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Presentation TCT 2016

Reimbursement Challenges For LAAC: Balancing The Clinical Need Vs. Robust Data Vs. Societal Economic Considerations

Presenter: Aaron V. Kaplan, Rachel Neubrander, Tamara Syrek Jensen

November 01, 2016

Presentation TCT 2016

Pivotal Trial Design Considerations: Noninferiority vs Superiority, Device, Control Arm Anticoagulation Durations, NOAC Considerations and More Industry and Clinician Perspectives

Presenter: Aaron V. Kaplan, Rachel Neubrander, Brian K. Whisenant

November 01, 2016

Presentation TCT 2016

Trial Designs For LAA Closure: Potential Regulatory Pathways and Unanswered Questions What FDA Would Like to See

Presenter: Aaron V. Kaplan, Rachel Neubrander, Katherine Wallon

November 01, 2016

Presentation TCT 2016

The Tricuspid Valve: Challenges for Clinical Investigation

Presenter: Matthew G. Hillebrenner, Michael J. Mack, Rebecca T. Hahn

November 01, 2016

Presentation TCT 2016

Learnings From A Pivotal Transcatheter Mitral Device Trial: Can The MVARC/COAPT Paradigm Be Shortened?

Presenter: Matthew G. Hillebrenner, Michael J. Mack, Gregg W. Stone

November 01, 2016

Presentation TCT 2016

Possible Approval Pathways for New Mitral and Tricuspid Valve Therapies

Presenter: Matthew G. Hillebrenner, Michael J. Mack, John C Laschinger

November 01, 2016

Presentation TCT 2016

Spectrum and Assessment of TAVR Accessory Devices (Valvuloplasty Balloons, Neuroprotection Systems, and More)

Presenter: Nicole Ibrahim, Martin B. Leon

November 01, 2016

Presentation TCT 2016

Valve Degeneration and Mobility Considerations: Assessing Clinical Relevance

Presenter: Nicole Ibrahim, Martin B. Leon, Raj Makkar

November 01, 2016

Presentation TCT 2016

FDA Perspectives on TAVR Label Expansion (E.G. Lower Risk Patients, Bicuspid Aortic Stenosis and Aortic Insufficiency), and New and Iterative Device Approval Pathways

Presenter: Nicole Ibrahim, Martin B. Leon, Jaime Raben

November 01, 2016

Presentation TCT 2016

Industry Perspectives: Balancing Innovation and Robust Clinical Evidence Generation With Declining DES Use and Reimbursement

Presenter: Michael C. John, Gregg W. Stone, Jason R. Weidman

November 01, 2016

Presentation TCT 2016

Bioresorbable Scaffolds - Lessons Learned From the ABSORB Odyssey: Industry Perspectives

Presenter: Michael C. John, Gregg W. Stone, Chuck Simonton

November 01, 2016

Presentation TCT 2016

FDA Perspectives on Short DAPT IDE Trials

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

November 01, 2016

Presentation TCT 2016

FDA Regulatory Considerations for Novel and Not-So-Novel New Metallic DES and Bioresorbable Scaffolds

Presenter: Michael C. John, Gregg W. Stone, P.F. Adrian Magee

November 01, 2016

Presentation TCT 2016

My Most Challenging Case 2016: STEMI with Multivessel Disease

Presenter: Shao-Liang Chen, Ajay J. Kirtane, Manish A. Parikh, Bo Xu, Ning Guo

October 31, 2016

Presentation TCT 2016

My Most Challenging Case 2016: Severe LV Dysfunction

Presenter: Shao-Liang Chen, Ajay J. Kirtane, Manish A. Parikh, Bo Xu, Qi Zhang

October 31, 2016

Presentation TCT 2016

My Most Challenging Case 2016: Chronic Total Occlusion

Presenter: Shao-Liang Chen, Ajay J. Kirtane, Manish A. Parikh, Bo Xu, Bin Zhang

October 31, 2016

Presentation TCT 2016

My Most Challenging Case 2016: Severe Calcified Lesion

Presenter: Shao-Liang Chen, Ajay J. Kirtane, Manish A. Parikh, Bo Xu, Juying Qian

October 31, 2016

Presentation TCT 2016

Welcome and Introduction

Presenter: Shao-Liang Chen, Ajay J. Kirtane, Manish A. Parikh, Bo Xu

October 31, 2016

Presentation TCT 2016

EFS in the USA: Challenges and Developments (An Investigators Perspective)

Presenter: Andrew Farb, Aaron V. Kaplan, Martin B. Leon

October 31, 2016

Presentation TCT 2016

Early Feasibility Studies in the USA: Early Example With Success

Presenter: Andrew Farb, Aaron V. Kaplan, Steven R. Bailey

October 31, 2016

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Reimbursement Challenges For LAAC: Balancing The Clinical Need Vs. Robust Data Vs. Societal Economic Considerations

Pivotal Trial Design Considerations: Noninferiority vs Superiority, Device, Control Arm Anticoagulation Durations, NOAC Considerations and More Industry and Clinician Perspectives

Trial Designs For LAA Closure: Potential Regulatory Pathways and Unanswered Questions What FDA Would Like to See

The Tricuspid Valve: Challenges for Clinical Investigation

Learnings From A Pivotal Transcatheter Mitral Device Trial: Can The MVARC/COAPT Paradigm Be Shortened?

Possible Approval Pathways for New Mitral and Tricuspid Valve Therapies

Spectrum and Assessment of TAVR Accessory Devices (Valvuloplasty Balloons, Neuroprotection Systems, and More)

Valve Degeneration and Mobility Considerations: Assessing Clinical Relevance

FDA Perspectives on TAVR Label Expansion (E.G. Lower Risk Patients, Bicuspid Aortic Stenosis and Aortic Insufficiency), and New and Iterative Device Approval Pathways

Industry Perspectives: Balancing Innovation and Robust Clinical Evidence Generation With Declining DES Use and Reimbursement

Bioresorbable Scaffolds - Lessons Learned From the ABSORB Odyssey: Industry Perspectives

FDA Perspectives on Short DAPT IDE Trials

FDA Regulatory Considerations for Novel and Not-So-Novel New Metallic DES and Bioresorbable Scaffolds

My Most Challenging Case 2016: STEMI with Multivessel Disease

My Most Challenging Case 2016: Severe LV Dysfunction

My Most Challenging Case 2016: Chronic Total Occlusion

My Most Challenging Case 2016: Severe Calcified Lesion

Welcome and Introduction

EFS in the USA: Challenges and Developments (An Investigators Perspective)

Early Feasibility Studies in the USA: Early Example With Success

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