As the founding Medical Advisory Board member for Liposonix, the first FDA-approved technology for noninvasive body contouring with High-Intensity Focused Ultrasound (HIFU), I have been involved in the clinical development from the beginning. Here is a list of peer-reviewed publications that I co-authored, which demonstrate the safety and effectiveness of Liposonix:
- Jewell MA, Baxter RA, Cox SE, Donofrio LM, Dover JS, Glogau RG, Kane MA, Weiss RA, Martin PM, Schlessinger J. Randomized sham-controlled trial to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for noninvasive body sculpting. Plastic & Reconstructive Surgery 2011 July;28(1):253-62.
ABSTRACT
BACKGROUND: High-intensity focused ultrasonography (HIFU) is a nonsurgical, noninvasive method for body sculpting in nonobese patients. The technique ablates subcutaneous adipose tissue by causing molecular vibrations that increase tissue temperature and induce rapid cell necrosis.
OBJECTIVES: The authors evaluate the long-term safety of a HIFU device for sculpting the abdomen and flanks.
METHODS: Adults with subcutaneous abdominal fat ≥2.5 cm in thickness who met screening criteria were randomized to receive HIFU treatment of the anterior abdomen and flanks at 1 of 3 energy levels (3 passes per patient): 47 J/cm(2) (141 J/cm(2) total), 59 J/cm(2) (177 J/cm(2) total), or 0 J/cm(2) (no energy applied; sham control). Safety was assessed for 24 weeks and included laboratory testing, physical examinations, and documentation of adverse events.
RESULTS: Adverse events (AE) included mild to moderate discomfort, ecchymosis, and edema, all of which were transient. There were no reports of scarring or burns and no clinically meaningful changes in lipid panel findings, inflammatory markers, or renal or hepatic function. Physical examination results were unremarkable. Conclusions: This HIFU device exhibited an AE profile similar to that of sham treatment. There were no significant changes from baseline in laboratory values, including lipid levels.
- Jewell MA, Baxter RA, Cox SE, Donofrio LM, Dover JS, Glogau RG, Kane MA, Weiss RA, Martin PM, Schlessinger J. Safety and tolerability of high-intensity focused ultrasonography [Liposonix] for noninvasive body sculpting: 24 week data from a randomized, sham-controlled study. Aesthetic Surgery Journal 2012 Sept 1;32(7):868-76.
ABSTRACT
BACKGROUND: High-intensity focused ultrasonography (HIFU) is a nonsurgical, noninvasive method for body sculpting in nonobese patients.
OBJECTIVES: The authors evaluate the long-term safety of a HIFU device [Liposonix] for sculpting the abdomen and flanks.
METHODS: Adults with subcutaneous abdominal fat ≥2.5 cm in thickness were randomized to receive HIFU treatment of the anterior abdomen and flanks at 1 of 3 energy levels (3 passes per patient): 47 J/cm(2) (141 J/cm(2) total), 59 J/cm(2) (177 J/cm(2) total), or 0 J/cm(2) (no energy applied; sham control).
RESULTS: There were no reports of scarring or burns and no clinically meaningful changes in lipid panel findings, inflammatory markers, or renal or hepatic function.
CONCLUSIONS: This HIFU device exhibited an AE profile similar to that of sham treatment. There were no significant changes from baseline in laboratory values, including lipid levels.
