The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with hydrocephalus.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patient implanted with the Polaris® 24 adjustable valve system for the following reasons:
* Primo implant of a valve shunt-based derivation system, or as a
* Replacement of another valve -based shunt system, or
* Endoscopic ventriculostomy (EVT) failure
* Patient having given his/her informed consent prior to inclusion in this study, as per local regulations
Exclusion Criteria:
* Confirmed or suspected infections along the length of the shunt (meningitis, ventriculitis, peritonitis, septicemia or bacteremia) or any infection present in any part of the body
* Patient on anticoagulant therapy, or presenting with bleeding diathesis, or with haemorrhagic CSF, as the presence of blood in the system could lead to an obstruction in the system
* Ventriculo-atrial shunts in patient suffering from congenital cardiopathies or other malformations of the cardio-pulmonary system
Primary outcome measure(s)
Device-related SAE / complications — 1 year Primary safety outcome will be assessed by the incidence of device-related serious adverse events / complications
Valve replacement — 1 year Primary performance outcome will be assessed by the incidence of valve replacements
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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