AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced the enrollment of the first patient at University of Miami Hospital in a randomized multi-center study investigating whether the BioFlo PICC will be associated with a reduced incidence of catheter-related venous thrombosis, including both symptomatic and asymptomatic, compared to another commercially available PICC, the Bard PowerPICC SOLO2.
BioFlo PICCs are manufactured with Endexo technology, a permanent and non-eluting integral polymer blended into the catheter shaft's polymer for long-term durability. The study, "PICC Related Obstruction of Flow" (PROOF), will enroll 354 patients at a maximum of five sites, including University of Miami Hospital, NorthShore University HealthSystem of Chicago and Ottawa Hospital Research Institute, Canada. 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.
"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," Dr. David Hahn, Chief in the Section of Interventional Radiology at NorthShore University HealthSystem and lead investigator said. "I look forward to examining the BioFlo PICC and submitting data for peer review, along with reviewing other researcher's findings."
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 substantially equivalent thromboresistant characteristics as a heparin coated vascular access catheter.*
"BioFlo PICCs show promise in decreasing the accumulation of catheter-related thrombus without incorporation of antibiotics or antimicrobials, agents potentially associated with bacterial resistance, or any other transient materials typically associated with coated or impregnated technologies," said Chuck Greiner, Sr. Vice President of AngioDynamics' Vascular Access Business. "At AngioDynamics, we share our customers' commitment to patient safety and comfort. PROOF not only reflects our mission to provide the best products available, but proven clinical and economic data that illustrates their value."
*Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.