**SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)**

**EXCLUDER™ Bifurcated Endoprosthesis (EBE)**

**Table of Contents**

**Section Page**

**1.0 General Information 2-4**

**2.0 Indications and Usage 2-4**

**3.0 Contraindications 2-4**

**4.0 Warnings and Precautions 2-4**

**5.0 Device Description 2-4**

**6.0 Alternative Practices and Procedures 2-9**

**7.0 Marketing History 2-9**

**8.0 Adverse Events 2-10**

**9.0 Summary of Pre-clinical Results 2-10**

9.1 Biocompatibility 2-10

9.2 Animal Studies 2-12

9.3 Product Testing 2-14

*9.3.1 Delivery System Test Results Summary 2-14*

*9.3.2 Implant Test Results Summary 2-16*

4.  Additional Studies 2-21

**10.0 Summary of Clinical Studies 2-21**

10.1 Objectives 2-21

10.2 Study Design 2-21

10.3 Description of Patients and Gender Bias 2-22

4.  Results 2-22

*10.4.1 Primary Outcomes: Safety and Effectiveness 2-23*

*10.4.2 Secondary Outcomes 2.27*

**11.0 Conclusions Drawn from the Studies 2.27**

**Table of Figures**

**Section Page**

**Device Description**

5-1 Trunk-Ipsilateral Leg Endoprosthesis 2-5

5-2 Contralateral Leg Endoprosthesis 2-6

5-3 Aortic Extender Endoprosthesis 2-6

5-4 Iliac Extender Endoprosthesis 2-7

5-5 EXCLUDER Endoprosthesis Delivery Catheter 2-7

**Table of Tables**

**Section Page**

**Device Description**

5.1 Trunk-Ipsilateral Leg Sizes 2-8

5.2 Contralateral Leg Endoprosthesis Sizes 2-8

5.3 Aortic Extender Endoprosthesis Sizes 2-8

5.4 Iliac Extender Endoprosthesis Sizes 2-9

**Adverse Events**

8.1 Major Adverse Events according to Type, Time and Study Group 2-10

**Summary of Pre-clinical Results**

9.1 Summary of Biocompatibility Test Results for the Implant 2-11

9.2 Summary of Biocompatibility Test Results for the Catheter 2-12

9.3 Summary of Preclinical *In Vivo* Studies 2-13

4.  Summary of Test Results Related to the EBE Delivery System

    Functionality 2-15

    9.5 Summary of Test Results Related to the EBE Implant Functionality
    2-17

    **Summary of Clinical Studies**

    10.1 Comparison of Subject Characteristics 2-22

    10.2 Aneurysm Diameter Distribution 2-23

    10.3 Principal Safety Results 2-23

    10.4 Device Integrity Assessment by KUB Imaging Data 2-24

    10.5 Occlusion or Narrowing of the Flow Channel by CT Imaging Data
    2-24

    10.6 CT Findings - Trunk Migration 2-24

    10.7 KUB Findings - Component Migration 2-24

    10.8 Endoleak Status according to Evaluation Interval 2-25

    10.9 Change in Aneurysm Size by Interval 2-25

    10.10 Maximum Aneurysm Diameter and Endoleaks at 12-Months 2-25

    10.11 Maximum Aneurysm Diameter and Endoleaks at 24-Months 2-25

    10.12 Interventions for Endoleak and Aneurysm Size Increases 2-26

    10.13 Secondary Outcomes by Treatment Group 2-27

    **Summary of Safety and Effectiveness Data (SSED)**

    **EXCLUDER™ Bifurcated Endoprosthesis**

**1.0 General Information**

Device Generic Name...................Endovascular Graft

Device Trade Name......................EXCLUDER Bifurcated
Endoprosthesis

> Applicant's Name and Address......\...W. L. Gore and Associates, Inc.

1327 Orleans Drive

> Sunnyvale, CA 94089

PMA Application Number........... .....M000014/PMA

**2.0 Indications and Usage**

The EXCLUDER Endoprosthesis is intended to exclude the aneurysm from the
blood circulation in patients diagnosed with infrarenal AAA disease and
who have appropriate anatomy.

**3.0 Contraindications**

Known contraindications include, but are not limited to:

-   significant thrombus at the arterial implantation sites,
    specifically proximal aortic neck and distal iliac artery interface

-   severe proximal aortic neck angulation \>60º

-   infrarenal aortic neck \<15 mm in length

-   illio-femoral access vessel morphology which is not compatible with
    vascular access techniques, devices and accessories.

**4.0 Warnings and Precautions**

See Warnings and Precaution in the labeling (Instructions for Use)

**5.0 Device Description**

The EXCLUDER Bifurcated Endoprosthesis is comprised of an implantable
prosthesis (endoprosthesis) and a catheter delivery system. The EXCLUDER
Bifurcated Endoprosthesis System consists of four modular components
(Figures 5-1 to 5-4). The two primary modular components are the
Trunk-Ipsilateral Leg and the Contralateral Leg. There are also two
optional components, the Aortic Extender and Iliac Extender. Each
component is loaded onto its own delivery catheter and is packaged
separately.

The Trunk-Ipsilateral Leg component is a single aorta-sized ultra-thin
expanded polytetrafluoroethylene (ePTFE) tube, with an external nitinol
supporting structure which bifurcates into two smaller tubes (Figure
5-1). One tube forms the longer Ipsilateral Leg limb, and the other a
shorter Contralateral Leg Hole. A radiopaque ring of gold wire is
embedded in the Contralateral Leg Hole for visualization of the leg hole
after deployment. The external nitinol supporting structure consists of
a nitinol wire shaped into an undulating helix. The nitinol supporting
structure is located on the outside of the graft material, and is
attached to the graft material with tape made of ePTFE and fluorinated
ethylene propylene (FEP). On the proximal end of the device, nitinol
anchors are incorporated into the supporting stent structure, and angle
away from the stent to provide anchoring support against the vessel. The
proximal end of the device also contains an external sealing cuff to aid
in preventing blood flow around the outside of the device.

