Innovation
Regulatory Science and Reimbursement Learning Series
FDA Townhall Meeting
Episodes
Pros and Cons of the Win Ratio as the Primary Endpoint for Pivotal Heart Failure Trial
10 min.
Strengths and Limitations of a Two-Phase (6-Month Intermediate Endpoints & 12-18 Month Mortality and Heart Failure Hospitalization) Design for Trials on Chronic Heart Failure Devices
10 min.
Regulatory Aspects for Chronic Heart Failure Devices - FDA Perspective
10 min.
Application of Exception from Informed Consent to a Multicenter Cardiogenic Shock Trial
9 min.
How Tightly Should Treatment Algorithms Be Prescribed in a Clinical Trial on Cardiogenic Shock? What Are The Key Treatment Protocol Elements?
9 min.
How Narrow or Broad Should Enrollment Criteria Be in Trials on Cardiogenic Shock to Achieve Clinically Interpretable Results?
7 min.
Clinically Meaningful and Practical Pivotal Trial Endpoints for Devices in Acute Decompensated Heart Failure
9 min.
Invasive Investigational Device IDE Studies for Acute Decompensated Heart Failure: For Diuretic-Resistant Patients Only?
9 min.
Regulatory Questions on Device Trials for Acute Decompensated Heart Failure - FDA Perspective
6 min.
The Conundrum of Clinical Trials in Cardiogenic Shock
16 min.
Screen Failures, Technology Woes, Lack of Clinical Evidence, and Difficult Clinical Trial Pathways – TMVR is No More than a Niche!
5 min.
Second Wave Technology Will Solve Most Problems – TMVR is Here to Stay in a Big Way!
16 min.
PROs are a Powerful Endpoint in TR Interventional Trials
8 min.
PROs Alone in Non-Blinded Studies Shouldn’t Drive Device Approval
28 min.
Acute Decompensated HF Trials: Who Should be Enrolled and What Should the Study Endpoints Be?
15 min.
Wearable HF Monitoring Devices: Landscape Overview, Patient Indications, and Implementation Science
25 min.
What Will the Next Trial Designs Look Like for Renal Denervation?
22 min.
Renal Denervation — Clinician Perspectives
19 min.
Renal Denervation — Industry Perspectives
5 min.
Renal Denervation — Trialist Perspectives
7 min.
FDA and Diversity Initiatives
8 min.
Diversity and Inclusion: Implications for RCTs and Work Force Considerations
35 min.
Clinician Perspectives
9 min.
Early Feasibility Studies (EFS) - A 10-Year Perspective - Lessons Learned
11 min.
Multiple perspectives on Early Feasibility Studies - Medical Device Innovation Consortium's Perspective
6 min.
EFS: Heart Valve Collaboratory
7 min.
Early Feasibility Program: Viewpoints From Europe
7 min.
MDIC and EFS: The Good, the Bad, and the Ugly (Case Examples)
6 min.
What Should EFS 2.0 Look Like?
42 min.
Status Update on the Breakthrough Device Transitional Coverage for Emerging Technologies Program (TCET)
10 min.
Understanding the New Technology Add-on Payments Program (NTAP)
9 min.
The FDA Total lifecycle Advisory Program (FDA-TAP)
36 min.
Overcoming the "Credibility Crisis" of Observational Data
13 min.
FDA Perspectives
8 min.
Industry Perspectives
9 min.
Challenges, Opportunities, and Future Projections for Device Innovation, Approval, and Implementation - FDA Perspective
59 min.
The Transformative Potential of Digital Health Strategies to Impact Clinical Research and Patient Outcomes
15 min.
The Importance of Pre-emptive TAVR in the Future Management of Aortic Stenosis
13 min.
Strengths and Limitations of Patient Reported Outcomes as Major Endpoints in "Modern Era" CV Trials
12 min.
Cardiogenic Shock Trials: Defining the Clinical Need and Framing the Issues
10 min.
Transformative Changes in Clinical Research: A Futurist’s Viewpoint
16 min.
Health Equity Issues in Clinical Trials: Can We Accelerate Progress?
15 min.
FDA Recovering From a Pandemic: Lessons Learned and Future Adjustments
10 min.
FDA Update on EFS Requirements for TTVR Technologies
9 min.