The US Food and Drug Administration (FDA) has granted expanded clearance for medical technology firm Zeltiq Aesthetics’s new CoolMini applicator.
The applicator is designed to treat smaller pockets of fat, including the submental, or chin fat area, more commonly referred to as the double chin.
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In more than 50 published clinical articles and 4,000 clinical trial patients, the CoolSculpting procedure has shown to non-invasively and consistently reduce unwanted fat.
The procedure has been successfully used in more than two million treatments.
Approval is based on data from a US pivotal clinical trial involving 60 male and female patients from the ages of 22 to 65.
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In the trial, patients were given one or two treatments in the area under the chin, each six weeks apart resulting in an average of 20% fat reduction, which is in line with results achieved with other CoolSculpting applicators.
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By GlobalDataZeltiq president Mark Foley said: "Through our continued introduction of new applicators together with expanded clearances from the FDA, we are successfully addressing additional problem areas for our customers.
"The CoolMini applicator will enable our CoolSculpting practices to treat small volume areas of unwanted fat with little to no downtime, and with a similar level of efficacy as our other applicators.
"I believe our new CoolMini applicator will provide a truly compelling alternative to other popular devices and methods currently used to treat and contour the neck, like liposuction.
"I have been particularly pleased with the very positive feedback we are receiving from both physicians and patients based on our limited European launch."
The applicator is designed for small volume areas of fat and its size, shape and curvature is designed to comfortably fit these problem areas.
The company noted that patients would see results as early as three weeks, with the most dramatic results generally observed one to three months following treatment.
The CoolSculpting procedure was developed by Harvard scientists and is based on the science of cryolipolysis, showing that when fat cells are exposed to extreme cold, they die and are eliminated naturally from the body.
It is a non-surgical, clinically proven procedure that selectively reduces unwanted fat using a patented cooling technology.
The procedure works by gently cooling targeted fat cells in the body to induce a natural, controlled elimination of fat cells without affecting surrounding tissue.
