Earlier this year, the FDA cleared Cynosure’s SculpSure for noninvasive flank area fat reduction, paving the way for the company’s late 2015 U.S. launch of the device.
Staten Island plastic surgeon John W. Decorato, M.D., a research consultant with Cynosure and one of the developers of SculpSure, says the technology is based on controlled hyperthermic, or temperature injury, to fat cells. Heating the fat cells to target temperatures, causes injury; then, the body’s immune system steps in to clear the body of those cells, and the treated area shrinks.
The basis of treatment is similar to that of CoolSculpting, according to Dr. Decorato, but while Zeltiq’s device uses cold to injure fat cells, SculpSure uses heat. Both devices are FDA cleared for treatment of the abdomen and flanks.
In the original SculpSure experiments, which are not yet published but were presented in 2014, Dr. Decorato and colleagues performed studies on abdominoplasty specimens. From this point, they directly compared CoolSculpting and SculpSure. They found one flank treatment with the new hyperthermic laser treatment was equivalent to one flank treatment with the CoolSculpting device.
But that’s where similarities seem to end. The ideal length of time for each SculpSure treatment is 25 minutes, which is less than half of the recommended 60-minute cycle for CoolSculpting, according to Lawrence Bass, M.D., a plastic surgeon in New York City and lead investigator in one of two FDA studies for SculpSure.
Dr. Bass, who has done more than 100 SculpSure cases in various clinical studies for Cynosure, says SculpSure works by passing 1060-nm diode laser light through the skin to achieve target temperatures of 42 to 47 degrees Celsius.
“So, [it’s] not a coagulation temperature. [It is] a temperature that shocks the fat cells, and they die over a few weeks. It’s an apoptosis mechanism,” Dr. Bass says. “At the same time that the fat is being heated, the skin is being chilled by the applicator head. So, this is something that can treat all skin types because there’s no reaction in the skin. Whether you’re fair or very dark skinned, the skin remains unaffected.”
CoolSculpting is performed by pulling, sucking and cooling fat between two plates. With the SculpSure device, there is no suction; there is no pulling of the tissue. The device lays flat on top of the tissue, while energy penetrates into the tissue and causes damage, according to Dr. Decorato.
Versatility is another benefit of using SculpSure, according to Dr. Bass.
“With SculpSure’s four separate applicator heads, I can treat multiple areas at once. Or I can adjust the pattern or arrangement of how I place the four heads, depending on where the patient needs it,” Dr. Bass says. “With CoolSculpting, you’re limited by the applicator shape and size. And if the patient is very young and very tight, and they don’t suck into the applicator, you can’t really go after their fat at all.”
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