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Regulatory approval: Zeltiq is a device approval, not an efficacy approval
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m Previous information was wrong. There is no device with two applicators operating at the same time. Research shows there is only one device with one applicator in use at one time. Doctors can have multiple devices.
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===Cost and treatment time===
===Cost and treatment time===
Typical cost per treatment area varies depending on location. Price in the US ranges from $750 to $1500,<ref>{{cite web|title=Can you freeze your fat away?|url=https://www.statnews.com/2015/12/24/freeze-fat-weight-loss/|accessdate=25 August 2016|date=24 December 2015}}</ref> with UK prices about £750 per area to be treated.<ref>{{cite web|title=CoolSculpting is only cold-based treatment cleared by US FDA for fat loss|url=http://www.ibtimes.com.au/coolsculpting-only-cold-based-treatment-cleared-us-fda-fat-loss-1509445|accessdate=25 August 2016|date=21 March 2016}}</ref> Treatment time for general use/application is 45–60 minutes per site. Some cryolipolysis devices have a pair of applicators that can be used simultaneously reducing the overall treatment time when treating corresponding areas such as the sides of the stomach, back of legs, and flanks.
Typical cost per treatment area varies depending on location. Price in the US ranges from $750 to $1500,<ref>{{cite web|title=Can you freeze your fat away?|url=https://www.statnews.com/2015/12/24/freeze-fat-weight-loss/|accessdate=25 August 2016|date=24 December 2015}}</ref> with UK prices about £750 per area to be treated.<ref>{{cite web|title=CoolSculpting is only cold-based treatment cleared by US FDA for fat loss|url=http://www.ibtimes.com.au/coolsculpting-only-cold-based-treatment-cleared-us-fda-fat-loss-1509445|accessdate=25 August 2016|date=21 March 2016}}</ref> Treatment time for general use/application is 45–60 minutes per site.


===Regulatory approval===
===Regulatory approval===

Revision as of 00:42, 3 January 2018

Cryolipolysis

Cryolipolysis is a medical treatment used to destroy fat cells by freezing. The functional principle is the controlled application of cooling, within the temperature range of +5 to −5 °C, for the non-invasive, localized reduction of fat deposits, in order to reshape the contours of the body. The degree of exposure to cooling causes the apoptosis (cell death) of subcutaneous fat tissue, without apparent damage to the overlying skin.[1]

As a medical procedure, cryolipolysis is a nonsurgical alternative to liposuction.[2] Etymologically, the term cryolipolysis (freezing of fat) is a portmanteau word derived from the conflation of cryogenic and lipolysis.[citation needed] In Europe, specific-design cryolipolysis machines are used in aesthetic clinics and spas; the brands of machine include CoolSculpting.[2]

Evidence

Cryolipolysis is used for removing certain areas of body fat that are just under the skin to contour a person.[3] Evidence supports its effectiveness at three to four months.[4]

It appears primarily applicable to limited discrete fat bulges.[5] According to a 2015 review it shows promise with the average fat reduction, measured by calipers of about 20 percent.[3] With the small number of people treated, clinical data remain scarce, thus it is not known how long the treatment effect will last, or when and if later treatments would be necessary to maintain the result.

Side effects

Side effect data are based on a limited experience. Transient local redness, bruising and numbness of the skin are common side effects of the treatment and are expected to subside.[5] Typically sensory deficits will subside within a month. The effect on peripheral nerves was investigated and failed to show permanent detrimental results.[6] No serious long-lasting side effects were encountered during follow-up time of six months.

Research on mechanism

Lipolysis procedures attempt to "dissolve" fat cells by nonsurgical means. A number of methods have been attempted, including the use of laser, ultrasound, and radio frequency current.[2] Popsicle panniculitis is a dermatologic condition that shows that exposure to low temperatures can selectively damage subcutaneous fat while leaving skin intact.[3][7] Based on the premise that fat cells are more easily damaged by cooling than skin cells, cryolipolysis was developed to apply low temperatures to tissue via thermal conduction. In order to avoid frostbite, a specific temperature level and exposure are determined, such as 60 minutes at −5 °C (23 °F).[8]

Initial studies to establish cryolipolysis methods were performed on pigs.[9][10] While the process is not fully understood, it appears that fatty tissue that is cooled below body temperature, but above freezing, undergoes localized cell death followed by a local inflammatory response called local panniculitis[9] that gradually over the course of several months results in a reduction of the fatty tissue layer.[6] When exposed to cold, the body's usual response is to restrict circulation to keep the core of the body at the correct temperature.

