A physician panel of cosmetic surgery experts presented the latest scientific advances in capacitive radiofrequency (RF) skin rejuvenation using the ThermaCool(TM) device at the 63rd annual meeting of the American Academy of Dermatology in New Orleans on February 19, 2005. The patented RF device from Thermage(R) received FDA clearance in June of 2004 for the treatment of facial rhythids and wrinkles.
More than 500 dermatologists attended the lecture series, "Thermage of Today," at the Advanced Cosmetic Surgery Course where specialists in plastic surgery, facial plastic surgery, occuloplastic surgery and dermatologic surgery provided the latest research findings on Thermage usage that shows:
-- Safe and effective treatment of wrinkled eyelid skin with a specialized treatment tip.
-- Potential new applications to tighten and contour lax skin on the abdomen and other body areas
-- Measurable evidence of tissue tightening and lifting with associated patient satisfaction
-- A prominent dermatologic research center reported dramatic improvement in cosmetic results and patient comfort using state-of-the-art treatment techniques.
-- Photographic comparison of non-invasive and endoscopic brow lifting techniques demonstrated unique evidence of the non-invasive lifting effects in a facial plastic surgery practice.
"What was most striking about these diverse presentations by this renowned panel of multi-specialty experts is the unique and valuable role Thermage technology plays in each of their cosmetic practices," said course director Michael S. Kaminer, MD, a Boston-based dermatologic surgeon on faculty in the departments of dermatology at Yale University and Dartmouth University. "For the traditional surgeon, Thermage is a non-invasive alternative that provides a treatment solution for those patients who are adverse to the knife and would likely seek another cosmetic specialist. On the flip side, for the specialist who does not typically perform major invasive surgery, Thermage is an effective treatment option for patients who might otherwise have been referred out of the practice for a surgical consultation," stated Dr. Kaminer, who also chairs the Thermage Scientific Advisory Board.
Highlights from the Advanced Cosmetic Surgery Course include:
Non-Invasive Tissue Tightening of the Upper and Lower Eyelids
Occuloplastic surgeon Dr. Brian Biesman presented his clinical results of 20 patients who underwent a Thermage procedure to tighten upper and lower eyelid tissue using a specially designed 0.25 cm(2) tip used in conjunction with eye shields. This unique tip underwent extensive safety testing and is now being studied in a group of patients seeking eyelid skin tightening and wrinkle reduction without surgery. The treatments were performed in the office without anesthetic creams, injections, or sedation. No significant complications were encountered with either the skin or the eyes. Treated patients described significant improvement in the appearance of their eyelids, notably modest tightening, smoothing of fine wrinkles on the eyelid skin and "crow's feet," and greater ease in application of makeup due to improved skin texture and tone. According to Dr. Biesman, "These specially designed 0.25 cm(2) tips allow safe treatment of the delicate tissue of the eyelids. This treatment inside the orbital rim cannot be done safely with the larger tips currently on the market." Dr. Beisman is director of the Nashville Centre for Laser and Facial Surgery and is on faculty at Vanderbilt University. This clinical study is part of a larger study being sponsored by Thermage to secure FDA clearance for this specialized tip and eyelid skin application.
Radiofrequency Tissue Tightening of Non-facial Skin
Plastic surgeon Dr. Dennis C. Hammond discussed his independent investigations of the Thermage procedure to treat generalized skin laxity in the abdomen, arms and thighs. Dr. Hammond described the early results of his studies as "promising results, with many cases of remarkable tightening of treated areas and significant contour improvement." Dramatic before and after photographs were presented along with video footage of patients describing the contouring changes they experienced as a result of treatment. Dr. Hammond noted that the outcomes presented were early findings of his own study of the ThermaCool system for an application not currently cleared by FDA. Dr. Hammond is affiliated with the Center for Breast and Body Contouring in Grand Rapids, Michigan.
The Facial Plastic Surgeon's Perspective
Dr. R. James Koch highlighted the differences between a Thermage "brow lift" and an endoscopic brow lift, noting the clinical indications and patient candidates for each modality. Using before and after patient images, Dr. Koch described photographic techniques he uses to capture the effects of treatment. He favorably compared the measured effects that can be demonstrated for a Thermage "brow lift" with those of an endoscopic brow lift when documented by well-controlled photography. Dr. Koch is affiliated with the ENT Clinic at Stanford Hospital and is on faculty at Stanford University.
Patient Satisfaction Study
Dermatologic surgeon Dr. Ronald Moy presented outcomes of 10 patients in a split-face study to detect objective changes in eyebrow elevation and reductions in midface volume. Photographs were taken before and 3 months after a single Thermage radiofrequency treatment to compare the treated side and untreated side versus baseline. Dr. Moy noted that statistically significant increase in brow elevation was observed along with considerable decrease of the jowl surface area. Overall, objective changes were seen in 100% of patients, with high patient satisfaction noted with the results. Co-authored with Dr. Walter Nahm, the study was recently published in the peer-reviewed journal Dermatologic Surgery. Dr. Moy is an associate clinical professor of dermatology at UCLA.
