Abstract
The International Consortium of Vascular Registries (ICVR) has rapidly developed into a global collaborative. Given the importance of vascular devices for public health, this is a priority direction for regulators, manufacturers, payers and patients advocacy groups. It is an innovative effort building on successes achieved in orthopedics and promotes cohesion among international registries. The ICVR will enable a collaboration of stakeholders to create a sustainable global system to evaluate the safety and efficacy of new and existing vascular devices and procedures, while promoting innovation and quality improvement.
Highlights
Major advantages of international investigations are the inclusion of a much larger number of patients, making it possible to study subgroups of patients, and to assess rare adverse events that are impossible to study in individual national registries
Most vascular devices are approved earlier in Europe than in the USA, but the US population provides a larger cohort for device evaluation
The International Consortium of Vascular Registries (ICVR) will enable a collaboration of stakeholders to create a sustainable global system to evaluate the safety and efficacy of new and existing vascular devices and procedures, while promoting innovation and quality improvement
Summary
Major advantages of international investigations are the inclusion of a much larger number of patients, making it possible to study subgroups of patients, and to assess rare adverse events that are impossible to study in individual national registries. International sharing of experience in quality improvement, desire to improve vascular care and evaluation of device performance are three main motivators that have led to enthusiastic participation of national registries and clinicianleaders. Case studies of device use and variation in carotid surgery
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