Zeltiq Consumer Q&A
IN THE NEWS
COOLSCULPTING in the news: The Dr. Oz Show
The Dr. Oz Show - Cutting-Edge Plastic Surgery, Pt. 1
The Dr. Oz Show - Cutting-Edge Plastic Surgery, Pt. 2
60 days after 1 treatment
90 days after 1 treatment
Q: WHAT IS COOLSCULPTING®? HOW DOES IT WORK?
A: CoolSculpting is a breakthrough, FDA-cleared and non-invasive procedure that gently and effectively reduces fat in problem areas of the body. This results in noticeable, natural-looking fat reduction in the treated areas for men and women. What makes CoolSculpting different than other fat reduction procedures is its patented cooling technology that targets and eliminates fat cells.
During the procedure, a non-invasive applicator delivers precisely controlled cooling to target and eliminate fat cells in specific areas of your body. When fat cells are exposed to cooling, it triggers a process of natural removal, which gradually reduces the thickness of the fat layer. The result is a reduction in fat bulges that is visible in most patients in two months.
Q: WHAT IS CRYOLIPOLYSIS™?
A: Exclusive to CoolSculpting, Cryolipolysis is the non-invasive cooling of fat cells to break them down without damage to other tissues. The result over two to four months is a noticeable, natural-looking reduction in fat. Cryolipolysis is based on the principle that fat cells are more vulnerable to cooling than surrounding tissues. A non-invasive applicator is attached to the targeted area to extract energy from the underlying fat tissue, while protecting the skin, nerves, muscles and other tissue. The cooled fat cells undergo apoptosis (programmed cell death) and are gradually eliminated, reducing the thickness of the fat layer.
Q: WHO INVENTED COOLSCULPTING?
A: The scientific principles of Cryolipolysis were discovered by renowned dermatologists Dieter Manstein, MD, and R. Rox Anderson, MD, of the Wellman Center for Photomedicine at Massachusetts General Hospital in Boston, a teaching affiliate of Harvard Medical School. The physicians and their team conducted research that demonstrated that, under carefully controlled conditions, subcutaneous fat cells are naturally more vulnerable to the effects of cold than other surrounding tissue. This discovery, called "selective Cryolipolysis," led to the development of the patented technology known as CoolSculpting.
Q: IS COOLSCULPTING FDA-CLEARED?
A: Yes, CoolSculpting is FDA-cleared in the U.S. for non-invasive fat reduction in the flank. The procedure has been available since 2009 in Europe, Asia and Canada, which in the past was sometimes referred to as the ZELTIQT Procedure.
Q: HOW LONG HAS COOLSCULPTING BEEN AVAILABLE? HOW MANY PEOPLE HAVE BEEN TREATED TO DATE?
A: CoolSculpting has been available since October 2009 in Canada, Europe and regions in Asia, with clinical studies beginning in May 2006. There have already been more than 140,000 treatments with the device worldwide.
Back 60 days after 1 treatment
Q HOW DO PATIENTS FIND DOCTORS THAT OFFER COOLSCULTPING?
A: CoolSculpting is made available only to premiere accredited doctors and treatment centers. Current distribution consists of dermatologists, plastic surgeons and other aesthetic specialists. Consumers can visit www.coolsculpting.com and enter their zip code into the center locator which will list several providers in their area. However, ZELTIQ encourages consumers to do their homework and ensure they accept no substitutes for CoolSculpting.
Q: IS COOLSCULTPING SAFE? PAINFUL? SIDE AFFECTS?
A: CoolSculpting is safe and generally comfortable for most patients. Typically, patients are comfortable enough to read, work on their laptop computers, listen to music, or just relax during the procedure. After the procedure some patients experience redness, tingling, bruising or numbness in the treated areas, but these are temporary and not experienced by all patients.
In approximately 50 reported cases out of 115,000 treatments, patients experienced more severe pain during and/or after treatment. In this case, patients are to contact their provider immediately. In 100% of cases, pain has naturally subsided over time and there have been no long-term effects of treatment. If discomfort is severe, your provider may prescribe an oral medication or topical anesthetic to help ease the effects until they go away naturally.
Q: WHO IS ELIGIBLE FOR COOLSCULPTING? IS THERE A MINIMUM AGE?
A: CoolSculpting is not a weight loss solution and it is not a substitute for invasive methods such as liposuction. The ideal CoolSculpting candidate maintains a healthy weight yet struggles with bulges that do not lend themselves to easy removal through exercise or diet. They are seeking spot reduction for specific areas of fat, but are not considering a surgical procedure. Your medical provider will decided on a case-by-case basis whether a patient is a candidate. CoolSculpting has only been studied in healthy adults
over 18 years of age, and only a doctor can decide if a patient is a candidate for the procedure.
Q: WHAT CAN PEOPLE EXPECT IN TERMS OF FAT REDUCTION - WHAT IS THE AVERAGE OUTCOME?