State-of-the-Art Treatment Approach
"Compared to the Thermage procedure of a year ago, the Thermage of today is more predictable and more comfortable using lower settings with multiple passes," according to Dermatologic laser surgeon Dr. Elizabeth Tanzi. Dr. Tanzi presented the improvements in predictable efficacy and patient satisfaction that she and coauthor Dr. Tina Alster have achieved since adopting state-of-the-art treatment guidelines, which call for multiple passes at moderate settings to achieve visible results at the time of treatment. Dr. Tanzi quoted enhanced efficacy from 65% in her early use of the device, to a new high of 85% of patients treated more recently, with a considerable reduction in patient discomfort using the current treatment algorithm. These results were reported to persist at least 18 months post-treatment and will be published in a peer-reviewed journal in the coming months. Dr. Tanzi is co director of the Washington Institute of Dermatologic Laser Surgery in Washington, DC.
Thermage is a leading medical device company that develops innovative aesthetic technologies, including its patented capacitive radiofrequency device, to achieve a desired cosmetic or therapeutic effect on and under the skin surface. Its flagship ThermaCool is currently installed in more than 1,200 dermatology, plastic surgery and other cosmetic surgery practices worldwide. Founded in 1996, the Company's headquarters are located in Hayward, California, proximate to the San Francisco Bay Area and the Silicon Valley.
Jeffrey Dover, MD, Director of SkinCare Physicians of Chestnut Hill in Boston, MA, and Roy Geronemus, MD, Director of the Laser & Skin Surgery Center of New York, NY, presented safety data on three years of clinical experience with the non-invasive Thermage procedure for skin tightening and facial contouring. The two cosmetic laser surgeons are world-renowned experts in researching emerging technologies and have introduced numerous advanced aesthetic innovations into clinical practice.
Speaking at the 13th Annual Congress of the European Academy of Dermatology and Venereology in Florence, Italy, Dr. Dover told colleagues that the Thermage procedure "has revolutionized my practice and expanded our patient base by allowing us to offer patients a scalpel-free alternative for achieving moderate improvement of skin laxity without the downtime of conventional face lifting techniques."
According to Dr. Dover, more than 120,000 Thermage treatments have been performed worldwide with an estimated 99.85% of those free of any significant side effects over the last several years. Moreover, when using the most recent treatment guidelines, even rare side effects are reduced threefold, making Thermage one of the safest cosmetic procedures available today.
Dr. Dover discussed the experience of his clinic using the multiple-pass algorithm and enhanced 1.5 treatment tips. These advancements have led to observations of increased clinical predictability, more consistent skin tightening results, reduction of the already rare incidence of adverse effects, and greatly reduced patient discomfort. He reported that the use of moderate treatment-level settings with multiple passes also enables the physician to treat to a clinical endpoint of immediate visual tightening to determine the number of passes, providing immediately noticeable results to the patient of the unique contouring effects seen with Thermage.
"The recent advancements in procedure technique have made Thermage more predictable, safer, and turned pain into a non-issue with my patients," said Dr. Dover. "Our Boston practice has successfully treated hundreds of patients with high satisfaction, and we have hundreds more people -- of all ages and skin types -- requesting this kinder, gentler and more natural approach to regaining a fresher, tighter and more youthful appearance."
At "Advances in Aesthetic Plastic Surgery: The Cutting Edge V Symposium," a premier educational event sponsored by Manhattan Eye, Ear and Throat Hospital and New York University Institute of Reconstructive Plastic Surgery and endorsed by the American Society for Aesthetic Plastic Surgery, Dr. Geronemus reported that he has successfully treated nearly 1,000 patients with the ThermaCool radiofrequency system. The clinical professor of dermatology at New York University Medical Center credits his success to Thermage's proven track record of delivering safe, yet highly effective results to patients demanding an alternative to invasive cosmetic surgery.
"Many of my patients want to rejuvenate their appearance to look as young as they feel but shun an "extreme makeover" or invasive surgeries involving prolonged and extensive recovery times before they see results," said Dr. Geronemus. "What makes the Thermage procedure so attractive to these patients is that they can achieve impressive and more natural results without the lengthy downtime or potential risks of more drastic cosmetic procedures."
Dr. Geronemus noted that the clinical observations of more consistent results, overall improved efficacy and reduced pain are supported by basic tissue science presented by Dr. Brian Zelickson, Minneapolis, MN, at recent medical meetings that showed a greater deep-collagen denaturation effect with multiple treatment passes at moderate heat settings compared to single passes at higher and more painful settings.
Bob Byrnes, Thermage's Chief Executive Officer commented: "We are proud that Thermage has delivered and continues to provide a positive patient experience based on safety and efficacy that is well-established both in the scientific literature and the clinical practices of more than 1,200 physicians worldwide. He added: "As with any cosmetic medical procedure, patients should have realistic expectations and discuss the associated benefits and risks of treatment with their physician."
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