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AngioDynamics Receives FDA Clearance for DuraMax Dialysis Catheter With BioFlo Technology to Reduce
ALBANY, N.Y., March 7, 2014 (GLOBE NEWSWIRE) -- 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.
In the News (Homepage Include)
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Rev. December 16, 2009
A Global Reach, A Community Presence
During the last 25 years, AngioDynamics has grown to have a global reach, with facilities in three U.S. states, The Netherlands, Hong Kong, Germany and Great Britain. The company has its Corporate Headquarters in Albany, N.Y., U.S., and continues to have a major presence in Queensbury, N.Y., U.S., and Glens Falls, N.Y., where it designs, develops and manufactures many of its products. The manufacturing of AngioDynamics’ port systems, electrosurgical devices and needle sets occurs at its Manchester, Ga., U.S., facility, while cutting-edge research and development is performed in Marlborough, Mass., U.S. The company also has opened an International Headquarters in Amsterdam, The Netherlands, and sales offices in Hong Kong and Hamburg, Germany, as well as a facility in Denmead, U.K., focused on the manufacture of its microwave ablation systems.
|New York – Global Headquarters
14 Plaza Drive
Latham, N.Y. 12110 USA
+1 (518) 795-1400
Fax: +1 (518) 795-1401
Airport: Albany International Airport (ALB)
Holiday Inn Express & Suites Latham
400 Old Loudon Road
Latham, NY 12110
(Closest to the Global Headquarters.)
New York – Queensbury Manufacturing Facility
Airport: Albany International (ALB)
Hampton Inn & Suites
New York - Glens Falls Manufacturing Facility
Airport: Albany International (ALB)
25 Lake Avenue
Saratoga Springs, NY 12866
(Within walking distance to restaurants and night life; approximately 30 minutes from facility)
1119 Bullsboro Drive
Newnan, GA 30265
(Closest to restaurants; about 50 miles from facility)
Airport: Logan (BOS)
At AngioDynamics we are focusing on patient care every day, but we understand that undergoing a procedure is not an everyday occurrence for most patients. You probably have a lot of questions, and we hope that the materials on this page will help answer some of the most common questions about our products and your upcoming procedure. Additionally, we have listed links to the Web sites of several organizations below that you may find helpful during your journey. Please remember these are only tools, and that your physician is best suited to answer your questions.
|National Cancer Institute
|American Academy of Dermatology
|American Cancer Society
|American Academy of Family Physicians
|Society of Interventional Radiology
|Vascular Disease Foundation
|American College of Phlebology
|American Venous Forum
To provide benefits to patients by being the leader in design, development, manufacturing and marketing of innovative, proprietary, therapeutic devices used by interventionalists and surgeons for the minimally invasive treatment of peripheral vascular disease, tumor therapy and other, non-vascular disease.
AngioDynamics is deeply committed to improving patient care by ethically serving its customers, shareholders and employees. We value the importance of trust and honesty in all of the relationships that we build. AngioDynamics is dedicated to its pursuit of innovation and tenaciously strives for continuous improvement in every area.
AngioDynamics seeks to add significant value in every interaction with its customers by providing unsurpassed service and the highest quality, best performing products. To accomplish this, AngioDynamics is committed to its employees receiving the highest level of training, and to providing an environment that promotes continual employee growth. All AngioDynamics employees constantly endeavor to be the best and the brightest in the medical device industry.
AngioDynamics® history is best characterized by innovation and growth. Originally founded in Queensbury, N.Y., U.S., in 1988, AngioDynamics® has grown into a NASDAQ-listed public company with a global reach.
Queensbury was chosen due to its location in the heart of “Catheter Valley,” an area in New York’s Adirondack Region named for its long history of catheter and other medical device manufacturing. Today, the Company has made its presence apparent far beyond Upstate New York with 1,400 employees worldwide at facilities in the United States, Europe and Asia. AngioDynamics is currently selling in more than 50 markets through direct sales and distributors.
Initially dedicated to the research and development of products used in interventional radiology, AngioDynamics began shipping product in the early 1990s. The Company soon became well established as a producer of diagnostic catheters for non-coronary angiography and thrombolytic delivery systems. In May 2004 the Company became publicly traded on the NASDAQ stock exchange under the symbol ANGO.
Through acquisitions of companies such as RITA Medical Systems in January 2007, Oncobionic in May 2008, and the assets of Diomed in June 2008 and FlowMedica in January 2009, AngioDynamics now boasts a diverse product line that includes market-leading radiofrequency ablation and NanoKnife® systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products, venous products and targeted renal therapy products.
Continuing its expansion, AngioDynamics opened a new headquarters in Albany, N.Y., in March 2010. Most recently, in May 2012, AngioDynamics acquired Navilyst Medical, bringing market-leading fluid management systems into its portfolio. The acquisition significantly expanded the Company’s scale, doubling its share of the vascular access market while building critical mass in the peripheral vascular market. A comprehensive look at the Company’s history can be found in the form of an interactive timeline of events at www.angiodynamics.com.
|Please be advised, effective January 21st, 2014, AngioDynamics and Navilyst Medical will merge under one unified business information system. This will impact the way our customers order products. All products in the AngioDynamics portfolio will now have universal part numbers. To avoid business interruptions, please visit our resource materials, herein, for further information and updates required.|
14 Plaza Drive
Latham, NY 12110
Hours of Operation:
8 a.m. to 5 p.m. ET
Tel: +1 518-795-1400
Fax: +1 518-795-1401
U.S. Customer Service
Physician Clinical Product Questions
Hong Kong Office
|Investor Relations Contacts
EVC Group, Inc.
Tel: +1 646-445-4801
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