This post-market follow-up registry will capture clinical data specific to the safety and performance of the Integra External Ventricular Drainage Systems and Accessories.
The purpose of this study is to investigate whether the Integra External Ventricular Drainage System listed as part of this study do perform to clinical expectations. Additionally, this study will focus on the safety of these devices by collecting any device-specific Adverse Events (AEs) or Device deficiencies (DDs) seen when used during standard of care procedures.
Study Type
OBSERVATIONAL
Enrollment
120
EVD of Cerebral Spinal Fluid from the lateral ventricles of the brain
Ziekenhuis Oost-limburg
Genk, Belgium
University Hospitals leuven
Leuven, Belgium
AZ Delta
Roeselare, Belgium
Hôpital Gui de Chauliac
Montpellier, France
Anticipated Drainage of Cerebrospinal Fluid (CSF)
Percentage of subjects with anticipated drainage (i.e., observed drainage consistent with the patient's clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System is no longer required.
Time frame: 1 month following device implantation
Success of the Access to the Intracranial Space
Percentage of subjects in whom the CODMAN Cranial Access Kit, when used with appropriate accessories, provided successful access to the intracranial space.
Time frame: 1 month following device implantation
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