![](media/image1.png){width="0.8048611111111111in" height="3.3in"}

Figure 5-1. Trunk-Ipsilateral Leg Endoprosthesis

The Contralateral Leg is a separate component which is placed in the
Trunk-Ipsilateral Leg. The Contralateral Leg consists of a tapered
expanded polytetrafluoroethylene (ePTFE) tube, an external nitinol
supporting stent structure, and radiopaque markers which aid in proper
positioning (Figure 5-2).

![](media/image2.png)

Figure 5-2. Contralateral Leg Endoprosthesis

The Aortic Extender (Figure 5-3) is intended to be used electively after
the EXCLUDER Bifurcated Endoprosthesis is placed in the abdominal aorta.
The Aortic Extender is intended to be used when additional length and/or
sealing for aneurysmal exclusion are desired. The Aortic Extender is
placed inside of the EXCLUDER Bifurcated Endoprosthesis. It is a
straight ePTFE tube with a nitinol supporting stent structure, and
radiopaque markers. It is compressed to a small diameter inside a sleeve
and mounted onto a delivery catheter.

![](media/image3.png)

Figure 5-3. Aortic Extender Endoprosthesis

The Iliac Extender (Figure 5-4) is intended to be used electively after
deployment of the EXCLUDER Bifurcated Endoprosthesis. The Iliac Extender
provides additional overall device length flexibility and/or sealing for
aneurysmal exclusion. The endoprosthesis can be inserted into either the
Contralateral or Ipsilateral leg component of the EXCLUDER Bifurcated
Endoprosthesis. The Iliac Extender consists of a tapered expanded
polytetrafluoroethylene (ePTFE) tube, an external nitinol supporting
stent structure, and radiopaque markers.

![](media/image4.png)

Figure 5-4. Iliac Extender Endoprosthesis

The EXCLUDER Endoprostheses are constrained with an ePTFE sleeve and are
packaged separately on the leading end of the delivery catheter (Figure
5-5). The delivery catheters for the Trunk-Ipsilateral Leg,
Contralateral Leg, Aortic and Iliac Extender Delivery Systems are
similar in materials and operation. All the catheters consist of
stainless steel braid-reinforced outer shaft tubing, two olives (oval
beads) on either side of the constrained endoprosthesis, a proximal
adapter, a single lumen inner tubing for the guidewire and a separate
lumen for the deployment line. An ePTFE deployment line, used to sew the
sleeve closed, is located within the deployment lumen of the catheter
shaft. The deployment line then leads to the deployment knob within the
proximal adapter. Thus the deployment line, the deployment knob and the
sleeve represent the deployment system.

![](media/image5.png){width="4.243055555555555in" height="0.825in"}

Figure 5-5. EXCLUDER Endoprosthesis Delivery Catheter

All the endoprostheses are available in a range of lengths and diameters
to accommodate variations in patient anatomy. The following tables
(5.1-5.4) list the Part Number and sizes for the Bifurcated EXCLUDER
Endoprosthesis (Trunk-Ipsilateral Leg and the Contralateral Leg) and the
EXLUDER Extender Endoprosthesis (Aortic and Iliac).

###  {#section .Table-1}

### **Table 5.1. Trunk-Ipsilateral Leg Sizes** {#table-5.1.-trunk-ipsilateral-leg-sizes .Table-1}

###  {#section-1 .Table-1}

+----------------+-----------------+-----------------+-----------------+
| **Part         | **E             | *               | **E             |
| Number**       | ndoprosthesis** | *Endoprosthesis | ndoprosthesis** |
|                |                 | Iliac Diameter  |                 |
|                | **Aortic        | \[mm\]**        | **Length**      |
|                | Diameter        |                 |                 |
|                | \[mm\]**        |                 | **\[cm\]**      |
+----------------+-----------------+-----------------+-----------------+
| **PCT231216**  | 23              | 12              | 16              |
+----------------+-----------------+-----------------+-----------------+
| **PCT231218**  | 23              | 12              | 18              |
+----------------+-----------------+-----------------+-----------------+
| **PCT231416**  | 23              | 14.5            | 16              |
+----------------+-----------------+-----------------+-----------------+
| **PCT231418**  | 23              | 14.5            | 18              |
+----------------+-----------------+-----------------+-----------------+
| **PCT261216**  | 26              | 12              | 16              |
+----------------+-----------------+-----------------+-----------------+
| **PCT261218**  | 26              | 12              | 18              |
+----------------+-----------------+-----------------+-----------------+
| **PCT261416**  | 26              | 14.5            | 16              |
+----------------+-----------------+-----------------+-----------------+
| **PCT261418**  | 26              | 14.5            | 18              |
+----------------+-----------------+-----------------+-----------------+
| **PCT281216**  | 28.5            | 12              | 16              |
+----------------+-----------------+-----------------+-----------------+
| **PCT281218**  | 28.5            | 12              | 18              |
+----------------+-----------------+-----------------+-----------------+
| **PCT281416**  | 28.5            | 14.5            | 16              |
+----------------+-----------------+-----------------+-----------------+
| **PCT281418**  | 28.5            | 14.5            | 18              |
+----------------+-----------------+-----------------+-----------------+

###   {#section-2 .Table-1}

###  {#section-3 .Table-1}

### **Table 5.2. Contralateral Leg Endoprosthesis Sizes** {#table-5.2.-contralateral-leg-endoprosthesis-sizes .Table-1}

###  {#section-4 .Table-1}

+--------------+-----------------+-----------------+-----------------+
| **Part       | *               | **E             | **E             |
| Numbers**    | *Endoprosthesis | ndoprosthesis** | ndoprosthesis** |
|              | Proximal        |                 |                 |
|              | Diameter**      | **Iliac         | **Length**      |
|              |                 | Diameter**      |                 |
|              | **\[mm\]**      |                 | **\[cm\]**      |
|              |                 | **\[mm\]**      |                 |
+--------------+-----------------+-----------------+-----------------+
| *            | 16              | 12              | 10              |
| *PCC121000** |                 |                 |                 |
+--------------+-----------------+-----------------+-----------------+
| *            | 16              | 12              | 12              |
| *PCC121200** |                 |                 |                 |
+--------------+-----------------+-----------------+-----------------+
| *            | 16              | 12              | 14              |
| *PCC121400** |                 |                 |                 |
+--------------+-----------------+-----------------+-----------------+
| *            | 16              | 14.5            | 10              |
| *PCC141000** |                 |                 |                 |
+--------------+-----------------+-----------------+-----------------+
| *            | 16              | 14.5            | 12              |
| *PCC141200** |                 |                 |                 |
+--------------+-----------------+-----------------+-----------------+
| *            | 16              | 14.5            | 14              |
| *PCC141400** |                 |                 |                 |
+--------------+-----------------+-----------------+-----------------+

