Deletion of adipocytes induced by a novel device simultaneously delivering synchronized radiofrequency and hifem: Human histological study

BACKGROUND: Radiofrequency (RF) is commonly recognized treatment option for fat reduction, utilizing heat‐induced adipocyte deletion. HIFEM treatment has been proven to be an effective tool for body shaping. OBJECTIVES: To document the structural changes in human subcutaneous tissue induced by the combination of RF treatment with the HIFEM procedure. METHODS: Four subjects (51.50 ± 6.35 years, 22.59 ± 3.21 kg/m(2)) received three 30‐minute abdominal treatments consisting of RF therapy and HIFEM. One subject (57 years, 23.60 kg/m(2)) served as a control. Punch biopsies were collected at baseline, 1‐week, and 1‐month post‐treatment. Samples were sliced and stained with H&E. Waist circumference, digital photographs, satisfaction, and therapy comfort were assessed. Subjects were monitored for any adverse event, and fat temperatures were measured. RESULTS: Baseline samples showed a healthy appearance of adipocytes, composed of round‐shaped unilocular cells of uniform size. At follow‐up, treated adipocytes demonstrated nuclear and shape changes with consequent fat reduction. Adipocytes were found to be flattened/shrunken and of smaller size (−33.5% at 1 week; −31.7% at 1‐month) along with occasional ruptures of the cytoplasmic membrane. In contrast to baseline, pyknotic nuclei with condensed nuclear chromatin were seen at 1‐week and 1‐month post‐treatment. The control samples showed no treatment‐related changes. Waist circumference decreased by an average of 2.20 cm in the treated patients. No adverse events were observed. The fat temperature reached 42‐45°C, during treatment; the therapy was comfortable with high patient satisfaction. CONCLUSIONS: Results suggest the efficacy and safety of the therapy combining RF and HIFEM. The adipocyte deletion and shrinkage resulted in overall reduction of fat tissue.