![](media/image1.png){width="0.59375in" height="0.59375in"} 2004 FDA
Workshop on Pre-Clinical

Testing *^for^* Endovascular Grafts

Dear Physician,

We are in the process of preparing for the second Workshop on
Pre-Clinical Testing for Endovascular Grafts, which will take place on
July 28-29, 2004, in Gaithersburg, MD. As with the previous meeting, we
are requesting input from the various areas involved with the
development, testing and use of endovascular grafts, such as industry,
the medical community and testing facilities.

We would greatly appreciate your input. We value your experience with
endovascular grafting and invite you to complete the simple survey which
is attached. As you will see, we are interested in capturing information
on your personal experience and opinions regarding endovascular grafts
today and in 2001. We are asking for your reflection on 2001, the year
of the previous workshop, to allow for an assessment of the evolution of
this technology. There are two ways to return your completed survey to
FDA: e-mail a copy to Dorothy Abel at dorothy.abel@fda.hhs.gov or fax it
to CDRH at (301) 827-4351 to the attention of Dorothy Abel.

Thank you in advance for your participation.

Dorothy Abel

Marianne Grunwaldt

Angela Smith

FDA/Office of Device Evaluation

**FDA Workshop Questionnaire**

1.  **Indicate the year you first completed an endovascular graft
    procedure by marking the appropriate box.**

  -------------- -------- ------- ------- ------- ------- ------- ------- -------
  Year of your                                                            
  first                                                                   
  endovascular                                                            
  graft                                                                   
  procedure                                                               

  Never          Before   91-92   93-94   95-96   97-98   99-00   01-02   03-04
                 1990                                                     

                                                                          
  -------------- -------- ------- ------- ------- ------- ------- ------- -------

2.  **Provide estimates regarding your AAA endovascular experience for
    the respective years by marking the appropriate box.**

  ---------------- -------- -------- -------- -------- -------- -------- --------
  Number of AAAs                                                         
  you treated                                                            
  endovascularly                                                         

  2001                                        2004                       

  0-10             11-50    51-100   101+     0-10     11-50    51-100   101+

                                                                         

  Percentage of                                                          
  AAAs you treated                                                       
  endovascularly                                                         

  2001                                        2004                       

  0-25             26-50    51-75    76-100   0-25     26-50    51-75    76-100

                                                                         
  ---------------- -------- -------- -------- -------- -------- -------- --------

3.  **Indicate the significance of each reason for choosing endovascular
    repair or surgical repair in the respective years by marking the
    appropriate box from 1 to 5, with 1 being the most important.**

  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------
  **Reason you chose endovascular repair over    **2001**                                   **2004**                           
  surgical repair**                                                                                                            

                                                 **1**      **2**   **3**   **4**   **5**   **1**      **2**   **3**   **4**   **5**

  Advances in endovascular devices                                                                                             

  Advances in endovascular techniques                                                                                          

  Amount of long-term data available for                                                                                       
  endovascular devices                                                                                                         

  Availability of endovascular devices                                                                                         

  Availability of particular configurations and                                                                                
  components                                                                                                                   

  Cost                                                                                                                         

  Novelty of endovascular devices                                                                                              

  Participation in a clinical study                                                                                            

  Patient preference                                                                                                           

  Patient SVS category                                                                                                         

  Procedure time                                                                                                               

  Recovery time                                                                                                                

  Reported rates of adverse events                                                                                             
  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------

  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------
  **Reason you chose surgical repair over        **2001**                                   **2004**                           
  endovascular repair**                                                                                                        

                                                 **1**      **2**   **3**   **4**   **5**   **1**      **2**   **3**   **4**   **5**

  Cost                                                                                                                         

  Implant sizes                                                                                                                

  Lack of availability of endovascular devices                                                                                 

  Lack of long-term data available for                                                                                         
  endovascular devices                                                                                                         

  Novelty of endovascular devices                                                                                              

  Patient anatomy                                                                                                              

  Patient gender                                                                                                               

  Patient preference                                                                                                           

  Patient SVS category                                                                                                         

  Reimbursement                                                                                                                

  Reported rates of adverse events                                                                                             
  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------

4.  **Indicate the significance of each criterion for selecting a
    specific device (e.g., Ancure, AneuRx, Zenith, Excluder) in the
    respective years by marking the appropriate box from 1 to 5, with 1
    being the most important.**

  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------
  **Criteria for selection of a specific         **2001**                                   **2004**                           
  device**                                                                                                                     

