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Education Session

C03: Endovascular Aortic Devices: From Regulatory Approval to Post-Market Oversight

Wednesday, June 19, 2024
12:30 PM – 1:30 PM CT
Location: West Building, Level 1, W183a

Summary: Review how a new aortic device gets to the market and discuss the role of practicing vascular surgeons in this process.

Objectives:

  • Review the FDA regulatory processes by which new aortic devices get to market.
  • Detail how aortic devices can be studied under an investigational device exemption (IDE), and how one may obtain a physician-sponsored IDE from the FDA.
  • Hear an experienced investigator discuss the challenges and rewards of obtaining a physician-sponsored IDE to study aortic devices.
  • Explain why the FDA requires the collection of post-market data for high-risk devices such as aortic endografts, and the importance of vascular surgeons participating in post-approval studies.
  • Present the process for voluntary reporting of adverse medical device events to the FDA and highlight the vascular surgeon's role in assuring safety of those devices employed in practice.

    • Presentations:

    • 12:30 PM – 12:38 PM CT
      Regulatory Pathways for Aortic Devices: How a New Aortic Product Gets Through FDA and to the Market

      Speaker: Robert Craig, DO

    • 12:38 PM – 12:46 PM CT
      Physician Sponsored Investigational Device Exemptions: Why They Are Needed and How to Obtain One

      Speaker: Ronald Fairman, MD

    • 12:46 PM – 12:54 PM CT
      My Experience with a Physician-Sponsored IDE Studying Aortic Devices

      Speaker: Gustavo S. Oderich, MD – Department of Cardiothoracic and Vascular Surgery, University of Texas Health Science Center at Houston, McGovern

    • 12:54 PM – 1:02 PM CT
      After Device Approval: When the FDA Requires Post-Market Studies and Why You Should Engage With Them

      Speaker: Robert Craig, DO

    • 1:02 PM – 1:10 PM CT
      Medical Device Event Reporting: Your Role in Assuring Safety of Marketed Devices

      Speaker: Robert E. Lee, MD

    • 1:10 PM – 1:30 PM CT
      Discussion