### **Table 5.3. Aortic Extender Endoprosthesis Sizes** {#table-5.3.-aortic-extender-endoprosthesis-sizes .Table-1}

###  {#section-5 .Table-1}

+----------------------+----------------------+-----------------------+
| **Part Numbers**     | **Endoprosthesis     | **Endoprosthesis**    |
|                      | Diameter**           |                       |
|                      |                      | **Lengths**           |
|                      | **\[mm\]**           |                       |
|                      |                      | **\[cm\]**            |
+----------------------+----------------------+-----------------------+
| **PCA230300**        | 23                   | 3.3                   |
+----------------------+----------------------+-----------------------+
| **PCA260300**        | 26                   | 3.3                   |
+----------------------+----------------------+-----------------------+
| **PCA280300**        | 28.5                 | 3.3                   |
+----------------------+----------------------+-----------------------+

### **Table 5.4. Iliac Extender Endoprosthesis Sizes** {#table-5.4.-iliac-extender-endoprosthesis-sizes .Table-1}

###  {#section-6 .Table-1}

+---------------+-----------------+-----------------+-----------------+
| **Part        | *               | *               | **E             |
| Numbers**     | *Endoprosthesis | *Endoprosthesis | ndoprosthesis** |
|               | Proximal        | Iliac           |                 |
|               | Diameter**      | Diameter**      | **Length**      |
|               |                 |                 |                 |
|               | **\[mm\]**      | **\[mm\]**      | **\[cm\]**      |
+---------------+-----------------+-----------------+-----------------+
| **PCL161007** | 16              | 10              | [7]{.smallcaps} |
+---------------+-----------------+-----------------+-----------------+
| **PCL161207** | 16              | 12              | 7               |
+---------------+-----------------+-----------------+-----------------+
| **PCL161407** | 16              | 14.5            | 7               |
+---------------+-----------------+-----------------+-----------------+

**6.0 Alternative Practices and Procedures**

The generally accepted treatment for AAA repairs is surgical repair,
which involves dissecting the aneurysm and placing a synthetic graft
inside the diseased tissue. AAA diagnosed patients who are considered
good or acceptable surgical and anesthetic risk are recommended for
elective surgical repair when the aneurysm shows rapid growth, becomes
symptomatic, or reaches a maximum diameter generally greater than 4.5
cm.

AAA diagnosed patients who are considered unacceptable surgical or
anesthesia risk candidates may be medically managed and closely
monitored, recommended for endovascular repair, or elect to forego
treatment and eventually succumb to death due to rupture or comorbid
disease.

**7.0 Marketing History**

The EXCLUDER Bifurcated Endoprosthesis has been commercially available
in many countries throughout the world, including Europe, Asia, Latin
America and Australia. The EXCLUDER Bifurcated Endoprosthesis has not
been withdrawn from marketing in any country for any reason, including
safety or effectiveness.

**8.0 Adverse Events**

**Table 8.1. Major Adverse Events according to Type, Time and Study
Group**

+-------------------------+----+----+----+----+-----+-----+-----+-----+
| **Major Adverse         | *  |    |    |    | **L |     |     |     |
| Events**                | *E |    |    |    | ate |     |     |     |
|                         | ar |    |    |    | (\> |     |     |     |
|                         | ly |    |    |    | 30  |     |     |     |
|                         | (  |    |    |    | d   |     |     |     |
|                         | [\ |    |    |    | ays |     |     |     |
|                         | <] |    |    |    | t   |     |     |     |
|                         | {. |    |    |    | o** |     |     |     |
|                         | un |    |    |    |     |     |     |     |
|                         | de |    |    |    | **  |     |     |     |
|                         | rl |    |    |    | 12- |     |     |     |
|                         | in |    |    |    | mon |     |     |     |
|                         | e} |    |    |    | ths |     |     |     |
|                         | 30 |    |    |    | )** |     |     |     |
|                         | d  |    |    |    |     |     |     |     |
|                         | ay |    |    |    |     |     |     |     |
|                         | s) |    |    |    |     |     |     |     |
|                         | ** |    |    |    |     |     |     |     |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
|                         | *  |    | *  |    | *   |     | **  |     |
|                         | *E |    | *C |    | *EB |     | Con |     |
|                         | BE |    | on |    | E** |     | tro |     |
|                         | ** |    | tr |    |     |     | l** |     |
|                         |    |    | ol |    | **% |     |     |     |
|                         | *  |    | ** |    | 23  |     | **% |     |
|                         | *% |    |    |    | 1** |     | 9   |     |
|                         | 2  |    | *  |    |     |     | 7** |     |
|                         | 35 |    | *% |    |     |     |     |     |
|                         | ** |    | 99 |    |     |     |     |     |
|                         |    |    | ** |    |     |     |     |     |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Deaths                  | 1  | 3  | 0  | 0  | 6   | 14  | 5   | 5   |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Other Adverse Events    |    |    |    |    |     |     |     |     |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Bleeding                | 4  | 10 | 32 | 32 | 0.4 | 1   | 1   | 1   |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Pulmonary               | 1  | 3  | 12 | 12 | 4   | 10  | 4   | 4   |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Cardiac                 | 3  | 7  | 14 | 14 | 7   | 16  | 13  | 13  |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Renal                   | 1  | 2  | 3  | 3  | 2   | 5   | 0   | 0   |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Wound                   | 3  | 7  | 4  | 4  | 4   | 9   | 2   | 2   |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Bowel                   | 2  | 5  | 16 | 16 | 3   | 6   | 3   | 3   |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Vascular                | 1  | 3  | 6  | 6  | 3   | 7   | 5   | 5   |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Endoleak with an        | 0  | 0  | NA | NA | 6   | 13  | NA  | NA  |
| Intervention            |    |    |    |    |     |     |     |     |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Aneurysm size increase  | 0  | 0  | NA | NA | 0.4 | 1   | NA  | NA  |
| with an Intervention    |    |    |    |    |     |     |     |     |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Neurologic              | 0  | 1  | 2  | 2  | 3   | 7   | 1   | 1   |
|                         | .4 |    |    |    |     |     |     |     |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Genitourinary           | 0  | 1  | 1  | 1  | 3   | 6   | 1   | 1   |
|                         | .4 |    |    |    |     |     |     |     |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Neoplasm                | 0  | 1  | 0  | 0  | 1   | 3   | 1   | 1   |
|                         | .4 |    |    |    |     |     |     |     |
+-------------------------+----+----+----+----+-----+-----+-----+-----+
| Other Complications     | 0  | 0  | 2  | 2  | 5   | 12  | 4   | 4   |
+-------------------------+----+----+----+----+-----+-----+-----+-----+

