Sponsored by Sofwave
SofwaveTM Medical (San Clemente, Calif.) announced late in 2021 that the FDA had cleared its Sofwave device for lifting the eyebrows, lax submental tissue and neck tissue. The technology was cleared previously to treat fine lines and wrinkles.
The more indications with this technology, the better for patients, says Yael Halaas, MD, a facial plastic and reconstructive surgeon at Science & Beauty in Manhattan, N.Y. Featuring propriety Synchronous Ultrasound Parallel Beam Technology, Dr. Halaas uses Sofwave to revitalize her patients’ skin and stimulate new collagen production.
“The main thing that I appreciate about Sofwave is it is a reliable, effective technology...that offers significant results [with minimal downtime],” Dr. Halaas expressed. “I can’t think of another device that can deliver these kinds of results when it comes to lifting the eyebrows, or under the chin, where patients can go right back to their daily routines.”
Patient Selection
Sofwave candidates include anybody with aging skin. There really are no age limitations, according to Dr. Halaas. “You can even use it on younger patients who just want to have a little bit of a higher brow,” she said. Ideal candidates, however, tend to be in their mid-40s to 50s.
Sofwave Medical studied the effect of the treatment on all Fitzpatrick skin types and did not report any complications, Dr. Halaas added. “The way that the device is designed, it should not result in surface heating of the skin, so there should be no problem with hyperpigmentation or hypopigmentation.”
Realistic Expectations
To support the FDA’s clearance of these expanded indications, Sofwave Medical conducted a multi-site clinical study on 80 subjects. Overall, 467 facial areas were treated, according to the company.
As a facial plastic surgeon, Dr. Halaas p
oints out that using devices will not offer the same outcomes as surgery. However, even she is impressed with what the patients and investigators reported in the study.
“For eyebrows, 80% of patients clearly demonstrated a lifting of the brows and could see a significant change with two Sofwave treatments, four weeks apart and three months of follow-up. That is pretty substantial,” Dr. Halaas reported.
Furthermore, according to Dr. Halaas, 85% of patients involved in the study had significant improvement in the submental region. These results were objectively measured as a significant change.
In Combination or Alone?
Sofwave can be used as an effective stand-alone treatment for lax skin, but Dr. Halaas also uses it in combination with minimally invasive and non-invasive treatments, including neuromodulators and fillers. “You can use Sofwave fairly contemporaneously with injectables because you are not worrying about ‘melting the fillers,’” she explained.
For patients who want to see results immediately, Dr. Halaas likes to use Sofwave in combination with the Silhouette Instalift® (manufactured by Sinclair Pharma Ltd.; distributed by Suneva Medical).
Dr. Halaas believes that Sofwave has mastered what other devices have not. She asserts that the technology is more tolerable and easier to use than most. “With Sofwave, the ultrasound is delivered in a safe, effective, comfortable manner every time. Outcomes are not as technician dependent as with other ultrasound devices,” she noted.
