FDA Clears Allergan's CoolTone Device
The FDA has cleared Allergan plc's CoolTone device for improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone is also indicated for strengthening, toning and firming of buttocks and thighs.
“By partnering with Allergan, I can offer my patients additional options in body contouring solutions,” said Dr. Grant Stevens, Founder and Medical Director of Marina Plastic Surgery, Co-Founder and Chief Medical Officer of Orange Twist, and Chairman of the USC-Marina Aesthetic Surgery Fellowship. “CoolSculpting®, for non-surgical fat reduction, is one of the most requested treatments in my practice, and now I can introduce my patients to CoolTone for muscle toning, strengthening and firming of the abdomen, buttocks and thighs.”
Using magnetic muscle stimulation (MMS), CoolTone technology penetrates into the muscle layers and induces involuntary muscle contractions. The body responds to these contractions by strengthening its muscle fibers, resulting in improved muscle conditioning. Whether targeting abdomen, buttocks or thighs, CoolTone strengthens, tones and firms the muscles in the treated area, resulting in a more defined and toned appearance. CoolTone has 50 percent more magnetic intensity than the leading competitor (1.35 T versus 0.9 T) at the point of contact (based on performance testing measuring magnetic field expressed in tesla [T] over the applicator surface.) The clinical significance of this data has not been established.
“As the global leader in medical aesthetics and body contouring, Allergan invests in the ongoing innovation and advancement of safe and effective non-surgical aesthetic solutions,” says Brad Hauser, Vice President, R&D and General Manager, Body Contouring, Allergan. “We do this by developing differentiated technology, such as the CoolTone device, that helps meet the needs of our customers.”
Allergan is now taking orders for the CoolTone device, and first units will ship early in the fourth quarter of this year.