Paul

Technology: BodyTite FaceTite

Published Date: 8/19/2016

Publication: Journal of Cosmetics, Dermatological Sciences and Applications

Scientific Report — Comparison of Treatment Uniformity of Laser Assisted Liposuction (LAL) and Radiofrequency Assisted Liposuction (RFAL)

Introduction:

Recently, LAL, specifically Smartlipo™ has gained a great deal of attention based on expectations of a skin tightening caused by laser thermal effect on collagen and connective tissue. LAL is based on manual scanning of the adipose tissue treatment volume with a cannula delivering laser radiation through a very small fiber with a 600 microns diameter. Due to the manual delivery during LAL and the relatively small size of the laser radiation source questions are raised about treatment uniformity. Hot spots in the treatment area may lead to adermal injury while undertreated areas reduce uniformity of the treatment, potentially compromising the overall result including soft tissue contraction. The development of a Radiofrequency Assisted Liposuction system(Bodytite™,InvasixLtd.), which delivers high power radiofrequency to adipose and connective tissue while continuously monitoring all parameters including temperature allowed an opportunity to compare RFAL heating characteristics with LAL.

Author: A. Waldman

Technology: BodyTite FaceTite

Published Date: 8/19/2016

Nonexcisional Tissue Tightening: Creating Skin Surface Area Reduction During Abdominal Liposuction by Adding Radiofrequency Heating

Abstract
Background: Recent publications show that heat-mediated tissue tightening is a promising treatment for the lax abdomen and may provide better long-term outcomes than traditional suction-assisted liposuction (SAL).

Objectives: The author evaluates the degree and duration of skin surface area contraction, as well as the influence of anatomic location of the treatment region on the degree of tissue tightening, in a study comparing SAL alone vs SAL plus radiofrequency-assisted liposuction (RFAL).

Methods: In this prospective, randomized, split abdominal study, 12 consecutive patients were treated with SAL alone on 1 side and with SAL plus RFAL on the other side. Each patient had 4 (3 × 3-cm) squares—2 per treatment type—tattooed in the lower abdominal region (2 on the right and 2 on the left). The surface area of these squares was measured with the Vectra computerized measurement system (Canfield, Inc, Fairfield, New Jersey) at pretreatment, at 6 weeks posttreatment, and at 1 year posttreatment. All measurements were subjected to statistical analysis using predictive analytic software and were evaluated for statistical significance.

Results: In regions treated with SAL alone, there was a 10.4% mean skin surface area contraction at 6 weeks and 8.3% at 1 year post treatment. The mean skin surface area reduction was 25.8% in regions treated with radiofrequency plus SAL at 6 weeks and 36.4% at 1 year. The anatomic location of each square (medial vs lateral) did not statistically correlate with more or less tissue tightening.

Conclusions: Radiofrequency-assisted tissue tightening, when applied in conjunction with SAL, is effective in achieving greater skin surface area
reduction.

Author: D. Duncan

Technology: FaceTite

Published Date: 8/19/2016

Publication: Aesthetic Surgery Journal

A prospective study analyzing the application of radiofrequency energy and high-voltage, ultrashort pulse duration electrical fields on the quantitive reduction of adipose tissue

Noninvasive fat reduction is claimed by many device manufacturers, but proof of efficacy has been difficult to established. This prospective study was designed to measure the reduction of fat thickness and actual volume reduction in 20 female patients treated with an external radiofrequency (RF) device. This device combines RF heat, suction coupled vacuum, and oscillating electrical pulses that induce adipocyte death over time. Patients underwent pre-and-post-treatment and intercurrent measurements of weight, body mass index, ultrasonic transcutaneous fat thickness, and 2D and 3D Vectra photography with independent calculation of circumferential and volumetric change. Mean transcutaneous ultrasound thickness at reproducible points was 2.78 cm; at 1-month post treatment, the mean fat thickness was 1.71 cm. At 3-month post-treatment, the mean fat thickness reduction was 39.6%. Vectra circumference measurements were taken at 10-mm intervals, with pastureland breathing cycle control. Independent analysis of serial measurements from +60 to — 70mm showed mean abdominal circumference measurement of 2.3 cm. Mean abdominal volume loss was 202.4 and 428.5 cc at 1- and 3-month post-treatment, respectively. Scanning electron microscopy confirmed that permanent cell destruction was caused by irreversible electroporation. Proptosis appears to be the mechanism of action.

Author: Diane Irvine Duncan, Theresa H. M. Kim, and Robbin Temaat

Technology: BodyFX

Published Date: 2/14/2014

Publication: Journal of Cosmetics and Laser Therapy

Long Term Follow-Up Results of a Fractional Radio Frequency Ablative Treatment of Acne Vulgaris and Related Acne Scars

Acne vulgaris and acne scarring are prevalent conditions that can have a negative effect on a patient’s quality of life. Fractional radiofrequency technologies have been shown to be clinically safe and effective in managing acne scars through dermal remodeling without causing direct damage to the epidermis. In a recently published study, we presented our clinical and histological results in the treatment of patients with active acne and acne related scarring using a Fractional RF (FRF) device. In the current article we demonstrate long term follow-up results, up to two years post last fractional treatment. Methods: Four out of the eight patients who completed a four treatment regimen were invited for long term follow-up visit to document treatment results. In some cases, touch-up treatments were conducted to optimize clinical results. Results: Patients demonstrated significant improvement of acne lesions, acne scarring, pores and skin texture. Long term photos demonstrated that clinical improvement progressed with time. Conclusion: The current study further supports the previous findings that FRF is a safe and effective treatment modality for active acne and acne related scars. Treatment protocol can be customized according to patient needs and clinical results last for long term.

