- Ideal candidates for cryolipolysis are those who are relatively fit and want to target stubborn, modest-sized fat bulges noninvasively
- UltraShape treatment breaks down fat with ultrasound technology, as focused energy selectively targets fat cells in specific area without harming surrounding tissues
Although medicine is a global community, specific protocols tend to be local. Most countries boast their own regulatory agencies that, in turn, impose their own guidelines regarding safety, efficacy, evidence and approval of medical devices, drugs and applications.
As a result, many products debut in stages, first entering foreign markets where requirements are not necessarily more relaxed, but possibly less complicated, comprehensive or confining. Companies often launch their products in European markets after obtaining a CE mark of approval, all the while completing trials for submission to the Food and Drug Administration (FDA). Subsequently, new protocols, including those in cosmetic surgery, frequently enter the mainstream overseas.
Protocols currently making a splash across the pond include two noninvasive body-contouring techniques — cryolipolysis (CoolSculpting, Zeltiq Aesthetics), which uses cold, and UltraShape (UltraShape), which employs focused ultrasound technology.
CRYOLIPOLYSIS Ironically, the principles upon which cryolipolysis are founded were discovered by two dermatologists working at Massachusetts General Hospital, Boston; all commercial development rights are held by Zeltiq, a medical device company headquartered in Pleasanton, Calif., that is marketing the product as CoolSculpting.
"Cryolipolysis is based on the principle that fat cells are more vulnerable to energy extraction than surrounding tissues. Cooled fat cells undergo apoptosis and are gradually eliminated, reducing the thickness of the fat layer," says Gerhard Sattler, M.D., a founder of Rosenpark Clinic, Darmstadt, Germany.
Precisely controlled cooling is applied through the skin to the fat layer using a noninvasive applicator that protects the skin, nerves, muscles and other tissue. Cooling is maintained for a predetermined time to damage the fat cells.
"Procedure time can take up to two hours or more depending on the size of the area to be treated," Dr. Sattler says. During the final phase, the fat cells are removed in a natural process that continues for several months and results in gradual fat-layer reduction.
"Clinical studies demonstrate the CoolSculpting procedure provides noticeable, measurable fat reduction in properly selected patients over the course of two to four months following the procedure. Additional procedures may be administered [then] to achieve greater fat reduction," Dr. Sattler says.
Long-term studies have not been completed, but available data presented as a poster at the 2009 annual meeting of the American Society for Dermatologic Surgery indicates patients show persistent results at least six months after the procedure. Results are expected to last as long as those from more invasive protocols (such as liposuction), although the actual effect is often less dramatic in comparison.
Ideal candidates are relatively fit and want to target stubborn, modest-sized fat bulges noninvasively.
"The CoolSculpting procedure is not intended for weight loss or obesity, and it is not a substitute for invasive methods, such as liposuction," Dr. Sattler says. It is currently most commonly used to treat "muffin tops," love handles and back fat, though other areas may also be addressed.
Contraindications for cryolipolysis treatment include two rare conditions — cryoglobulinemia and paroxysmal cold hemoglobinuria. Otherwise, risks are low, side effects rare and recovery immediate.
"Some patients experience redness, tingling, minor bruising or numbness in the treated areas, but this is temporary," Dr. Sattler says.
The Zeltiq CoolSculpting cryolipolysis device.
Before use, physicians need to be trained on the device, committing to specific patient selection criteria, case management responsibilities and protocol requirements. Zeltiq CoolSculpting has been cleared for use in the United States for applications related to skin cooling during dermatologic treatments, and it holds a pending application with the FDA for use in noninvasive fat-layer reduction.