BURLINGTON, MA--The United States Food and Drug Administration (FDA) has cleared the Lux1540 Fractional non-ablative laser handpiece for use in the treatment of striae (stretch marks).
According to Palomar Medical Technologies, ongoing clinical studies have shown that subjects treated with its Lux1540 achieved an average improvement of between 51% and 75% in the appearance of their striae, based upon a blinded review of photographs comparing the pre-treatment appearance of striae versus the results three months post-treatment.
Striae pretreatment (left) and post treatment (right).
Francesca de Angelis, MD, a leading plastic surgeon from Naples, Italy who has led the research effort, noted, "Through our ongoing clinical study, and with thousands of satisfied patients treated throughout Italy, we have found that the Lux1540 is the first laser treatment for stretch marks that truly works." "Our experience with the Palomar Lux1540 is consistent with the results seen in Europe," noted Vic Narurkar, MD, a dermatologist in San Francisco, CA, and past president of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "For the right patient, the Lux1540 provides a laser treatment option for stretch marks that offers significant improvement. The non-ablative fractional laser allows for comfortable treatments with little to no impact on the patient's daily activities."
This new clearance expands the broad range of treatments offered by the Lux1540, which may be used to treat surgical scars, acne scars, and melasma, as well as offer non-ablative skin resurfacing. In support of this new clearance, Palomar in conjunction with Body1.com has released a consumer education site, Stretchmarks1.com, to help consumers understand more about treatment options and locate providers of Palomar's Lux1540 technology for stretch marks.
The Lux1540 Fractional non-ablative laser handpiece is available for use with Palomar's flagship StarLux® 500 laser and pulsed light platform. The StarLux 500 allows practitioners to attach a variety of application-specific handpieces to one base unit that easily expands as their practice grows.