Allergan receives FDA clearance for CoolSculpting

12 Oct 2018

CoolSculpting, owned by global pharmaceutical company Allergan, has received FDA clearance to treat the submandibular area.

According to Allergan, the FDA clearance was also expanded to include patients with a body mass index of up to 46.2 when treating the submental and submandibular areas.

This clearance makes CoolSculpting the first and only non-surgical fat reduction treatment to contour the area below the jawline and improve the appearance of lax tissue in conjunction with submental fat treatments, the company claims.

"The CoolSculpting treatment is the clinically proven safe and effective, leader in non-surgical fat reduction with nine clearances and over seven million treatments performed," said David Nicholson, chief research and development officer at Allergan. He added, "This new indication to treat the submandibular area underscores Allergan's dedication to research and innovation within the body contouring category."

According to Allergan, CoolSculpting has had an 85% average patient satisfaction rate reported across three studies, while a 22-week study demonstrated an average of 33% reduction in fat layer thickness after two treatments.

Dr Eric Bernstein, director for the Main Line Center for Laser Surgery in Pennsylvania, US, added, "As a physician and CoolSculpting provider, I applaud the company's ongoing investment in advancing the CoolSculpting treatment. The ability to treat the area below the jawline allows me to offer my patients even more opportunities for nonsurgical fat reduction."


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