When compared to conventional blood tubing, Streamline® reduced dialysate flow
`and conserved fresh water while improving average Kt/V.1
`
`Streamline Bloodlines Improve Kt/V While Lowering Dialysate Usage
`Renal Advantage, Inc.
`
`Smith, P. – In this cross-over study of 117 patients at Renal Advantage, Inc., Streamline improved average Kt/V while reducing dialysate
`and fresh water usage as compared to conventional bloodlines.
`
`With Streamline, average blood flow
`rates increased by 19 mL/min (p<0.001)
`
`With Streamline, average Kt/V increased by 0.09
`
`Streamline Conventional
`1.73
`1.64
`
`Change
`+5%
`
`P-value
`<0.001
`
`Avg. Kt/V
`
`This study reported a 5% improvement in average Kt/V. 100% of patients
`achieved Kt/V ≥ 1.2 vs. 96% with conventional bloodlines.
`
`With Streamline, monthly fresh water consumption
`decreased by 27,000 liters per month*
`
`404,000
`
`377,000
`
`■ Streamline
`
`■ Conventional
`
`420,000
`
`410,000
`
`400,000
`
`390,000
`
`380,000
`
`370,000
`
`360,000
`
`350,000
`
`Monthly Fresh Water Usage (L)
`
` Monthly fresh water reduced by 7% after reducing dialysate flow rates
`with Streamline.
`
`* Calculated reduction based on RO Recovery Rate = 50%; 12 treatments
`per patient per month, 117 patients, 45x Proportioning Ratio (1:44)
`
`459
`
`440
`
`■ Streamline
`
`■ Conventional
`
`475
`
`450
`
`425
`
`400
`
`BFR (mL/min)
`
`When compared to conventional bloodlines higher
`blood flow rates were achievable with Streamline
`due to significantly lower arterial pressure readings.
`This study recorded a 4% increase in average blood
`flow rates with Streamline, which increased average
`blood liters processed by 5% (p<0.001).
`
`With Streamline, dialysate flow rates
`decreased by 44 mL/min (p<0.001)
`
`669
`
`625
`
`■ Streamline
`
`■ Conventional
`
`700
`
`650
`
`600
`
`DFR (mL/min)
`
`Dialysate flow rates decreased by 7% with
`Streamline as compared to conventional bloodlines.
`
`Clinical Evidence
`
`NxSTAGE Ex 2007-1
`Nipro v NxStage
`IPR2016-00744
`
`

`
`Implications of Improved Blood Flow Rates
`
`The study reported a reduction in dialysate usage and fresh water consumption while improving average Kt/V as a result
`of the higher bloodflow rates enabled by Streamline. By increasing bloodflow rates by an average of 19 mL/min, dialysate
`flow rates were reduced by an average of 44 mL/min, the provider conserved an average of 27,000 L of fresh water per
`month, and all patients achieved a Kt/V greater than or equal to 1.2.
`
`Study Design: 3-month, cross-over study evaluation of 117 patients (51% male, mean age of 59, mean weight of 75 kg) to determine
`the clinical and operational impact of Streamline blood tubing. Outcomes and measurements include average blood flow rate, average
`arterial pressure, average blood liters processed, average Kt/V, average dialysate flow rate, fresh water usage assumed, and average
`treatment time.
`
`Study Limitations: This was a cross-over study. Limitations of cross-over studies may include confounding due to issues of order,
`carry-over and learning.
`
`Important Information: The Streamline blood tubing sets are prescription devices and, like all medical devices, involve some risks.
`Failure to observe all warnings and precautions noted in the Streamline Instructions for Use may result in serious complications, including
`blood loss due to clotting or air entering the bloodstream. Each patient’s care plan should be determined by the physician, based on the
`individual facts and circumstances of the patient. The use of anticoagulation is at the discretion of the prescribing physician.
`
`References:
`1. Smith P. Streamline bloodlines improve Kt/V while lowering dialysate usage. Poster presented at National Kidney Foundation
`Conference, 2010.
`
`350 Merrimack St. • Lawrence, MA 01843 USA • www.medisystems.com • 1.800.369.MEDI
`
`© 2015 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. System One is a trademark of NxStage Medical, Inc.
`CAUTION: Federal law restricts this device to sale by or on the order of a physician. APM1709 Rev. A
`
`NxSTAGE Ex 2007-2
`Nipro v NxStage
`IPR2016-00744