                                                 **1**      **2**   **3**   **4**   **5**   **1**      **2**   **3**   **4**   **5**

  Access to device                                                                                                             

  Accuracy of deployment                                                                                                       

  Amount of long-term data available                                                                                           

  Availability of particular configurations and                                                                                
  components                                                                                                                   

  Cost                                                                                                                         

  Delivery system size                                                                                                         

  Ease of deployment                                                                                                           

  Implant sizes                                                                                                                

  Materials of construction                                                                                                    

  Novelty (latest and greatest device)                                                                                         

  Participation in a clinical study                                                                                            

  Patient anatomy                                                                                                              

  Reimbursement                                                                                                                

  Reported rates of adverse events                                                                                             
  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------

5.  **Specify the number of devices you regularly used for the
    respective years by marking the appropriate box.**

  ----------- ----- ----- ----- ----- ----- ------ ----- ----- ----- ----- -----
  Number of                                                                
  specific                                                                 
  devices                                                                  
  (e.g.,                                                                   
  Ancure,                                                                  
  AneuRx,                                                                  
  Zenith,                                                                  
  Excluder)                                                                
  you                                                                      
  regularly                                                                
  use to                                                                   
  treat AAA                                                                

  2001                                      2004                           

  0           1     2     3     4     5+    0      1     2     3     4     5+

                                                                           
  ----------- ----- ----- ----- ----- ----- ------ ----- ----- ----- ----- -----

6.  **Indicate the number of devices you have stopped using according to
    the main reason.**

  ------------------------------------------------- ---------- ----------
  **Reasons for stopping use of a specific device** **2001**   **2004**

  Poor personal results                                        

  Poor literature reports                                      

  FDA communications                                           

  Manufacturer communications                                  

  Removal from market                                          

  Other: please specify                                        
  ------------------------------------------------- ---------- ----------

7.  **Indicate the significance of each criterion for your definition of
    successful treatment in the respective years by marking the
    appropriate box from 1 to 5, with 1 being the most important.**

  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------
  **Required for treatment to be successful**    **2001**                                   **2004**                           

                                                 **1**      **2**   **3**   **4**   **5**   **1**      **2**   **3**   **4**   **5**

  Absence of aneurysm expansion                                                                                                

  Absence of migration                                                                                                         

  Absence of type I endoleak                                                                                                   

  Absence of type II endoleak                                                                                                  

  Absence of type III endoleak                                                                                                 

  Absence of type IV endoleak                                                                                                  

  Aneurysm shrinkage                                                                                                           

  Device integrity                                                                                                             

  Patency                                                                                                                      

  Re-intervention not needed                                                                                                   
  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------

8.  **Indicate the significance of each characteristic which you believe
    provides the most challenging anatomical limitations in endovascular
    grafting in the respective years by marking the appropriate box from
    1 to 5, with 1 being the most important.**

  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------
  **Characteristic**                             **2001**                                   **2004**                           

                                                 **1**      **2**   **3**   **4**   **5**   **1**      **2**   **3**   **4**   **5**

  Proximal neck angulation                                                                                                     

  Proximal neck shape                                                                                                          

  Proximal neck length                                                                                                         

  Calcification in proximal neck                                                                                               

  Thrombus in proximal neck                                                                                                    

  Calcification at distal attachment site                                                                                      

  Distal attachment site length                                                                                                

  Distal attachment site tortuosity                                                                                            

  Thrombus at distal attachment site                                                                                           

  Thrombus in aneurysm sack                                                                                                    

  Access vessel size                                                                                                           

  Access vessel morphology (e.g., calcification,                                                                               
  tortuosity)                                                                                                                  

  Accessory renal arteries                                                                                                     

  Narrow distal aorta                                                                                                          

  Involvement of iliac artery (i.e., extent of                                                                                 
  iliac aneurysmal disease)                                                                                                    

  Physician training                                                                                                           

  Physician ego                                                                                                                
  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------

9.  **Indicate the significance of each failure mode in the respective
    years by marking the appropriate box from 1 to 5, with 1 being the
    most important.**

  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------
  **Failure Mode**                               **2001**                                   **2004**                           

                                                 **1**      **2**   **3**   **4**   **5**   **1**      **2**   **3**   **4**   **5**

  Aneurysm rupture                                                                                                             

  Component separation                                                                                                         

  Endotension                                                                                                                  

  Graft wear holes                                                                                                             

  Limb occlusion                                                                                                               

  Migration                                                                                                                    

  Seam failure                                                                                                                 

  Stent fracture                                                                                                               

  Suture breaks                                                                                                                

  Type I endoleak                                                                                                              
  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------