9.  **Summary of Pre-clinical Results**

**9.1 Biocompatibility**

Toxicology and biocompatibility testing was conducted for materials in
the EXCLUDER Bifurcated Endoprosthesis System. Testing was conducted in
accordance with Federal Good Laboratory Practices per 21 CFR §58. The
EXCLUDER Bifurcated Endoprosthesis was classified per ISO 10993 as an
implant device with permanent contact. The EXCLUDER delivery catheter
was classified as an externally communicating device with limited
exposure (≤ 24 hr).

The EXCLUDER Bifurcated Endoprosthesis is made of gold radiopaque
markers, ePTFE (expanded polytetrafluoroethylene), ePTFE/FEP
(fluorinated tape) and nickel titanium alloy (nitinol). Historically,
ePTFE and FEP have been characterized as safe biomaterials. Literature
reviews have documented that ePTFE and FEP have an acceptable long term
history of human implantation.

The materials used to manufacture the delivery catheters are commonly
used in other commercially available medical devices, such as
percutaneous transluminal coronary angioplasty (PTCA) catheters,
peripheral transluminal angioplasty (PTA) catheters, and ePTFE sutures.
The materials in these devices have been documented and have been
demonstrated to be safe to use in limited-duration, blood-contacting
medical devices. No component of the catheter is intended to have
greater than limited (≤ 24 hr) contact with the patient.

Table 9.1 summaries the biocompatibility test results for the implant.
Table 9.2 summarizes the biocompatibility test results for the catheter.

**Table 9.1. Summary of Biocompatibility Test Results for the Implant**

+-----------------------+-----------------------+-----------------------+
| **Test Name**         | **Test Method**       | **Results**           |
+-----------------------+-----------------------+-----------------------+
| Cytotoxicity          | [MEM]{.smallcaps}     | Non-Cytotoxic         |
|                       | Elution Test [--      |                       |
|                       | ISO]{.smallcaps}      |                       |
+-----------------------+-----------------------+-----------------------+
| Sensitization         | Kligman Maximization  | Non-Sensitizing       |
|                       | Study -- ISO          |                       |
+-----------------------+-----------------------+-----------------------+
| Irri                  | Intracutaneous        | Negligible Irritant   |
| tation/Intracutaneous | Injection Test -      |                       |
|                       | [ISO]{.smallcaps}     |                       |
| Toxicity              |                       |                       |
+-----------------------+-----------------------+-----------------------+
| Acute Systemic        | Systemic Injection    | No significantly      |
| Toxicity              | Test                  | greater biological    |
|                       | [-ISO]{.smallcaps}    | reaction than the     |
|                       |                       | controls.             |
+-----------------------+-----------------------+-----------------------+
| Pyrogenicity          | Rabbit Pyrogen Test   | Non-Pyrogenic         |
|                       | (Material Mediated)   |                       |
|                       | [-ISO]{.smallcaps}    |                       |
+-----------------------+-----------------------+-----------------------+
| Hemocompatibility     | Hemolysis: Direct     | Non-Hemolytic         |
|                       | Contact-Rabbit Blood  |                       |
|                       | --ISO                 |                       |
+-----------------------+-----------------------+-----------------------+
| Subchronic Toxicity   | Canine Implant Study  | No Systemic Effects   |
|                       |                       | Observed              |
+-----------------------+-----------------------+-----------------------+
| Geno                  | *Salmonella           | Non-Mutagenic         |
| toxicity/Mutagenicity | typhimurium* and      |                       |
|                       | *Escherichia coli*    |                       |
|                       | Reverse Mutation      |                       |
|                       | Assay --ISO           |                       |
+-----------------------+-----------------------+-----------------------+
|                       | CHO/HGPRT Forward     | Non-Mutagenic         |
|                       | Mutation Assay --ISO  |                       |
+-----------------------+-----------------------+-----------------------+
|                       | Chromosomal           | Non-Clastogenic       |
|                       | Aberration Assay      |                       |
|                       | --ISO                 |                       |
+-----------------------+-----------------------+-----------------------+
| Implantation          | Intramuscular         | Test Article and      |
|                       | Implantation --ISO    | Negative Control had  |
|                       |                       | Comparative Results   |
+-----------------------+-----------------------+-----------------------+
| Chronic Toxicity      | Canine Implant Study  | No Systemic Effects   |
|                       |                       | Observed              |
+-----------------------+-----------------------+-----------------------+

**Table 9.2. Summary of Biocompatibility Test Results for the Catheter**

  --------------------------- ------------------------------- -----------------
  **Test Name**               **Test Method**                 **Results**

  Cytotoxicity                MEM Elution Test --             Non-Cytotoxic
                              [ISO]{.smallcaps}               

  Sensitization               Kligman Maximization Study --   Non-Sensitizing
                              [ISO]{.smallcaps}               

  Irritation/Intracutaneous   Intracutaneous Injection [--    Negligible
  Toxicity                    ISO]{.smallcaps}                Irritant

  Acute Systemic Toxicity     Systemic Injection Test [--     Non-Toxic
                              ISO]{.smallcaps}                

  Pyrogenicity Test           Rabbit Pyrogen Test (Material   Non-Pyrogenic
                              Mediated) [-- ISO]{.smallcaps}  

  Hemocompatibility           Hemolysis Rabbit Blood [--      Non-Hemolytic
                              ISO]{.smallcaps}                
  --------------------------- ------------------------------- -----------------

All test results indicate that the materials and processes used to
manufacture the EXCLUDER implant and catheter are biocompatible and
suitable for their intended use.