A: In all CoolSculpting cases, patients will experience an undeniable reduction in fat in the area treated. However, visible results can vary based on the patients' initial fat deposits in the area treated.
Q: IN ESSENCE, COOLSCULPTING "FREEZES" FAT, RIGHT? AT WHAT TEMPERATURES DO THE FAT CELLS DIE?
A: No. In fact, CoolSculpting does not "freeze fat." The system delivers precisely controlled cooling to target areas and eliminates fat cells in those specific areas of your body. When fat cells are exposed to cooling, it triggers a process of natural removal, which gradually reduces the thickness of the fat layer.
Q: IF COOLSCULPTING IS SIMPLY JUST FREEZING FAT AWAY, WHY COULDN'T I JUST APPLY AN ICE PACK AND GET THE SAME RESULT?
A: An ice pack would not be able to reach cold enough temperatures in order to effectively kill fat cells. And, the application of the cooling technology is done through a controlled process which could not be duplicated with an ice pack.
Q: HOW LONG IS EACH COOLSCULPTING TREATMENT?
A: Each treatment can last one to two hours or more depending on the size of the area to be treated. During the consultation, the doctor will discuss how long the procedure will take and how much time should be allotted for your office visit.
Q: HOW MANY TREATMENTS ARE NECESSARY TO ACHIEVE DESIRED RESULTS?
A: Fat cells are killed with every treatment. Every patient/case is different which is why it is recommended that a follow-up visit be scheduled with the doctor post-procedure to assess the cosmetic improvement and consider additional CoolSculpting to achieve greater fat reduction.
Q: WHAT HAPPENS TO THE FAT CELLS ONCE THEY DIE? HOW DOES THE BODY PROCESS THEM?
A: The dead fat cells are broken down and digested by the immune cells in the body. The fats that are released by the dead fat cells are processed by the liver which is an organ in the body designed to perform that very function.
Q: WHAT IS THE COST OF COOLSCULPTING?
A: Each procedure typically costs anywhere from $1,500 to $3,000 but cost can vary based on individual treatment plans and providers.
Q: IS COOLSCULPTING SOMETHING PEOPLE CAN DO ON THEIR LUNCHBREAK?
A: Yes, one of the many benefits of CoolSculpting is its convenience. Because it's non-invasive, the procedure can usually be completed within one to two hours which means no downtime for patients. In fact, during treatment, most patients can be positioned comfortably enough to read or work on a laptop.
Q: WHAT IS THE RECOVERY PROCESS ONCE YOU'VE HAD THE PROCEDURE DONE?
A: There is no recovery (down) time after CoolSculpting. Patients may resume normal activities on the same day as their procedure, including work and exercise. While uncommon, a small percentage of patients may experience pain related to their treatment. Pain subsides over time.
Q: CAN TREATMENT RESULT IN NERVE DAMAGE OR PERMANENT NUMBNESS?
A: CoolSculpting is very selective in killing fat while sparing other structures. Clinical studies indicate that the procedure does not cause any nerve damage or permanent numbness. A small number of patients may experience temporary symptoms that may include skin sensitivity, stinging and/or pain. These symptoms are temporary and will subside over time. An oral medication or topical anesthetic may be prescribed as needed.
Flanks 30 days after 1 treatment
Male Flank 90 days after 1 treatment
Q: WHEN YOU KILL THE FAT IN ONE AREA, WHAT HAPPENS TO THE FAT CELLS IN OTHER AREAS? DO THEY MOVE OVER TO COMPENSATE? IF THERE ARE FAT DEPOSITS THROUGHOUT THE BODY AND YOU ONLY TARGET THAT ONE AREA, WHAT HAPPENS TO THE REST OF IT?
A: Once the fat cells are killed from CoolSculpting, those cells are eliminated. Fat will never deposit again in the same area that was treated. So there is no risk of fat from other areas moving over to the treated area to compensate.
Q: CAN COOLSCULPTING TREAT GYNECOMASTIA ("MAN BOOBS")?
A: CoolSculpting is not cleared in the United States for use in the treatment of gynecomastia or pseudogynecomastia. CoolSculpting is being considered for the treatment of gynecomastia, an area that has already demonstrated strong interest in the United States (according to many of our doctors) and has shown significant growth in international markets.
Q: CAN COOLSCULPTNG CAUSE ANY DIMPLING OR UNEVEN SKIN TONE?
A: In clinical research, CoolSculpting was not noted to cause any change in skin tone or color and was not observed to cause any rippling or dimpling.
Q: IS THERE A HIGHER RISK OF SKIN DISCOLORATION OR OTHER SKIN PROBLEMS IN ANY SKIN TYPES? FOR INSTANCE, DIFFERENT ETHNICITIES?
A: Physician experience with the product shows it to be safe for all skin types.
