Currently, neurotoxin injections, like Botox®, are the main treatment option for erasing frown lines on the forehead. For those who might be concerned about injections, those worries may be alleviated as patients may soon have an alternative therapy for treating frown lines. The GFX Nerve Ablation System (GFX) is currently cleared via a 510(k) by the FDA to create radiofrequency (RF) heat lesions in nerve tissue, and the manufacturer hopes to obtain clearance, anticipated to occur in 2009, for aesthetic applications.
The device uses minimally-invasive radiofrequency energy selectively to weaken nerve signals. The use of this technology on nerves that control the muscles of the forehead may reduce the appearance of frown lines, or glabellar furrows. The product is comprised of a RF energy generator box, approximately the size of a small monitor, a handheld probe and a foot pedal to activate energy delivery. According to the manufacturer, the probe has two functions -- stimulating the nerve to identify the proper location for treatment, and delivering the heat energy in a measured dose to reduce activity of the targeted nerve. The minimally invasive procedure can be conducted in a physician's office or a hospital with local anesthesia, usually taking approximately 30 minutes. The probe tip is inserted under the skin and the correct nerve is identified through stimulation, which causes visible muscle contraction. The same probe delivers localized and controlled RF energy for approximately 30 seconds to reduce nerve function.
According to the manufacturer approximately 300 patients have received nerve ablation treatment with the device worldwide, many in clinical studies intended to support development and evaluation of this device and procedure for aesthetics applications. Results are said to last up to 18 months, as opposed to 4-6 months for Botox. However, Botox is approved for other areas in addition to the glabella, such as the forehead, brow and neck. Based on current data, GFX may not be a substitute for most Botox facial applications. Commonly reported adverse effects include some pain or discomfort during the treatment, and swelling following the treatment.
Many of the topics discussed in this section are procedures or technologies that are relatively new or currently under clinical investigation and may require further scientific study to determine efficacy and success rate.
These topics are presented for research and education purposes only. The ASPS does not endorse the procedures or technologies in this section.
Physicians using such procedures or technologies are advised to make individual treatment decisions according to their own medical judgment in light of each patient's individual circumstance.
Further, any reporting or publication of the information presented must be done responsibly with full disclosure of its unproven nature.