UltraShape announces the commencement of its Investigational Device Exemption (IDE) study to evaluate Contour Plus, the first noninvasive device for fat reduction and body contouring using nonthermal selective focused ultrasound.
Contour Plus is based on the Contour I platform, which is available outside of the US and has been shown in pre-clinical and clinical studies to target and selectively break down fat cells, leaving surrounding critical structures such as skin, blood vessels, nerves, and connective tissue intact.
"This is a groundbreaking study for the aesthetics field," says Jeffery M. Kenkel, MD, FACS, lead investigator and vice chairman and professor of plastic surgery at the University of Texas Southwestern Medical Center, and chairman of the UltraShape Medical Advisory Board. “The Contour Plus has the potential to be the first system to create a durable, measurable fat thickness reduction. I believe the UltraShape study will demonstrate the ability of Contour Plus to selectively target and break down fat cells through nonthermal, acoustic effects.”
The UltraShape Contour Plus IDE study builds upon positive clinical studies conducted with Contour I, including two peer-reviewed published studies. The first study, a multi-center worldwide study, was published in Plastic and Reconstructive Surgery. The study demonstrated measurable and durable body circumference and fat thickness reduction after a single UltraShape treatment.
The second study was an independent clinical trial showing the efficacy of multiple treatments with the UltraShape Contour I, published in Lasers in Surgery and Medicine. The study, using Contour I as a noninvasive method for reducing unwanted fat deposits, produced a 100% response rate with a mean reduction in fat thickness of 2.28 cm, as much as 3.94 cm, and a mean reduction in circumference of 3.95 cm, as much as 10 cm. The study demonstrated definitive, measurable results of the UltraShape system.
The study will enroll patients at six centers in the United States. The primary endpoint will be an objective, quantifiable fat reduction assessment. UltraShape intends to submit the pivotal study results to the FDA in a premarket approval submission.
[Business Wire, June 12, 2008]