A multi-center (up to 4 sites) clinical case series of 110 patients treated with Collagen Dura Regeneration Membrane - Repair (DMR) for a dural defect in the dura mater will be evaluated prospectively. The primary endpoint is the rate of adverse events related to the Subject Device requiring surgical intervention. Patients will have a follow-up evaluation post-operatively in line with standard or care of the study site, and 8 months after the initial surgery. No original patient records or personal identifying information will be disclosed to CMI.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with a dural defect requiring repair with a dural substitute as per routine clinical practice
Patient is 18 years or older
Patient of child-bearing potential is not pregnant or nursing
Participant is willing and able to provide consent
You may not be if
Patients with a known history of hypersensitivity to bovine derived materials
