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UltraShape(TM) Controlled Clinical Study Results Featured in ASDS Presentation by Karyn Grossman, M.D. Definite, Measurable Results in a Single Treatment (press release from UltraShape NA Inc.) SAN RAMON, CALIF., October 30 - Results of a multi-center controlled clinical study of the UltraShape(TM) Contour I G-NIUS(TM) Technology, the first non-invasive ultrasound solution for body contouring, were featured in this year's American Society for Dermatologic Surgery (ASDS) conference. Karyn Grossman, M.D., co-director, Santa Monica Institute of Laser and Esthetic Surgery and chief, division of dermatology at St. John's Hospital, Santa Monica, CA, presented results of a 137 patient study that showed that a single treatment using the UltraShape(TM) Contour I yielded definitive, measurable results of an average of 2 cm (0.79 in) reduction. "UltraShape's Contour I with G-NIUS(TM) Technology has been scientifically demonstrated to produce definitive, measurable circumferential reduction in a single treatment. It has also been shown to selectively target localized fat deposits without harming surrounding tissues," said Dr. Grossman. "In addition, worldwide commercial experience has produced incremental results and high patient satisfaction rates with multiple treatments." Since its launch outside the United States last year, the UltraShape(TM) Contour I has been successfully integrated into nearly 150 aesthetic practices in 37 countries. It has been applied in more than 15,000 patient treatments with no reported serious side effects. "Consumers are seeking a non-invasive, painless, no-downtime alternative to current body contouring techniques while physicians are looking for an effective solution that will expand their practices. The UltraShape(TM) Contour I fulfills this unmet need as demonstrated by its rapid adoption and success outside the United States," said Bob Gerberich, president of UltraShape North America. According to the American Society of Aesthetic Plastic Surgeons, liposuction continues to be the number one aesthetic surgical procedure for men and women in the United States. However, risks associated with surgery and relatively long recovery times have resulted in a shift towards non-surgical procedures with non-surgical procedures growing 726% from 1997 to 2005 in the United States. This continued shift is expected to drive rapid growth of the non-invasive body contouring market. About the Presentation Dr. Grossman's partner, Dr. Steven Teitelbaum, was a lead investigator for UltraShape's multi-center controlled clinical study. The study included five sites -- two in the United States, one in the United Kingdom, and two in Japan -- in which 137 patients underwent a single UltraShape(TM) procedure. On average, a 2 cm reduction in circumference was observed post-treatment, using a customized measuring system and technique to ensure consistency in pre- and post- circumferential measurements. About the Contour I The UltraShape(TM) Contour I with G-NIUS(TM) (Guided, Non-Invasive, Focused Ultrasound, Selective) Technology is the first non-invasive ultrasound solution for body contouring that has been clinically demonstrated to deliver measurable circumferential reduction in a single treatment. The G-NIUS(TM) Technology is based on two proprietary technological innovations: Non-Invasive Focused Ultrasound The UltraShape(TM) G-NIUS(TM) Technology is based on focused therapeutic ultrasound which is designed to selectively target adipocytes (fat cells). A predetermined amount of ultrasound energy is applied to the subcutaneous fat layer where acoustic waves converge in a confined focal volume causing a selective mechanical affect on fat cell membranes. Most importantly, since energy is delivered in pulses, there is no significant temperature elevation. This mechanical effect allows for tissue selectivity - only adipose cells within the targeted area are affected while surrounding tissues including blood vessels, nerves, and connective tissue remain unharmed. Advanced Tracking and Guiding Software The UltraShape(TM) treatment is guided by a real-time tracking and guidance system designed to deliver smooth, uniform body contouring results. The system's software algorithm maps the treatment area and guarantees adherence to pre-determined treatment parameters minimizing risk of contour irregularities, a common side effect of liposuction. The tracking system also addresses the dynamic nature of the treated area, as it monitors and synchronizes the body's position in real-time, enabling the patient to move freely without impacting the treatment. Precision and safety are reinforced by an acoustic contact sensor which provides real-time feedback on acoustic contact, thus ensuring proper transducer-to-skin contact and efficient energy delivery to the treatment area. The UltraShape(TM) Contour I system is not cleared by the FDA for marketing in the United States. About UltraShape North America UltraShape NA Inc., headquartered in San Ramon, Calif., is a wholly owned subsidiary of UltraShape Inc., a privately held Delaware Corporation. UltraShape Inc. operates through its wholly owned subsidiary UltraShape Ltd. headquartered in Israel. UltraShape Inc. develops, manufactures and markets innovative, non-invasive solutions for the aesthetic medical field. The UltraShape expert team of scientists and engineers are dedicated to the development of cutting-edge non-invasive body-contouring technology in a bid to enhance patients' self-image and sense of well-being. Additional information is available at www.ultrashape.com.
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