Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
brief summary
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
detailed description
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.
official title
Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve