Hologic recently announced an expanded FDA 510(k) clearance for Cynosure’s non-invasive body contouring technology SculpSure to the submental area.
The September FDA clearance for under the chin is very important for the brand, according to Lawrence Bass, M.D., F.A.C.S., a clinical assistant professor of plastic surgery at the Zucker School of Medicine at Hofstra/Northwell in New York City. “Our research indicates that the addition of the submental area will expand potential patient populations who are interested in this noninvasive space. We also believe that submental opens the door to more male patients than with previous clearances.”
Dr. Bass, who is a principal investigator for SculpSure clinical trials, notes that research shows a high percentage of people are concerned with their appearance in the submental area, including both younger people and the aging population.
To treat, a technician positions a piece of equipment around the patient’s head that holds the submental applicator in place.
The laser is then turned on. “The patient feels a cooling sensation, helping keep the skin comfortable,” Dr. Bass tells The Aesthetic Channel.
As the laser cycles on and off, the temperature of the fat cells rise. “Fat is heated to the point where the cells are shocked, then dying over a few weeks and being slowly removed from the body,” Dr. Bass explains.
Treatment is brief, only 25 minutes, but creates a substantial impact on the neck contour, according to Dr. Bass.
The Pivotal Trial
For the pivotal 57-patient trial, patients received two 25-minute treatments spaced 6 weeks apart.
Six weeks after the second treatment, fat thickness was measured by ultrasound and photographs were taken to compare with the baseline measurements.
“Patients generally showed a dramatic contour reduction, with a 100% patient satisfaction rate,” Dr. Bass states.
Still, most patients experienced swelling and tenderness for a few days after each treatment. An occasional patient also had firm areas which took several weeks to clear. “But there were no cases of blistering or pigment change, even in dark skinned patients, or any instances of skin loss or scarring,” Dr. Bass says.
The FDA clearance also encompasses patients with a body mass index (BMI) up to 43. “This clearance is very significant, as alternative technologies for this noninvasive space are only cleared to treat patients with a BMI index up to 30,” Dr. Bass says. “This provides practitioners with a SculpSure device assurance that they can effectively treat a much wider variety of patients.”
Furthermore, Dr. Bass says the effect of SculpSure heating on skin tightness bears investigation because tissue heating on the deep surface of skin or in connective tissue fibers has the potential to provide some tightening effects.
“MRI data also indicates that subplatysmal fat is affected by SculpSure in the submental area, which would be another advantage,” he says.