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Pristine™ Long-Term Hemodialysis Catheter

Designed to be Different from Day 1

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  1. Tested using 19 cm (n=38); 23 cm (n=40); 28 cm (n=38); 33 cm (n=40) and 55 cm (n=39) tip-to-cuff length Pristine™ Long-Term Hemodialysis Catheters. Flow test performed using glycerin: water solution with a viscosity of 3.2-3.7 cP at 36-38° C. At an arterial maximum pressure of -250 mmHg or less, the maximum flow rates observed were 500 mL/min (19 cm through 33 cm tip-to-cuff lengths) and 379 mL/min (55 cm tip-to-cuff length). In order to show the the flow rate at -250 mmHg pressure limit, the linear curve fit for the negative side was used to find the flow rate corresponding to indicated pressure, then the flow rate value was used to estimate the positive venous pressure. Bench data on file. Bench data may not necessarily correlate to clinical performance. Different test methods may yield different results.
  2. Tested using 55 cm tip-to-cuff length Pristine™ Long-Term Hemodialysis Catheters (n=37). Recirculation test performed using 5% saline as blood simulant at a blood flow rate of ~5 liters/minute and catheter flow rate of 350 mL/min. The mean recirculation rates were 2.7% in forward flow and 2.8% in reverse flow. Bench data on file, Becton, Dickinson and Company, Tempe, AZ. Bench data may not necessarily correlate to clinical performance. Different test methods may yield different results.
  3. Primary endpoint defined as primary patency at 30 days following catheter insertion. Primary patency defined as a catheter which provides adequate hemodialysis (flow >300 mL/min) without need for additional interventions to maintain flow or correct device failures. Data on File, Becton, Dickinson and Company, Tempe, AZ.

Please consult product labels and instructions for use for indications, contraindications, hazards, warnings and precautions.

BD-32537

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