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Presentation TCT 2018

The Second-Generation Cardiovascular EFS Pilot: Progress Report

Presenter: Andrew Farb, Martin B. Leon, David R. Holmes Jr.

September 22, 2018

Presentation TCT 2018

The US EFS Program: FDA Update

Presenter: Andrew Farb, Martin B. Leon

September 22, 2018

Presentation TCT 2018

Industry Perspective

Presenter: C. Michael Gibson, William H. Maisel, Campbell Rogers

September 22, 2018

Presentation TCT 2018

Clinician Scientist/Trialist Perspective

Presenter: C. Michael Gibson, William H. Maisel, James K. Min

September 22, 2018

Presentation TCT 2018

FDA Perspectives

Presenter: C. Michael Gibson, William H. Maisel, Mohua Choudhury

September 22, 2018

Presentation TCT 2018

Keynote Lecture: The Potential Impact of Machine Learning/Artificial Intelligence on Cardiovascular Medical Device Development

Presenter: C. Michael Gibson, William H. Maisel, Peter J. Fitzgerald

September 22, 2018

Presentation TCT 2018

Case #10: From Indonesia: Half-Way Rotational Atherectomy in a Heavily Angulated and Heavily Calcified Lesion- A New Technique

Presenter: Teguh Santoso, Wei-Hsian Yin, Kenneth Chin, Seung-Jung Park, Huay Cheem Tan, Chiung Jen Wu

September 22, 2018

Presentation TCT 2018

Case #9: From Taiwan: Heavily Calcified LM Bifurcation and Near Ostial Occlusion of a Highly Angulated Dominant LCX

Presenter: Teguh Santoso, Wei-Hsian Yin, Kenneth Chin, Seung-Jung Park, Huay Cheem Tan, Chiung Jen Wu

September 22, 2018

Presentation TCT 2018

Case #8: From India: Trans-Radial Rotational Atherectomy of a Critical Left Main Stenosis

Presenter: Teguh Santoso, Wei-Hsian Yin, Kenneth Chin, Seung-Jung Park, Huay Cheem Tan, Chiung Jen Wu

September 22, 2018

Presentation TCT 2018

CMS Perspectives

Presenter: Lori M Ashby

September 22, 2018

Presentation TCT 2018

Clinician Perspectives

Presenter: Megan Coylewright

September 22, 2018

Case #7: From Bangladesh: Post CABG LM Calcified Lesion - Rotablation and Single Stent Strategy

Presentation TCT 2018

Case #7: From Bangladesh: Post CABG LM Calcified Lesion - Rotablation and Double Stent Strategy

Presenter: Teguh Santoso, Wei-Hsian Yin, Kenneth Chin, Seung-Jung Park, Huay Cheem Tan, Chiung Jen Wu

September 22, 2018

Presentation TCT 2018

Case #6: From Malaysia: Recurrent ISR at the Distal Anastomotic Site of SVG to RCA

Presenter: Teguh Santoso, Wei-Hsian Yin, Kenneth Chin, Seung-Jung Park, Huay Cheem Tan, Chiung Jen Wu

September 22, 2018

Presentation TCT 2018

Patient-Centered Engagement in Trials: Case Example - ADAPTABLE

Presenter: John C Laschinger, J. Dawn Abbott, Lori M Ashby, Robert A. Byrne, David A. Cox, Mona Fiuzat, Christopher O'Connor, John A. Spertus, Susan Strong

September 22, 2018

Presentation TCT 2018

FDAs Patient Engagement Initiatives: How FDA Can Incorporate Patient Centered and Patient Reported Outcomes in Regulatory Decision-Making

Presenter: John C Laschinger

September 22, 2018

Presentation TCT 2018

Case #5: From South Korea: Tear of a Calcified Coronary Artery

Presenter: Vinay K. Bahl, Huay Cheem Tan, Jun-Jack Cheng, Kenneth Chin, Jeehoon Kang, Sreenivas Arramraju Kumar, Linda Lison, Fazila T. Malik

September 22, 2018

Presentation TCT 2018

Case #4: From Singapore: Finding a Missing Bioresorbable Scaffold

Presenter: Vinay K. Bahl, Huay Cheem Tan, Jun-Jack Cheng, Kenneth Chin, Jeehoon Kang, Sreenivas Arramraju Kumar, Linda Lison, Fazila T. Malik

September 22, 2018

Presentation TCT 2018

Case #3: From India: Rotational Atherectomy With Left Main Perforation

Presenter: Vinay K. Bahl, Huay Cheem Tan, Jun-Jack Cheng, Kenneth Chin, Jeehoon Kang, Sreenivas Arramraju Kumar, Linda Lison, Fazila T. Malik

September 22, 2018

Presentation TCT 2018

Case #2: From Taiwan: Lightening Will Strike Again- 2 Wire Breakages Happening in 1 Procedure

Presenter: Vinay K. Bahl, Huay Cheem Tan, Jun-Jack Cheng, Kenneth Chin, Jeehoon Kang, Sreenivas Arramraju Kumar, Linda Lison, Fazila T. Malik

September 22, 2018

Presentation TCT 2018

Keynote Lecture: FDA/CDRH - The Year in Review

Presenter: Mitchell W. Krucoff, Gregg W. Stone, William H. Maisel

September 22, 2018

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The Second-Generation Cardiovascular EFS Pilot: Progress Report

The US EFS Program: FDA Update

Industry Perspective

Clinician Scientist/Trialist Perspective

FDA Perspectives

Keynote Lecture: The Potential Impact of Machine Learning/Artificial Intelligence on Cardiovascular Medical Device Development

Case #10: From Indonesia: Half-Way Rotational Atherectomy in a Heavily Angulated and Heavily Calcified Lesion- A New Technique

Case #9: From Taiwan: Heavily Calcified LM Bifurcation and Near Ostial Occlusion of a Highly Angulated Dominant LCX

Case #8: From India: Trans-Radial Rotational Atherectomy of a Critical Left Main Stenosis

CMS Perspectives

Clinician Perspectives

Case #7: From Bangladesh: Post CABG LM Calcified Lesion - Rotablation and Double Stent Strategy

Case #6: From Malaysia: Recurrent ISR at the Distal Anastomotic Site of SVG to RCA

Patient-Centered Engagement in Trials: Case Example - ADAPTABLE

FDAs Patient Engagement Initiatives: How FDA Can Incorporate Patient Centered and Patient Reported Outcomes in Regulatory Decision-Making

Case #5: From South Korea: Tear of a Calcified Coronary Artery

Case #4: From Singapore: Finding a Missing Bioresorbable Scaffold

Case #3: From India: Rotational Atherectomy With Left Main Perforation

Case #2: From Taiwan: Lightening Will Strike Again- 2 Wire Breakages Happening in 1 Procedure

Keynote Lecture: FDA/CDRH - The Year in Review

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