The U.S. Food and Drug Administration (FDA) had cleared Allergan’s CoolSculpting to treat the submandibular area. In addition, the FDA clearance was expanded to include patients with a BMI of up to 46.2 when treating the submental and submandibular areas.
The efficacy of the CoolSculpting treatment in the area right below the jawline was proven in a 22-week clinical study, which demonstrated an average 33 percent reduction in fat layer thickness after two treatments. Additionally, patient satisfaction with the treatment averaged 85 percent across three studies
“The CoolSculpting treatment is the clinically proven safe and effective leader in nonsurgical fat reduction with nine clearances and over 7 million treatments performed,” said David Nicholson, chief research and development officer at Allergan. “This new indication to treat the submandibular area underscores Allergan’s dedication to research and innovation within the body contouring category.”
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