AngioDynamics, a provider of medical devices used for the treatment of peripheral vascular disease, has revealed positive results from its U.S. preliminary study of Centros, a self-centering, tunneled hemodialysis access catheter.
The study indicated that the self-centering catheter provides an 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, according to Stephen R. Ash, MD, FACP.
Ash presented the study on Jan. 23 at the International Symposium for Endovascular Therapy (ISET) in Hollywood, Fla., last week.
At four U.S. sites, Ash directed the study of nine end stage renal disease patients, who were identified as needing a tunneled catheter for dialysis and an open right internal jugular vein. The 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, the company reported.
The patients used the catheter for outpatient dialysis, three times per week. For a seven-week follow-up, 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, Ash reported.
Ash said that the 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.
“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,” Ash said.