FDA grants approval for ZELTIQ to conduct CoolSculpting procedure at lower temperatures - Verdict Medical Devices
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FDA grants approval for ZELTIQ to conduct CoolSculpting procedure at lower temperatures

29 Jan 2015 (Last Updated January 29th, 2015 18:30)

US Food and Drug Administration (FDA) has granted clearance for ZELTIQ Aesthetics to carry out a CoolSculpting procedure at lower temperatures, which will help reduce treatment times.

US Food and Drug Administration (FDA) has granted clearance for ZELTIQ Aesthetics to carry out a CoolSculpting procedure at lower temperatures, which will help reduce treatment times.

The non-surgical, clinically proven CoolSculpting procedure selectively reduces fat bulges in problem areas using a patented cooling technology.

ZELTIQ Aesthetics president Mark Foley said: "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 practise, while also improving the patient experience.

"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."

"The non-surgical, clinically proven CoolSculpting procedure selectively reduces fat bulges in problem areas using a patented cooling technology."

Approval was based on clinical data, which showed optimised temperatures allow shorter treatment times with equivalent benefits, safety, efficacy and customer satisfaction, compared against current CoolSculpting procedures.

In line with this clearance, the company is set to introduce its brand new applicator, CoolSmooth PRO in the second quarter of 2015.

CoolSmooth PRO is a surface applicator that features non-vacuum based cooling to treat non-pinchable fat bulges such as the outer thigh area.

Approved for non-invasive fat reduction in the abdomen, flank and thighs, the CoolSculpting procedure gently cools unwanted fat cells in the body to induce a natural, controlled elimination of fat cells, without harming surrounding tissue.

New treatment parameters will be provided with the CoolSmooth PRO applicator, which allows control over treatments at colder temperatures.

CoolSmooth PRO applicator features an enhanced strapping system, which offers increased conformity at the treatment site, and improves ease of use and patient comfort.