The NVQI-QOD registry captures data about medical devices used in the treatment of acute ischemic stroke, intracranial arterial aneurysms and cerebral AVM. These data can be used to assess the safety and efficacy of such 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 NVQI-QOD offer device manufacturers an opportunity to understand their device performance in specific patient populations, in order to make recommendations on best patient selection, to potentially expand labeling indications to reflect safe and effective use, or to design new devices better suited to certain subgroups.
To improve patient care, the Society of NeuroInterventional Surgery (SNIS) and the NeuroPoint Alliance (NPA) and the Society of Vascular and Internventional Neurology (SVIN) have aligned to create one unified registry. NeuroVascular Quality Initiative (NVQI) and the Quality Outcomes Database Neurovascular (QOD NV), into one unified registry. This collaboration, NVQI-QOD, has increased the size of the parent registries and provides greater opportunities for collecting and analyzing data.
Both the U.S. Food and Drug Administration (FDA) and the European Union (EU) have emphasized the importance of real-world evidence for total product life cycle device evaluation. Data already collected as part of the NVQI-QOD registries provides an efficient and cost-effective route to meet regulatory requirements, including:
1. Post-approval surveillance studies required by the FDA after initial approval of new devices.
2. Label expansion for existing devices based on analysis of “off-label” device use in practice.
3. Contemporary control cases from standard care for propensity matching with new devices.
4. EU Medical Device Regulation (MDR) reports of real-world practice, including long-term follow-up.
Fivos®, the technology and service provider for the NVQI-QOD, has extensive experience managing all such projects for industry. Custom data elements and follow-up requirements can be added to the existing NVQI-QOD registry if required for specific projects. Site recruitment and contracting, data monitoring, site reimbursement, data analysis and report generation are done by an experienced team at Fivos. Analyses have shown substantial cost saving for industry using the existing network of centers already collecting most of the needed data in a registry.
The NVQI-QOD is uniquely positioned to help device manufacturers obtain rapid, efficient, flexible, and cost-effective results. For additional information, contact Michael Alcala, Business Development Director, email@example.com.