**9.2 Animal Studies**

Three preclinical *in vivo* studies were conducted to evaluate the
performance of the EXCLUDER Bifurcated Endoprosthesis. A canine model
was used to assess the ability of the delivery system to successfully
access the target site, deploy the graft and be withdrawn from the
vasculature, to assess device functionality, and to assess the
sub-chronic and chronic biological response to the implanted
endoprosthesis. A bovine model was used for acute assessment, in a near
human-size animal model, of the delivery system to successfully access
the target site, deploy the graft and be withdrawn from the vasculature,
and the ability of the device to resist migration. A summary of these
studies follows in Table 9.3.

**Table 9.3. Summary of Preclinical *In Vivo* Studies**

  ---------------- ---------- ------------------- ----------------- ------------------
  **Animal Study** **#/ Type  **Test Article**    **Methods**       **Results/
                   of                                               Conclusions**
                   Animal**                                         

  Sub-chronic and  15 Canines Scaled-down,        Catheter delivery All devices were
  Chronic Study of            trunk-ipsilateral   and device        successfully
  Bifurcated                  leg, contralateral  functionality     delivered and
  Endoprosthesis              leg devices, and    were assessed     deployed. The
                              delivery catheter.  sub-chronically   functional
                                                  and chronically   requirements of
                                                  in 15 animals.    the device were
                                                  Two sub-chronic   met and the
                                                  animals were      devices performed
                                                  maintained in     as intended. All
                                                  life for          devices were
                                                  approximately one patent at
                                                  week.             retrieval, and the
                                                  Additionally,     host tissue
                                                  three canines     response was
                                                  were maintained   judged to be
                                                  in life for one   acceptable at both
                                                  month, one canine gross and
                                                  for two months,   histological
                                                  three canines for examination. There
                                                  three months, and was no evidence of
                                                  four canines for  device/component
                                                  six months. Two   migration or graft
                                                  canines in the    disruption.
                                                  chronic phase     
                                                  were retrieved    
                                                  within one day    
                                                  post-op.          

  Acute Study of   6 Bovines  Human size,         Six bovines were  All devices were
  Bifurcated                  trunk-ipsilateral   assessed for      successfully and
  Endoprosthesis              leg, contralateral  acute delivery    accurately
                              leg devices, and    catheter and      deployed. The
                              delivery catheter.  device            devices were
                                                  functionality.    patent and
                                                                    exhibited normal
                                                                    antegrade flow
                                                                    after deployment.
                                                                    There was no
                                                                    evidence of
                                                                    migration or graft
                                                                    disruption.

  Acute Study of   2 Bovines  Human size, aortic  Six aortic        All devices were
  Aortic and Iliac            and iliac extender  extenders on long successfully
  Extenders                   devices. Short      catheters, six    deployed. Both
                              trunk               iliac extenders   aortic and iliac
                              endoprosthesis and  on catheters, and extenders could be
                              delivery catheter.  six short trunks  accurately placed
                                                  were deployed in  and deployed
                                                  two bovines.      within another
                                                  These animal      stent-graft or
                                                  procedures were   separately.
                                                  assessed for      Radiographic
                                                  acute delivery    evidence showed
                                                  catheter and      that no migration
                                                  device            had occurred
                                                  performance of    during the acute
                                                  the aortic and    phase.
                                                  iliac extender    Post-deployment
                                                  components.       angiography showed
                                                                    patency.
  ---------------- ---------- ------------------- ----------------- ------------------

**9.3 Product Testing**

W.L. Gore and Associates, Inc. (GORE), conducted comprehensive
pre-clinical bench and analytical testing on the EXCLUDER Bifurcated
Endoprosthesis (EBE) implant and delivery system. The express intent of
this *in vitro* testing was to verify that the performance attributes of
the EBE system are sufficient to minimize the risk of adverse events
under anticipated clinical use conditions. Results obtained from the *in
vitro* test regimen provide evidence substantiating the safety and
effectiveness of the EBE system.

A summary of results is presented below for each of the *in vitro*
tests. Table 9.4 summarizes test results associated with the functional
requirements of the delivery system, and Table 9.5 summarizes test
results related functional requirements of the implant.

The results of the *in vitro* testing, taken as a whole, demonstrate
that the EBE system meets established functional requirements for aortic
endovascular devices. Furthermore, these data substantiate the safety
and effectiveness of the EBE system, which, consequently, is expected to
perform as intended when used in accordance with its labeled
indications.

**9.3.1 Delivery System Test Results Summary**

The following table contains test results that were performed to
evaluate the ability of the EBE delivery system to access the implant
location, accurately deploy the device, safely withdraw the delivery
system catheter, maintain hemostasis, and be fluoroscopically
visualized.

