Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus. The valve can be set to 8 different performance settings for intraventricular pressure and drainage of CSF. The performance setting of the valve can be set preoperatively and can also be noninvasively changed post-implantation. This clinical investigation will maintain data for each patient from the date of implant through 3 years post-implantation. Data collection for each patient will occur per standard of care. However, the clinical investigation specifically aims to collect and analyze data from the day of procedure, and post-operatively at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months. Data from follow-up visits will be analyzed according to pre-defined time-intervals referring to these follow-up moments.
Study Type
OBSERVATIONAL
Enrollment
158
Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
University Hospital Leuven
Leuven, Belgium
RECRUITINGAZ Delta - Roeselare
Roeselare, Belgium
RECRUITINGKlinikum Dortmund Wirbelsäulenchirurgie
Dortmund, Germany
Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment
Device Success is defined as: 1. Deployment with the correct valve positioning 2. Original intended device in place, and 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure.
Time frame: 30 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
Düsseldorf, Germany
RECRUITINGUniversitätsklinikum Essen
Essen, Germany
RECRUITINGFreiburg University Hospital
Freiburg im Breisgau, Germany
RECRUITINGKatharinenhospital - Neurochirurgische Klinik Stuttgart
Stuttgart, Germany
RECRUITINGHospital12 de Octubre
Madrid, Spain
RECRUITINGCanton Hospital St. Gallen
Sankt Gallen, Switzerland
RECRUITING