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CoolSculpting Indications

The CoolSculpting® System, also labeled as the ZELTIQ® System or the ZELTIQ® Breeze System (system), is a non-invasive thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site on the patient’s skin. Uses of the system in cooling mode include: fat layer reduction through cold-assisted lipolysis, minimizing pain and thermal injury during laser and dermatological treatments, and acting as a local anesthetic for procedures that induce minor local discomfort. The system can also provide localized thermal therapy (hot or cold) to minimize pain for post-traumatic and/or post-surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for: temporary relief of minor muscle aches, pain, and spasm, and temporary improvement in local circulation.

The use of the CoolSculpting® system has not been studied in children, or those who are pregnant or lactating.1

The CoolSculpting® procedure is not for you if you have the following:1

  • Cryoglobulinaemia
  • Cold agglutinin disease
  • Paroxysmal cold haemoglobinuria
  • Areas of impaired peripheral circulation
  • Pregnancy and lactation

Use caution before performing localized cooling under the following conditions, the effects of which have not been studied:1

  • Known sensitivity to cold such as cold urticaria, Raynaud’s disease, or chilblains (pernio)
  • Known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol
  • Impaired peripheral circulation in the area to be treated
  • Neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy
  • Impaired skin sensation
  • Open or infected wounds
  • Bleeding disorders or concomitant use of blood thinners
  • Recent surgery or scar tissue in the area to be treated
  • Hernia in or adjacent to the treatment site
  • Skin conditions such as eczema, dermatitis or rashes in the area to be treated
  • The effect of performing treatments directly overactive implanted devices, such as pacemakers and defibrillators, is not known
  • Areas of recent bleeding or hemorrhage (heating)

The following effects can occur in the treatment area during and after a treatment.1

These effects are temporary and generally resolve within days or weeks.1

During a treatment:1

  • Sensations of pulling, tugging and mild pinching at the treatment site
  • Intense cold, tingling, stinging, aching, and cramping. These sensations may subside as the area becomes numb

Immediately after a treatment:1

  • Redness and firmness
  • Transient blanching and/or mild bruising around the edges of the treatment area
  • Tingling and stinging

1 to 2 weeks after a treatment:1

  • Redness, bruising, and swelling
  • Tenderness, cramping, and aching
  • Itching, skin sensitivity, tingling and numbness. Numbness can persist up to several weeks after a treatment
  • Sensation of fullness in the back of the throat after submental area treatment

Rare side effects:1

  • Paradoxical hyperplasia: visibly enlarged tissue volume within the treatment area, which may develop 2 to 5 months after treatment. Surgical intervention may be required
  • Late-onset pain with a typical onset several days after a treatment and resolution within several weeks
  • Freeze burn:* first- and second-degree freeze burn may occur during treatment. It typically resolves without sequelae with proper care
  • Vasovagal symptoms:* dizziness, lightheadedness, nausea, flushing, sweating, or fainting during or immediately after the treatment
  • Subcutaneous induration: generalized hardness and/or discrete nodules within the treatment area, which may develop after the treatment, and may present with pain and/or discomfort
  • Hyperpigmentation:* hyperpigmentation may occur after treatment. Typically, it resolves spontaneously
  • Hernia: treatment may cause new hernia formation or exacerbate pre-existing hernia, which may require surgical repair

* Freeze burn, vasovagal symptoms, and hyperpigmentation were observed during clinical trials, while the others were reported in post-market use.

1. Allergan Inc. CoolSculpting® system user manual. BRZ-101-TUM-EN3-J. 2018

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