# Presentation: 318911

## Session 4 – Clinical and Preclinical Performance: Past, Present, and Future 

## Workshop Comments

- Controls:
- Animal study
- Look for biological response and compare to devices already marketed (devices may be hard to obtain)
- Dependent on what you want to evaluate
- Used to shed light on anomalies
- Clinical study
- Surgical, historical
- Not comparable patient populations
- Comparison to currently marketed EVG – shift in gold standard?

## Session 1: Workshop Wrap-up 

| Session Wrap-up Conclusions | What information is needed? | How should this be accomplished or obtained? | When should this be accomplished or obtained? |
| --- | --- | --- | --- |
|  |  |  |  |
|  |  |  |  |

## Slide 4

| Animal Study Conclusions | How should this be accomplished or obtained? | When should this be accomplished or obtained? |
| --- | --- | --- |
| Primary endpoints: biological response and delivery and deployment | Modification to methodology | Immediately |
| Secondary endpoints: document any anomalies  | Modification to methodology | Immediately |

## Slide 5

| Animal Study Conclusions | How should this be accomplished or obtained? | When should this be accomplished or obtained? |
| --- | --- | --- |
| Testing plans for the future could include stopping rules and possible incorporation of non-destructive evaluations | Modification to methodology | Immediate |
| It may be possible to develop a battery of standardized tests (e.g., different animal models to test different parameters.)
 |  | proposal |

## Slide 6

| Animal Study Conclusions | How should this be accomplished or obtained? | When should this be accomplished or obtained? |
| --- | --- | --- |
| It may be worthwhile to develop and validate an atherosclerotic diseased model | Academic research | If funded |
| It may be of value to develop and validate an aneurysmal model | Academic research |  |

## Session 2: Workshop Wrap-up

| Sealing and Fixation Effectiveness Conclusions | How should this be accomplished or obtained? | When should this be accomplished or obtained? |
| --- | --- | --- |
| Incorporate tolerance limits and “safety factors”  | Modifications to ISO standard | Begin within a year |
| Consider testing to failure – (not in labeling) | Modifications to ISO standard | Begin within a year |

## Slide 8

| Sealing and Fixation Effectiveness Conclusions | How should this be accomplished or obtained? | When should this be accomplished or obtained? |
| --- | --- | --- |
| Consider evaluating parameters as a function of neck angles, oversizing
 | Modifications to ISO standard
Industry-sponsored development of test method
 | Begin within a year

Individually – now
Mainstream – a few years
 |
| Modify migration resistance testing to incorporate vessel morphology (e.g., eccentric lumen) | Industry-sponsored development of test method | Individually – now
Mainstream – a few years |

## Slide 9

| Sealing and Fixation Effectiveness Conclusions | How should this be accomplished or obtained? | When should this be accomplished or obtained? |
| --- | --- | --- |
| Be aware of potential for hysteresis in your test set-up or your device in evaluation of radial force | Industry - Modification to testing methodology | Immediate |

## Session 3: Workshop Wrap-up

| Device Integrity Conclusions | How should this be accomplished or obtained? | When should this be accomplished or obtained? |
| --- | --- | --- |
| Current pulsatile fatigue testing only addressed metallic fatigue other tests are needed to evaluate other failure modes |  |  |
| Angulated graft and suture wear | Industry-sponsored development of test method
Individually – now
Mainstream – a few years

 |  |
| Bending fatigue test |  |  |
| Longitudinal fatigue test |  |  |

## Slide 11

| Device Integrity Conclusions | How should this be accomplished or obtained? | When should this be accomplished or obtained? |
| --- | --- | --- |
| Current pulsatile fatigue testing only addressed metallic fatigue other tests are needed to evaluate other failure modes |  |  |
| Test constrained and unconstrained transition | Industry-sponsored development of test method
Individually – now
Mainstream – a few years |  |
| Test to address failures seen in devices with clinical use |  |  |
| Test for pulsatile with an angulated neck |  |  |

## Slide 12

| Device Integrity Conclusions | How should this be accomplished or obtained? | When should this be accomplished or obtained? |
| --- | --- | --- |
| May be possible to develop one test incorporating more characteristics (see Lombard Medical) | Industry-sponsored development of test method | Individually – now
Mainstream – a few years |
| Consider testing to failure | Modifications to ISO standard | Begin within a year |

## Slide 13

| What information is needed to improve implant integrity testing? | How should this be accomplished or obtained? | When should this be accomplished or obtained? |
| --- | --- | --- |
| Compliance | Academic research | Within a year  |
| Better define anatomy of aneurysms (for design) | Review available clinical information, aggregate database  | Within a couple of years |