Heart and Blood Diseases

All Conditions

Nervous System Diseases

Neoplasms

Rare Diseases

Hypertension

Stroke

Intracranial Hypertension

Pseudotumor Cerebri

Hydrocephalus

Hydrocephalus, Normal Pressure

Brain Neoplasms

Hemorrhagic Stroke

Vascular Diseases

Brain Diseases

Central Nervous System Diseases

Cerebrovascular Disorders

Idiopathic Intracranial Hypertension

CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.

Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.

CODMAN CERTAS Plus Programmable Valve

Maria Salmon-Sargeant

Andrew Tummon

Dimitri Vanhauwaert, MD

Stijn Van Damme, SC

Dr. Oliver Müller

Thomas Beez, MD

Fljamur Aljiji, SC

Dr. Philipp Dammann

Dr. Mukesch Johannes Shah

Dr. Oliver Gandslandt

Sherese Fralin, MSN, FNP, PhD

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.

Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve

Incidence of Valve replacement post - implantation

Incidence of Adverse Events post - implantation

Long term safety will be assessed by the incidence of all adverse events/complications including number of subjects with shunt and/or shunt system infections.

Incidence of inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves post - implantation prior to MRI

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.

Integra LifeSciences Corporation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve	NCT05397106	Hydrocephalus Hydrocephalus i... NPH (Normal Pre... IIH - Idiopathi... Brain Tumor Post-Traumatic ... Hemorrhagic Str...	CODMAN CERTAS P...	-	Integra LifeSciences Corporation
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve	NCT05397106	Hydrocephalus Hydrocephalus i... NPH (Normal Pre... IIH - Idiopathi... Brain Tumor Post-Traumatic ... Hemorrhagic Str...	CODMAN CERTAS P...	-	Integra LifeSciences Corporation

Spots Global Cancer Trial Database for codman certas plus programmable valve