The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of unintended residual risks associated with the use of DuraGen Secure that were not anticipated or identified in the animal studies, bench studies or clinical evaluation report.
Study Type
OBSERVATIONAL
Enrollment
100
Hopital Lariboisière
Paris, France
die Charité - Universitätsmedizin Berlin
Berlin, Germany
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Fe
Valencia, Spain
Patient's Outcome
Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)
Time frame: Day 30
Occurence of Adverse Event
Adverse event that occured 72 hours post-operatively
Time frame: first 72 hours post-op
Occurence of Adverse Event
Adverse event that occured between days 4-14 post-operatively
Time frame: between days 4-14
Occurence of Adverse Event
Adverse event that occured between days 15-30 post-operatively
Time frame: Between days 15-30
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National Hospital for Neurology and Neurosurgery
London, United Kingdom