See answers to some of the most commonly asked questions about Cryolipolysis®, ZELTIQ, and the CoolSculpting procedure.
Cryolipolysis®, is the non-invasive cooling of adipose tissue to induce lipolysis (the breakdown down fat cells) without damage to other tissues. The result over 2 to 4 months is a noticeable, natural-looking reduction in fat.
Cryolipolysis® is based on the principle that fat cells are more vulnerable to energy extraction (cooling) than surrounding tissues.1 A non-invasive applicator is attached to the targeted procedure area to extract energy from the underlying fat tissue while protecting the skin, nerves, muscles, and other tissue. The cooled fat cells undergo apoptosis (controlled cell death) and are gradually eliminated, reducing the thickness of the fat layer.
During the procedure, exposure to cooling causes fat cell apoptosis, which leads to the release of cytokines and other inflammatory mediators. Inflammatory cells gradually digest the affected fat cells in the months after the procedure. Lipids from these fat cells are slowly released and transported by the lymphatic system to be processed, much like fat from food. Because the lipid clearance process is gradual, there is no harmful change in blood lipids or liver function.5
Lipids in fat cells crystallize at warmer temperatures than other water-containing cells. This is how Cryolipolysis® targets only fat cells for destruction and spares other tissue such as skin, muscle, and nerves. The CoolSculpting system controls the rate of energy extraction or cooling during the procedure.
Cryolipolysis® was discovered by dermatologists Dieter Manstein, MD, PhD and R. Rox Anderson, MD, of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, MA, a teaching affiliate of Harvard Medical School. Doctors Manstein and Anderson and their research team proved that, under carefully controlled laboratory conditions, subcutaneous fat cells are naturally more vulnerable to the effects of cold than surrounding tissues. Their initial evidence, published in Lasers in Surgery and Medicine in November 2008, concluded that prolonged, controlled local tissue cooling can induce selective fat cell reduction and subsequent loss of subcutaneous fat without damaging the overlying skin.1 This discovery, called "selective cryolysis," led to the development of the patented technology behind the non-invasive CoolSculpting procedure.
ZELTIQ is a science-based medical device company located in the San Francisco Bay Area in the United States. It has licensed the commercial rights to Cryolipolysis®, from Massachusetts General Hospital (MGH) as a non-invasive method of reducing fat, the science behind the CoolSculpting procedure. ZELTIQ is advancing the basic science, clinical evaluation, and commercial development of this technology.
About the CoolSculpting Procedure
The CoolSculpting procedure is a new non-invasive method clinically proven to reduce fat. CoolSculpting is clinically proven to reduce the fat layer.2,3 Fat is uniquely susceptible to cold while sparing all other tissue. The mechanism of action is Cryolipolysis®.
The science behind the CoolSculpting procedure, called Cryolipolysis®, was discovered by physicians Dieter Manstein, MD, PhD and R. Rox Anderson, MD, of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, MA, a teaching affiliate of Harvard Medical School. Drs. Manstein and Anderson and their team conducted research demonstrating that, under carefully controlled laboratory conditions, subcutaneous fat cells are naturally more vulnerable to the effects of cold than surrounding tissues. Their initial work, published in Lasers in Surgery and Medicine in November 2008, concluded that prolonged, controlled, local tissue cooling can induce selective fat cell reduction and subsequent loss of subcutaneous fat without damaging the overlying skin.1 This discovery, called "selective cryolysis," led to the development of the patented technology behind the non-invasive CoolSculpting procedure.
The CoolSculpting system includes a selection of non-invasive, tissue-cooling applicators controlled by a precisely engineered monitoring system. To perform the CoolSculpting procedure, the physician attaches an applicator to the targeted procedure area to extract energy from (or cool) the underlying fat tissue. The specially designed vacuum applicator draws tissue into the applicator cup and gently holds it between two cooling panels, extracting heat according to the selected procedure profile. Sensors embedded in the applicator monitor the skin during the procedure to ensure a consistent and uniform procedure. The sensors are linked to the control console to continuously monitor and adjust cooling throughout the CoolSculpting procedure and provide continuous feedback to the physician. A paging system automatically alerts the physician of any device or patient issues that need attention and notifies him or her when the CoolSculpting procedure is complete.
