Harness the Power of Device Performance Data

Accelerate device innovation and approval with real world data from the nation’s leading neurovascular registry.

Real-World Evidence

Optimize the Speed and Efficiency of Device Evaluation

The NVQI-QOD captures data about medical devices used in the treatment of acute ischemic stroke, intracranial arterial aneurysms, and cerebral AVM. This information 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.

Data collected by the NVQI-QOD provides device manufacturers with the insight necessary 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.

Ease the burden of regulatory requirements with real world evidence that works for you.

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 lifecycle device evaluation. Data already collected as part of the NVQI-QOD registries provides an efficient, cost-effective means for industry to meet regulatory requirements, including:

  • 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

Experience the benefits of a registry-driven approach to device development.

Fivos, the technology and service provider for the NVQI-QOD, has extensive experience managing projects for industry. Custom data elements and follow-up requirements can be added to the existing NVQI-QOD registry if required for specific projects. Our team is well-versed in site recruitment and contracting, data monitoring, site reimbursement, data analysis, and report generation. Analyses have shown substantial cost savings 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. Contact to begin your project.