Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

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.

Inclusion criteria

• Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
• Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves.
• Patient (legally designated representative) is willing to comply with the study protocol timelines & requirements.
• For patients who have had the Codman CERTAS Plus Programmable Valve implanted prior to study enrollment, have available data from implantation to the current time.

Exclusion criteria

• Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
• Patient's planned shunt has distal drainage to the heart.
• Patient has ventriculitis, peritonitis or meningitis.
• Patient has sepsis.
• Patient has a history of poor wound healing.
• Patient has symptoms pertaining to a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this study.
• Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant.
• Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
• Patient is currently enrolled in another drug or device trial or has been previously entered in this trial.
• Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
• Patients with known hypersensitivity to rifampin or clindamycin hydrochloride. This criterion applies for patients to be treated with the BACTISEAL Catheters (included in some models of the valve) only.