Clinical studies demonstrate that the CoolSculpting procedure provides noticeable, measurable fat reduction in properly selected patients over the course of 2 to 4 months after the procedure.3,4 Additional procedures may be administered 2 to 4 months after the initial procedure to achieve greater fat reduction.
Patients experiencing fat layer reduction show persistent results at least 6 months after the CoolSculpting treatment. Longer-term studies have not yet been completed. It is known that the exposure to cooling causes the fat cells to begin a process of natural removal, which gradually reduces the thickness of the fat layer. The fat cells in the treated area are gently eliminated through the body's normal metabolism process, like fat from food. The elimination of fat cells as a result of the CoolSculpting procedure is expected to last about as long as fat cells removed by invasive procedures such as liposuction.
The results of the CoolSculpting procedure are not as rapid or dramatic as invasive procedures such as liposuction. However, for patients who wish to avoid the pain, risk, and recovery time associated with surgical procedures, the CoolSculpting procedure may be the preferred option.
The CoolSculpting procedure is completely non-invasive, which allows immediate return to normal activities such as work or exercise. Redness may appear in the treated area, and may last from a few minutes to a few hours. Some localized bruising or swelling may occur, which clears within a few weeks. Many patients experience a temporary dulling of sensation in the treated area, lasting 1 to 8 weeks.
Ideal candidates for the CoolSculpting procedure are relatively fit, but have some modest-size fat bulges that are not easily reduced through diet and exercise. They are seeking spot reduction for specific areas of fat, but are not considering a surgical procedure. The CoolSculpting procedure is not intended for weight loss or obesity, and it is not a substitute for invasive methods such as liposuction.
The controlled cooling of the CoolSculpting procedure targets and eliminates only fat cells. Other treatment modalities, such as lasers, radiofrequency and focused ultrasound, affect fat cells and may affect other adjacent tissue in a way that is not comparable to the CoolSculpting method of Cryolipolysis®.
Well-controlled studies to determine whether the fat-reducing effects of the CoolSculpting procedure will result in the improved appearance of cellulite have not been completed. ZELTIQ does not recommend the CoolSculpting procedure using the current applicators for cellulite at this time.
The CoolSculpting procedure for non-invasive fat layer reduction is available in more than 70 countries. See Providers to search for CoolSculpting practices by country.
References: 1. Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson R. Selective cryolysis: a novel method of non-invasive fat removal. Laser Surg Med. 2008;40:595-604. 2. Zelickson B, Egbert BM, Preciado J, Allison J, Springer K, Manstein D. Cryolipolysis for noninvasive fat cell destruction: initial results from a pig model. Poster presented at 2008 Annual Meeting of the American Society for Dermatologic Surgery; November 6-9 2008; Orlando, Fla. 3. Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical Efficacy of Noninvasive Cryolipolysis and Its Effects on Peripheral Nerves. Aesthetic Plast Surg. 2009;33(4):482-488. 4. Dover J, Burns J, Coleman S, Fitzpatrick R, Garden J, Goldberg D, Geronemus R, Kilmer S, Mayoral F, Tanzi E, Weiss R, Zelickson B. A prospective clinical study of noninvasive cryolipolysis for subcutaneous fat layer reduction – interim report of available subject data. Lasers Surg Med. 2009;41:S21:43. 5. Klein K, Zelickson B, Riopelle JG, Okamoto E, Bachelor EP, Harry RS, Preciado JA. Non-invasive cryolipolysis for subcutaneous fat reduction does not affect serum lipid levels or liver function tests. Lasers Surg Med. 2009;41:785-790.