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Presentation TCT 2019

Designing Controlled Trials for Shock Devices: Population Targets and Safety and Effectiveness Considerations

Presenter: Anthony Gershlick

September 27, 2019

Presentation TCT 2019

Industry Perspectives on Controlled Trials for Shock Devices

Presenter: Seth Bilazarian

September 27, 2019

Presentation TCT 2019

Devices to Treat Shock: Regulatory Perspectives

Presenter: Fernando Aguel

September 27, 2019

Presentation TCT 2019

Perspectives on Infarct Size as a Surrogate in STEMI

Presenter: Navin Kapur

September 27, 2019

Presentation TCT 2019

Industry View on Controlled Trials for Heart Failure and Shock Devices

Presenter: William Abraham

September 27, 2019

Presentation TCT 2019

ARC Initiative for Heart Failure and Shock: HF ARC, Shock ARC, and More

Presenter: Christopher O'Connor

September 27, 2019

Presentation TCT 2019

Devices for Heart Failure: FDA Perspectives on Trial Designs and Endpoints

Presenter: Bram Zuckerman

September 27, 2019

Presentation TCT 2019

Emerging Safety Signals and FDA’s Medical Device Safety Action Plan: Responses to the Late Mortality Signal

Presenter: Rebecca Ward

September 26, 2019

Presentation TCT 2019

Potential Study Designs to Address the Mortality Safety Signal

Presenter: Laura Mauri

September 26, 2019

Presentation TCT 2019

Informed Consent and Impact on Clinical Practice: A Clinician’s Perspective and a Pathway Forward

Presenter: Sahil Parikh

September 26, 2019

Presentation TCT 2019

Drug-Eluting Technologies for SFA Disease: Industry’s Perspective and a Pathway Forward

Presenter: Ian Meredith AM

September 26, 2019

Presentation TCT 2019

Is Paclitaxel-Related Mortality From SFA Drug-Eluting Technologies Biologically Plausible?

Presenter: Elazer Edelman

September 26, 2019

Presentation TCT 2019

Paclitaxel-Coated Devices for SFA Disease: An Independent, Patient-Level Meta-Analysis and Other Emerging Data

Presenter: Krishna Rocha-Singh

September 26, 2019

Presentation TCT 2019

New Insights From Our Meta-Analysis of Paclitaxel-Coated Device Randomized Trials for SFA Disease (And the Response It Has Generated)

Presenter: Konstantinos Katsanos

September 26, 2019

Presentation TCT 2019

Industry’s Perspectives on the US and Non-US EFS Landscape

Presenter: Neil Moat

September 26, 2019

Presentation TCT 2019

From EFS to Pivotal Trial: Bridging the Gap and Lessons Learned

Presenter: Pieter Kappetein

September 26, 2019

Presentation TCT 2019

Promoting Innovation Through EFS: MDIC Perspectives

Presenter: Chip Hance

September 26, 2019

Presentation TCT 2019

The US EFS and Breakthrough Devices Programs: An FDA Update

Presenter: Andrew Farb

September 26, 2019

Presentation TCT 2019

Keynote Lecture: A Vision for an Evolving Regulatory and Healthcare System

Presenter: Robert Califf

September 26, 2019

Presentation TCT 2019

Keynote Lecture: New Technology Assessment and Reimbursement Synergy — Forward Strides

Presenter: Lori Ashby

September 26, 2019

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Designing Controlled Trials for Shock Devices: Population Targets and Safety and Effectiveness Considerations

Industry Perspectives on Controlled Trials for Shock Devices

Devices to Treat Shock: Regulatory Perspectives

Perspectives on Infarct Size as a Surrogate in STEMI

Industry View on Controlled Trials for Heart Failure and Shock Devices

ARC Initiative for Heart Failure and Shock: HF ARC, Shock ARC, and More

Devices for Heart Failure: FDA Perspectives on Trial Designs and Endpoints

Emerging Safety Signals and FDA’s Medical Device Safety Action Plan: Responses to the Late Mortality Signal

Potential Study Designs to Address the Mortality Safety Signal

Informed Consent and Impact on Clinical Practice: A Clinician’s Perspective and a Pathway Forward

Drug-Eluting Technologies for SFA Disease: Industry’s Perspective and a Pathway Forward

Is Paclitaxel-Related Mortality From SFA Drug-Eluting Technologies Biologically Plausible?

Paclitaxel-Coated Devices for SFA Disease: An Independent, Patient-Level Meta-Analysis and Other Emerging Data

New Insights From Our Meta-Analysis of Paclitaxel-Coated Device Randomized Trials for SFA Disease (And the Response It Has Generated)

Industry’s Perspectives on the US and Non-US EFS Landscape

From EFS to Pivotal Trial: Bridging the Gap and Lessons Learned

Promoting Innovation Through EFS: MDIC Perspectives

The US EFS and Breakthrough Devices Programs: An FDA Update

Keynote Lecture: A Vision for an Evolving Regulatory and Healthcare System

Keynote Lecture: New Technology Assessment and Reimbursement Synergy — Forward Strides

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