UltraShape, the Tel Aviv, Israel, company that developed the handheld ultrasound device, purports that it would allow removal of fat in a completely noninvasive way. "It is designed to break up the fat nonsurgically," said Rod Rohrich, M.D., plastic surgeon, University of Texas, and advisory board member, UltraShape. Not yet approved in the United States, the high frequency sound wave technique, will allow more accurate targeting of fat cells, with far less "collateral damage" to blood vessels and other tissues such as skin and muscle, reported the company. To date, the device has only been tested in southern Israel on porcine models, whose high fat content makes them ideal for testing.
Clinical trials and research are set to begin in the United States in six months in the hope of getting an FDA nod 2004. Until now, conventional liposuction, which breaks down fat cells and releases the fat contained within them, has made use of ultrasound probes that liquefy fat and suck it out of the body. Israeli researchers found that, even when used externally, the broken down fatty liquid could simply be reabsorbed back into the bloodstream over the weeks following the procedure.
Yoram Eshel, managing director and one of the founders of UltraShape, founded in 2000, said tests have shown that the machine can destroy fat cells selectively without any damage to surrounding areas. "Ultrasonic waves destroy cell membranes, causing the cells within to disintegrate," Eshel said. "We also found that blood cholesterol and triglycerides did not change - if they did, it could damage the liver. "We are the only device that is totally noninvasive," he said. "This is a breakthrough in plastic surgery." UltraShape's product consists of an ultrasonic transducer, developed in-house, which provides dual functionality - it also serves as an ultrasonic guidance system that works in conjunction with an accompanying video imaging system, enabling precise localization of treatment.
Eshel said that the guidance system reduces human error during the treatment. This is in sharp contrast to liposuction, which is sight- and touch-guided.
In addition, Eshel noted the device would allow a physician to begin the procedure, establish the boundaries of the treatment area, and turn the bulk of the actual procedure over to a technician, if desired. Clinical trials scheduled to begin early this year will lyse 500 cc of fat tissue per treatment, or about one-fourth of the quantity of tissue that is normally removed in a single liposuction operation.
UltraShape is currently in the final stages of developing a prototype that will be used to demonstrate the device's fat-lysing capability in tissue from cadavers. Initial indications will be the removal of fat from the abdomen and hips. Because it will only remove one-fourth the fat of a conventional procedure, this device will not provide results that are as immediate as liposuction. However, Eshel maintained that the company's technology would enable much smaller, controlled amounts of fat to be removed than with current procedures.
"The inherent safety of our method lies in the fact that we do half the traditional job compared to liposuction and let nature do the rest," Eshel said.
For physicians, the new procedure could offer a greater source of revenue because less time is spent on each treatment. In addition, costs of an operating room, attendant personnel, and other related expenses, are not needed, reported the company. According to a Reuters report, UltraShape attempts to stress risks and conveniences associated with liposuction, despite new research suggesting that the procedure may have health benefits, including improving cholesterol levels and helping to relieve complications of breast cancer surgery.
Despite the potential risks, liposuction remains the most popular cosmetic surgery procedure in the United States.
UltraShape estimated that its new procedure, upon approval by the FDA, could be performed without anesthetic and will be competitively priced with conventional liposuction treatments. Dr. Rohrich has no financial interest in the procedure mentioned but he is on the advisory board for UltraShape.