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The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices.

Publication ,  Journal Article
Tsougranis, G; Eldrup-Jorgensen, J; Bertges, D; Schermerhorn, M; Morales, P; Williams, S; Bloss, R; Simons, J; Deery, SE; Scali, S; Mureebe, L ...
Published in: J Vasc Surg
December 2020

The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) is a Coordinated Registry Network (CRN) a member of Medical Device Epidemiology Network, a U.S. 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 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 using CRNs 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.

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Published In

J Vasc Surg

DOI

EISSN

1097-6809

Publication Date

December 2020

Volume

72

Issue

6

Start / End Page

2153 / 2160

Location

United States

Related Subject Headings

  • Vascular Surgical Procedures
  • United States Food and Drug Administration
  • United States
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Risk Assessment
  • Registries
  • Public-Private Sector Partnerships
  • Product Surveillance, Postmarketing
 

Citation

APA
Chicago
ICMJE
MLA
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Tsougranis, G., Eldrup-Jorgensen, J., Bertges, D., Schermerhorn, M., Morales, P., Williams, S., … Goodney, P. P. (2020). The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices. J Vasc Surg, 72(6), 2153–2160. https://doi.org/10.1016/j.jvs.2020.04.507
Tsougranis, Greg, Jens Eldrup-Jorgensen, Daniel Bertges, Marc Schermerhorn, Pablo Morales, Scott Williams, Roberta Bloss, et al. “The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices.J Vasc Surg 72, no. 6 (December 2020): 2153–60. https://doi.org/10.1016/j.jvs.2020.04.507.
Tsougranis G, Eldrup-Jorgensen J, Bertges D, Schermerhorn M, Morales P, Williams S, et al. The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices. J Vasc Surg. 2020 Dec;72(6):2153–60.
Tsougranis, Greg, et al. “The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices.J Vasc Surg, vol. 72, no. 6, Dec. 2020, pp. 2153–60. Pubmed, doi:10.1016/j.jvs.2020.04.507.
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 (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices. J Vasc Surg. 2020 Dec;72(6):2153–2160.
Journal cover image

Published In

J Vasc Surg

DOI

EISSN

1097-6809

Publication Date

December 2020

Volume

72

Issue

6

Start / End Page

2153 / 2160

Location

United States

Related Subject Headings

  • Vascular Surgical Procedures
  • United States Food and Drug Administration
  • United States
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Risk Assessment
  • Registries
  • Public-Private Sector Partnerships
  • Product Surveillance, Postmarketing