Allergan has secured approval from the US Food and Drug Administration (FDA) for its CoolTone device to improve abdominal tone and strengthen abdominal muscles, as well as develop firmer abdomen.
Image: Allergan has secured FDA approval for CoolTone device. Photo: courtesy of PRNewsfoto / Allergan plc.
Part of the Allergan body contouring portfolio, CoolTone is also indicated for strengthening, toning and firming buttocks and thighs.
CoolTone technology will penetrate into the muscle layers using magnetic muscle stimulation (MMS) and induces involuntary muscle contractions.
The body is said to respond to these contractions by strengthening its muscle fibers, helping to improve muscle conditioning.
CoolSculpting is a non-surgical and clinically proven treatment, which selectively reduces unwanted fat using a patented cooling technology.
CoolSculpting will work by lightly cooling targeted fat cells in the body to induce a natural and controlled elimination of fat cells without affecting surrounding tissue.
The procedure secured FDA approval to treat visible fat bulges in the thigh, abdomen and flank, along with bra fat, back fat, underneath the buttocks, as well as upper arm in patients with a Body Mass Index (BMI) of ≤30 and in submental and submandibular areas in patients with a BMI of ≤46.2.
CoolSculpting treatment was also approved by the FDA to affect the appearance of lax tissue with submental area treatments
According to the firm, CoolTone should not be used in the head or heart area and is contraindicated in placing the active applicator over metal or electronic implants/devices in the treatment area like cardiac pacemakers, cochlear implants, intrathecal pumps, implanted defibrillators, implanted neurostimulators, drug pumps, and hearing aids.
The company is providing the treatment via network of CoolSculpting centres across the world.
Allergan body contouring general manager and R&D vice president Brad Hauser said: “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.
“We do this by developing differentiated technology, such as the CoolTone device, that helps meet the needs of our customers.”
Based in Dublin of Ireland, Allergan is a global pharmaceutical firm involved in the development, manufacturing and commercialisation of branded pharmaceutical, device, biologic, surgical and regenerative medicine products.