Procedures
UltraShape™ CONTOUR I
(Coming Soon, Pending FDA Approval)
The UltraShape™ CONTOUR I system, based on proprietary focused ultrasound technology, is the first clinically proven non-invasive body contouring solution for both men and women. Currently marketed in over 46 countries worldwide, the UltraShape CONTOUR I system is not cleared by the FDA for marketing in the United States.
The UltraShape CONTOUR I uses a patented ultrasonic technology to deliver focused ultrasound at a precise depth within the subcutaneous fat layer. It is designed to target and disrupt only adipose tissue, leaving critical surrounding structures such as skin, blood vessels, nerves and connective tissue intact. The acoustic waves of ultrasonic energy delivered by the UltraShape CONTOUR I converge in a confined focal volume and cause a selective mechanical effect. Mechanical (non-thermal) effects are produced because of optimized acoustic parameters and pulsed energy delivery. Histological and clinical evidence demonstrate that surrounding structures exposed to the mechanical effects are not damaged. Unlike thermal effects, mechanical effects allow for tissue selectivity whereby fat cells are disrupted while surrounding tissues remain unharmed.
Precision and safety are reinforced by an integrated 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.
Real-Time Tracking and Guidance System
The UltraShape™ procedure is guided by a proprietary real-time tracking and guidance system designed to deliver smooth, uniform body contouring results. The system’s software maps the treatment area in three dimensions and guarantees adherence to a pre-determined treatment algorithm. This algorithm ensures complete and uniform energy delivery over the entire treatment area, thus minimizing the risk of contour irregularities, a common side effect of liposuction.
Additional benefits of the treatment algorithm include:
- Treatment can only be performed within the marked treatment area.
- Each point within the treatment area is treated only once.
- Each pulse of energy is delivered immediately adjacent to the prior pulse ensuring complete uniform coverage over the entire treatment area.
The tracking system, by addressing the dynamic nature of the treatment area as it monitors and synchronizes patient position in real-time, enables the patient to move freely without impacting the treatment.
Natural Fat Clearance After Treatment
UltraShape CONTOUR I is designed to target and disrupt fat cells so that any released triglycerides can be processed by the body’s natural physiological and metabolic pathways in the same way as fat during weight loss. Immediately following completion of treatment, the patient can simply go back to his or her normal routine but will be advised to exercise regularly and maintain a healthy diet. Results of UltraShape’s published multi-center controlled clinical study and other independent clinical trials have shown that released triglycerides do not accumulate to any clinically significant extent in the blood or liver.
Clinical Evidence
Publication of clinical data in two premier peer-reviewed journals support the safety and efficacy of the UltraShape CONTOUR I and documented patient satisfaction is consistent with the clinical experience of many physicians performing the UltraShape procedure outside of the United States.
The worldwide multi-center single treatment controlled clinical trial results are currently available as an Advance online article at www.plasreconsurg.com, the Web site for Plastic and Reconstructive Surgery®, the Journal of the American Society of Plastic Surgeons. The article, "Non-Invasive Body Contouring by Focused Ultrasound: Safety and Efficacy of the Contour I Device in a Multi-Center Controlled Clinical Study," Teitelbaum et al., is a report on 164 patients which shows durable and measurable circumference and fat thickness reduction of the abdomen, flanks and thighs after a single treatment without pain or downtime. These results will also be published in the September issue of the journal.
In addition, an independent clinical trial showing the efficacy of multiple treatments with the UltraShape CONTOUR I is published in the April issue of Lasers in Surgery and Medicine, the journal for the American Society for Laser Medicine & Surgery. The article “Body Contouring by Non-Invasive Transdermal Focused Ultrasound”, Moreno-Moraga et al., demonstrates that multiple treatments using UltraShape CONTOUR I as a non-invasive method for reducing unwanted fat deposits produce a 100% response rate with a mean reduction in fat thickness of 2.28 + 0.80 cm and a mean reduction in circumference of 3.95 + 1.99 cm. The study included 30 patients who received 3 treatments at 30 day intervals including the following areas of the body: abdomen, flanks and thighs with no adverse effects on patients following the three treatments. As a control, weight loss was monitored to ensure results were not due to weight loss. Since UltraShape received CE approval from the European Commission over 30,000 commercial patient treatments in 250 installed sites have been performed worldwide without a single reported serious adverse event.
The UltraShape Procedure
As currently performed outside the United States, the UltraShape procedure is a convenient, “walk-in, walk-out” session carried out in an office-based environment; it requires no anesthesia or sedation, and the vast majority of patients report no pain or discomfort. There is no bruising, swelling or downtime associated with the UltraShape procedure. After treatment, patients immediately resume their daily routines and there is no need for maintenance treatments.
