German regulatory endorsement, European "CE" mark granted to wide range of Candela products
WAYLAND, Mass.--(BUSINESS WIRE)--March 5, 1997- Candela Corp announced today that the German government has cleared a wide range of its
cosmetic, medical laser products. The endorsements include the "CE" mark, a designation necessary for the use of the devices by physicians throughout the European Community (EC).
Among the newly cleared products for Europe are Candela's ScleroLASER(TM), the ScleroPLUS(TM), and the elongated spot handpiece for use with the SPTL-1b laser. The elongated spot handpiece, which recently received a US patent, is used with the SPTL-1b Vascular Lesion Laser to enable physicians more precisely to treat linear lesions, such as leg veins, stretch marks and facial spider veins. It also reduces temporary discoloration by avoiding unnecessary laser
exposure to surrounding, uninvolved tissue. The SPTL-1b received German clearance in November 1995.
The CE mark for the ScleroLASER and ScleroPLUS permits the use of these lasers in all EC member countries, including Belgium, France, Italy, Greece, The Netherlands, Portugal, Spain, the United Kingdom, Sweden, Denmark, Austria and Germany.
Commenting on the development, Gerard E. Puorro, president and CEO, stated, "As with U.S. Food and Drug Administration clearance, which these devices already have, they must meet very stringent safety, performance and efficacy requirements to get the CE mark. European phlebologists and other physicians can now use our proven technologies to treat patients more effectively when they have problems associated with leg veins and various other vascular lesions."
The ScleroLASER is used for the treatment of leg telangiectasia (leg veins) and the ScleroPLUS is an advanced laser system that combines the capabilities of the ScleroLASER and the SPTL-1b to provide the widest array of wavelengths available today for the treatment of conditions such as port wine stains, stretch marks, scars, warts and other vascular abnormalities.
Candela also announced that it has received clearance of the company's entire line of dermatology products from the Russian Ministry of Health. Russian clearance includes the previously mentioned SPTL-1b Vascular Lesion Laser, ScleroLASER and ScleroPLUS, as well as the ALEXLAZR(TM), YAGLAZR(TM), and PLTL Pigmented Lesion/TATULAZR(TM), advanced laser systems for treating pigmented lesions and unwanted tattoos of multiple colors. All of these products are FDA cleared for use in the United States
"The growing international acceptance of Candela's products," Mr. Puorro added, "enables us to expand our penetration of huge key markets in Europe and Japan. Developments such as these should prove to be beneficial to physicians and their patients and for our businesses around the world."
Candela Corporation develops, manufactures, and distributes innovative clinical solutions that enable physicians, surgeons and personal care practitioners to treat selected cosmetic and medical problems using lasers, cryosurgery and other proven technologies. In addition, the company is applying its capabilities and experience with skin care and related problems to develop a network of company-owned skin care centers and spas. Founded near Boston in 1970 as Candela Laser
Corporation, Candela markets and services its products in over 40 countries from offices in the United States, Europe and the Far East.
This press release includes certain forward-looking statements. Any such statements are subject to risks that could cause the actual results to vary materially, including negative developments relating to unforeseen order cancellations or push-outs, Candela's strategic relationships, the impact of intense competition, and changes in the laser industry.
CONTACT: Jane Smith
Candela Corporation
508-358-7400, x247
or
Stuart Pearlman,
Stuart Pearlman & Co., Inc.
212-370-4940 |
