U.S. and World News
:
Medical
:
Devices and Research
News
Alma Lasers(TM) Receives FDA Clearance for the Accent(TM) Dual Mode RF System
Mon, 30 Apr 2007, 15:44:00 EDT
BUFFALO GROVE, Ill. - Apr. 30 (SEND2PRESS NEWSWIRE) -- Alma Lasers a global leader in laser, light-based, and radio frequency (RF) technologies used in aesthetic medicine announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the Accent(TM) Dual Mode RF System in the United States.
 Receiving its first FDA indication for the treatment of wrinkles and rhytids, the Accent System has been used successfully by medical professionals worldwide to treat a variety of dermatological and aesthetic conditions.
"We're delighted to receive the marketing clearance for the Accent product in the U.S.," stated Howard Kelly, CEO for Alma Lasers. "The unique dual mode RF modalities of the Accent system will provide physicians with the most advanced technology available in non-invasive aesthetic medicine, creating a higher standard in patient satisfaction. The Company is committed to pursuing additional clearances from the FDA, in order to expand the clinical indications for the Accent system in the United States."
Non-invasive, non-ablative, and virtually pain free, the Accent system combines two radio frequency modes into one device. Each mode is delivered by a discrete handpiece to enable volumetric RF thermotherapy at different tissue depths within the body.
In the BiPolar mode, RF energy penetrates the skin superficially, facilitating the treatment of areas where skin is thinner and more delicate such as areas of the face where the skin rests directly over the bone. The Alma proprietary UniPolar? mode, delivers RF energy deep into the dermal and sub-dermal layers to efficiently treat large volumes of tissue. Unlike other RF based technologies, the Accent system does not require consumables. Therefore, treatments are clean, efficient and economical.
Ziv Karni PhD President and founder of Alma Lasers stated; "The Accent product was engineered for safety and ease of use while maximizing efficacy. The continuous movement of either handpiece results in a gradual build-up of heat to achieve the optimal therapeutic effect, while offering greater patient comfort. With over one thousand Accent systems installed world wide, the product has enjoyed an unparalleled safety record."
"Non-invasive treatments are the largest and fastest growing category in aesthetic medicine," said Yariv Matzliach, Executive Vice President of Global Marketing for Alma Lasers. "The Accent system has been approved for use in Europe, Asia, Australia, Latin America and Canada, where dermatologists, plastic surgeons, OB/GYN's and general practitioners have achieved outstanding results and a consistently high level of patient satisfaction. Now with its first FDA cleared indications, the Accent system is poised to provide medical professionals and their patients in the United States with a new level of safety, efficacy and satisfaction in the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar RF technologies."
According to one Principal Investigator in the FDA study, Macrene Alexiades-Armenakas, MD, PHD, Assistant Clinical Professor, Yale University School of Medicine, and Director, Dermatology and Laser Surgery in New York City, "I found the Accent system to be superior to prior generations of RF technology in the treatment of skin laxity, particularly on the neck. It is also a remarkable breakthrough that the system is painless and requires no anesthesia. Accent treatments can be performed rapidly with no downtime and can be applied concurrently with other non-ablative modalities, such as injectables to achieve better results in what is termed the 'non-surgical facelift.' Immediate skin tightening is evident and the results are often considered striking."
"We have found the Accent system to be very safe and relatively comfortable with a high percentage of responders," states David H. McDaniel, MD, Assistant Professor of Clinical Dermatology and Plastic Surgery, Eastern Virginia Medical School, and Director of the Institute of Anti-Aging Research Center of Virginia in Virginia Beach. "Compared to other RF devices we have used, treatment with the Accent system is much less painful, faster and easier to perform. It also allows more 'artistic' use on the face. Although responses vary, a high percentage of treated subjects showed a visible response. Some observe an immediate skin tightening of the face. Many of the subjects noticed a difference in the way their clothes fit after a few treatment sessions. It can also be used as part of a broader spectrum of non-surgical facial rejuvenation treatments or procedures which might include fractional resurfacing, IPL or LED photomodulation, and Botox? or other injectable fillers."
