AngioDynamics Begins PROOF Study of the BioFlo PICC

October 3, 2013—AngioDynamics, Inc. (Latham, NY) announced the commencement of the randomized, multicenter PROOF study, which is investigating whether the company's BioFlo peripherally inserted central catheter (PICC) will be associated with a reduced incidence of symptomatic and asymptomatic catheter-related venous thrombosis compared to another commercially available device, the Bard PowerPICC Solo2 (Bard Access Systems, Inc., Salt Lake City, UT).

According to the company, the PROOF (PICC Related Obstruction Of Flow) study will enroll 354 patients at a maximum of five sites, including University of Miami Hospital, NorthShore University Health System of Chicago, and Ottawa Hospital Research Institute, Canada. The trial's first patient was enrolled at University of Miami Hospital in Miami, Florida.

The primary objective is to investigate the incidence of catheter-related venous thrombosis, with a secondary objective to investigate the incidence of catheter-related complications. In addition, detailed medical resource utilization data will be captured to allow for cost comparisons between the treatment groups, demonstrating the likely savings to medical facilities associated with the observed reduction in thrombosis and other relevant catheter-related complications.

PROOF lead investigator David Hahn, MD, Chief in the Section of Interventional Radiology at NorthShore University Health System, commented in the company's press release, “Finding a solution to the risks and high cost of catheter-related thrombosis has made the long-term effectiveness of a catheter a top concern for healthcare providers. I look forward to examining the BioFlo PICC and submitting data for peer review, along with reviewing other researchers' findings.”

The company advised that in vitro blood loop model test results show the BioFlo PICC has 87% less thrombus accumulation on its surface on average compared to commonly used PICCs based on platelet count. In addition, side-by-side in vivo test results demonstrate thromboresistant characteristics substantially equivalent to a heparin-coated vascular access catheter.

AngioDynamic's BioFlo PICCs are manufactured with Endexo technology (Interface Biologics, Inc., Toronto, Canada), which is a permanent and noneluting integral polymer blended into the catheter shaft's polymer for long-term durability, stated the company.