**Table 9.4. Summary of Test Results Related to the EBE Delivery System
Functionality**

+----------+------------------+---------------------------------------+
| ***In    | **Relevant       | **Summary of Test Results**           |
| Vitro*** | Functional       |                                       |
|          | Requirement**    |                                       |
| **Test** |                  |                                       |
+==========+==================+=======================================+
| Catheter | -   Ability to   | Finished delivery catheters were      |
| Angular  |     access the   | tested to determine angular rotation  |
| Rotation |     intended     | to failure. All delivery systems      |
| to       |     location     | tested for angular rotation to        |
| Failure  |                  | failure conformed to established      |
| Test     | -   Ability to   | design specifications. Based on the   |
|          |     deploy the   | results of these tests, the EBE       |
|          |     implant      | delivery catheters would not be       |
|          |                  | expected to fail in torsion during    |
|          | -   Ability to   | anticipated clinical use.             |
|          |     withdraw the |                                       |
|          |     delivery     |                                       |
|          |     system       |                                       |
+----------+------------------+---------------------------------------+
| Catheter | -   Ability to   | The longitudinal tensile strength of  |
| Bond     |     access the   | the critical bonds and joints of the  |
| Tensile  |     intended     | EBE delivery catheters were           |
| Strength |     location     | determined. Results indicate that     |
| Test     |                  | there is at least 95% confidence      |
|          | -   Ability to   | level that the minimum tensile        |
|          |     deploy the   | strength of each critical catheter    |
|          |     implant      | junction will exceed the ISO 10555-1  |
|          |                  | standard of 3.37lbf.                  |
|          | -   Ability to   |                                       |
|          |     withdraw the |                                       |
|          |     delivery     |                                       |
|          |     system       |                                       |
+----------+------------------+---------------------------------------+
| Catheter | -   Ability to   | The tensile strength of the catheter  |
| De       |     deploy the   | deployment knob/line assembly was     |
| ployment |     implant      | determined to demonstrate conformance |
| K        |                  | to design requirements. The data      |
| nob-Line |                  | demonstrates that there is at least   |
| Assembly |                  | 95% confidence that there is a 95%    |
| Tensile  |                  | probability that any individual       |
| Test     |                  | deployment knob/line tensile strength |
|          |                  | exceeds the maximum expected          |
|          |                  | deployment force.                     |
+----------+------------------+---------------------------------------+
| Catheter | -   Hemostasis   | The leak resistance of the delivery   |
| Leak     |     of the       | catheters was evaluated. No catheter  |
| Test     |     delivery     | leakage was observed in any of the    |
|          |     system       | test samples when tested up to        |
|          |                  | pressures of 20 atmospheres. These    |
|          |                  | data indicate there is a 95%          |
|          |                  | confidence that there is at least a   |
|          |                  | 95% probability that any EBE delivery |
|          |                  | catheter will meet the minimum design |
|          |                  | requirement of 1.5 atm.               |
+----------+------------------+---------------------------------------+
| Catheter | -   Ability to   | The minimum and maximum expected      |
| Length   |     access the   | catheter working lengths for all      |
| Test     |     intended     | tested delivery system configurations |
|          |     location     | met the established design            |
|          |                  | specifications at a minimum           |
|          | -   Ability to   | confidence level of 95%.              |
|          |     deploy the   |                                       |
|          |     implant      |                                       |
+----------+------------------+---------------------------------------+
| Catheter | -   Ability to   | All tested catheters met the design   |
| Profile  |     access the   | specifications with at least 95%      |
| Test     |     intended     | confidence. Compatibility with        |
|          |     location     | recommended introducer sheath         |
|          |                  | accessories is expected.              |
|          | -   Ability to   |                                       |
|          |     deploy the   |                                       |
|          |     implant      |                                       |
|          |                  |                                       |
|          | -   Ability to   |                                       |
|          |     withdraw the |                                       |
|          |     delivery     |                                       |
|          |     system       |                                       |
|          |                  |                                       |
|          | -   Hemostasis   |                                       |
|          |     of the       |                                       |
|          |     delivery     |                                       |
|          |     system       |                                       |
+----------+------------------+---------------------------------------+
| Catheter | -   Ability to   | The torsional strength of the two     |
| T        |     access the   | catheter junctions that will be       |
| orsional |     intended     | subjected to the greatest torsional   |
| Bond     |     location     | load during deployment were           |
| Strength |                  | determined to have torsional bond     |
| Test     | -   Ability to   | strengths significantly in excess of  |
|          |     deploy the   | established design specifications.    |
|          |     implant      |                                       |
|          |                  |                                       |
|          | -   Ability to   |                                       |
|          |     withdraw the |                                       |
|          |     delivery     |                                       |
|          |     system       |                                       |
+----------+------------------+---------------------------------------+
| Delivery | -   Ability to   | All delivery system configurations    |
| System   |     access the   | were dimensionally compatible with    |
| A        |     intended     | the recommended guidewires and        |
| ccessory |     location     | introducer sheaths per established    |
| Compa    |                  | design specifications.                |
| tibility | -   Ability to   |                                       |
|          |     deploy the   |                                       |
|          |     implant      |                                       |
|          |                  |                                       |
|          | -   Ability to   |                                       |
|          |     withdraw the |                                       |
|          |     delivery     |                                       |
|          |     system       |                                       |
|          |                  |                                       |
|          | -   Hemostasis   |                                       |
|          |     of the       |                                       |
|          |     delivery     |                                       |
|          |     system       |                                       |
+----------+------------------+---------------------------------------+
| Delivery | -   Ability to   | The force required to deploy the EBE  |
| System   |     deploy the   | was determined. The maximum expected  |
| De       |     implant      | deployment force does not exceed the  |
| ployment |                  | minimum expected strength of the EBE  |
| Force    |                  | delivery catheter deployment          |
| Test     |                  | knob/line tensile strength.           |
+----------+------------------+---------------------------------------+
| Delivery | -   Ability to   | A comprehensive evaluation of *in     |
| System   |     access the   | vitro* deployments was conducted.     |
| De       |     intended     | Binomial statistics demonstrate with  |
| ployment |     location     | a 95% confidence level that at least  |
| Rel      |                  | 98% of the EBE will access the        |
| iability | -   Ability to   | intended implant location, safety     |
| Test     |     deploy the   | deploy the implant, and be            |
|          |     implant      | successfully withdrawn when used in a |
|          |                  | manner consistent with labeling or    |
|          | -   Ability to   | under anticipated clinical use.       |
|          |     withdraw the |                                       |
|          |     delivery     |                                       |
|          |     system       |                                       |
+----------+------------------+---------------------------------------+
| Delivery | -   Fluoroscopic | The results of the *in vitro*         |
| System   |                  | radiopacity testing show that the     |
| Rad      |    visualization | radiopacity of the EBE delivery       |
| iopacity |                  | systems have sufficient radiopacity   |
| Conf     |                  | for clinical use.                     |
| irmation |                  |                                       |
| Test     |                  |                                       |
+----------+------------------+---------------------------------------+
| Delivery | -   Ability to   | The torque response of the delivery   |
| System   |     access the   | system and the torque effect on       |
| Torq     |     intended     | deployment reliability were           |
| uability |     location     | evaluated. All tested delivery        |
| Test     |                  | systems exhibited acceptable torque   |
|          | -   Ability to   | response after being tracked through  |
|          |     deploy the   | an *in vitro* aneurysmal deployment   |
|          |     implant      | model. All tested delivery systems    |
|          |                  | deployed successfully after being     |
|          | -   Ability to   | subjected to design-specific torque   |
|          |     withdraw the | testing.                              |
|          |     delivery     |                                       |
|          |     system       |                                       |
+----------+------------------+---------------------------------------+
| Sewn     | -   Ability to   | The burst strength of representative  |
| Sleeve   |     access the   | corsets was characterized and         |
| (Corset) |     intended     | determined to be adequate to          |
| Burst    |     location     | constrain the stent-graft prior to    |
| Strength |                  | implantation.                         |
| Test     | -   Ability to   |                                       |
|          |     deploy the   |                                       |
|          |     implant      |                                       |
+----------+------------------+---------------------------------------+

