Cynosure’s SculpSure Snags Expanded Indication
Cynosure’s SculpSure lipolysis laser treatment has won an expanded FDA indication, the Westford, Mass., devicemaker said Tuesday.
The product can be used to eliminate fat in the abdomen. SculpSure was previously cleared in May for lipolysis of the flanks.
The device works by disrupting subcutaneous fat cells without the need for surgery, with procedure time taking about 25 minutes for an individual area, the company says.
In a multicenter clinical trial, 90 percent of patients reported satisfaction with their treatment, the devicemaker claims. Overall, patients demonstrated a significant reduction in fat layer thickness during six- and 12-week follow-ups.
The World Health Organization estimates that 1.3 billion adults are overweight. — Jason Scott