Q: HOW ARE DOCTORS TRAINED TO DO COOLSCULPTING? HOW CAN PEOPLE BE SURE THEY ARE RECEIVING TREATMENT FROM A DOCTOR EXPERIENCED IN THIS PROCEDURE?
A: All doctors who perform CoolSculpting are carefully selected and undergo thorough training for certification to ensure a successful outcome for every patient. These doctors also commit to specific patient selection criteria, case management responsibilities and protocol requirements. Patients can visit www.coolsculpting.com and enter their zip code into the center locator which will list several providers in their area.
Q: WHAT PROOF/CLINICAL EVIDENCE IS AVAILABLE THAT COOLSCULPTING WORKS?
A: Clinical studies involving hundreds of patients (in the United States, Canada, Europe and Asia) show that CoolSculpting is an effective way to reduce fat without the pain, risk, and recovery time of surgical procedures. The result is noticeable, natural-looking fat reduction in the treated areas. Specific results can be found in the case gallery on our Website at: www.coolsculpting.com/for-physicians/clinical-results/.
Q: ONCE THE TREATMENT IS COMPLETE, ARE COOLSCULPTING RESULTS PERMANENT? HOW LONG DO THE RESULTS LAST?
A: CoolSculpting results are durable and cumulative. The elimination of fat cells as the result of the procedure is expected to last about as long as fat cells removed by invasive procedures such as liposuction.
Q: IS THERE ANYTHING COOLSCULPTING CAN NOT DO? (I.E., WHAT KIND OF CASES IS IT NOT APPROPRIATE FOR?)
A: Yes, CoolSculpting is not a weight loss solution, it is not for people who are obese, and it is not a substitute for invasive methods such as liposuction.
Q: HOW MUCH TIME (AT A MINIMUM) IS NEEDED BETWEEN EACH COOLSCULPTING APPOINTMENT?
A: This is a decision that should be discussed between the patient and physician as it relates to reaching specific goals and ensuring the best possible outcomes. Some patients experience their desired results after one procedure. However if more than one procedure is selected or recommended, physicians typically wait four to eight weeks between treatments.
Q: WHAT ARE THE SPECIFIC AREAS OF THE BODY THAT ARE BEING TREATED WITH COOLSCULPTING ?
A: In the United States, CoolSculpting's FDA clearance is for the flank region, also known as love handles. Internationally, CoolSculpting is cleared for the entire body and some other common "problem areas" being treated worldwide include back fat areas and the abdomen or "muffin top."
Q: CAN COOLSCULPTING WORK ON ANY OTHER THINGS SUCH AS CELLULITE?
A: Cellulite is comprised of several types of tissue including fat and, because CoolSculpting selectively eliminates fat, the procedure would not do a thorough job treating cellulite. So while some patients may experience a temporary reduction in the appearance of cellulite immediately after the procedure, CoolSculpting is most effective in providing non-invasive fat reduction.
Q: ARE THERE PLANS TO OFFER COOLSCULPTING IN SPAS?
A: Currently, CoolSculpting is only offered through top doctors at carefully selected and qualified treatment centers where patients can be assured that a trained physician will be overseeing the procedure.
Q: DOES COOLSCULPTNG WORK BETTER THAN OTHER COMPETITIVE PRODUCTS/PROCEDURES?
A: The results of CoolSculpting are not as rapid or dramatic as invasive procedures such as liposuction or a tummy tuck. But, if people want to avoid the higher cost, pain, risk and recovery time associated with surgical procedures, then CoolSculpting is an effective alternative. When compared to other non-invasive fat reduction and/or body contouring techniques, dermatologists and plastic surgeons often note that CoolSculpting is an efficacious procedure.
Q: WHAT IS THE DIFFERENCE BETWEEN COOLSCULPTING AND OTHER BODY CONTOURING/FAT REDUCTION PROCEDURES? WHAT IS THE DIFFERENCE IN RESULTS?
A: CoolSculpting is FDA-cleared for non-invasive fat reduction in the flank region. CoolSculpting is the only procedure that uses patented cooling technology to kill fat cells. 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 CoolSculpting. Additionally, CoolSculpting produces an undeniable fat reduction in the area treated and does not require special diet and supplements. ZELTIQ cannot speak for other technologies, but what is certain is that CoolSculpting is the only product worldwide that is based on the extensive research and licensed patented technology developed at the Wellman Center for Photomedicine at Massachusetts General Hospital, a teaching affiliate of Harvard Medical School.
Q: WHO MANUFACTURES COOLSCULPTING?
A: CoolSculpting is manufactured and marketed by ZELTIQ™, a global medical device company located in the San Francisco Bay Area. It has licensed the commercial rights to a process called Cryolipolysis from the Wellman Center for Photomedicine at Massachusetts General Hospital, a teaching affiliate of Harvard Medical School as a non-invasive method of reducing fat. ZELTIQ is advancing the basic science, clinical evaluation, and commercial development of this patented technology.
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