Reliant Technologies Receives FDA Clearance For Fraxel re:pair Laser System
Mountain View, CA - Reliant Technologies, Inc. recently announced its Fraxel re:pair laser system has received FDA clearance for ablation, coagulation and skin resurfacing, based on ongoing results from two rounds of clinical trials. The Fraxel re:pair system provides the Fractional Deep Dermal Ablation (FDDA) treatment, which leads to tissue contraction, tightening and collagen remodeling. The Fraxel re:pair laser removes and eliminates aged and damaged skin without the prolonged downtime and adverse reactions associated with conventional ablative resurfacing lasers (also known as 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:store and Fraxel re:fine lasers, 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 (MTZ). The Fraxel re:pair laser's high speed optics allow these MTZ to be spaced across the skin's surface to provide even, thorough tissue tightening for effective resurfacing.
FDDA treatment is safe to treat even delicate areas such as the neck and chest due to its tissue sparing design. In contrast, conventional bulk ablative laser skin resurfacing ablates 100 percent of the epidermis and therefore is too aggressive to treat the neck and chest, which often leaves patients with an undesirable line of demarcation and can lead to hypopigmentation.
"Fraxel re:pair treatment provides dramatic results that patients and clinicians want without the considerable risks and recovery time that come with traditional CO2 lasers and surgical procedures," said Zakia Rahman, M.D., clinical instructor of dermatology at Stanford University in Palo Alto, CA, and medical director of the Fraxel Laser Clinic. "For patients who have spent years in the sun or smoking and wish to have tighter, smoother, and more even skin tone, the Fraxel re:pair laser provides a safe and effective resurfacing solution."
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 of rhytids,(a) vascular dyschromia(a) and pigmentation,(a) as well as skin laxity(a), as reported by Dr. Rahman at the annual meeting of the American Society of Lasers in Surgery & Medicine in April. Rounds two and three of the trial are evaluating the effectiveness of the Fraxel re:pair laser in treating atrophic scars, including acne scars(a); traumatic and surgical scars, and striae (stretch marks).
"In my 20 years of using lasers, I have not seen an ablative technology safely capable of targeting striae, laxity, severe photodamage and surgical scars off the face, which may all be possible with the new Fraxel re:pair system," said Suzanne Kilmer, M.D., director of the Skin Surgery Center of Northern California in Sacramento, CA. "The Fraxel re:pair laser fills a major niche in my treatment armentarium to safely resurface all regions of the body. I look forward to publishing the results of my study in the near future."
"The Fraxel family of lasers is the most advanced system on the market today for safe, precise and effective skin restoration and repair," said Len DeBenedictis, chief technology officer of Reliant Technologies. "The Fraxel product line gives physicians the tools they need to treat the full range of aesthetic patients, from those seeking deep tightening and thorough resurfacing to those looking for a gentle, topical treatment to maintain their skin's healthy tone and texture."
About the Fraxel Systems
The Fraxel family of products, which includes the Fraxel re:store laser system (formerly called the Fraxel SR 1500 laser), the Fraxel re:pair laser system and the Fraxel re:fine laser system, has quickly become the industry standard for fractional aesthetic skin treatment. Unlike traditional laser devices, Fraxel brand fractional laser systems treat only a fraction of skin at a time, leaving the surrounding area intact for fast healing. Fraxel lasers have received multiple FDA clearances and have been found safe and effective in treating all areas of the face and body. The versatility of the product line ensures that patients can choose the best treatment for various stages in their lives as their skin care needs evolve.
The prototype Fraxel re:pair laser has been proven in clinical studies to improve severe photodamage(a), including rhytids(a), skin laxity(a) and vascular lesions(a). The product, employing Fractional Deep Dermal Ablation (FDDA treatment), was introduced to plastic and dermatologic surgeons in April, 2007.
The Fraxel re:store laser, delivering Non-ablative Fractional Resurfacing (NFR) treatment, was introduced in 2004 and has been adopted by more than 1,200 dermatologists, plastic surgeons and aesthetic physicians worldwide. It is the accepted gold standard for treating acne scars and periorbital wrinkles, and for skin resurfacing procedures on the face, neck, chest and hands.
The Fraxel re:fine laser, offering superficial non-invasive skin rejuvenation, combines the unique method of fractional delivery with a lighter treatment. Performed in 20-25 minutes, Fraxel re:fine treatment is excellent for medical spas and family physicians seeking a safe and gentle option.
About Reliant Technologies
Reliant Technologies develops clinical solutions to repair and rejuvenate aging and environmentally damaged skin. Reliant is dedicated to providing the most advanced research, engineering and products to the global aesthetic marketplace. The company pioneered the development of fractional laser resurfacing that relies on novel high-speed scanning systems and the Intelligent Optical Tracking(R) system to produce safe and effective results with minimal recovery time. Reliant is based in Mountain View, Calif.
(a)pending FDA 510(k) clearance
SOURCE: Reliant Technologies