AngioDynamics (ANGO) Win FDA Nod For DuraMax Dialysis Catheter
3/7/2014 7:09:04 AM
AngioDynamics Receives FDA Clearance for DuraMax Dialysis Catheter With BioFlo Technology to Reduce Catheter-Related Thrombus
ALBANY, N.Y., March 7, 2014 -- AngioDynamics (Nasdaq: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 granted 510(k) clearance for its BioFlo DuraMax chronic hemodialysis catheter.
This marks the third U.S. clearance of a BioFlo product line in the Company's Vascular Access business. Indicated for use in attaining long-term vascular access for hemodialysis and apheresis, AngioDynamics expects a commercial launch in the fourth quarter of fiscal year 2014.
"BioFlo continues to be an exceptional platform for our vascular access products," said Joseph DeVivo, AngioDynamics' President and CEO. "With the addition of dialysis, our broad offering of vascular access products featuring advanced thromboresistant technology gives us a unique position in the marketplace."
Thrombotic occlusions can occur within 24 hours and are prevalent in up to 40 percent of chronic dialysis patients.1 The BioFlo DuraMax chronic hemodialysis catheter is the first dialysis catheter with Endexo technology, creating a catheter material more resistant to the accumulations of blood components compared to non-coated conventional catheters. In vitro blood loop model test results show the catheter had 90% less thrombus accumulation on its surface on average compared to non-coated conventional catheters based on platelet count2 and 83% less thrombus accumulation on its surface compared to a heparin coated dialysis catheter.3 In addition, results of an in-vivo sheep study with 31-day indwell time, demonstrated comparable thromboresistance characteristics to a heparin coated dialysis catheter.
"AngioDynamics currently has a 15 percent share of the approximately $100 million U.S. chronic dialysis catheter market," said Chuck Greiner, Senior Vice President of the Global Vascular Access Franchise. "Similar to the PICC and Port markets, we see growing interest in thromboresistance among nephrologists and dialysis centers due to the significant mortality rates DVT and PE present to this patient population. With the BioFlo DuraMax dialysis catheter, we strengthen our position by offering customers a premium technology at a price that can help them meet a significant, everyday need."
1 Whitman ED: Complications associated with the use of central venous access devices. Curr Probl Surg 33: 319-378, 1996
2 The reduction in thrombus accumulation (based on platelet count) is supported by acute in-vitro testing. Pre-clinical in-vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.
3 Based on benchtop testing performed up to two hours using bovine blood which may not be indicative of clinical results. Data on file.
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, BioFlo and DuraMax are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary. Endexo is a trademark of Interface Biologics.
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.
Mark Frost, CFO
(800) 772-6446 x1981
Investor Relations Contacts:
EVC Group, Inc.
Michael Polyviou/Robert Jones
(212) 850-6020; (646) 201-5447
EVC Group, Inc.
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