AngioDynamics Announces FDA 510k Clearance of SpeedLyser Infusion Catheter
QUEENSBURY, N.Y.--(BUSINESS WIRE)--Feb. 6, 2004--AngioDynamics, Inc., a wholly owned subsidiary of E-Z-EM, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance for the Company to market the SpeedLyser infusion catheter -- the first infusion catheter exclusively designed for dissolving thrombus from a blocked dialysis access site. AngioDynamics expects to begin marketing the product to the dialysis market in the first quarter of 2004 calendar year.
Unlike catheters constructed with side holes, the SpeedLyser infusion catheter has pressure responsive orifices, which help evenly distribute the thrombolytic agent to the blockage. This new product also features a coaxial system, consisting of a 3F inner and a 5F outer catheter, which provides a combination of fast access and even drug delivery across the entire thrombosed graft. This innovative design allows a physician to treat stenosis immediately after dissolving the thrombus by providing access for angioplasty through the 5F catheter -- an advantage that helps to minimize overall treatment time and patient discomfort. The SpeedLyser catheter will be offered in infusion lengths of 10, 15, and 20cm, giving the physician greater flexibility in treating blockages of varying sizes and locations.
Commenting on the announcement, Robert M. Rossell, Vice President of Marketing for AngioDynamics, said, "We estimate that the number of dialysis procedures is growing 15% annually, so physicians are in need of a faster and more precise way to maintain dialysis access grafts. The SpeedLyser infusion catheter addresses these requirements in the innovative way physicians have come to expect from AngioDynamics. It complements our well-recognized portfolio of thrombolytic drug delivery systems, and further establishes AngioDynamics as a leading provider of peripheral vascular care products."
For additional information on the SpeedLyser Infusion catheter, please contact Kevin Ostrander at 1-800-772-6446, ext. 145, Email: kostrander@angiodynamics.com or visit the AngioDynamics web site at www.angiodynamics.com.
About AngioDynamics
AngioDynamics, Inc. (www.angiodynamics.com) manufactures a wide range of products, including angiographic, dialysis, PTA dilation, thrombolytic, image-guided vascular access, endovascular laser venous system, as well as abdominal infection drainage products. AngioDynamics' focus is on therapeutic products that enable interventional physicians to treat peripheral vascular diseases and other non-coronary diseases.
About E-Z-EM, Inc.
E-Z-EM is the world's largest manufacturer of contrast agents for gastrointestinal radiology. The Company has developed the only CT injector on the market that can help detect contrast extravasation, the EmpowerCT® with patented EDA technology; it also offers a complete product set for the virtual colonoscopy practitioner. This product line consists of virtual colonoscopy hardware, software, nutritional prep kits and bowel cleaners, tagging agents and a carbon dioxide colon insufflation system. E-Z-EM's wholly owned subsidiary, AngioDynamics, manufactures a wide range of products including angiographic, dialysis, PTA dilation, thrombolytic, image-guided vascular access, endovascular laser venous system, as well as abdominal infection drainage products. AngioDynamics' focus is on therapeutic products that enable interventional physicians to treat peripheral vascular diseases and other non-coronary diseases.
The statements made in this document contain certain forward-looking statements that involve a number of risks and uncertainties. Words such as "expects," "intends," "anticipates," "plans," "believes," "seeks," "estimates," or variations of such words and similar expressions, are intended to identify such forward-looking statements. Investors are cautioned that actual events or results may differ from the Company's expectations. In addition to the matters described above, the ability of the Company to develop its products, market acceptance of the SpeedLyser Infusion Catheter, market acceptance of virtual colonoscopy as a new imaging procedure, the impact, if any, of the Pickhardt study published in the New England Journal of Medicine, market acceptance and sales of Tagitol V, the size and quantity of orders for RSDL, successful completion of the Company's Manufacture, Streamlining and Reduction program, future actions by the FDA or other regulatory agencies, results of pending or future clinical trials, overall economic conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from Group Purchasing Organizations, competition, including alternative procedures which continue to replace traditional fluoroscopic procedures, as well as the risk factors listed from time to time in the SEC filings of E-Z-EM, Inc., including but not limited to its Form 10-Q for the quarter ended November 29, 2003, as well as its Annual Report on Form 10-K for the year ended May 31, 2003, may affect the actual results achieved by the Company.
Contact:
AngioDynamics, Inc.
Kevin Ostrander, 518-798-1215, Ext. 145
www.angiodynamics.com
or
E-Z-EM, Inc.
Tom Johnson, 800-544-4624 x3317
www.ezem.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com