July 3, 2007, Mountain View, CA--Reliant Technologies announced that its Fraxel re:pair laser system received U.S. Food and Drug Administration (FDA) clearance for ablation, coagulation, and skin resurfacing based on ongoing results from two rounds of clinical trials.
The Fractional Deep Dermal Ablation (FDDA) treatment leads to tissue contraction, tightening, and collagen remodeling without the prolonged downtime and adverse reactions associated with conventional ablative resurfacing lasers (CO2 or erbium YAG lasers) and surgical procedures.
The Fraxel re:pair laser combines benefits of conventional CO2 resurfacing with the safety of fractional photothermolysis. As with Reliant's other product offerings, the Fraxel re:pair system treats a portion of the skin's surface and leaves the surrounding areas intact to allow for rapid healing. With FDDA treatment, the skin is ablated and coagulated in deep (up to 1.6 mm) columns called Microscopic Treatment Zones (MTZs). The Fraxel re:pair laser's high speed optics allow these MTZs to be spaced across the skin's surface to provide even, thorough tissue tightening for effective resurfacing.
The recent FDA clearance was based on a comprehensive, multi-site clinical trial of FDDA treatment. The study is underway at 10 sites throughout the U.S. and is comprised of 3 phases for a total enrollment of more than 200 enrolled subjects. The first round of trials demonstrated that more than 75 percent of patients experienced improved appearance as reported by Dr. Rahman at the annual meeting of the American Society of Lasers in Surgery & Medicine in April.
For more information, visit www.reliant-tech.com.