Q: Does the ultrasound energy produce free radicals that are mutagenic?

A: The accumulated evidence from the use of ultrasound treatments, including ultrasound-assisted liposuction, in hundreds of thousands of patients, together with data regarding the biology and chemistry of free radicals, supports the safety of therapeutic ultrasound. The safety is also reinforced by the FDA approval of numerous devices that use high intensity ultrasound for therapeutic applications, including repetitive application of ultrasound in physiotherapy, for kidney stone destruction, for ablation of arrhythmogenic cardic foci and for non-invasive treatment of uterine myomas and renal tumors. The sum of these presents strong support for the safety of Ultrashape's use of ultrasound for fat targeting.

 

Q: Why Mechanical vs Thermal effect?

A: There are 2 modes by which ultrasound energy can interact with tissue: by mechanical and by thermal. The mechanical mode of interaction differentiates between tissue types based on their specific elastic characteristics. This allows the targeting of tissue that are most susceptible to mechanical disruption, while more resistant structures remain intact. By contrast, ultrasound energy that relies on temperature elevation for its effect is less tissue selective, as all tissue within the focus are heated to varying degrees.


Q: What did the safety assessment include?

A:The assessment included the following:
Physical examination
Pulse oximetry (to detect hypoxia suggestive of pulmonary events, during treatment and at day 1)
Blood cell counts (to assess bleeding and inflammation)
Electrolytes, urea, creatinine, and urinalysis ( to assess any renal injury).
Liver function (to assess any liver injury)
Serum lipids ( to assess hyperlipidemia)
Liver ultrasound ( to assess any fat deposition in the liver, at day 14 and 28)
2- point discrimination (to assess neurosensory loss at treatment site.)

The results were as follows:
No clinically significant changes in blood counts or chemistries were observed.
No evidence of bleeding, inflammation altered renal function or renal damage.
No evidence of altered liver function or liver damage.
No abnormal pulse oximetry .
No clinically changes in neurosensory.
No clinically significant elevation in serum lipids.
No serious adverse events were reported.