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Presentation TCT 2018

FDA Perspectives on DCB in Coronary and Peripheral Interventions

Presenter: Juan F. Granada, Bruno Scheller, P.F. Adrian Magee

September 23, 2018

Presentation TCT 2018

DCB for Coronary Artery Disease: In-Stent Restenosis, NSTEMI, and Small Vessels

Presenter: Juan F. Granada, Bruno Scheller

September 23, 2018

Presentation TCT 2018

DCB for BTK: Clinical Challenges and Lessons Learned

Presenter: Juan F. Granada, Bruno Scheller, Sahil A. Parikh

September 23, 2018

Presentation TCT 2018

Percutaneous Mechanical Support Devices for Shock and Pre-Shock: Clinical and Regulatory Considerations

Presenter: Nicole Ibrahim, David E. Kandzari, John C Laschinger

September 23, 2018

Presentation TCT 2018

Are Randomized Trials Feasible for Percutaneous Mechanical Support Devices?

Presenter: Nicole Ibrahim, David E. Kandzari, Holger Thiele

September 23, 2018

Presentation TCT 2018

Regulatory Considerations for Transcatheter Tricuspid Valve Therapies

Presenter: Jaime Raben, Josep Rodés-Cabau, Bernard Vasseur

September 23, 2018

Presentation TCT 2018

Transcatheter Tricuspid Valve Therapies: Challenging Technologies and Clinical Trial Pathways

Presenter: Jaime Raben, Josep Rodés-Cabau

September 23, 2018

Presentation TCT 2018

Transcatheter Mitral Valve Replacement: Trial Design Considerations

Presenter: Michael J. Mack, Changfu Wu, John C Laschinger

September 23, 2018

Presentation TCT 2018

Pivotal Transcatheter FMR Device Trials: Focus on COAPT and MITRA-FR, with Implications for Other Transcatheter Mitral Valve Device Investigations

Presenter: Michael J. Mack, Changfu Wu, Gregg W. Stone

September 23, 2018

Presentation TCT 2018

Cerebral Embolic Protection: Regulatory Perspectives

Presenter: Jeffrey J. Popma, Changfu Wu, Kenneth J. Cavanaugh Jr

September 23, 2018

Presentation TCT 2018

Cerebral Embolic Protection for TAVR Procedures: A Critical Appraisal

Presenter: Jeffrey J. Popma, Changfu Wu, Samir R. Kapadia

September 23, 2018

Presentation TCT 2018

Patient Perspectives on Sham-Controlled Trials

Presenter: Kenneth J. Cavanaugh Jr, Roxana Mehran, Debbe McCall

September 23, 2018

Presentation TCT 2018

FDA Perspectives on Sham-Controlled Trials

Presenter: Kenneth J. Cavanaugh Jr, Roxana Mehran, Hiren Mistry

September 23, 2018

Presentation TCT 2018

Sham Controls in Renal Denervation Studies: Need to Have vs Nice to Have?

Presenter: Kenneth J. Cavanaugh Jr, Roxana Mehran, David E. Kandzari

September 23, 2018

Presentation TCT 2018

ORBITA One Year Later: What Would I Do Differently, If Anything?

Presenter: Kenneth J. Cavanaugh Jr, Roxana Mehran, Rasha Al-Lamee

September 23, 2018

Presentation TCT 2018

EFS Experiences Grom the Industry Client Perspective: Whats Good and What Needs to Change?

Presenter: Andrew Farb, Martin B. Leon, Donald E. Bobo Jr

September 22, 2018

Presentation TCT 2018

EFS Decisions: Start-up Company Considerations

Presenter: Andrew Farb, Martin B. Leon, Beverly A Huss

September 22, 2018

Presentation TCT 2018

Promoting Medical Device Innovation: MDIC Perspectives

Presenter: Andrew Farb, Martin B. Leon, Liz McDermott

September 22, 2018

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

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FDA Perspectives on DCB in Coronary and Peripheral Interventions

DCB for Coronary Artery Disease: In-Stent Restenosis, NSTEMI, and Small Vessels

DCB for BTK: Clinical Challenges and Lessons Learned

Percutaneous Mechanical Support Devices for Shock and Pre-Shock: Clinical and Regulatory Considerations

Are Randomized Trials Feasible for Percutaneous Mechanical Support Devices?

Regulatory Considerations for Transcatheter Tricuspid Valve Therapies

Transcatheter Tricuspid Valve Therapies: Challenging Technologies and Clinical Trial Pathways

Transcatheter Mitral Valve Replacement: Trial Design Considerations

Pivotal Transcatheter FMR Device Trials: Focus on COAPT and MITRA-FR, with Implications for Other Transcatheter Mitral Valve Device Investigations

Cerebral Embolic Protection: Regulatory Perspectives

Cerebral Embolic Protection for TAVR Procedures: A Critical Appraisal

Patient Perspectives on Sham-Controlled Trials

FDA Perspectives on Sham-Controlled Trials

Sham Controls in Renal Denervation Studies: Need to Have vs Nice to Have?

ORBITA One Year Later: What Would I Do Differently, If Anything?

EFS Experiences Grom the Industry Client Perspective: Whats Good and What Needs to Change?

EFS Decisions: Start-up Company Considerations

Promoting Medical Device Innovation: MDIC Perspectives

The Second-Generation Cardiovascular EFS Pilot: Progress Report

The US EFS Program: FDA Update

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