Scientific Publications by FDA Staff

J Vasc Surg 2020 May 20 [Epub ahead of print]

The Vascular Implant Surveillance and Interventional Outcomes (VISION) coordinated registry network: an effort to advance evidence evaluation for vascular devices.

Tsougranis G, Eldrup-Jorgensen J, Bertges D, Schermerhorn M, Morales P, Williams S, Bloss R, Simons J, Deery SE, Scali S, Roche-Nagle G, Mureebe L, Mell M, Malas M, Pullin B, Stone DH, Malone M, Beck AW, Wang G, Marinac-Dabic D, Sedrakyan A, Goodney PP

The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) is a Coordinated Registry Network (CRN) a member of Medical Device Epidemiology Network (MDEpiNet), a Food and Drug Administration (FDA)-supported global public-private partnership that seeks to advance the collection and use of real-world data to improve patient outcomes. The VISION Coordinated Registry Network (CRN) began in September 2015 and held its first strategic meeting on September 10, 2018, at the FDA headquarters in Silver Spring, Maryland. VISION is a collaboration of the Vascular Quality Initiative (VQI), the FDA, and other stakeholders. At this annual meeting, leaders from the FDA, VQI, industry representatives, population health researchers, and regulatory science experts gathered to discuss strategic goals and opportunities for VISION. One of the key focus areas for VISION is linkage of VQI registry data to Medicare, longitudinal data sources maintained by various states, and other relevant data sources, as a model for efficient, cost-saving, and effectual, evidence generation and appraisal. This would provide the means to expand data collection, assess long-term procedural outcomes across the carotid, lower extremity, aortic and venous intervention datasets, and execute registry-based trials through the CRN structure, in an efficient, cost-effective manner. Looking forward, VISION strives to validate long-term outcome data in the VQI using industry datasets, in hopes of utilizing Coordinated Registry Networks to make device regulatory decisions. With the guidance of a Steering Committee, VISION will provide vascular surgeons, industry, and regulators the appropriate data to improve care for patients with vascular disease.