3D 2016 Presentations

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Welcome and Opening Comments
Aaron V. Kaplan, M.D. Symposium Chair

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Established Registries-NCDR: Basic Facts
Jeptha Curtis, M.D.

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Established Registries-TVT: Basic Facts
John D. Carroll, M.D.

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Established Registries: Supporting the PMA Process
John C. Laschinger, M.D.

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Basic Definitions & Perspective
David O. Williams, M.D.

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Basic Definitions & Perspective
Pro:
Mitchell W. Krucoff, M.D.-

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Basic Definitions & Perspective
Con:
Donald E. Cutlip, M.D.

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CMS Mandated Registries: An Overview & Perspective
David R. Holmes, Jr. M.D.

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CMS Registries-Understanding the Costs
Shawn M. Ahmad, M.D.

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CMS Registries: An FDA Perspective
John C. Laschinger, M.D.

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CMS Registries: A CMS Perspective
Daniel A. Caños, Ph.D.

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CMS Registries: An Industry Perspective
Larry Wood

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CMS Registries: A NICE Perspective From Across The Pond
Peter Groves, M.D.

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NEST: National Evaluation System for Health Technology
A Real World Evaluation of Medical Technology Across the Total Product Lifecycle
Richard E. Kuntz, M.D.

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A Comprehensive Medical Evaluation System: A Vision Moving Forward
Heather Colvin

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The Role of Private Insurers
Lonny Reisman, M.D.

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Utilization of Real World Data
Implications for Market Access and Reimbursement
Sean Tunis, M.D.

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Early Feasibility Studies: A Progress Report
Andrew Farb, M.D.

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Early Feasibility Studies: Medicare Coverage
Daniel A. Caños, Ph.D.

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Early Feasibility Studies: A Site Perspective
Martin B. Leon, M.D.

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Early Feasibility Studies: An Entrepreneur’s Perspective
Todd J. Brinton, M.D.

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Large Investments/Large Expectations
Will Mitral Valve Replacement be TAVR II?
Martin B. Leon, M.D.

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COAPT Trial: If I knew then what I know now!
Michael J. Mack, M.D.

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Percutaneous Mitral Implants: Next Steps
What is the appropriate standard and comparator?
Ted Feldman, M.D

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Shared Decisions Tools
What Can They Tell Us-How Can We Implement and Utilize Them Effectively?
Megan Coylewright, M.D.

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Mandatory Bundle Payments
Forcing a More Comprehensive Approach
Mary Ann Clark

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The Changing World of Financing Medical Device Companies
Yuval Binur, Ph.D.

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The Role of Investors from Emerging Markets
Joanna Yeung

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Closing Comments
Aaron V. Kaplan, M.D.

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