Tue, Apr 12 | FDA White Oak Bldg 32

Passion II Think Tank

Predictable And SuStainable Implementation Of National Registries For Cardiovascular Devices (PASSION) II
Registration is Closed

Time & Location

Apr 12, 2016, 7:00 AM
FDA White Oak Bldg 32, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA

About the Event

 

Predictable And SuStainable Implementation Of National Registries For Cardiovascular Devices (PASSION) II

Links to recordings

https://collaboration.fda.gov/p64u6r4j3at/

https://collaboration.fda.gov/p6hlkxb4zlr/

https://collaboration.fda.gov/p9nduaf8cj5/

MEETING BACKGROUND AND OBJECTIVES

The MDEpiNet Public Private Partnership (PPP) leverages thinktank/incubator meetings to promote Disease Specific/Device Specific Working Group projects.  By charter Working Group projects are required to deliver:

  1. Immediate impact on a specific device-evaluation related question(s), and
  2. Infrastructure or analytic solutions generalizable to other device areas

Over the 18 months since the PASSION I launch meeting there has been significant progress within the specific working group areas and projects, as well as in FDA strategic priorities and the National Device Evaluation System.

Thus the general objectives of the PASSION II Thinktank/Incubator meeting are to:

  1. educate working group participants, MDEpiNet PPP members and other interested parties on the current status of these topics and projects, and
  2. to engage, inspire and invite members to consider new CV device-related projects for submission to the Scientific Oversight Committee.
Specific objectives and emphases for presentations and discussion 
  1. Update on new 2016 CDRH priorities and on the National Device Evaluation System.
  2. Update on progress, current status and directions for existing Working Group programs over 18 months since PASSION 1, with specific emphasis on:
    1. The Working Group “value propositions” within and across projects, from discrete practical deliverables to generalizable principles suitable for application to evaluations of other devices.
    2. Emphasis on project-specific what’s working, what’s not working, what are priorities for going forward in near term and long term.
    3. Compare and contrast solutions and problems encountered within and across working groups, including:
      1. Informed consent
      2. Registry integration and data integrity
      3. Statistical analyses
      4. Monitoring
  3. Distill practical suggestions, timelines and solutions for application within Working Group meetings on day 2.
AGENDA

07:30-08:00  Continental breakfast

08:00-08:15  Welcome & Introductions:  Mitchell Krucoff, Duke University/MDEpiNet PPP

08:15-09:15  Plenary Session: Priorities, The National Medical Device Evaluation System & The Import of Open Science (10 minute presentations)

Moderators:  Greg Pappas, FDA; Owen Faris, FDA

09:15-10:30:  PASSION for Peripheral Vascular Devices (10 minute presentations)

Moderators:  Neal Fearnot, Cook; Jimmy Tcheng, Duke University

10:30-10:45:  Break

10:45-12:00:  PASSION CV for Valves (10 minute presentations)

Moderators:  Roxana Mehran, Mount Sinai; Sid Cohen, Medtronic

  • Structured registry data for valves: An Overview — John Laschinger, FDA
  • Registry-based IDEs for TAVR: An Industry View — Heather Prince, Edwards Lifesciences
  • Registry-based mitral valve evaluations: where can we go? — Robin Eckert, Abbott Vascular
  • Comprehensive Registry-Based Surveillance — Danica Marinac Dabic, FDA
  • Open Discussion (40 minutes) — Lead Discussants:  Craig Thompson, Boston Scientific; Fred Edwards, University of Florida; Roseann White, Duke University

12:00-12:30  Lunch

12:30-14:00  PASSION for Coronary Stents (10 minute presentations)

Moderators:  Bram Zuckerman, FDA; Jennifer Jones-McMeans, Abbott Vascular

14:00-15:15  PASSION for Rhythm & Heart Failure (10 minute presentations)

Moderators:  Mitch Shein, FDA; Myoung Kim, J&J

15:30-16:30  Priority Themes From the Day

Moderators:  Mitchell Krucoff, Duke University; Owen Faris, FDA

  • Open Discussion (60 minutes) — Lead Discussants:  Nabil Dib, University of Arizona, University of California – San Diego, ISCTR

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