The CoolSculpting treatment is a clinically proven, noninvasive method to reduce the fat layer by way of freezing fat. The mechanism of action is cryolipolysis. Fat is uniquely susceptible to cold while sparing all other tissue.¹ CoolSculpting is FDA-cleared to treat 9 different areas of the body: Visible bulges in the abdomen and love handles, thighs, bra fat, back fat, underneath the buttocks, upper arms, under the chin and jawline areas.

The science behind CoolSculpting 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. Their research demonstrated that under carefully controlled laboratory conditions, subcutaneous fat cells are naturally more vulnerable to the effects of cold than other tissues. Their initial work, published in Lasers in Surgery and Medicine, Nov. 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 CoolSculpting.

The CoolSculpting system includes a selection of noninvasive, tissue-cooling applicators controlled by a precisely engineered monitoring system. The provider applies an applicator to the targeted procedure area to extract energy from (or cool) the underlying fat tissue. Sensors embedded in the applicator monitor the skin during the procedure to continuously monitor and adjust cooling throughout the CoolSculpting procedure and provide continuous feedback to the provider. A paging system automatically alerts the provider of any device or patient issues that need attention as well as when the CoolSculpting treatment is complete.

Each CoolSculpting® treatment plan is unique—while 89.2% of patients (91/102) were satisfied or very satisfied with CoolSculpting® after two visits^4,*,†, some patients may require more or fewer treatments. That’s why it’s so important to set patient expectations from the start. Besides, when treatment plans meet or etxceed expectations, patients are more likely to share their positive experiences, refer family and friends, and return for additional treatments!

* Prospective, nonrandomized, single-arm, open-label, multicountry, postmarketing study. Patients aged 22 to 65 with a BMI of 18.5 to 30 received CoolSculpting® treatments on their abdomen and/or flanks in an outpatient clinical setting (N = 112). Patients could receive up to 2 treatment sessions 8 weeks apart. 96.2% (102/106) of patients were treated with 2 sessions on the abdomen and/or flanks. The primary objective was to evaluate overall patient satisfaction for noninvasive fat reduction with CoolSculpting. Change in fat volume (mL) was a secondary endpoint measured by 3D image analysis. Final follow- up was conducted approximately 12 weeks after the participant’s final treatment, at Week 12 for patients receiving 1 treatment session or at Week 20 for patients receiving 2 treatment sessions. Treatments were performed using the legacy CoolSculpting system.

^†The primary and additional objectives were captured via a 4-item patient-reported outcome survey assessing patient satisfaction with treatment of the abdomen and/or flanks, visible fat reduction, improvement in fit of clothing, and overall effect of treatment.

During the procedure, patients may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment. Rare side effects may also occur. Paradoxical hyperplasia (visibly enlarged tissue volume in the treated area) may develop 2-5 months after treatment , will not resolve on its own, and may require surgical intervention for correction. Consult the CoolSculpting® User Manual and the CoolSculpting® Elite User Manual for full product and safety information.

Ideal candidates for the CoolSculpting treatment 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 treatment is not a treatment for weight loss and it is not a substitute for invasive methods such as liposuction.

CoolSculpting is contraindicated in patients with cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.

Cryolipolysis is the noninvasive cooling of adipose tissue to induce lipolysis (the breakdown of fat cells) without damage to other tissues. The result is a noticeable reduction of fat in the treated area as soon as 1-3 months post-treatment.

Cryolipolysis is based on the principle that fat cells are more vulnerable to energy extraction (cooling) than surrounding tissues. A noninvasive 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 CoolSculpting system controls the rate of energy extraction or cooling during the procedure. The cooled fat cells undergo apoptosis (controlled cell death) and are gradually eliminated, reducing the thickness of the fat layer in the treated area.

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.³