• The rate of infection for the Codman B-EVD in comparison to the conventional EVD catheter (ventriculostomy-related infections) throughout the duration of the implanted EVD systems and for a 2-week period post-explant. [ Time Frame: End of trial ] [ Designated as safety issue: No ]
  

• The time to infection [ Time Frame: End of trial ] [ Designated as safety issue: No ]
  
• The class of bacteria [ Time Frame: End of trial ] [ Designated as safety issue: No ]
  
• The rate and extent of intraluminal bacterial colonization in EVD catheter systems [ Time Frame: End of trial ] [ Designated as safety issue: No ]
  
• Device related adverse events [ Time Frame: On-going ] [ Designated as safety issue: Yes ]
  
• Influence of number of days with indwelling catheter [ Time Frame: End of trial ] [ Designated as safety issue: No ]
  
• Subject age and diagnosis (reasons for catheter placement) on infection rates [ Time Frame: End of trial ] [ Designated as safety issue: No ]
  
• Procedural differences and techniques [ Time Frame: End of trial ] [ Designated as safety issue: No ]
  
• The influence of concurrent systemic antibiotics on infection rates [ Time Frame: End of trial ] [ Designated as safety issue: No ]
  
• Health economic inferences. [ Time Frame: End of trial ] [ Designated as safety issue: No ]
  

Device: Bactiseal TM EVD
Standard of care implantation of external ventricular drainage catheter

External ventricular drainage catheters are widely used in the management of Subjects with elevated intra-cranial pressure (ICP) secondary to acute hydrocephalus due to sub-arachnoid hemorrhage, intra-cerebral hemorrhage, intra-ventricular hemorrhage and other causes that obstruct the cerebrospinal fluid (CSF) circulation. However, this mode of treatment could be compromised by the increased risk of catheter related CSF infection.

B-EVD is manufactured using a patented process to impregnate silicone catheters with two antibiotics, rifampin and clindamycin. These antibiotics are impregnated throughout the silicone matrix. After implantation, slow release of both antibiotics at the extra- and intra-luminal catheter surfaces minimizes the likelihood of bacterial colonization. The B-EVD Catheter System has, to date, been well accepted by domestic and European customers. Currently there exists sound scientific rationale and promising bench-top in vitro data to anticipate low levels of ventriculostomy-related infection in Subjects using this system. Published BACTISEAL shunt data and direct feedback from U.S. market experience also support this notion. There are no published clinical studies reporting infection rates with the use of the B-EVD System, making all statements regarding its propensity to minimize clinical risk for catheter-related infection mere speculation and anecdotal. Therefore, Codman proposes to undertake a controlled clinical evaluation of this product to demonstrate its influence on EVD catheter-related infections, using a conventional EVD catheter as a standard of reference.

Immediately following successful screening, the Subject will be randomized to test or control group and will have the appropriate EVD system implanted. The Treatment Phase will cover the duration of the implanted EVD system.

Subjects will be monitored for 2 weeks post-explant.

This study is expected to enroll 600 evaluable implanted Subjects at up to 15 Investigational Sites in US, Europe and Asia-Pacific