Comprehensive Evaluation of the BeShape One Device: Assessing Thermal Safety in Noninvasive Body Contouring Using
Yuval Ramot1,2, Vitaly Karakuz3, Ehud P Willenz4
1Department of Dermatology, Hadassah Medical Center, Jerusalem, Israel.
Lasers in Surgery and Medicine
|June 18, 2024
Summary
The BeShape One Device, a noninvasive ultrasound tool for waist reduction, showed a safe thermal profile in swine studies. Advanced analysis confirmed no heat-related skin damage, supporting its use in body contouring.
Area of Science:
- Biomedical Engineering
- Dermatology
- Medical Device Safety
Background:
- Noninvasive body contouring is increasingly popular.
- High-intensity focused ultrasound (HIFU) devices are used for fat reduction.
- Assessing the thermal safety of new devices is crucial before clinical application.
Purpose of the Study:
- To evaluate the thermal safety profile of the BeShape One Device.
- To assess temperature-related physiological changes using thermal safety analysis and histopathology.
- To compare the BeShape One Device with other commercial ultrasound fat reduction devices.
Main Methods:
- Utilized three applicator types (active, demo, modified) on swine models.
- Conducted clinical observations, skin reaction evaluations, and gross pathology.
- Performed histopathological analyses and advanced temperature measurements (needle thermocouples, thermal cameras, COMSOL modeling, CEM43 analysis).
Main Results:
- No significant treatment-related adverse effects or heat-related lesions were observed clinically or histopathologically.
- Temporary skin reactions like erythema and edema resolved over time.
- Advanced temperature measurements and modeling confirmed thermal homogeneity and predicted no thermal damage.
Conclusions:
- The BeShape One Device demonstrated a favorable thermal safety profile in the swine model.
- The device is clinically and histopathologically safe for noninvasive body contouring.
- Validated thermal homogeneity supports its potential for effective and safe waist circumference reduction.
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