10. **Provide estimates regarding your AAA endovascular experience for
    the respective years by marking the appropriate box.**

  ----------------- -------- -------- -------- -------- -------- -------- --------
  Percentage of                                                           
  patients                                                                
  requiring                                                               
  endovascular                                                            
  re-intervention                                                         

  2001                                         2004                       

  0-25              26-50    51-75    76-100   0-25     26-50    51-75    76-100

                                                                          

  Percentage of                                                           
  patients                                                                
  requiring                                                               
  conversion to                                                           
  surgical repair                                                         

  2001                                         2004                       

  0-25              26-50    51-75    76-100   0-25     26-50    51-75    76-100

                                                                          
  ----------------- -------- -------- -------- -------- -------- -------- --------

11. **Rank order your top five (from 1 to 5, with 1 being the most
    important) causes for re-intervention in the respective years.**

  ------------------------------ ------------------ ---------- ------------ ----------
  **Causes for Re-intervention** **Endovascular**              **Surgical   
                                                               Repair**     

                                 **2001**           **2004**   **2001**     **2004**

  Aneurysm expansion                                                        

  Aneurysm rupture                                                          

  Component separation                                                      

  Endotension                                                               

  Limb occlusion                                                            

  Loss of device integrity                                                  

  Migration                                                                 

  Neck expansion                                                            

  Type I endoleak                                                           

  Type II endoleak                                                          

  Type III endoleak                                                         

  Type IV endoleak                                                          
  ------------------------------ ------------------ ---------- ------------ ----------

12. **Indicate the significance of each reason that would lead you to
    intervene if you have an expanding aneurysm in absence of an
    endoleak in the respective years by marking the appropriate box from
    1 to 5, with 1 being the most important.**

  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------
  **Reasons for Intervention**                   **2001**                                   **2004**                           

                                                 **1**      **2**   **3**   **4**   **5**   **1**      **2**   **3**   **4**   **5**

  Amount of growth                                                                                                             

  Gestalt                                                                                                                      

  Migration                                                                                                                    

  Patient becomes symptomatic                                                                                                  

  Patient request                                                                                                              

  Wouldn't intervene                                                                                                           
  ---------------------------------------------- ---------- ------- ------- ------- ------- ---------- ------- ------- ------- -------

13. **Indicate your use of IFUs by marking the appropriate box.**

  -------------- -------- ---------- ----------- ---------------- ----------- ------- --------------
  First time you                                                                      
  read an IFU                                                                         
  for an                                                                              
  endovascular                                                                        
  graft (check                                                                        
  all that                                                                            
  apply)                                                                              

  Never          Before              1990-1995                    1996-2000           2001-2004
                 1990                                                                 

                                                                                      

  Last time you                                                                       
  read an IFU                                                                         
  for an                                                                              
  endovascular                                                                        
  graft                                                                               

  Same as above  Before              1990-1995                    1996-2000           2001-2004
                 1990                                                                 

                                                                                      

  How often do                                                                        
  you read an                                                                         
  IFU for an                                                                          
  endovascular                                                                        
  graft (check                                                                        
  all that                                                                            
  apply)                                                                              

  Never                   Only                   Intermittently               Every   
                          during                                              case    
                          training                                                    

                                                                                      
  -------------- -------- ---------- ----------- ---------------- ----------- ------- --------------

14. **Mark the appropriate box regarding your AAA endovascular
    experience.**

  -------------------------------------------------------- --------- --------
  **AAA Endovascular Experience**                          **Yes**   **No**

  Have you been involved in the design of endovascular               
  devices?                                                           

  Have you been involved in the preclinical testing of               
  endovascular devices (e.g., animal studies, bench                  
  testing)?                                                          

  Have you done an endovascular fellowship?                          

  Did you receive interventional training from:                      

  vascular surgeon                                                   

  radiologist                                                        

  endovascular specialist                                            

  Have you submitted any investigator-sponsored IDEs?                

  Have you participated in any manufacturer-sponsored IDE            
  studies?                                                           

  You are 60 years old and have a 5.5 cm abdominal aortic            
  aneurysm. You have no co-morbidities and are a good open           
  repair candidate. Would **you** get endovascular repair?           
  -------------------------------------------------------- --------- --------