Zeltiq announced September 23 that the FDA expanded clearance for the CoolSculpting procedure with the company’s new CoolMini applicator to treat smaller pockets of fat, including the submental area.
The FDA’s clearance is based on clinical trial data from 60 male and female patients, ages 22 to 65 years. Patients received one to two treatments, six weeks apart, under the chin. Those studied achieved an average 20% fat reduction and no significant adverse events were observed, according to Zeltiq.
Patients treated with the CoolMini applicator might see results as early as three weeks post treatment, but full results generally take from one to three months, according to a company press release.
“The outcomes I have observed using the CoolMini applicator to treat the submental area have been very positive, with high levels of patient satisfaction with… fat reduction and the lack of discomfort and downtime afterward,” says Suzanne Kilmer, M.D., a dermatologist in Sacramento, Calif., and medical advisory board member, principle investigator for the CoolMini submental trial and speaker for Zeltiq. “The CoolSculpting procedure’s predictable results, non-invasive technology, comfort, lack of downtime and affordable pricing make it a very attractive treatment option for patients looking to eliminate unwanted fat.”
Jason Emer, M.D., a cosmetic dermatologic surgeon in Beverly Hills, Calif., says technologies to treat localized fat areas, including those under the neck, are a big trend.
“Localized areas of fat under the chin are often genetic and give the neck an aged appearance with lack of definition and contour and increased size,” Dr. Emer tells Cosmetic Surgery Times. “The CoolMini is another addition to the trend of other fat-busting technologies (such as Kybella) that are focused on the growing demand for subtle improvements with little downtime. This treatment is particularly attractive to those younger patients with only mild submental fat …; post-procedural patients who still have residual small pockets of fat or skin laxity …; and for those that cannot undergo surgery due to medical issues… or who do not want a surgical procedure.”
According to Dr. Emer, the debate will be whether CoolSculpting with the CoolMini can result in similar contouring and lifting that surgical procedures, such as lipo-contouring of the neck and jawline, can. And will the newly cleared technology give substantial results with little downtime? How will it fare given liposuction results are immediate, while patients may have to wait months to see the full effect of a single CoolMini treatment?
Related: Will soaking in a hot tub prior to CoolSculpting help improve results?
The good news, Dr. Emer says, is the CoolMini is backed by CoolSculpting technology’s years of substantial efficacious and safe clinical research, and it is at the forefront of noninvasive options for targeting stubborn neck fat.
“Time will determine its popularity, best practices and combinations that promote its best ultimate use,” he says.
Dr. Emer is a consultant or luminary for: Syneron/Candela, Venus Concepts, Kythera, Valeant, Carestream America, Viora and Eclipse.
Dr. Kilmer is on the medical advisory board for Candela/Syneron, Living Proof/Strateris, Lumenis and Lutronics. She receives research support from Candela/Syneron, Living Proof/ Strateris, Lumenis, Lutronics, Allergan, Cutera, Cynosure/Palomar and Valeant.