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About the CoolSculpting® Treatment.

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.

Clinical studies demonstrate that the CoolSculpting treatment provides noticeable, measurable fat reduction in properly selected patients as soon as 1-3 months post-treatment.2 Additional CoolSculpting treatments may be administered in the months following the initial procedure to achieve the patient's desired treatment goals.

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 and requires surgical intervention for correction. Consult the 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.

About cryolipolysis

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.2

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

INDICATIONS & SAFETY INFO

CoolSculpting® Indications
The CoolSculpting® procedure is FDA-cleared for the treatment of visible fat bulges in the thigh, abdomen and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm in patients with a Body Mass Index (BMI) of ≤ 30 and in submental and submandibular areas in patients with a BMI of ≤ 46.2. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments.

CoolSculpting® Important Safety Information
CoolSculpting® is contraindicated in patients with cryoglobulinemia, cold agglutinin disease, or paroysmal cold hemoglobinuria.

Ask your patient about any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.

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 and requires surgical intervention for correction.

As with any medical procedure, a consultation should be done by a licensed healthcare professional to determine if the patient is a candidate for treatment. Consult the CoolSculpting® System User Manual for a complete list of Contraindications, Warnings, Precautions, and potential side effects. Treatment applications that deviate from the guidelines are not recommended.

References: 1. Avram MM, Harry RS. Cryolipolysis for subcutaneous fat layer reduction. Lasers Surg Med. 2009;41(10):703-708. 2. Data on file, Allergan. Zeltiq Study Report TR-415.1. 3. 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.

INDICATIONS & SAFETY INFO
CoolSculpting® Indications
CoolSculpting® procedure is FDA-cleared for the treatment of visible fat bulges in the thigh, abdomen and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm in patients with a Body Mass Index (BMI) of ≤ 30 and in submental and submandibular areas in patients with a BMI of ≤ 46.2. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments.
INDICATIONS & SAFETY INFO