FDA Clears CoolSculpting® Therapy for Lower Temperatures/Shorter Treatment Times

Cosmetic treatment technology company ZELTIQ® Aesthetics, Inc., has announced that it has received U.S. FDA clearance to perform the CoolSculpting® procedure at lower temperatures, which will enable shorter treatment times.


A newcomer to our pages, Zeltiq is a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform. Its CoolSculpting procedure is a non-surgical, clinically treatment for selectively reducing fat bulges in problem areas using a patented cooling technology. Cleared by the FDA for noninvasive fat reduction in the abdomen, flank and thighs, it gently cools unwanted fat cells in the body to induce a natural, controlled elimination of fat cells without harming surrounding tissue, and the treated fat cells are gone for good.

The new FDA clearance allows for a modification in treatment parameter and is based on clinical study data demonstrating that optimized temperatures enable shorter treatment times with equivalent benefits, safety, efficacy and customer satisfaction, when compared to current CoolSculpting procedures.

The new parameters will initially be offered with the CoolSmooth PRO applicator, which is uniquely designed to safely control treatments at colder temperatures. The CoolSmooth PRO applicator also includes an enhanced strapping system that provides increased conformity at the treatment site, while also improving ease of use and patient comfort.

In conjunction with this clearance, ZELTIQ will be introducing a brand new applicator, CoolSmooth PRO™, which is a second generation surface applicator that features non-vacuum based cooling to treat non-pinchable fat bulges, such as the outer thigh area.

Company comments

“This FDA clearance will enable healthcare professionals to perform the CoolSmooth procedure in nearly half the time with the same outcomes, which will significantly enhance the procedural efficiency and profitability for the practice while also improving the patient experience,” said Mark Foley, President and Chief Executive Officer of ZELTIQ. “Through an ongoing investment in R&D and technological innovation, we are pleased to continue to provide our CoolSculpting partners with differentiated solutions that enhance their treatment options. And, we look forward to applying this technological advancement to our other CoolSculpting applicators in the future.”

Source: Business Wire


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