Maurice Sherman, MD, Associate Professor of Clinical Surgery, University of California - San Diego, and the owner of the Del Mar Cosmetic Medical Center in southern California, said "We obtained remarkably good results with the Accent system. It was consistent for all of the patients that followed the protocol. All of them showed an improvement. Some dramatic, some moderate, but every patient expressed satisfaction with the results. Everyone said that their skin felt tighter the day after the first treatment." Added Dr. Sherman, "Of all the RF systems on the market today, I feel the Accent is the most effective technology out there."
About Alma Lasers
With over 1000 Accent installations worldwide, Alma Lasers is a global developer, manufacturer and marketer of laser, light-based, and radio frequency devices for aesthetic applications. Since 1980, the founders of Alma Lasers have been at the forefront of innovative technologies for use in aesthetic medicine. Technical expertise combined with a thorough understanding of practitioners' needs led to the development of Alma Lasers' multi-technology / multi-application systems.
The Company's mission is to provide modular, cost-effective and high performance systems that enable medical practitioners to confidently offer safe, effective, and profitable aesthetic treatments.
More information about Alma Lasers can be found at www.almalasers.com.
NEWS SOURCE: Alma Lasers
Send2Press® is the originating wire service for this story.
» Read More Devices and Research News
» Other Send2Press Industry News by Category
More Information and Media Contact:
For questions about this story, contact the news source:
»
Click Here for Contact Information
THE CONTENT OF THE ABOVE NEWS STORY WAS PROVIDED BY THE NEWS SOURCE WHO IS SOLELY RESPONSIBLE FOR ITS ACCURACY. FOR QUESTIONS ABOUT THIS STORY CONTACT THE NEWS SOURCE AND NOT SEND2PRESS (THIS WEBSITE).
O T H E R R E S O U R C E S
T E R M S O F U S E
This article is Copr. © 1983-2008 Neotrope / Send2Press. Reproduction of this news article version requires written authorization. You may freely link to this article. Journalists (see the section "Journalist Resources" above) may use orig. news release as the basis for an article.
News Websites may republish the "news release" text version linked to above under "Journalist Resources" except must retain "Send2Press Newswire" as the source of this news if used verbatim. Websites which offer/sell PR or newswire services, or web promotion services, or "splogs" may NOT reprint our content in ANY form. Send2Press Newswire is a service mark of, and "Send2Press" is a registered trademark of, Neotrope. Creative Commons - Some Rights Reserved (3.0) - Attribution Required.
DISCLAIMER: the above article is believed accurate but not guaranteed, and is based on business news supplied by the source (Alma Lasers). The noted source is solely responsible for its accuracy. Financial/Stock news may contain forward looking statements. Neotrope/Send2Press makes no claims of accuracy or suitability for any purpose. Any opinions expressed by representatives of company(s) mentioned in news and profiles are solely those of the person indicated, and do not reflect any opinion or policy of Neotrope or Send2Press. Your use of any information contained herein is done solely at your own risk, and you are fully responsible for using any information herein, or on sites mentioned or linked to in the article. All trademarks acknowledged.
REFERENCES: Alma Lasers(TM) Receives FDA Clearance for the Accent(TM) Dual Mode RF System, Alma Lasers, laser, light-based, and radio frequency devices for aesthetic applications, technologies for use in aesthetic medicine, BiPolar mode, RF energy penetrates the skin superficially, Howard Kelly, Accent system, Accent Dual Mode RF, FDA approval, Apr 30, 2007.
VIEWED BY MEDIA (and public): 3358 times (1 today, 1 this week,
30 this month, 1252 this year)
|
|
|
Subscribe in a reader
PLAIN TEXT FORMAT (UTF-8)
PDF FORMAT
