Assessment of the Performance of LYoplant® ONlay for Duraplasty

Assessment of the Performance of LYoplant® ONlay for Duraplasty. A Non-interventional, Multi-centre Post Market Clinical Follow-up (PMCF) Study.

The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.

Inclusion Criteria:

• Patients undergoing an elective cranial or spinal surgery, probably with the need of a duraplasty using Lyoplant® Onlay
• Written informed consent
• Life expectancy > 6 months
• Age > 18 years

Exclusion Criteria:

• Active local or systemic infections
• Open cranial trauma
• Open spina bifida
• Known hypersensitivity to proteins of bovine origin
• Representation by a legal guardian or under involuntary commitment
• Pregnancy
• Participation in another clinical study
• Known primary immunodeficiency