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Emsculpt NEO Achieves Two Key FDA Clearances

Article-Emsculpt NEO Achieves Two Key FDA Clearances

Since its launch, Emsculpt Neo from BTL Aesthetics (Boston, Mass.) has been wowing both patients and practitioners by melting fat and building muscle via an advanced, simultaneous emission of radiofrequency (RF) and high intensity focused electromagnetic (HIFEM) energy.

Sponsored By: BTL Aestetics

Since its launch,  Emsculpt  Neo from  BTL  Aesthetics  (Boston,  Mass.)  has been wowing both patients and practitioners by melting fat and building muscle via an advanced,  simultaneous emission of radiofrequency  (RF)  and high intensity focused electromagnetic (HIFEM) energy. 

As a result, fat reduction is coupled with hypertrophy and hyperplasia of targeted local muscle groups,  yielding unrivaled non-invasive body contouring outcomes. BTL has continued to pursue and develop additional applications for the device, having recently announced FDA clearances for darker skin types (through VI) as well as lipolysis of the thighs. 

1.JPG“The skin type clearance opens up a richer range of skin tones for treatment with this competitive device to build muscle and burn fat,” according to dermatologist Jeanine Downie, MD, medical director of Image Dermatology P.C. (Montclair, N.J.). “This literally affects a huge potential worldwide patient base, doubling it and then some. As a community, I don’t think we expected that there would be problems treating darker skin types, and I have undergone treatment even though I am among those with darker skin and have had zero trouble. However, the clearance is extremely important.”1-1.JPG

RF energy is often thought of as color-blind, meaning that skin pigmentation isn’t an issue or not nearly the issue it would be compared to light-based modalities such as lasers. Nevertheless, any energy-based therapy could theoretically cause burns or induce postinflammatory hyperpigmentation (PIH) when there is superficial treatment, and could potentially cause thermal injury to the dermal-epidermal junction. “In the community, we have not seen issues with Emsculpt Neo, which is remarkable given the number of treatments administered since launch,” Dr. Downie expressed, “but BTL is always extremely cautious with their devices so until the FDA clearance for all skin types was announced, we were advised that Neo was only cleared for types I – III. It is a credit to BTL that they are so careful and thorough about the science backing their devices. Since initial trials weren’t directed specifically at enough patients with skin of color, they did not market Emsculpt Neo for darker skin types.”

“Emsculpt Neo is still young, but the careful limitation of treatment recommendation to lighter skin types was a remarkable act of restraint by BTL because there is a lot of money to be made given the huge population of potential patients with darker skin types,” said Diane Duncan, MD, medical director of Plastic Surgical Associates (Fort Collins, Colo.). “They typically do at least two years’ worth of studies before releasing a new device. Safe, credible and profitable expansion into the world marketplace surely depends on that kind of methodical, careful movement forward.”

“Discussing this issue with a patient of mine with darker skin,” Dr. Duncan continued, “I found it amazing how restricted many people with darker skin are, overall, from so many great therapies out there. When I consider that reality, it becomes more obvious how important it is that we can instantly expand our offerings to these populations with the clearance for darker skin types. The device treats localized fat, muscle, visceral fat, diastasis recti, incontinence and other universally experienced issues. Now the majority of Americans, and people around the world, can confidently obtain safe treatment with Emsculpt Neo and be very happy with their outcomes.”

A New Solution for Thigh

Thighs are a vital treatment area for any body sculpting therapy, according to Dr. Duncan. “The inner thigh is known for its thin skin, making it hard to treat,” she said, “especially with a single modality.” Two abstracts presented at the May 2021 virtual meeting of the American Society for Laser Medicine and Surgery (ASLMS) dealt with the utility of Emsculpt Neo for thighs. Both trials included skin types I – VI. Dr. Duncan treated the inner thighs1 of 16 subjects (age range 24 to 69 years, BMI 21.3 to 35 kg/m2) using Emsculpt Neo in four 30-minute sessions, a typical course of therapy. Preliminary results of evaluation by MRI revealed an average reduction in fat thickness of 0.84 cm at one month (n=15) and 1.02 cm at three months (n=6); and average thigh circumference decreased by 1.0 cm at one month. Unsurprisingly, 94% of patients were satisfied with the outcomes.2.JPG

For the lateral thighs or ‘saddlebag’ region, a challenging area in which to manage localized fatty deposits, Palm and colleagues2 performed a course of four once-per-week 30-minute sessions on the lateral thighs of subjects (n=30, age range 29 to 65 years, BMI 19 to 34.5 kg/m2) and assessed the outcomes via MRI. Interim results show average fat reduction of 1.4 cm in the saddlebags at one-month follow-up, coupled with a decrease in average hip circumference of 3 cm. It should be noted that there were no nonresponders among subjects.

According to Melanie Palm, MD, board-certified dermatologist and medical director of Art of Skin MD (San Diego, Calif.), the study is ongoing. “So far, at one month we’ve seen fat thickness reductions of more than 22% visualized by MRI, increased to 28% at three months,” she stated. “MRIs are emerging as the go-to unbiased measurement tool for changes in fat layer thickness and muscle mass for therapies such as Emsculpt Neo, and with good reason. I am eager to see the six-month data. Not only is patient satisfaction very high, but the treatments are always rated as being comfortable.”

Additionally, the prevalence of presentation of cellulite in the thigh means these clearances herald further expansion of the Taut and Toned procedure, which combines Emsculpt or Emsculpt Neo with BTL’s Emtone to bolster results by adding an additional treatment vector – Emtone’s targeted pressure energy (TPE). “The improvement in microcirculation and mechanical manipulation enhances local lymphatic drainage and breaks up the fibrous septae to improve the appearance of cellulite,” Dr. Palm explained.

Dr. Duncan shared that she almost always combines the above devices. She noted that “doing the Emsculpt first, followed by Emtone is ideal. Emsculpt alone will not be a primary cellulite therapy but Emtone will treat the depressions and improve the skin, especially in an area such as the inner thigh because skin laxity will be a problem.”

“Everybody wants to reduce fat and build muscle,” added Dr. Downie, “so in Emsculpt Neo, we have a device that safely and effectively treats virtually anyone regardless of body type or ethnicity – White, Black, Latino, Asian or
Native American, and virtually any body area. The value of this cannot be overstated.”

1. Duncan D. Efficacy and safety of simultaneous application of HIFEM and synchronized radiofrequency for non-invasive lipolysis in inner thighs: preliminary data. Presented at: 40th Annual Conference of the American Society for Laser Medicine and Surgery (ASLMS) virtual meeting, May 15 – 16 2021.

2. Palm M, Kinney B, Halaas Y. Simultaneous emission of synchronized radiofrequency and HIFEM energy for treatment of lateral thighs: interim results of the MRI multicenter study. Presented at: 40th Annual Conference of the American Society for Laser Medicine and Surgery (ASLMS) virtual meeting, May 15 – 16 2021.

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