Healthcare Industry News: vascular access
News Release - June 18, 2014
AngioDynamics Announces FDA Clearance for Celerity Tip Location SystemALBANY, N.Y., June 18, 2014 -- (Healthcare Sales & Marketing Network) -- AngioDynamics (ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Celerity tip location system.
The Celerity System has been cleared by the FDA as an adjunct to aid in positioning Peripherally Inserted Central Catheters (PICCs) in adults by providing real time catheter tip location utilizing the patient's cardiac electrical activity. The Company expects to begin U.S. distribution in early July. In March, AngioDynamics announced an agreement to acquire regulatory control over the Celerity platform from the Company's business partner, Medcomp, and its development partner, after the FDA rejected Medcomp's initial 510(k) application.
"We committed ourselves to establishing a clear regulatory pathway to bring Celerity to the U.S. market by mid-summer and this first 510(k) Clearance places us squarely on that timeline," said Joseph M. DeVivo, AngioDynamics' President and Chief Executive Officer. "Not only does this clearance highlight the expertise of our regulatory affairs team, it is the first step in a long-term strategy that includes bringing next generation devices with navigation capabilities to market."
"Celerity's FDA clearance marks a milestone in the development of AngioDynamics' vascular access Business," added Chuck Greiner, Senior Vice President of AngioDynamics' vascular access Business. "The Celerity tip location system, coupled with our thromboresistant BioFlo PICCs, positions us to provide an unparalleled product offering to our customers. At a time when our innovative BioFlo platform has already led the business to returned growth, Celerity is poised to strengthen those gains."
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, fluid management 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.
AngioDynamics, the AngioDynamics logo and BioFlo are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary. Medcomp and Celerity are trademarks and/or registered trademarks of Medical Components Inc.
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, including Navilyst Medical and its products, R&D capabilities, infrastructure and employees 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, 2013. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
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