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CST Web Exclusive: RF procedure may offer longer-lasting results than neurotoxins

Article-CST Web Exclusive: RF procedure may offer longer-lasting results than neurotoxins

Not Botox, it’s ‘No-tox’
RF procedure may offer longer-lasting results than neurotoxins

John Jesitus
Senior Staff Correspondent

National Report — Glabellar furrow relaxation (GFX; Advanced Cosmetic Intervention [ACI], Centennial, Colo.) offers results that last at least a year, and the treatment may have applications beyond the glabellar region, says one physician who recently started using the technique.

“Everyone knows about Botox Cosmetic (botulinum toxin A; Allergan, Irvine, Calif.). It's the most popular procedure we do,” says Brett S. Kotlus, M.D., M.S., an oculofacial plastic surgeon who practices at Allure Medical Spa, based in Shelby Twp., Mich., a Detroit suburb. However, he adds, “People are looking for longer-lasting alternatives to Botox. That's the niche that GFX is filling.”

Also called “No-tox,” the treatment is ideal for patients for whom Botox isn't working as well as it used to or for those who dislike returning every three to four months for maintenance treatments, says Dr. Kotlus. “It's also an effective addition to other procedures, such as brow lifts,” he states.

GFX involves bipolar radiofrequency (RF) ablation of the corrugator and procerus nerves, according to Dr. Kotlus.

The procedure typically begins with oral sedation and analgesia. Physicians also can use regional nerve blocks in the areas being treated. “I usually do supraorbital and zygomaticotemporal and lacrimal infraorbital blocks, and I may even do an infratrochlear and a supratrochlear block, performed in a sequential manner as I work on each area because I don't want the anesthesia to block the muscle action,” Dr. Kotlus explains.

After the patient is comfortable, he adds, “Some doctors are doing an external nerve stimulation to localize the nerves that they're focusing on externally first. Other people skip that step” and proceed to making two small punctures in the skin on both sides of the face — one in the lateral canthal area; one at the side of the nose.

The next step involves localizing and stimulating the appropriate nerves. “A nerve stimulator built into the probe of the GFX helps us localize the procerus and corrugator nerves. So we're really looking at a temporal and an angular branch of the facial nerve,” he explains.

After localizing the nerves, Dr. Kotlus says, “Then we apply the RF energy [460 kHz] using a foot pedal.” Each of the four treatment areas typically requires three to five treatments lasting 30 seconds each, though some patients require eight to 10 treatments per area, he says. Between treatments, he explains, “I ask the patient to frown again. If I see any movement (in the corrugator or procerus muscles), I may do more treatments.”

The entire procedure takes about 30 minutes. “There's minimal swelling and bruising afterward but almost no downtime — patients are back to regular activities within a day,” Dr. Kotlus says.

Natural Results
Moreover, GFX creates natural-looking corrections, Dr. Kotlus says. “Some people are afraid of Botox because they think it's going to make them look frozen. That's not what we're seeing with GFX — patients have natural relaxation of the muscles between their eyes,” he explains. Not only does the procedure improve vertical creases between the eyebrows, but it also lifts somewhat the medial portion of the brow, according to Dr. Kotlus. “When we inject Botox in that area,” he explains, “we're also weakening some of the frontalis muscle there. But GFX is more selective, targeting only the corrugators and the procerus.”

According to Roger Mixter, M.D., a Milwaukee-based plastic surgeon who began performing GFX as an ACI study investigator and who has been performing the procedure for a year now, “We've learned that GFX provides a benefit relative to raising the medial eyebrow, which gives a nonsurgical brow lift effect. In my practice, some people are merely looking for improvement of the frown wrinkle, and some are looking for a little of that eyebrow elevation.”

When one performs GFX in conjunction with a brow lift, Dr. Kotlus adds, GFX eliminates the need to surgically remove portions of the corrugator muscles.

Birth of a Procedure
GFX represents a natural outgrowth of RF nerve ablation procedures that cardiologists have used for more than a decade to treat arrhythmias, Dr. Kotlus says. To date, ACI has completed an IRB-approved safety trial that included 90 procedures and produced no major side effects, according to the company's Web site. Study results showed that the treatment achieved wrinkle reductions in 86 percent of subjects. The company has now initiated a multicenter longevity trial the data from which it plans to submit to the FDA later this year in order to apply for a cosmetic indication for the technology.

In the ongoing clinical trial, results so far are lasting at least a year, Dr. Kotlus reports. “But I wouldn't be surprised if they lasted two or three years,” he adds.

GFX’s inventor James Newman, M.D., has followed patients up to approximately 18 months, adds Dr. Mixter. “He's seen improvement lasting certainly through a year. And with the newer technology we've just been given and the newer techniques we've just developed, we're probably in the range of nine to 12 months.”

More specifically, Dr. Mixter explains that regarding technique, “The closer you get to the nerve, the better the results.” Additionally, he says ACI has changed the GFX system's software and hardware to provide stimulation closer to the nerve and use the RF energy more aggressively.

As for any downside to GFX, Dr. Mixter reports that, in patients treated by ACI’s group of 20 clinical investigators, the aggregate complication rate totaled less than one percent. “Those included some sensory nerve changes — discomfort on the top of the head which was gone by six months. And as in any treatment that uses RF stimulation, there was one skin burn early on, but none since,” says Dr. Mixter, who has treated approximately 75 patients with the technique.

Creating Buzz
GFX has earned high patient satisfaction from the start, he adds, although patients initially expressed concern that results of the original GFX technology only lasted a few months. “As we've been developing the technology and the technique,” says Dr. Mixter, “those results are clearly getting better and lasting longer. We needed to make results last longer than Botox, and we're in that range now.”

Dr. Kotlus says that ultimately, RF nerve ablation could provide effective treatment for benign essential blepharospasm, and for other areas in which physicians use neurotoxins, including crow's feet and the corners of the mouth, he says.

“The main draw for patients is that GFX provides long-lasting results with one treatment,” Dr. Kotlus says. Nationally, he says patients typically pay around $1,500 to $2,000 per treatment. Physicians' costs include $40,000 for the GFX system and a few hundred dollars per disposable probe, he adds. Nationally, about 40 GFX systems are in use, reports Doug McBurney, ACI spokesman.

At Allure Medical Spa, Dr. Kotlus says, “GFX has generated excitement. The staff is excited, and patients see that.”

Virtually every new technology creates a buzz that's not necessarily commensurate with the device's effectiveness, he notes. “But GFX is going to be around for awhile. This technology represents a direction in which many of our procedures are moving — people want something that's going to work well for a long time,” Dr. Kotlus concludes. CST

Dr. Kotlus reports no relevant financial interests.
Dr. Mixter is an investigator in ACI's ongoing longevity trial, but receives no financial compensation from the company.

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