GlidePath™ Long-Term Hemodialysis Catheters

* Bench data on file. May not necessarily correlate to clinical performance.

¹Tested using blood simulant composed of glycerin and water and a 5% saline solution at a max arterial pressure of -250 mmHg. N = 40 for each size tested. The Max Flow Rate ranges are shown in forward for 15 – 35 cm for 13F and 15 – 50 cm for 14.5F. Bench data on file. May not necessarily correlate to clinical performance. Different test methods may yield different results.

²Groups found to be statistically different using an Unstacked ANOVA with p-value less than 0.05 at 95% confidence (0.000 for all comparative groups). Calculation of 15% Higher Flow Rate based upon the average of the maximum flow rate values in forward and reverse. Data on file. May not be representative of actual clinical experience.

³Flow rates were recorded once the maximum allowable pressure (-250 mmHg) was achieved in the arterial lumen. -250 mmHg is the maximum allowable arterial pressure established for hemodialysis based upon the KDOQI standard (Clinical Practice Guidelines and Clinical Practice Recommendations - 2006 Updates).

⁴Tested using 23 cm tip to cuff straight catheters for both groups. Flow test performed using blood simulant as flow media for both groups.

⁵Groups found to be statistically different using an Unstacked ANOVA with p-value less than 0.05 at 95% confidence (0.000 for all comparative groups). Calculation of 16% lower pressures based upon the average of the mean arterial pressure values. Data on file. May not be representative of actual clinical experience.

⁶The flow rate through the catheter was maintained at the specified values (300 and 400 mL/min respectively) and the corresponding pressures were recorded.

⁷Groups found to be statistically different using an Unstacked ANOVA with p-value less than 0.05 at 95% confidence (0.000 for all comparative groups). Calculation of 16% lower pressures based upon the average of the mean arterial pressure values. Data on file. May not be representative of actual clinical experience.

⁸300 mL/min flow was kept consistent during this test. This is the minimum flow rate established for hemodialysis by the National Kidney Foundation (Clinical Practice Guidelines and Clinical Practice Recommendations - 2006 updates).  

⁹Represents catheter lumen wall and septum deflection when flowing at 400 ml/min and at max. allowable arterial pressure (when -250 mmHg is reached per KDOQI Standard). Fluid Structure Interaction Model was run using both catheter tubes as used in the straight catheter configuration. Data on file. May not be representative of actual clinical experience.

¹⁰Computational Fluid Dynamics Model was created for analyzing blood simulant recirculation at the catheter tip. Data on file. May not be representative of actual clinical experience.

¹¹Tested using 35 cm tip to cuff straight catheters (GlidePath™ n = 40). Recirculation test performed using a blood stimulant composed of glycerin and water and a 5% saline solution as the recirculation media delivered at a blood flow rate of ~ 12 L/min and catheter flow rate of 300 mL/min. Bench data on file. May not necessarily correlate to clinical performance. Different test methods may yield different results.

¹²Tested using catheter shafts from 23 cm tip to cuff straight catheters (GlidePath n = 20, Palindrome Precision n = 20).

¹³Groups found to be statistically different using an Unstacked ANOVA with p-value less than 0.05 at 95% confidence (0.000 for all comparative groups). Calculation based upon the ratios of average kink diameter values. Data on file. May not be representative of actual clinical experience.

¹⁴Tested using 23 cm tip to cuff straight catheters (GlidePath n = 40, Hemo-Cath = 5). Calculations based upon the ratios of average kink diameter values of 0.475 in for GlidePath 13F and 0.555 in for Medcomp Hemo-Cath™ LT. Bench data on file. May not necessarily correlate to clinical performance. Different test methods may yield different results.

BD-35475v3