Society and culture

Cost and treatment time

Typical cost per treatment area varies depending on location. Price in the US ranges from $750 to $1500,[11] with UK prices about £750 per area to be treated.[12] Treatment time for general use/application is 45–60 minutes per site.

Regulatory approval

In September 2000, Zeltiq received EU CE Mark approval for their cryolipolysis device.[13] In September 2010, the US Food and Drug Administration approved the cryolipolysis device and procedure for skin cooling, but not for fat removal.[2][14][citation needed]

References

  1. ^ "Clinical Efficacy of Noninvasive Cryolipolysis and Its Effects on Peripheral Nerves". Aesthetic Plastic Surgery. 33: 482–488. July 2009. {{cite journal}}: Unknown parameter |authors= ignored (help)
  2. ^ a b c d "Cryolipolysis for Noninvasive Body contouring: Clinical Efficacy and Patient Satisfaction". Clinical Cosmetic Investigational Dermatology. 7: 201–5. 26 June 2014. doi:10.2147/CCID.S44371. PMC 4079633. PMID 25061326. {{cite journal}}: Unknown parameter |authors= ignored (help)CS1 maint: unflagged free DOI (link)
  3. ^ a b c Ingargiola, MJ.; Motakef, S.; Chung, MT.; Vasconez, HC.; Sasaki, GH. (June 2015). "Cryolipolysis for fat reduction and body contouring: safety and efficacy of current treatment paradigms". Plastic and Reconstructive Surgery. 135 (6): 1581–90. doi:10.1097/PRS.0000000000001236. PMC 4444424. PMID 26017594.
  4. ^ Derrick, CD; Shridharani, SM; Broyles, JM (June 2015). "The Safety and Efficacy of Cryolipolysis: A Systematic Review of Available Literature". Aesthetic Surgery Journal. 35: 830–6. doi:10.1093/asj/sjv039. PMID 26038367.
  5. ^ a b Nelson, AA; Wasserman, D; Avram, MM (2009). "Cryolipolysis for reduction of excess adipose tissue". Seminars in Cutaneous Medicine and Surgery. 28 (4): 244–9. doi:10.1016/j.sder.2009.11.004. PMID 20123423.
  6. ^ a b Coleman, SR; Sachdeva, K; Egbert, BM; Preciado, J; Allison, J (2009). "Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves" (PDF). Aesthetic Plastic Surgery. 33 (4): 482–8. doi:10.1007/s00266-008-9286-8. PMID 19296153. {{cite journal}}: Unknown parameter |displayauthors= ignored (|display-authors= suggested) (help)
  7. ^ Avram, MM; Harry, RS (2009). "Cryolipolysis for subcutaneous fat layer reduction". Lasers in Surgery and Medicine. 41 (10): 703–8. doi:10.1002/lsm.20864. PMID 20014262.
  8. ^ "Effects of Cryolipolysis on Abdominal Adiposity". Case Reports in Dermatological Medicine. 2016. doi:10.1155/2016/6052194. {{cite journal}}: Unknown parameter |authors= ignored (help)CS1 maint: unflagged free DOI (link)
  9. ^ a b Manstein, D; Laubach, H; Watanabe, K; Farinelli, W; Zurakowski, D; Anderson, RR (2008). "Selective cryolysis: A novel method of non-invasive fat removal". Lasers in Surgery and Medicine. 40 (9): 595–604. doi:10.1002/lsm.20719. PMID 18951424. {{cite journal}}: Unknown parameter |displayauthors= ignored (|display-authors= suggested) (help)
  10. ^ Zelickson, B; Egbert, BM; Preciado, J; Allison, J; Springer, K; Rhoades, RW; Manstein, D (2009). "Cryolipolysis for noninvasive fat cell destruction: Initial results from a pig model". Dermatologic Surgery. 35 (10): 1462–70. doi:10.1111/j.1524-4725.2009.01259.x. PMID 19614940. {{cite journal}}: Unknown parameter |displayauthors= ignored (|display-authors= suggested) (help)
  11. ^ "Can you freeze your fat away?". 24 December 2015. Retrieved 25 August 2016.
  12. ^ "CoolSculpting is only cold-based treatment cleared by US FDA for fat loss". 21 March 2016. Retrieved 25 August 2016.
  13. ^ "ZELTIQ Announces European CE Mark Approval for Non-Invasive Fat Layer Reduction Using Cryolipolysis".
  14. ^ Binita S. Ashar (24 September 2015). "Contact cooling system for aesthetic use" (PDF). Division of Surgical Devices, US Food and Drug Administration. Retrieved 3 January 2018.