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SculpSure Clinical

Clinical and Histological Evaluations of a 1060nm Laser Device for Non-Invasive Fat Reduction

JOHN W. DECORATO, MD, FACS

Study Design:

17 subjects in total were treated; 11 treatments being in the abdomen and 6 in the FLank.
Pre- and post-treatment, a thermocouple needle was placed into the treatment area to measure tissue temp at interval depths (5, 10, 15, 20, 25, 30mm).
1060nm diode laser with contact cooling for skin protection to cause injury to subcutaneous adipose tissue (SAT) by establishing a controlled hyperthermic temperature of 42-47°C.

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Evaluation:


Ultrasound measurements of fat thickness were performed at baseline, 6 and 12 weeks post-treatment.
High-resolution photographs were taken at baseline and 12 weeks post-treatment.

Results:


Laser treatments were well-tolerated by all subjects with no damage to the skin.
Side effects included mild pain, stinging and numbness, all resolved by 2 weeks.

Conclusion:


Ultrasound, MRI, and photographic evaluations show similar level of fat reduction by laser hyperthermic treatment as compared to cryolipolysis (24%).
The in vivo tissue response demonstrated that a prolonged hyperthermic exposure can cause adipocyte injury.

Fat thickness changes demonstrated by ultrasound


Baseline 3 Month Post Tx 6 Month Post Tx
Total depth of adipose tissue (cm)
Results-MRI Measurements

PATIENT TESTIMONIALS

5/5
*Individual results may vary.

Average reduction in fat volume as compared to cryolipolysis:

 3 MONTH POST TX6 MONTH POST TX
Fat Volume ReductionLaser SideCryo SideLaser SideCryo Side
 24%22%21%19%
Average Reduction    
 (±9%)(±13%)(±10%)(±9%)

Example of fat thickness changes demonstrated by MRI:

Control Side Laser Tx Control Side Laser Tx


Control Side
Laser Tx
Baseline 3 Month Post Tx
6 Month Post Tx

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© 2015 Cynosure, Inc. Cynosure is a registered trademark of Cynosure, Inc. 921-0571-000 Rev.1 09/15

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*Individual results may vary.