Passion II Think Tank

 

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

• The 2016 CDRH Strategic Priorities — Bill Maisel, FDA
• The National Medical Device Evaluation System — Greg Daniel, Duke University
• The Import and Challenges of Open Science: An Industry View — Ken Stein, Boston Scientific
• The Import and Challenges of Open Science: A Patient View — Mary McGowan
• The Import and Challenges of Open Science: A Professional Society View — Ralph Brindis, ACC/NCDR

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

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

• The RAPID Program: An Overview — Jack Cronenwett, Dartmouth-Hitchcock
• RAPID: An FDA View — Pablo Morales, FDA
• RAPID: An Industry View — Robert Thatcher, Cardiovascular Systems
• RAPID/BUILD: Leveraging Synergies — Joseph Drozda, Mercy
• Open Discussion (40 minutes) — Lead Discussants:  Terrie Reed, FDA; Schuyler Jones, Duke University; Bret Shillingstad, Epic; Christopher Ronk, FDA

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

• SAFE STEMI for Seniors: registry-based RCT pilot — Mitchell Krucoff, Duke University
• Registry-based IDEs: FDA view — Andy Farb, FDA
• Registry-based IDEs for diagnostic devices: Industry view — Elisa Hebb, Volcano/Philips
• Registry-based IDEs for therapeutic devices: Industry view — Sandeep Brar, Medtronic
• Open Discussion (40 minutes) — Lead Discussants:  Daniel Canos, CMS; Kathleen Hewitt, ACC/NCDR; Hans Peter Stoll, Biosensors

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

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

• Impact of active surveillance for implantable lead evaluation: An Industry View — Rick Kuntz, Medtronic
• Active Surveillance Opportunities: FDA view — Nilsa Loyo-Berrios, FDA
• Opportunities for registry-based IDEs: An Academic View — William Abraham, Ohio State
• Opportunities for registry-based post-approval studies: FDA View — Rob Kazmierski, FDA and Daniel Canos, CMS
• Open Discussion (35 minutes) — Lead Discussants: Larry Kessler, University of Washington; Phil Adamson, St Jude; Isaac Cheng, FDA

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