• #3-1. Body Sculpting Using Pulse Focused Ultrasound(PFU)



    A pioneer in non-invasive fat removal treatment is an American medical device manufacturer, Syneron. The era of body sculpting procedures began in 2007 when Syneron’s VelaShape (RF-device) obtained FDA approval for use in thigh circumference reduction and temporary cellulite reduction. In the same year, Health Canada followed suit by introducing UltraShape Contour I and UltraShape Contour I Version 3(Ultrasound-device) in 2012. Devices boasting both the RF and ultrasound functionalities continued to be introduced for use in non-invasive body sculpting treatments. Abroad, this device is marketed under the trade name of UltraShape Contour I Version 3 and is known as Neoultra in Korea. Since its FDA approval in 2013, it has been in use in Korea. The most well-known names for ultrasound technology used for body sculpting and skin tightening include Syneron’s Ultrashpe and Solta’s Liposonix (HIFU system). I already discussed about Liposonix in the previous article. All these devices use ultrasound for non-invasive fat removal treatments, however, they differ in terms of treatment approach.


    Figure 1. In vivo study in pig (magnification of the cross-section). Figure credit: Syneron


    Neoultra irradiates ultrasound in a focused manner to induce tissue change in the subcutaneous fat (Image 1). It was also approved by FDA for non-invasive destruction of adipocytes in the abdomen for waistline reduction. Unlike high intensity focused ultrasound (HIFU) devices that generate heat through continuous irradiation of focused ultrasound energy to dissolve fat, Neoultra uses the PFU mode where a high amount of energy is emitted in a short window of time to rupture the cell membrane of adipocytes and eventually remove them. This method continuously induces apoptosis of adipocytes in the treated area. Unlike the HIFU treatment where the outcome is evaluated 3-4 months after the treatment, Neoultra induces immediate cavitation to allow effective fat removal. Therefore, its effects are visible much more quickly and the treatments can be repeated over shorter intervals.  


    Neoultra offers two modes of delivery; focused beam where the energy increases toward the focal points rather than the contact area of the transducer (Image 2); and pulsed energy. The heat is dissipates through gaps in the energy delivery (pulses), the treatment can be carried out little discomfort for the patient. The target tissues are destroyed through non-thermal mechanical effect, which is followed by necrosis and excretion of cell debris. The period may vary across individuals, however, the waist circumference will start to decrease in 1-2 weeks after treatment in most cases. After 3-5 treatments, some patients experience 6-10 cm reduction in their abdominal circumference (Image 3). Post-treatment cell removal care can enhance the results of just a single treatment. Unlike other devices that induce apoptosis, Neoultra delivers energy in a brief period of time before heat affects the tissues and cell removal care is possible on the same day as the treatment. Moreover, it brings effects more quickly and does not have downtime. Treatments can be repeated every 1-2 weeks and doctors can monitor patients’ dietary habits, exercise, and medication more closely.


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    Neoultra obtained KFDA approval under the category of extracorporeal shock wave therapy that destroys subcutaneous adipocytes with focused ultrasound energy for abdominal circumference reduction. The extracorporeal shock wave therapy was derived from extracorporeal shock wave lithotripsy (ESWL) used in removing kidney stones. ESWL was first developed for improving ligament or muscle disorders in orthopedics or neurosurgery. Shock waves are delivered to areas of pain to destroy abnormal deposits and induce growth of healthy cells. The focused mode and radial mode are most frequently used. The focus mode lowers the energy delivered to the skin surface and delivers powerful, focused energy onto the target area. The radial mode spreads the energy radially over an extensive area. These devices are also being used in aesthetic treatments and the radial mode is effective in cellulite removal over an extensive area but can cause bruising or pain as the energy is focused onto the skin surface. 


    -To be continued

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