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Peripheral vascular & endovascular device registries: what do we need A regulatory view

Peripheral vascular & endovascular device registries: what do we need A regulatory view. Jose Pablo Morales, MD FDA Division of Cardiovascular Devices. P redictable A nd S u S tainable I mplementation O f N ational Registries For Cardiovascular Devices October 15, 2014.

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Peripheral vascular & endovascular device registries: what do we need A regulatory view

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  1. Peripheral vascular & endovascular device registries: what do we needA regulatory view Jose Pablo Morales, MD FDA Division of Cardiovascular Devices Predictable And SuStainable Implementation Of National Registries For Cardiovascular Devices October 15, 2014

  2. Pre-Market Regulatory Perspective • DCD has actively worked with manufacturers and professional societies on peripheral vascular projects • Registries are useful data collection tools

  3. Good Practices • Pre-specified definitions and questions to be answered • Proactive Collaboration • Early engagement with industry, government agencies and professional societies • SVS VQI Aortic Dissection Surveillance • Shorten pre-market and enhanced post-market with specific goals

  4. Potential Future Applications? • Aortic Interventions • Lower Profile Systems, More Challenging Anatomies • Venous Interventions • Chronic Venous Occlusions, Varicose Veins • Lower limb interventions • Stents, Drug Coated Balloons, Atherectomy Devices, etc.

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