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Long-Term Reduction in {orange:Proximal Shunt Revisions}

A 9-patient case series peer-reviewed in {orange:Pediatric Neurosurgery} demonstrating a dramatic reduction in {orange:proximal shunt failures} following ReFlow implantation.

{orange:Overview}

In a case series peer-reviewed in Pediatric Neurosurgery, researchers followed 9 pediatric hydrocephalus patients who had experienced 14 proximal shunt failures in the two years prior to ReFlow implantation. Each patient received the ReFlow® Mini Flusher and began regular flushing as part of their shunt maintenance.

Follow-up was conducted over a 2–4 year period post-implantation, with the primary endpoint being the number of proximal shunt failures requiring revision surgery.

{orange:Key Findings}

Across all 9 patients over the 2–4 year follow-up period:

  • 14 proximal failures occurred in the two years before ReFlow implantation
  • Only 1 proximal failure occurred in the 2–4 years following ReFlow implantation
  • Caregiver compliance with the maintenance flushing protocol averaged 94% at two years, demonstrating real-world feasibility of the protocol outside clinical settings.
  • Represents a substantial reduction in revision-requiring events within this cohort
  • No device-related adverse events reported during the follow-up window

{orange:Clinical Implications}

For a pediatric population where shunt failure within the first year can reach 40–50%, these early results suggest that routine, noninvasive flushing may meaningfully shift the trajectory of long-term shunt management.

While these findings are from a small cohort and further study is warranted, they support the hypothesis that proactive maintenance, rather than reactive revision, may improve outcomes for children living with hydrocephalus.

Vinzani et al. Pediatr Neurosurg 2023;58:136–141

Read the paper
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Frequently Asked Questions

Common questions about ReFlow® technology, our clinical evidence, and the condition it's designed to treat.

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What is hydrocephalus?
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How does the ReFlow® Mini Flusher work?
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Is the device FDA cleared?
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Who performs the flushing — a clinician or the patient?
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How often should the Mini Flusher be used?
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Are there clinical studies supporting ReFlow?
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Is ReFlow suitable for pediatric patients?
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Does ReFlow implantation take longer than a standard shunt surgery?
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Where is the ReFlow Mini Flusher currently available?
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Who do I contact to learn more?