Author: Judith Hellman

Technology: Fractora

Published Date: 8/11/2013

Publication: Journal of Cosmetics, Dermatological Sciences and Applications

FACIAL SKIN REJUVENATION BY COMBINATION TREATMENT OF IPL FOLLOWED BY CONTINUOUS AND FRACTIONAL RADIOFREQUENCY

Objective
The objective of this study was to evaluate the safety and efficacy of combination facial treatment by 3 technologies. Materials and methods: Eleven patients completed the clinical trial that consisted of alternate treatments of intense pulsed light (IPL) in 3 sessions and continuous fractional bipolar radiofrequency (RF) in 3 alternating sessions, 3 weeks apart. Follow-up visits were made at 6 and 12 weeks following the last treatment. Lesions were evaluated by photographs taken at baseline and at follow-up time points according to predetermined scales.

Results
Results showed statistically significant improvement in wrinkling, pigmentation, vascular lesions, and laxity.

Conclusion
The outcome of the clinical trial performed demonstrates that the combined treatment with IPL, continuous RF, and ablative RF technologies yields a safe and effective combination treatment to address a few clinical indications simultaneously. The results were all statistically significant and no safety issues were recorded.

Author: Michael H. Gold, Julie A. Biron, Whitney Sensing

Technology: Fractora

Published Date: 2/5/2016

Publication: Journal of Cosmetic and Laser Therapy

Pyroptosis Of Fat: Dr. Diane Duncan Discusses The Bodyfx Treatment And How Cell Death Mechanism Affect Clinical Results

Objective
To assess the process of cell death mechanisms and its effect on clinical results of radio frequency (RF) fat reduction devices. Can moving radio frequency kill fat alone and does hotter temperature create better tissue result in patients?

Materials and methods
In a control study, researchers observed serial scanning electron microscopy sections of fat treated over time by Forma at different maximum temperatures 40, 41, 42 and 43 degrees Celsius.  Researchers then looked at the adipose cells immediately following the eighth treatment, at one month following treatment cessation and again at three month following treatment cessation. To better understand the pyroptosis and cryolipolysis process, researchers took control samples of fat tissue injected with saline.

Results and conclusions
At one month and three months all adipocytes had recovered, and no fat death was noted with Forma treatments. Researchers proved bulk heating with radio frequency to be effective in killing fat cells. However, the level of fibrous ingrowth into the adipose layer did not vary significantly with temperature level. Even at 40 degrees there was significant tissue response in treated areas. Therefore clinical results are just as good with lower temperatures and longer treatments when compared to higher temperatures. In another control study for the assessment of cryolipolysis, we observed cell membrane peeling without poration. Lipid droplets were released for a uniformed reduction of adipocyte size. The ideal cell death mechanism includes adipose cell death is not necrosis due to its long downtime nor is it apoptosis for the absence of inflammation. Poroptosis is the best cell death mechanism for fat reduction. Poroptosis is a fractionAL pyroptosis-like mechanism that occurs in devices like Body FX. Body FX with has a moving external radiofrequency which kills fat cells similar to pyroptosis, creating pores in the cell membrane causing cytosol to leak out and the cell to die.

Author: Diane Irvine Duncan, MD, FACS

Technology: BodyFX

Published Date: 2/14/2014

Publication: BodyLanguage

Synchronous Fractional Radio-Frequency Ablative and Non-Ablative Treatment for Comprehensive Rejuvenation of Aging Skin

 

Facial aging is a combination of intrinsic, hereditary and extrinsic forces. Extrinsic factors, including UV light exposure, smoking and diet, combined with the heretics and intrinsic aging factors results in facial deflation (loss of fat), descent (laxity) and deterioration (aging skin). Skin aging and deterioration is characterized by reduced and abnormal collagen, elastin and ground substances, together with discoloration, both in increased melanin based lesions and vascular proliferation. Anti-aging physicians have generally had to combine various lasers, intense pulsed light (IPL), infrared (IR) and radio-frequency (RF) energy systems to treat the combination of these aging dermal and epidermal elements. (Table 1). Fractional and non-fractional radio-frequency energy systems have become popular options in the treatment of skin laxity and wrinkles, but have not been generally effective in treating vascular and melanin based dyschromia of the aging skin. This paper reports on the comprehensive anti-aging effects of a novel new fractional radio-frequency device, the Fractora (Invasix, Yokneam, Israel).

An analysis of the technologies listed in Table 1 reveals the following therapeutic interventions are required for the wide array of aging effects we see in the skin:

  • Pigmented malformation treatment requires superficial ablation or coagulation
  • Vascular lesion treatment requires coagulation of blood vessels in papillary and reticular dermis
  • Wrinkle treatment requires ablative and/or sub-necrotic heating of the reticular dermis
  • Skin laxity improvement requires deeper heating of the reticular dermis and dermal-fat junction

The ideal situation for the aesthetic professional would be to have one technology with the tunable ability to address all the clinical manifestations of aging skin. The principal difference between the ablative and non-ablative RF in the novel device used in the current study, when compared with light based deep fractional ablation is that the action of RF is not limited by the ablation crater and adjacent tissue based upon a chromophore, but rather, RF current flows through the ablative lesion and the entire reticular dermis, creating the potential for additional anti-aging effects [10].

This current study describes the results of the clinical evaluation of a novel fractional radio-frequency ablative and semi-ablative treatment used to treat the multiple aging pathologies of the skin.

Author: S. Theodorou, S. Mulholland, M. Kreindel

Technology: Fractora

Published Date: 8/13/2013

Publication: Anti-Aging Medical News

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