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Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis.

Jonathan Aaron BarnesMark A EidKayla MooreSuvekshya AryalEden GebreJennifer Nicole WoodardNapong KitpanitJialin MaoDavid P KuwayamaBjoern D SuckowDarren SchneiderTiffany AbushaikhaRobbert ZusterzeelSreekanth VemulapalliElizabeth A ShenkmanJames WilliamsArt SedrakyanPhilip P Goodney
Published in: BMJ surgery, interventions, & health technologies (2022)
This project demonstrates the feasibility of identifying and integrating real-world evidence, as it pertains to an unapproved combination of endovascular devices (IBE+VBX stent graft), for short-term outcomes analysis. This new paradigm of evidence has potential to be used for device monitoring, submission to regulatory agencies, or consideration in indication expansions and approvals with further efforts to systematise data collection and transmission mechanisms.
Keyphrases
  • electronic health record
  • quality improvement
  • big data
  • healthcare
  • data analysis
  • risk assessment
  • artificial intelligence
  • health insurance