Healthcare Industry News: vascular access
News Release - March 11, 2014
AngioDynamics Receives Expanded FDA Clearance for AngioVacALBANY, N.Y., March 11, 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) cleared an expanded indication for its AngioVac cannula for venous drainage during extracorporeal bypass for up to six hours to include removal of fresh, soft thrombi or emboli.
"Since its introduction to our portfolio in October 2012, the AngioVac cannula and circuit has shown strong market acceptance across the U.S. due to its ability to improve patient outcomes and reduce the cost of treatment," said John Soto, Executive Vice President and Chief Commercial Officer. "The expanded FDA clearance, which includes the removal of fresh, soft thrombi or emboli during extracorporeal bypass, makes this a more powerful tool for physicians in the U.S., where an estimated 1 million people are affected by venous thromboembolic disease (VTE)."
The AngioVac cannula and circuit, when combined with other manufacturers' filters, pumps and return cannula, comprise an extracorporeal bypass circuit that facilitates drainage, filtration and reinfusion of blood for up to six hours. The AngioVac Cannula has a proprietary balloon-actuated, expandable, funnel-shaped distal tip to enhance flow, prevent clogging of the cannula and facilitate en bloc removal of undesirable intravascular material such as fresh, soft thrombi or emboli.
Venous thromboembolic events are a leading cause of morbidity and mortality, and the annual number of VTE-related deaths has been estimated at more than 300,000 across the U.S. Pharmacomechanical therapies and catheter-directed thrombolysis offer many benefits over the current standard of care, anticoagulant therapy; however, these treatments can cause major bleeding complications and a significant number of patients have contraindications. Removal of undesirable intravascular material may provide an effective alternative, minimizing the potential risks and comorbidities associated with these treatments.
"Products like AngioVac represent our commitment to pioneering new technologies that not only provide a clinical benefit to our customers, but also economic value," said Joseph M. DeVivo, AngioDynamics' President and CEO. "This expanded indication allows us to grow awareness of the significant morbidity and mortality associated with VTE and the role AngioVac can play in meeting the significant need it presents."
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 AngioVac are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary.
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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