Ash Access Technology, Inc. and Commercial Partner AngioDynamics Highlight Results From Preliminary Study of Centros(TM)
Published: Jan 25, 2008
LAFAYETTE, IN--(MARKET WIRE)--Jan 25, 2008 -- Ash Access Technology, Inc., a privately held specialty pharmaceutical and medical device company focused on innovations to improve vascular access outcomes, in partnership with AngioDynamics highlighted the results from a United States preliminary study of Centros(TM), a self-centering, tunneled hemodialysis access catheter. Dr. Ash, who designed Centros(TM), is renowned as the inventor of the original split tip dialysis catheter. He is the 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(TM) dialysis catheter.
"Centros(TM) 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(TM) could have long-term advantages for patients."
The preliminary study confirmed that the self-centering designed 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 right atrium. Flow rates for Centros(TM) at the seven week follow-up point was 401mL/min, compared to a control group of competitive catheters at 348mL/min. (p < 0.05). Nine end-stage renal disease (ESRD) patients participated in the trial at 4 study sites. Catheters were placed under local anesthesia, fluoroscopy and ultrasound guidance and tips were in the lower third of the SVC. Patients immediately used the catheter for outpatient dialysis, three times per week. One of the nine self-centering catheters was removed due to a presumed exit infection, and one was removed when it was no longer needed.
"We believe Centros(TM) is an innovative design as compared to today's hemodialysis catheters and the preliminary trial data demonstrates the success of the self-centering curved tip design," said Bob Truitt, President and CEO of Ash Access Technology, Inc. "We feel this combination of the Centros(TM) unique design and now validated clinical results has the potential to enhance patient outcomes for those requiring a catheter for dialysis."
About Ash Access Technology, Inc.
Ash Access Technology, Inc. (AshAccess.com) is a privately held specialty pharmaceutical / medical device company focused on the development and commercialization of proprietary products and devices to improve vascular access outcomes. The Company's diverse product portfolio includes innovative hemodialysis and peritoneal dialysis catheters and a unique antimicrobial / antithrombotic solution, Zuragen®, being developed for the prevention and treatment of catheter related bloodstream infection (CRBSI). Ash Access Technology is located in Lafayette, Indiana in the INOK Business Center.
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 other risk factors may affect the actual results achieved by the Company.
Source: Ash Access Technology, Inc.