# Presentation: 337063

## 2004 FDA Workshop on Pre-clinical Testing for AAA Endovascular Grafts

- Dorothy B. Abel
- FDA/CDRH/DCD/PVDB

## Acknowledgements

- Organizers
- Dorothy Abel
- Angie Smith
- Marianne Grunwaldt

- Scientific Advisory Committee
- Matt Waninger
- Stuart Rodger
- Mark Dedashtian
- Lou Smith

**Notes:**
I think you need to have your name as one of the organizers !!!!!

## Introduction

- Describe the purpose of pre-clinical testing, beyond trying to predict clinical performance
- Identify the basic design requirements for endovascular grafts which will be the focus of the workshop
- Describe the workshop game-plan

## Purpose of Pre-clinical Testing

- Provide initial data on the device function, on the bench and in animals, prior to initiating a clinical study
- Anticipate the longer-term clinical performance of the device, given the relatively short term clinical results available at the time of approval

**Notes:**
My version is red – yours is green 

## Purpose of Pre-clinical Testing

- Characterize the device in order to identify the root cause of any subsequent failures
- Characterize the device so if changes are made it is possible to compare important parameters between the original and modified device
- Helps in identifying testing needed to be repeated or added
- May be useful in determining the root cause of failures observed in either design

**Notes:**
Again, my version in red – yours in green.

## Assessment of Pre-clinical Testing for Endovascular Grafts 

- Evaluating performance – not terrible, but there is a long list of clinical events that were not predicted by the pre-clinical testing
- Predicting longer-term clinical performance – about as good as evaluating performance
- Characterizing the device or modified device – pretty good, but inconsistent between manufacturers
- There is room for improvement!

**Notes:**
I highlighted the 3 categories and the last sentence for clarity.

## Hence this workshop.

## Basic Design Requirements for AAA Endovascular Grafts

- Get a grip
- Patient selection
- Delivery and deployment
- Hold on! (have adequate attachment strength)
- “Active” fixation, such as hooks or barbs
- Radial force
- No leaking (have adequate sealing)
- Radial force
- Other sealing mechanisms or enhancements
- Conformance to vessel wall

## Basic Design Requirements

- Maintain strength
- Device integrity
- Maintain performance under changing physiologic conditions
- Enlarging necks
- Aneurysm shape changes
- Changes in relative pressures

## AAA Endovascular Grafts

**AAA***** *****Endovascular Grafts**

## Topics for Discussion

- Session 1 - Animal Studies: A Retrospective and Prospective Evaluation
- Session 2 - Sealing and Fixation Effectiveness
- Session 3 - Device Integrity, Fatigue and Durability
- Session 4 - Clinical and Preclinical Performance: Past, Present and Future

## The Approach

- Look at what has been done in the past
- Identify the clinical failure modes that could and should be evaluated in animal testing or specific tests to evaluate sealing and fixation effectiveness or implant integrity
- Identify modifications required in test methods
- Determine additional information needed to improve testing parameters

## Session Structure

- Presentation(s) in effort to stimulate discussion
- Summary of our goals for the session
- Discussion with scheduled audience participation, with real time documentation