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Presentation TCT 2017

The Landscape of CV Device Innovation for Children: Regulatory View

Presenter: Nicole Ibrahim, Satoshi Yasukochi, Nicole Milligan

October 30, 2017

Presentation TCT 2017

The Landscape of CV Device Innovation for Children: Industry View

Presenter: Nicole Ibrahim, Satoshi Yasukochi, Lisa Becker

October 30, 2017

Presentation TCT 2017

CMS Perspectives on Post-Approval Device Evaluation(Including NEST) and Reimbursement

Presenter: Mitchell W. Krucoff, John C Laschinger, Daniel A Canos

October 30, 2017

Presentation TCT 2017

The Landscape of CV Device Innovation for Children: Industry View

Presenter: Nicole Ibrahim, Satoshi Yasukochi, Declan Dineen

October 30, 2017

Presentation TCT 2017

National Evaluation System for Health Technology (NEST): Objectives, Accomplishments and Future Directions

Presenter: Mitchell W. Krucoff, John C Laschinger, Rachael L. Fleurence

October 30, 2017

Presentation TCT 2017

Current CV Device Use and Unmet Needs in Children: US Academic View

Presenter: Nicole Ibrahim, Satoshi Yasukochi, Frank F. Ing

October 30, 2017

Presentation TCT 2017

Can Post-Approval Registries Inform Device Label Expansion? The TVT Case Example

Presenter: Mitchell W. Krucoff, John C Laschinger, E. Murat Tuzcu

October 30, 2017

Presentation TCT 2017

Current CV Device Use and Unmet Needs in Children: Japanese Academic View

Presenter: Nicole Ibrahim, Satoshi Yasukochi, Hideshi Tomita

October 30, 2017

Presentation TCT 2017

Introduction and Achievement of HBD-for-Children

Presenter: Nicole Ibrahim, Satoshi Yasukochi, Yasuko Nakamura

October 30, 2017

Presentation TCT 2017

Enhancing Pre-Approval Studies to Better Evaluate Real-World Use: Lessons Learned and Future Opportunities

Presenter: Mitchell W. Krucoff, John C Laschinger

October 30, 2017

Presentation TCT 2017

EFS in Japan & USA: Industry View

Presenter: Mitchell W. Krucoff, Kiyohito Nakai, Robert Thatcher

October 30, 2017

Presentation TCT 2017

EFS in Japan: PMDA View

Presenter: Mitchell W. Krucoff, Kiyohito Nakai, Sara Takahashi

October 30, 2017

Presentation TCT 2017

Do Japanese Patients & Doctors Want EFS: Academic View

Presenter: Mitchell W. Krucoff, Kiyohito Nakai, Shigeru Saito

October 30, 2017

Presentation TCT 2017

EFS FDA Guidance: History & Overview

Presenter: Mitchell W. Krucoff, Kiyohito Nakai, Andrew Farb

October 30, 2017

Presentation TCT 2017

Real World Evidence: Industry view

Presenter: Daniel A Canos, Kazuhiro Sase, Larry L. Wood

October 30, 2017

Presentation TCT 2017

Real World Evidence: Academic view

Presenter: Daniel A Canos, Kazuhiro Sase, Mitchell W. Krucoff

October 30, 2017

Presentation TCT 2017

Real World Evidence: PMDA view

Presenter: Daniel A Canos, Kazuhiro Sase, Haruki Shirato

October 30, 2017

Presentation TCT 2017

Real World Evidence and The National Evaluation System for health Technologies (NEST): FDA View

Presenter: Daniel A Canos, Kazuhiro Sase

October 30, 2017

Presentation TCT 2017

Japan-USA Endovascular AV Fistula

Presenter: Robert Thatcher, Hiroyoshi Yokoi, Prabir Roy-Chaudhury

October 30, 2017

Presentation TCT 2017

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions

Presenter: Robert Thatcher, Hiroyoshi Yokoi, Brad Martinsen

October 30, 2017

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The Landscape of CV Device Innovation for Children: Regulatory View

The Landscape of CV Device Innovation for Children: Industry View

CMS Perspectives on Post-Approval Device Evaluation(Including NEST) and Reimbursement

The Landscape of CV Device Innovation for Children: Industry View

National Evaluation System for Health Technology (NEST): Objectives, Accomplishments and Future Directions

Current CV Device Use and Unmet Needs in Children: US Academic View

Can Post-Approval Registries Inform Device Label Expansion? The TVT Case Example

Current CV Device Use and Unmet Needs in Children: Japanese Academic View

Introduction and Achievement of HBD-for-Children

Enhancing Pre-Approval Studies to Better Evaluate Real-World Use: Lessons Learned and Future Opportunities

EFS in Japan & USA: Industry View

EFS in Japan: PMDA View

Do Japanese Patients & Doctors Want EFS: Academic View

EFS FDA Guidance: History & Overview

Real World Evidence: Industry view

Real World Evidence: Academic view

Real World Evidence: PMDA view

Real World Evidence and The National Evaluation System for health Technologies (NEST): FDA View

Japan-USA Endovascular AV Fistula

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions

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