**9.3.2 Implant Test Results Summary**

The following table contains tests results that were performed to assess
the EBE implant's ability to accurately deploy, fixation effectiveness,
durability, ability to exclude the aneurysm (permeability
considerations), modularity, sizing, patency, and MRI compatibility, and
ability to be fluoroscopically visualized.

**Table 9.5. Summary of Test Results Related to the EBE Implant
Functionality**

+------------+---+---------------+---+----------------------------------------+
| ## *In     |   | **Relevant    |   | **Summary of**                         |
| Vitro* {#i |   | Functional    |   |                                        |
| n-vitro .u |   | Requirement** |   | **Test Result**                        |
| nnumbered} |   |               |   |                                        |
|            |   |               |   |                                        |
| ## Test    |   |               |   |                                        |
|  {#test .u |   |               |   |                                        |
| nnumbered} |   |               |   |                                        |
+============+===+===============+===+========================================+
| Acute      |   | -   Fixation  |   | Acute resistance to migration of the   |
| Anchoring  |   |               |   | EBE was demonstrated under simulated   |
| Test       |   | effectiveness |   | physiological conditions when used in  |
|            |   |     of the    |   | a manner consistent with those set     |
|            |   |     implant   |   | forth in the Instructions for Use      |
|            |   |               |   | (over-sizing, appropriate device       |
|            |   |               |   | placement, post-deployment balloon     |
|            |   |               |   | touch-up).                             |
+------------+---+---------------+---+----------------------------------------+
| A          |   | -             |   | Anchor fatigue resistance was          |
| ccelerated |   |    Durability |   | evaluated for 10 years simulated       |
| Anchor     |   |     and       |   | physiological loading (380 million     |
| Fatigue    |   |     integrity |   | cycles) under "worst-case" test        |
| Test       |   |     of the    |   | conditions. Samples were subjected to  |
|            |   |     implanted |   | severe loading, far in excess of       |
|            |   |     device    |   | clinically expected loads. Only one    |
|            |   |               |   | anchor fatigue fracture out of 112     |
|            |   |               |   | tested anchors was noted at the        |
|            |   |               |   | ten-year equivalent inspection. The    |
|            |   |               |   | fractured anchor was attached to the   |
|            |   |               |   | stent-graft. No compromise of device   |
|            |   |               |   | function was noted. From the data      |
|            |   |               |   | generated from this "worst-case"       |
|            |   |               |   | testing, it is expected that the       |
|            |   |               |   | anchors will survive ten years of      |
|            |   |               |   | pulsatile loading under anticipated    |
|            |   |               |   | physiological conditions without       |
|            |   |               |   | fatigue related anchor fracture or     |
|            |   |               |   | compromise of device fixation.         |
+------------+---+---------------+---+----------------------------------------+
| Deployment |   | -   Ability   |   | The Aortic Extender was selected for   |
| Accuracy   |   |     to        |   | deployment testing as it is the        |
| Test       |   |               |   | component most likely to produce       |
|            |   |    accurately |   | deployment inaccuracies. Based on      |
|            |   |     deploy    |   | testing in straight and angulated      |
|            |   |               |   | segments of an *in vitro* test model,  |
|            |   |               |   | the EBE is expected to be deployed no  |
|            |   |               |   | more than 5 mm proximal to the         |
|            |   |               |   | intended implant site at a 95%         |
|            |   |               |   | confidence level.                      |
+------------+---+---------------+---+----------------------------------------+
| Endo       |   | -             |   | The radiographic visibility of the EBE |
| prosthesis |   |  Fluoroscopic |   | was determined to be sufficient for    |
| R          |   |               |   | clinical use when compared to          |
| adiopacity |   | visualization |   | clinically validated devices under a   |
| Co         |   |               |   | range of simulated tissue              |
| nfirmation |   |               |   | densifications.                        |
| Test       |   |               |   |                                        |
+------------+---+---------------+---+----------------------------------------+
| Finite     | - |               | T |                                        |
| Element    |   |               | h |                                        |
| Analysis   |   |               | e |                                        |
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+------------+---+---------------+---+----------------------------------------+

