Healthcare Industry News: vascular access
News Release - October 29, 2013
AngioDynamics Achieves CE Approval for AngioVacCE Mark Covers Venous Drainage Cannula and Cardiopulmonary Bypass Circuit; Cannula Indicated for Removal of Fresh, Soft Thrombi or Emboli
ALBANY, N.Y., Oct. 29, 2013 -- (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 EU CE Mark approval for its AngioVac venous drainage cannula and cardiopulmonary bypass circuit for use during extracorporeal bypass for up to six hours. Under the CE Mark approval the AngioVac cannula is also approved for removal of fresh, soft thrombi or emboli.
"The AngioVac cannula and circuit have shown great promise in improving patient outcomes and reducing the cost of treatment when dealing with the removal of soft thrombus," said John Soto, Senior Vice President of AngioDynamics' Global Peripheral Vascular Franchise. "CE Mark approval makes this powerful tool available to physicians across the EU."
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.
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 500,000 across the European Union.1 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. The en bloc removal of undesirable intravascular material may provide an effective alternative, minimizing the potential risks and comorbidities associated with these treatments.
"We recently exhibited the AngioVac cannula and circuit at the congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), and the reception was very encouraging," said Stephen McGill, Senior Vice President and General Manager of AngioDynamics' International Business. "AngioDynamics has established itself as a leader and innovator in delivering minimally-invasive, image-guided solutions to interventional radiologists, vascular surgeons, cardiologists and surgical oncologists, and the AngioVac devices continue that tradition."
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, Vortex Medical 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.
In the United States, the AngioVac venous drainage cannula and cardiopulmonary bypass circuit are FDA-cleared for use during extracorporeal bypass for up to six hours. Vortex Medical Inc., a wholly owned subsidiary of AngioDynamics, intends to file a 510(k) with the FDA for expanded indications to align with its EU approval regarding removal of fresh, soft thrombi or emboli.
1 1. Cohen AT, Agnelli G, Anderson FA et al. Venous thromboembolism (VTE) in Europe. Thromb Haemost 2007; 98:756-64
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