Accelerate device development and approval.
Meet the NeuroVascular Quality Initiative-Quality Outcomes Database
NeuroVascular Quality Initiative-Quality Outcomes Database (NVQI-QOD) is widely regarded as the premier neurointerventional and cerebrovascular surgical registry. Physicians, quality managers, and device manufacturers leverage registry data to better understand and improve clinical care and outcomes for patients with stroke and cerebrovascular diseases—with increasing volumes and statistical power.
NVQI-QOD data can be used to assess the safety and efficacy of medical devices, and can provide manufacturers with real-world data to inform health economics, research and development, internal sales and marketing, and regulatory needs. Further, data collected by the registry offers an opportunity to understand device performance in specific patient populations in order to make recommendations on best patient selection, expand labeling indications to reflect safe and effective use, or design new devices better suited to certain subgroups.
NVQI-QOD By the Numbers
Advantages of the NVQI-QOD
Leverage NVQI-QOD Data for Medical Device Evaluation
Real-world evidence (RWE) is increasingly required to meet regulatory requirements for medical devices. The FDA recommends the use of registry data for post-approval surveillance and the EU now requires RWE for most vascular devices. NVQI-QOD collects granular clinical and follow-up data including device identifiers, for most neurovascular procedures.
- Perform internal company planning, such as that for new device development
- Meet FDA-required post-approval surveillance (PAS) requirements
- Expand indications for use based on off-label device usage in NVQI
- Provide propensity-matched control patients for new device comparison
- Generate contemporary objective performance goals for device categories
- Create EU MDR reports, including blinded comparison with similar device types, and meet EU MDR requirements
- Meet CMS requirements for Medicare coverage with evidence development
- Nest pre-market trials in the registry
Available Procedure Registries
*Provided by the Society for Vascular Surgery® Vascular Quality Initiative®