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| Name | Class |
|---|---|
| Stryker Nordic | INDUSTRY |
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Monitoring the Use of Collagen Dura Regeneration Membrane - Repair (DMR) in the Post-market Phase.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Revision Surgery | Rate of adverse events related to the Subject Device requiring surgical intervention. | at least one timepoint at 8 months or more post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse Events | Intra-operative and post-operative adverse events (i.e., infection, CSF Leak, and Pseudomeningocele) | at least one timepoint at 8 months or more post-surgery |
| Product Performance |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with a dural defect requiring repair with a dural substitute.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meenakshi Paliwal | Contact | 347-439-1634 | mpaliwal@regenity.com | |
| Sarah Grace Dennis-Little, PhD | Contact | 706-247-0251 | sgdennislittle@regenity.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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Score of adequacy of product performance - 1 (poor) to 4 (excellent)
| at least one timepoint at 8 months or more post-surgery |
| Product Handling at Implantation | Score for product handling at implantation - 1 (poor) to 4 (excellent) | Initial surgery |
| Product Adaptability at Implantation | Score for product adaptability at implantation - 1 (poor) to 4 (excellent) | Initial surgery |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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