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Pristine™ Long-Term Hemodialysis Catheter

Designed to be Different from Day 1

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A New Generation of Hemodialysis Catheters

Meet the Pristine™ Long-Term Hemodialysis Catheter, BD's next generation of hemodialysis catheters. It is a side-hole free hemodialysis catheter with a unique Y-Tip™ distal lumen design.

  • Side-hole free tip is designed to help minimize thrombus adhesion that can be associated with side-hole catheters and to help facilitate blood clot aspiration prior to hemodialysis treatment.
  • The Pristine™ Catheter demonstrated high flow rates at low pressures1 and with its symmetric tip demonstrated low recirculation rates in both forward and reverse2.
  • The catheter is uniquely designed to help facilitate accurate Y-Tip™ distal lumen placement in the mid right atrium. The notched tip is designed to help resist positional occlusion.
  • In a prospective, single-center, non-randomized, open-label feasibility study performed in the Dominican Republic, 45 patients who received the 15.5F Pristine™ Long-Term Hemodialysis Catheter were followed for 6 months post-catheter implantation. All catheters were patent at 30 days post implantation. Primary patency at 60- and 180-days post procedure was 100% and 91%, respectively. This was a prospective analysis without prespecified, hypothesis-tested endpoints. Data are descriptive only. The study was conducted on subjects with End Stage Renal Disease or Acute Renal Failure outside of the United States where clinical practices may differ and results may or may not be representative of patients in the United States3.
  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.