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Date Announced: 02 Feb 2011
Cellulaze Receives CE Mark Certification; Product Set for Q2 European Introduction.
WESTFORD, Mass., Feb. 2, 2011 /PRNewswire/ -- Building on the success of its Smartlipo™ technology for laser lipolysis, Cynosure, Inc. (Nasdaq:CYNO - News) today introduced the Cellulaze™ Cellulite Laser Workstation, the world's first minimally invasive surgical device designed to reduce cellulite by restoring the normal structure of the skin and underlying connective tissue. Cellulaze has recently received CE Mark certification and will be available in the European Union in the second quarter of 2011. Cynosure (Booth #2921) will exhibit Cellulaze at the American Academy of Dermatology's 69th Annual Meeting Feb. 4-8 in New Orleans.
An estimated 85 percent of women over age 20 are affected by cellulite(1), a degenerative and largely untreated condition in which dimply herniations and depressions develop within the layers of the skin.
"Cellulaze is supported by two years of clinical research that has led to the development of a revolutionary approach that has been shown to reduce cellulite for 12 months or longer, with a high level of patient satisfaction," said Cynosure President and Chief Executive Officer Michael Davin. "Unlike the non-invasive treatment approaches that aim to temporarily treat the appearance of cellulite, Cellulaze uses a three-dimensional approach to directly target the subdermal structure that forms the foundation of cellulite."
Cellulite is caused by several physiological changes as women age including: 1) an increase in the number or size of fat cells pushing up through the tissue beneath the skin; 2) thin connective tissue under the skin that becomes stretched or distended as a result of aging or weight gain; and 3) undulations caused by hardening of tissue underneath the skin.
In the Cellulaze procedure, which is performed under a local anesthetic, the physician inserts a small cannula -- a narrow tube the size of the tip of a pen -- under the skin. Cynosure's proprietary SideLight 3D™ side-firing technology directs controlled, laser thermal energy to the treatment zones -- typically the buttocks and thighs. The laser is designed to diminish the lumpy pockets of fat, release the areas of skin depression and increase the elasticity and thickness of the skin. Patients require just one treatment.
Patients in one U.S. study demonstrated an average increase in skin thickness of 23 percent and 27 percent at one month and one year, respectively, while skin elasticity increased an average of 32.5 percent at one month and 21 percent at one year.
"The cases we have performed with Cellulaze to date demonstrate a benefit from the use of subcutaneous laser energy in terms of tissue tightening through tissue coagulation as well as the regeneration of collagen and connective tissue," said Dr. Gerhard Sattler, M.D., Cosmetic Surgeon and Director of the Rosenpark Klinik in Darmstadt, Germany.
As with Cynosure's minimally invasive Smartlipo MPX and Triplex workstations, Cellulaze incorporates the company's proprietary ThermaGuide™ intelligent energy delivery system. ThermaGuide is designed to provide the physician with the ability to accurately determine the treatment doses that are likely to provide safer and more effective tissue tightening through tissue coagulation. In addition, the temperature-sensing ThermaGuide technology allows the physician to maintain an even, controlled flow of laser energy.
With CE Mark certification, Cellulaze will be available for sale to physicians in the European Union in the second quarter of 2011. Cellulaze will be marketed and sold through Cynosure's European direct sales force in France, Germany, Spain, and the United Kingdom, and through international distributors in other EU countries.
Cellulaze is not available in the United States. The U.S. Food and Drug Administration (FDA) has determined that clearance of Cellulaze in the United States requires a 510(k) submission, which the company has filed in late 2010. The FDA has approved an Investigational Device Exemption ("IDE") for Cellulaze, and nearly 100 patients have been treated as part of a clinical IDE study. Regulatory action on the 510(k) submission is currently expected in the first half of 2011.
Source: Cynosure
E-mail: TBaker@cynosure.com
Web Site: www.cynosure.com
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