{orange:Overview}

This multicenter case series, peer-reviewed in Cureus, documents the first clinical experiences with the full ReFlow® Ventricular System across 5 leading US hospitals (4 pediatric and 1 adult). A total of 25 patients were implanted with the system and followed to assess safety, implant feasibility, and initial clinical outcomes.

The study represents the earliest real-world look at how the ReFlow System performs outside of a single-center setting, an important step in validating the device across diverse patient populations and surgical teams.

{orange:Key Findings}

Across all 25 patients and 5 hospitals:

• 25 patients successfully implanted with the ReFlow Ventricular System
• Implantation across 5 US hospitals (4 pediatric and 1 adult)
• 7 patients presented with symptoms of shunt malfunction:
  • 3 of 7 patients improved after flushing and avoiding additional invasive evaluation or operative revision
  • 3 of 7 patients had revisions unrelated to proximal obstruction (infection, distal catheter and disconnection)
  • 1 of 7 patients had proximal obstruction requiring revision

{orange:Clinical Implications}

In this initial multicenter case series, the ReFlow demonstrated clinical feasibility as a noninvasive means of retrograde flushing. These preliminary findings suggest ReFlow may help address proximal catheter obstruction, which is a major driver of shunt failure.