AngioDynamics Announces 510-K- Clearance of ELVS Endovascular Laser Venous System for Treatment of Varicose Veins.Business Editors/Health/Medical Writers QUEENSBURY, N.Y.--(BUSINESS WIRE)--Nov. 6, 2002 AngioDynamics, Inc., a wholly-owned subsidiary of E-Z-EM, Inc., (AMEX AMEX See: American Stock Exchange : EZM) announced today that the Company received 510(k) clearance for the ELVS ELVS E-Learning in the Voluntary Sector ELVS Electro-Magnetic Log Voltage Simulator (TM) endovascular laser venous system as a treatment for varicose veins Varicose Veins Definition Varicose veins are dilated, tortuous, elongated superficial veins that are usually seen in the legs. Description . Clearance was for the Precision 980nm diode laser and disposable treatment kits for the specific indication of endovascular occlusion of leg veins procedure. In conjunction with today's announcement, the Company officially began its full market release of the ELVS system in the United States. The ELVS system is a patient friendly, minimally invasive alternative for the treatment of varicose veins, a frequently painful condition that according to the American College of Dermatology affects an estimated 80 million people in the United States alone. Current treatment options for varicose veins include surgical ligation ligation /li·ga·tion/ (li-ga´shun) the application of a ligature. tubal ligation sterilization of the female by constricting, severing, or crushing the uterine tubes. and vein stripping vein stripping Surgery The surgical removal of a varicose vein of the leg by ligating it–eg, the great saphenous vein and its tributaries at the junction with the common femoral vein in the groin, then yanking it, which pops off the collaterals, 'stripping' , invasive procedures that require an overnight hospital stay. The ELVS treatment is performed on an outpatient basis under local anesthetic local anesthetic n. An agent that, when applied directly to mucous membranes or when injected about the nerves, produces loss of sensation by inhibiting nerve excitation or conduction. . Doctors thread a tiny laser fiber into the saphenous vein saphenous vein n. Either of two main superficial veins of the leg, one larger than the other, that begin at the foot. Saphenous vein A long vein in the thigh or calf commonly used for bypass grafts. to seal it and thereby correct the cause of varicose veins. The entire therapy takes less than an hour to perform and the results are often visible immediately. Patients who undergo the ELVS treatment usually experience a rapid recovery time with no scarring, and generally can return to their normal activities upon leaving the doctor's office. To support the launch of ELVS, the Company is also introducing a comprehensive marketing program designed to support physicians offering the ELVS procedure in their practice. Referred to as "Business in a Box", the program provides physicians with turn-key practice development models and patient education materials. The Company is also implementing a direct-to-patient marketing program, and will devote a special section of the AngioDynamics website where interested patients can learn more about the ELVS treatment and locate participating physicians in their area. Commenting on the announcement, Eamonn P. Hobbs, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of AngioDynamics, said, "Approximately one in five people in the United States experience painful and unattractive varicose veins. While traditional removal methods such as surgical ligation and stripping are effective, they are lengthy procedures requiring overnight hospitalization and carry potential risk of infection. The ELVS system represents an important new alternative to these more invasive procedures that is also affordable, less time consuming, and yet just as effective." For more information on the ELVS system, please contact David Doster at 1-800-772-6446, ext. 126, Email: ddoster@angiodynamics.com, or visit the AngioDynamics web site at www.angiodynamics.com. About E-Z-EM E-Z-EM, Inc. (www.ezem.com) is a leading supplier of products used by radiologists, gastroenterologists and speech language pathologists for the diagnostic imaging of diseases and disorders of the GI tract, ranging from swallowing disorders (dysphagia dysphagia /dys·pha·gia/ (-fa´jah) difficulty in swallowing. dys·pha·gia or dys·pha·gy n. Difficulty in swallowing or inability to swallow. ) to colorectal cancers. E-Z-EM also is a third-party contract manufacturer of diagnostic contrast media, pharmaceuticals, non-prescription healthcare products, and defense decontaminants. About AngioDynamics AngioDynamics, Inc. (www.angiodynamics.com) is a leading supplier of products used by interventional radiologists and other physicians for the minimally invasive diagnosis and therapeutic treatment of peripheral vascular disease Peripheral Vascular Disease Definition Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms. . The statements made in this document contain certain forward-looking statements that involve a number of risks and uncertainties. Words such as "expects", "intends", "anticipates", "plans", "believes", "seeks", "estimates," or variations of such words and similar expressions, are intended to identify such forward-looking statements. Investors are cautioned that actual events or results may differ from the Company's expectations. In addition to the matters described above, the ability of the Company to develop its products, future actions by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. or other regulatory agencies, results of pending or future clinical trials, overall economic conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from Group Purchasing Organizations, competition, including alternative procedures which continue to replace traditional fluoroscopic Fluoroscopic (fluoroscopy) An x-ray procedure that produces immediate images and motion on a screen. The images look like those seen at airport baggage security stations. Mentioned in: Hypotonic Duodenography procedures, as well as the risk factors listed from time to time in the SEC filings of E-Z-EM, Inc., including but not limited to its Form 10-Q for the quarter ended August 31, 2002, as well as its Annual Report on Form 10-K for the year ended June 1, 2002, may affect the actual results achieved by the Company. |
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