AngioDynamics (NASDAQ:ANGO), a leading provider of innovative medical devices used by interventional radiologists, nephrologists, and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease, today highlighted results from a United States preliminary study of Centros™, a self-centering, tunneled hemodialysis access catheter.
This preliminary study indicates that the self-centering catheter provides highly acceptable flow rates at modest negative pressure without deterioration in flow rate over seven weeks of use, even with tips positioned in the superior vena cava (SVC) rather than within the atrium. Flow rate for Centros at the seven week follow-up point was 401mL/min, compared to the control group of competitive catheters at 348mL/min. (p < 0.05).
Stephen R. Ash, MD, FACP, presented the study on January 23 at the International Symposium for Endovascular Therapy (ISET) in Hollywood, Florida. Dr. Ash, who designed Centros, is renowned as the inventor of the original split tip dialysis catheter. He is Adjunct Associate Professor at Purdue University in West Lafayette, Indiana and Clinical Associate at Indiana University Medical Center in Indianapolis. He is also Chairman and Director of R&D of Lafayette, Indiana-based Ash Access Technology, Inc., from which AngioDynamics acquired exclusive worldwide rights to manufacture and market the Centros dialysis catheter.
“Centros changes the conventional catheter paradigm from a line to a plane, meaning the catheter fits into a cylinder in the middle of the vein and won’t lie in contact against the vein wall like prevalent dual-lumen tunneled dialysis catheters,” said Dr. Ash. “Contact with the vein wall often results in sheathing or clots, which can easily obstruct the ports. While a large clinical study will more fully document the benefits of this new design approach, the preliminary study gives us confidence that Centros will have long-term advantages for patients.”
“We believe Centros is a distinct improvement over standard catheters, and this preliminary study demonstrates its successful self-centering curved design,” said Eamonn Hobbs, President and CEO of AngioDynamics. “Clinicians at ISET have welcomed the new approach with enthusiasm, and we look forward to our first shipments beginning on schedule shortly after the conference.”
Dr. Ash directed the study of nine End Stage Renal Disease (ESRD) patients at four sites in the U.S. who were identified as having a need for tunneled catheters for dialysis and an open right internal jugular vein. Catheters were placed under local anesthesia, fluoroscopy and ultrasound guidance using a 16 French split sheath, and tips were in the lower third of the SVC, as opposed to the atrium. Patients immediately used the catheter for outpatient dialysis, three times per week. For the next seven weeks, blood flow rate was measured at a modest negative pressure of the arterial line, and complications and reasons for catheter removal were recorded. One of the nine self-centering catheters was removed due to presumed exit infection, and one was removed when it was no longer needed.
About AngioDynamics
AngioDynamics, Inc. is a leading provider of innovative medical devices used by interventional radiologists, surgeons, and other physicians for the minimally invasive treatment of cancer and peripheral vascular disease. The Company's diverse product line includes market-leading radiofrequency ablation systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products. More information is available at www.angiodynamics.com.
Safe Harbor
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, 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 and competition, as well as the risk factors listed from time to time in the SEC filings of AngioDynamics, Inc., including but not limited to its Annual Report on Form 10-K for the year ended June 2, 2007, may affect the actual results achieved by the Company.
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