IDEs in a New Device Space: An FDA View of Mitral John Laschinger, MD CDRH, ODE, DCD, SHDB...
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Transcript of IDEs in a New Device Space: An FDA View of Mitral John Laschinger, MD CDRH, ODE, DCD, SHDB...
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IDEs in a New Device Space:
An FDA View of Mitral
John Laschinger, MD CDRH, ODE, DCD, SHDB
Predictable And SuStainable Implementation Of National Registries For Cardiovascular Devices
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Key Issues to Consider
Registry Use in MV IDE Trials
• Applying Lessons learned from TAVR
• US Regulatory realities– Pre-Market– Post-Market • Sustainable model for
success utilizing Registries
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Clinical Considerations
What Currently Works Well – Lessons form TAVR
FLEXABILITY – Tailor Trials
• New Device for New Use (TMVR)Strategy trial vs. established SOC
• New Device for Established Use New Device Approval
• Iteration of Approved DeviceIterative Device Approval
• Old Device for New Use Label Expansion – Anchors, Access & populations
• Staged Pre-Clinical Testing• Standardized Outcome
Measures • 30 day Safety Composites• Time-Insensitive Effectiveness
Composites• Benchmark Outcomes –
Early PG
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What Currently Doesn’t Work Well – US Device Lag
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•Pre-Clinical Studies •Clinical Studies•FIH•Feasibility•Pivotal
•Other
EVIDENCEData Acquisition and
Analysis
•Evidence •Quality and Integrity•Quantity
UNCERTAINTY around the evidence
• Scientific Judgment
BETTERREGULATORY
DECISIONS
•Post-Market Data•Post market studies•MDR’s•Harmonized Registries
•Case for Quality Initiative•Design and Production
POST-MARKET REGISTRY
SURVEILLANCE
Changing the Pre – Post Market Balance
CDRH InitiativesPre-post Market BalanceExpedited Access PMA
Post-Market Surveillance
Short Term Goals: Optimizing Pre-Market Data
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Long Term Goals – Attracting Sponsors to the US
Enhanced Post-MarketSurveillance
Steps:• Early Entry: FIH and
EFS• Rapid Transitions
• Tailored Data Requirements
• Standardized Outcomes Measures
• “Staged” Trial Design
FIM EFS (30 d) Pivotal
JIT Pre-Clinical TestingStandardized Outcomes
Performance GoalsTailored Trials
Pre-Post Market Balance
Early Device
ApprovalU.S. EFS
(30d S & E)
Optimizing Data and Time
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Tiered Certification – Device Development
Enhancing the Value of Registries - SUSTAINABILITY
*Research Infrastructure /expertise for Pivotal Trials Full dataset capabilities: 0- 30-day to 1-5 year
Premarket uses – Essential for sustainability and industry support• Assurance of high quality reliable data• Recognition that capabilities of participants vary
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RisksHarmful eventsDevice: • Unsafe• Ineffective Benefits
Earlier Patient AccessAlternatives:• Absent• Limited use
Robust National
Medical Device Post-market Surveillance
System
Striking the Right Balance – Essential Role of Registries
Closing the Gap - Minimizing Pre-Market Data
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Robust
Accurate - real-world performance Timely
Quickly identifies• poorly performing devices • need for new or improved devices
Transparent Patients and Physicians Payors Regulators Industry
Facilitate device approval or clearance Reliable and Sustainable Registries
Requirements For an Effective Post-Market Registry
Information needed to make well-informed decisions
Closing the Gap - Minimizing Pre-Market Data
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Acute Device Safety Performance Goals - Future:• Risk population based• Individual or Composite 30 day MAE rates
for:– Mortality – Stroke– Paravalvular leak > 1+– Major Vascular Injury– Life Threatening Bleeding– AKI Grade 3– New Pacemaker/LBBB– Coronary Occlusion/MI– Urgent/Emergent OR
Safety: Timing and Performance Goals
• First Steps - We have developed Standard Outcomes for 30 day
Safety!Standardized 30 day Safety Composite:• Non-hierarchical composite • Includes:
• all-cause mortality,• disabling stroke, • life threatening bleeding,• acute kidney injury
requiring dialysis• major vascular
complications
Minimizing Pre-Market Data - Outcome Standardization
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Effectiveness: Timing and Performance Goals
Device Success:• Disabling Stroke free survival• Original/Intended device in place• No Additional valve/access related procedures• No paravalvular Complications (e.g. PPM,
Coronary occlusion, PVL > mild)• Intended performance of valve
‒ Gradient < 5mmHg, EOA > 1.5cm2
‒ MR < 2+‒ No hemolysis, fracture, migration,
endocarditis or thrombosis
• We have developed clinically meaningful composite measures of effectiveness that are time insensitive*
* Can be determined at any time point post procedure – followed post-market over time
Individual Patient Success:Device success AND
• No re-hospitalizations for HF or treated valve related causes
• NYHA class ≤ 2, or improvement in NYHA class by at least 1 level from baseline
• 6MWT >50 meter increase vs. baseline• KCCQ improvement by > 10 vs. baseline
Minimizing Pre-Market Data - Outcome Standardization
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Closing the Gap: Time to ApprovalNo Control Over Quality/Quantity of Early Data
Out of Our Control!
CE Mark
IDE Approval
FIM and EFS OUS DATA
Safety and Performance
≈Sufficient Safety to
initiate a clinical trial
Current Reality
TIME
PMA ApprovalSafety and Effectiveness
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CE Mark
IDE Approval
FIM and EFS OUS DATA
Safety and Performance
≈Sufficient Safety to
initiate a clinical trial
Current Regulatory Reality
TIMEPMA ApprovalSafety and Effectiveness
No Control Over Quality/Quantity of Early Data
Out of Our Control!
Time to Device Approval: US vs. EU
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Getting better Data Earlier
CE Mark
PMA Approval
US FIM /EFS PIVOTAL DATA
Safety and Performance
Getting Control:More Data Better Data
Earlier
Safety and Effectiveness
Closing the Gap: Time to Approval
Changing Reality
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Discussion