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Presentation TCT 2015

Key Elements of BRS Nonclinical Testing to Support IDE Approval

Presenter: Andrew Farb, Gregg W. Stone, Michael C. John

October 14, 2015

Presentation TCT 2015

Controversial Viewpoint: Characterizing BRS Class Effects BRS Designs Are More Different Than Alike (Regulatory Implications)

Presenter: Andrew Farb, Gregg W. Stone, Juan F. Granada

October 14, 2015

Presentation TCT 2015

Assessing Whether Superiority Exists: Design, Rationale, and Status of ABSORB IV

Presenter: Stephen G. Ellis, Patrick W. Serruys, Gregg W. Stone

October 14, 2015

Presentation TCT 2015

Featured Lecture: One-Year Patient-Level Pooled Meta-analysis From 4 ABSORB Trials in 3389 Randomized Patients

Presenter: Stephen G. Ellis, Patrick W. Serruys, Gregg W. Stone

October 14, 2015

Presentation TCT 2015

Identifying and Studying Data Gaps: Cangrelor Use What's Settled, and What's Not?

Presenter: Deepak L. Bhatt, Martin Rose, Gregg W. Stone

October 14, 2015

Presentation TCT 2015

When and How to Treat a Claudicant With an Occluded SFA

Presenter: William A. Gray, Gregg W. Stone, D. Christopher Metzger, Herbert D. Aronow

October 14, 2015

Presentation TCT 2015

Stable CAD With Substantial Ischemia and No-to-Mild Symptoms: Initial Revascularization vs Medical Therapy

Presenter: William A. Gray, Gregg W. Stone, D. Christopher Metzger, Sripal Bangalore

October 14, 2015

Presentation TCT 2015

TCT 79: Efficacy of Cangrelor in Lesions With High-Risk and Low-Risk Angiographic Characteristics The CHAMPION PHOENIX Trial

Presenter: Lisa K. Jennings, Neal S. Kleiman, Gregg W. Stone

October 13, 2015

Presentation TCT 2015

Keynote Lecture 1: A Revitalization Plan for the FDA-CDRH Emphasis on Policy Changes, Innovation, and Technology

Presenter: Gregg W. Stone, Bram D. Zuckerman, Jeffrey Shuren

October 13, 2015

Presentation TCT 2015

My 3 Decades at FDA-CDRH: Historical Perspectives, Landmark Changes, and Major Accomplishments

Presenter: Gregg W. Stone, Bram D. Zuckerman

October 13, 2015

Presentation TCT 2015

VALcare: Device Description, Experiences, and Future Directions

Presenter: David H. Adams, Gregg W. Stone, David Meerkin

October 12, 2015

Presentation TCT 2015

MValve Docking System: Novel Design Features and Clinical Updates

Presenter: David H. Adams, Gregg W. Stone, Maurice Buchbinder

October 12, 2015

Presentation TCT 2015

Valtech Cardiovalve: Novel Design Features and Clinical Updates

Presenter: David H. Adams, Gregg W. Stone, Francesco Maisano

October 12, 2015

Presentation TCT 2015

A Novel Transcatheter Mitral Valved Stent for Secondary MR

Presenter: David H. Adams, Gregg W. Stone, Jose Luis Navia

October 12, 2015

Presentation TCT 2015

SinoMed AccuFit: Novel Design Features and Clinical Updates

Presenter: David H. Adams, Gregg W. Stone, Patrick W. Serruys

October 12, 2015

Presentation TCT 2015

Tiara: Novel Design Features and Clinical Updates

Presenter: David H. Adams, Gregg W. Stone, Anson Cheung

October 12, 2015

Presentation TCT 2015

Fortis: Novel Design Features and Clinical Updates

Presenter: David H. Adams, Gregg W. Stone, Vinod H. Thourani

October 12, 2015

Presentation TCT 2015

Tendyne: Novel Design Features and Clinical Updates

Presenter: David H. Adams, Gregg W. Stone, Neil E. Moat

October 12, 2015

Presentation TCT 2015

CardiAQ: Novel Design Features and Clinical Updates

Presenter: David H. Adams, Gregg W. Stone, Gian Paolo Ussia

October 12, 2015

Presentation TCT 2015

HOT TOPIC 2: Balancing Safety and Efficacy Endpoints How Do Net Clinical Benefit and Quality of Life Fit Into the Equation? FOCUS on DAPT, PEGASUS, and MATRIX: Clinical/Trialist Perspective

Presenter: Bernard J. Gersh, William S. Weintraub, Gregg W. Stone

October 12, 2015

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Key Elements of BRS Nonclinical Testing to Support IDE Approval

Controversial Viewpoint: Characterizing BRS Class Effects BRS Designs Are More Different Than Alike (Regulatory Implications)

Assessing Whether Superiority Exists: Design, Rationale, and Status of ABSORB IV

Featured Lecture: One-Year Patient-Level Pooled Meta-analysis From 4 ABSORB Trials in 3389 Randomized Patients

Identifying and Studying Data Gaps: Cangrelor Use What's Settled, and What's Not?

When and How to Treat a Claudicant With an Occluded SFA

Stable CAD With Substantial Ischemia and No-to-Mild Symptoms: Initial Revascularization vs Medical Therapy

TCT 79: Efficacy of Cangrelor in Lesions With High-Risk and Low-Risk Angiographic Characteristics The CHAMPION PHOENIX Trial

Keynote Lecture 1: A Revitalization Plan for the FDA-CDRH Emphasis on Policy Changes, Innovation, and Technology

My 3 Decades at FDA-CDRH: Historical Perspectives, Landmark Changes, and Major Accomplishments

VALcare: Device Description, Experiences, and Future Directions

MValve Docking System: Novel Design Features and Clinical Updates

Valtech Cardiovalve: Novel Design Features and Clinical Updates

A Novel Transcatheter Mitral Valved Stent for Secondary MR

SinoMed AccuFit: Novel Design Features and Clinical Updates

Tiara: Novel Design Features and Clinical Updates

Fortis: Novel Design Features and Clinical Updates

Tendyne: Novel Design Features and Clinical Updates

CardiAQ: Novel Design Features and Clinical Updates

HOT TOPIC 2: Balancing Safety and Efficacy Endpoints How Do Net Clinical Benefit and Quality of Life Fit Into the Equation? FOCUS on DAPT, PEGASUS, and MATRIX: Clinical/Trialist Perspective

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