Thought you might be interested in this:Newly Enhanced PhotoDerm PL Receives Clearance From FDA to Treat Pigmented Lesio"
NEEDHAM, Mass., Oct. 24 /PRNewswire/ -- ESC Medical Systems Inc. (Nasdaq-NNM: ESCMF) announced yesterday that the US Food and Drug Administration (FDA) cleared its non-invasive pulsed light device, PhotoDerm(R) PL, for use in treating pigmented lesions, such as sun spots, age spots and birthmarks, as well as multicolored tattoos.
The newly enhanced PhotoDerm(R) uses the same technology as ESC's PhotoDerm(R) VL, which was cleared by the FDA in August 1995. PhotoDerm VL successfully eliminates benign vascular lesions, leg veins and facial spider veins.
PhotoDerm PL is an intense pulsed light source, similar to but not the same as a laser. The device rids healthy tissue of undesired pigmentation, which consists of a naturally occurring over-abundance of melanin, the dark pigment in the skin, usually caused by sunlight exposure, aging or congenital factors.
A key benefit of PhotoDerm PL is its ability to treat pigmented spots and multicolored tattoos with fewer adverse effects that other methods of treatment, such as traditional lasers, surgery or bleaching agents. Plus, clearance of the lesions can be achieved after as few as two treatments. Since the new procedure is non-invasive, there is no cutting, virtually no scarring, and minimal pain or discomfort to the patient. In fact, a major advantage of PhotoDerm PL lies in its nearly painless and rapid treatment, thus avoiding the need for anesthesia.
"The advent of PhotoDerm PL provides a safe and effective way to treat the broad range of epidermal pigmented lesions," says Mark Taylor, MD, a dermatologic surgeon in Salt Lake City, Utah, who tested the device in clinical trials. "Just about everyone has a few noticeable brown spots on their skin, many of which are unattractive and can cause embarrassment. With the introduction of PhotoDerm PL, we can remove or significantly lighten superficial pigmented lesions, leaving the treated skin looking younger and more natural in color and texture," Dr. Taylor notes.
PhotoDerm PL uses thermal energy generated by a broad spectrum of pulsed light waves which is absorbed by the pigment (e.g. melanin) in the lesions. The light pulses are short enough to selectively destroy the undesired pigment without damaging the surrounding healthy skin tissues.
The clinical success of PhotoDerm PL is largely attributed to its flexible treatment parameters, which can be adjusted to optimally fit the color and depth of the lesion with the natural skin pigmentation of the patient. This flexibility and versatility of a single unit allow the physician to achieve excellent clearance in most types of benign pigmented lesions, regardless of their size and location on the body. Further, multicolored amateur, professional and traumatic tattoos can be successfully treated with PhotoDerm PL.
PhotoDerm PL is manufactured by ESC Medical Systems Ltd. of Yokneam, Israel, and is available either as a stand-alone device or as an add-on to PhotoDerm VL which treats leg veins and other benign vascular lesions. Marketing and clinical support for the US market are provided by ESC Medical Systems Inc., a wholly owned subsidiary in Needham, MA. At present, there are more that 250 PhotoDerm systems installed in clinics worldwide.
The following have given expert commentary on PhotoDerm:
PhotoDerm PL Expert Commentary
"PhotoDerm PL treatment results have been uniformly excellent, rapid and pleasing for my patients who present with age spots on the back of the hands, face and chest. Of the many technologies I've utilized to treat my patients' brown pigmented spots, none have been more effective or more gentle."
-- Dr. Rick K. Wilson, a dermatologic surgeon in Plano, TX
"The PhotoDerm VL/PL light system is an excellent modality for treating vascular lesions on the face, trunk or legs, as well as pigmented lesions and multicolored tattoos. There has been minimal patient discomfort and good patient acceptance."
-- Dr. Janee D. Steinberg, a dermatologic surgeon in
Lauderdale Lakes, FL
"When compared with other lasers, PhotoDerm PL requires fewer treatment sessions to improve sun spots and age spots. The procedure is well tolerated by patients so anesthesia is not typically required. Since unsightly bruises are not usually seen after the procedure, my patients may resume normal activity immediately."
-- Dr. Agatha Parks, a dermatologist in Beverly Bills, CA
"I am excited about the extra options PhotoDerm PL affords me in treating my patients and the increased range of diseases I can now treat. I have seen some remarkable results with no significant side effects. Almost every patient has responded to some extent, and some patients have had phenomenal results, e.g., patients with tattoos, age spots and hyperpigmentation."
-- Dr. Robert Hashemiyoon, a phlebologist in Washington, DC
"PhotoDerm PL has opened up a whole new scope of possibilities for treating other benign pigmented skin lesions like age spots, sun spots, birthmarks and tattoos ... I have found the PhotoDerm PL to be an effective alternative to laser for removal of tattoos. The treatments are quick, relatively painless, with a low incidence of severe and permanent side effects."
-- Dr. Salvador Yunez, a phlebologist in Chicago, IL
SOURCE ESC Medical Systems Inc.
-0- 10/24/96
/NOTE TO EDITORS: For patient information on the treatment of brown spots, tattoos, birthmarks, leg veins and other vascular lesions, along with referrals to physicians by geographical location, please contact ESC Medical Systems' consumer hotline, 1-888-ESC-1001./
/CONTACT: Nadine Tosk, 504-483-6957, or Hillel Bachrach, 617-444-8446, for ESC Medical Systems/
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