Healthcare Industry News: HSMN NewsFeed
News Release - February 14, 2012
AngioDynamics Receives FDA Clearance for NeverTouch Direct(TM) Procedure Kit to be Used With the VenaCure EVLT(R) SystemNeverTouch Direct Kit Allows Physicians to Treat Varicose Veins With Fewer Procedure Steps
ALBANY, N.Y., Feb. 14, 2012 -- (Healthcare Sales & Marketing Network) -- AngioDynamics (Nasdaq:ANGO ), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the U.S. Food and Drug Administration has granted 510(k) clearance for its NeverTouch Direct(TM) Procedure Kit for use with the Company's VenaCure EVLT(R) Laser Vein Ablation System. The NeverTouch Direct kit offers physicians the ability to treat varicose veins with fewer procedure steps -- by eliminating the need for a long guide wire or guiding sheath -- while continuing to deliver to patients less pain and bruising compared to bare-tip fibers.
"NeverTouch Direct and the sheathless fiber option further expands the physician's ability to tailor treatment to each individual patient, and avoid one-size-fits-all approaches that limit the physician's ability to exercise their clinical judgment," said Alan Panzer, Senior Vice President and General Manager for AngioDynamics. "Taken together with the advantages delivered by our new VenaCure(R) 1470 laser, and the new NeverTouch(R) 90cm fiber, AngioDynamics remains the clear choice for clinicians who demand tools that take advantage of their full range of skill and experience."
The NeverTouch Direct kit, expected to launch in summer 2012, is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease and oncology. AngioDynamics' diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at www.AngioDynamics.com.
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics' expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as "expects," "reaffirms," "intends," "anticipates," "plans," "believes," "seeks," "estimates," "optimistic," or variations of such words and similar expressions, are forward-looking statements. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from AngioDynamics' expectations. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to integrate purchased businesses, as well as the risk factors listed from time to time in AngioDynamics' SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2011, and AngioDynamics' Form 10-Q for the quarterly period ended November 30, 2011. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
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