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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Recovery and Pain
Dr. Decorato says there is no recovery time associated with SculpSure treatment.
“And when we were doing our original experiments on patients, none of them needed pain medications,” he says.
Studies looking at before-and-after ultrasound measurements of the thickness of fat layers treated with SculpSure indicate one treatment results, on average, in slightly more than a 3 mm, or 24%, reduction, according to Dr. Bass.
Complications and Contraindications
Dr. Decorato says SculpSure treatment has been well tolerated in recent studies.
“When we were initially doing our experiments to try and determine our settings… we did see some complications as far as fat necrosis and nodule formation. But we determined that we were overtreating the patients. We were treating for about 45 minutes, and we found that over time we only need to treat for 25 minutes,” Dr. Decorato says.
Patients who might not be good candidates for SculpSure treatment, according to Dr. Bass, include those with cutaneous open sores or infections, as well as scars at the treatment site.
Is It a Good Fit for My Practice?
SculpSure is easy for providers to use, according to Dr. Bass.
“In terms of delivering the cycle, the device basically does the work. The skill set — the provider contribution in terms of expertise — relates more to picking the right areas; picking the right pattern of applicators to address the patient’s shape and bulge,” Dr. Bass says.
Dr. Decorato, who says he does a lot of liposuction, says noninvasive fat lipolysis with SculpSure is a good option for patients who aren’t interested in a surgical intervention and the recovery time associated with it.
“I would describe this as a significant advance in current technology of noninvasive fat removal,” Dr. Decorato says.
Dr. Bass says SculpSure has become his mainstay noninvasive lipolysis option.
“If the patient needs a big change and wants to see that big change all in one step, they should go in the operating room and have a liposuction. If the patient only needs a small- or medium-sized change, noninvasive is the best way to go. If the patient is maybe a little bigger than a small or medium change but really doesn’t have the downtime to go to the operating room and is willing to do a couple of rounds of treatment, then this is also a good option.”
Cosmetic Surgery Times advisor plastic surgeon Jason N. Pozner, M.D., Boca Raton, Fla., has not yet used the SculpSure device but says his conversations with other doctors suggest the new technology could have an edge on CoolSculpting in ease of use and treatment time.
“[SculpSure] is another versatile fat-busting device that I believe is complementary to CoolSculpting,” Dr. Pozner.
Experience, or time, will tell which device is better for which indications, according to Dr. Pozner.
Dr. Pozner has done workshops for Cynosure but not on SculpSure. Dr. Bass has been paid as a clinical investigator with Cynosure. Dr. Decorato is a research consultant for Cynosure.