EDUCATE: A NESTcc Demonstration Project Regulatory Perspective

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Disclaimer The presentation is intended for educational purposes only and does not replace independent professional judgement. Statements of fact and opinions.

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Presentation transcript:

EDUCATE: A NESTcc Demonstration Project Regulatory Perspective Jose Pablo Morales, MD FDA Division of Cardiovascular Devices VISION Think Tank September 10, 2018

Disclosure Statement I, Jose Pablo Morales, do not have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation www.fda.gov

Registry Data: Pre-Market Regulatory Perspective Division of Cardiovascular Devices (DCD) has actively worked with manufacturers and professional societies on peripheral vascular projects Registries are useful data collection tools Pre-specified definitions and questions to be answered Proactive Collaboration Early engagement with industry, government agencies and professional societies

DCD and MDEpiNet http://mdepinet.org/rapid/

DCD and NESTcc https://nestcc.org/demonstration-projects/

EDUCATE and MDEpiNet www.fda.gov

www.fda.gov

EDUCATE Goals Evaluate the accuracy of claims data for assessing the effectiveness of endovascular grafts via a 3-way linkage (industry pre-market device trials, Medicare claims, and the Vascular Quality Initiative registry). Long term monitoring is central to total life cycle surveillance.

EDUCATE Goals Serve as a potential data source to optimize the interval and modality of surveillance imaging for follow-up of patients with implanted EVAR devices, or in some instances for specific patient characteristics (personalized medicine). CT with contrast has inherent risks of contrast induced nephropathy and excessive radiation, plus a significant cost burden to our health system Potential Favorable Benefit/Risk to move in this direction www.fda.gov

Potential Regulatory Benefits If this innovative data set proves capable of mirroring the findings derived from the current standard data collected in industry sponsored IDE studies, the FDA may be willing to consider alternative data sources to lessen the burden on manufacturers. For example, FDA could use registry data linked with claims as a measure to assess the long-term effectiveness of the devices Take care of issues related to incomplete follow-up, poor patient compliance and procedures performed at other centers This process could result in greater efficiency, coverage, accuracy and economy of device monitoring. www.fda.gov

Current Limitations Current CT imaging requirements on FDA regulated studies assess loss of patency, endoleak, migration, aneurysm expansion. Not all these device events result in intervention. Do we need new legislation? Do data sharing regulation and policies allow for this model to be adopted? Are FDA and manufacturers willing to test this approach with a real application? www.fda.gov

Contact Information Jose Pablo Morales, MD Medical Officer FDA Division of Cardiovascular Devices (301) 776-8936 Jose.Morales@fda.hhs.gov

Thank You www.fda.gov