Abstract No. 588 A thromboresistant hydrogel material for vascular access

Abstract

The peripherally inserted central catheter (PICC) has become increasingly popular over recent years as an alternative for venous access over traditional central venous lines. However, PICCs are more than twice as likely to experience catheter-related thrombus leading to dysfunction, infection, loss of central venous flow, or upper extremity deep vein thrombosis. Access Vascular, Inc.’s HydroPICC™ device is constructed of a proprietary combination of biocompatible polymers to create a high-strength thromboresistant hydrogel. Quantification of the thromboresistance of the HydroPICC material was evaluated in this work using established in vitro and in vivo models. Thrombus accumulation and platelet adhesion were assessed by Thrombodyne, Inc., using an in vitro blood flow loop model against two competitors (Bard PowerPICC & Navilyst BioFlo). In vivo assessment of the HydroPICC device thrombogenicity was evaluated in an ovine jugular model. The HydroPICC and BioFlo devices were found to exhibit a statistically significant reduction of thrombus formation compared to PowerPICC based on a paired, two-sided t-test (p-values of 0.017 and 0.035, respectively). The HydroPICC device was also found to exhibit a statistically significant decrease in thrombus accumulation when compared to BioFlo (p-value of 0.033). Six of the seven HydroPICC devices implanted in the ovine jugular model exhibited a sheath extending no more than 10-15% of the total length of the catheter after 14- and 28-days in vivo. This sheath was observed to be non-adherent and slid off with minimal force during explantation. The main bodies of all the implanted HydroPICC devices showed no signs of thrombosis and were functional at term. On average, the HydroPICC device exhibited a 97% reduction in thrombus accumulation as compared to a conventional TPU catheter (PowerPICC), and a 64% reduction in thrombus accumulation as compared to a fluoro-oligomer modified TPU catheter (BioFlo) based on an in vitro blood loop model. HydroPICC devices implanted for 28-days in an ovine jugular model were found to exhibit no significant thrombus formation.