+------------+---+---------------+---+----------------------------------------+
| ## *In Vi  |   | **Relevant    |   | **Summary of**                         |
| tro* {#in- |   | Functional    |   |                                        |
| vitro-1 .u |   | Requirement** |   | **Test Result**                        |
| nnumbered} |   |               |   |                                        |
|            |   |               |   |                                        |
| ## Test {  |   |               |   |                                        |
| #test-1 .u |   |               |   |                                        |
| nnumbered} |   |               |   |                                        |
+============+===+===============+===+========================================+
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|            |   |               | s |                                        |
|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| Lo         | - |               | T |                                        |
| ngitudinal |   |               | h |                                        |
| Tensile    |   |               | e |                                        |
| Strength   |   |               | l |                                        |
| Test       | D |               | o |                                        |
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|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| Magnetic   | - |               | T |                                        |
| Resonance  |   |               | h |                                        |
| Imaging    |   |               | e |                                        |
| Safety     |   |               | E |                                        |
| Test       | M |               | B |                                        |
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|            |   |               | c |                                        |
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|            |   |               | n |                                        |
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|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| M          | - |               | T |                                        |
| icroscopic |   |               | h |                                        |
| Det        |   |               | e |                                        |
| ermination |   |               | f |                                        |
| of         | P |               | i |                                        |
| Porosity   | e |               | b |                                        |
| Test       | r |               | r |                                        |
|            | m |               | i |                                        |
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|            |   |               | G |                                        |
|            |   |               | O |                                        |
|            |   |               | R |                                        |
|            |   |               | E |                                        |
|            |   |               | - |                                        |
|            |   |               | T |                                        |
|            |   |               | E |                                        |
|            |   |               | X |                                        |
|            |   |               | ™ |                                        |
|            |   |               | V |                                        |
|            |   |               | a |                                        |
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|            |   |               | c |                                        |
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|            |   |               | a |                                        |
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|            |   |               | G |                                        |
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|            |   |               | c |                                        |
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|            |   |               | s |                                        |
|            |   |               | f |                                        |
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|            |   |               | l |                                        |
|            |   |               | l |                                        |
|            |   |               | y |                                        |
|            |   |               | u |                                        |
|            |   |               | s |                                        |
|            |   |               | e |                                        |
|            |   |               | d |                                        |
|            |   |               | i |                                        |
|            |   |               | n |                                        |
|            |   |               | a |                                        |
|            |   |               | o |                                        |
|            |   |               | r |                                        |
|            |   |               | t |                                        |
|            |   |               | i |                                        |
|            |   |               | c |                                        |
|            |   |               | a |                                        |
|            |   |               | p |                                        |
|            |   |               | p |                                        |
|            |   |               | l |                                        |
|            |   |               | i |                                        |
|            |   |               | c |                                        |
|            |   |               | a |                                        |
|            |   |               | t |                                        |
|            |   |               | i |                                        |
|            |   |               | o |                                        |
|            |   |               | n |                                        |
|            |   |               | s |                                        |
|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| Nitinol    | - |               | T |                                        |
| Material   |   |               | h |                                        |
| Analysis   |   |               | e |                                        |
| Test       |   |               | b |                                        |
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|            |   |               | T |                                        |
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|            |   |               | a |                                        |
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|            |   |               | p |                                        |
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|            |   |               | t |                                        |
|            |   |               | t |                                        |
|            |   |               | i |                                        |
|            |   |               | n |                                        |
|            |   |               | g |                                        |
|            |   |               | , |                                        |
|            |   |               | c |                                        |
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|            |   |               | a |                                        |
|            |   |               | c |                                        |
|            |   |               | k |                                        |
|            |   |               | s |                                        |
|            |   |               | , |                                        |
|            |   |               | o |                                        |
|            |   |               | r |                                        |
|            |   |               | c |                                        |
|            |   |               | o |                                        |
|            |   |               | n |                                        |
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|            |   |               | a |                                        |
|            |   |               | m |                                        |
|            |   |               | i |                                        |
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|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| Nitinol    | - |               | T |                                        |
| Stent      |   |               | h |                                        |
| Corrosion  |   |               | e |                                        |
| Resistance |   |               | c |                                        |
| Test       | D |               | o |                                        |
|            | u |               | r |                                        |
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|            |   |               | f |                                        |
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+------------+---+---------------+---+----------------------------------------+
|            |   |               |   |                                        |
+------------+---+---------------+---+----------------------------------------+
| Nitinol    | - |               | T |                                        |
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+------------+---+---------------+---+----------------------------------------+
| Pull Test  | - |               | T |                                        |
| for        |   |               | h |                                        |
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+------------+---+---------------+---+----------------------------------------+
| Pulsatile  | - |               | A |                                        |
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|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| Radial     | - |               | T |                                        |
| C          |   |               | h |                                        |
| ompression |   |               | e |                                        |
| Strength   |   |               | r |                                        |
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|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| Sealing    | - |               | T |                                        |
| Test       |   |               | h |                                        |
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|            |   |               | r |                                        |
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|            |   |               | n |                                        |
|            |   |               | d |                                        |
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|            |   |               | n |                                        |
|            |   |               | d |                                        |
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|            |   |               | a |                                        |
|            |   |               | s |                                        |
|            |   |               | c |                                        |
|            |   |               | u |                                        |
|            |   |               | l |                                        |
|            |   |               | a |                                        |
|            |   |               | r |                                        |
|            |   |               | a |                                        |
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|            |   |               | p |                                        |
|            |   |               | l |                                        |
|            |   |               | i |                                        |
|            |   |               | c |                                        |
|            |   |               | a |                                        |
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|            |   |               | n |                                        |
|            |   |               | s |                                        |
|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
|            |   |               |   |                                        |
+------------+---+---------------+---+----------------------------------------+
| S          | - |               | T |                                        |
| tent-Graft |   |               | h |                                        |
| Bend       |   |               | e |                                        |
| Radius     |   |               | b |                                        |
| Test       | A |               | e |                                        |
|            | b |               | n |                                        |
|            | i |               | d |                                        |
|            | l |               | r |                                        |
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|            | p |               | B |                                        |
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|            | i |               | a |                                        |
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|            |   |               | i |                                        |
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|            |   |               | m |                                        |
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|            |   |               | t |                                        |
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|            |   |               | i |                                        |
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|            |   |               | n |                                        |
|            |   |               | g |                                        |
|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| S          | - |               | T |                                        |
| tent-Graft |   |               | h |                                        |
| Burst      |   |               | e |                                        |
| Strength   |   |               | b |                                        |
| Test       | D |               | u |                                        |
|            | u |               | r |                                        |
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|            |   |               | B |                                        |
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|            |   |               | a |                                        |
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|            |   |               | s |                                        |
|            |   |               | . |                                        |
|            |   |               | A |                                        |
|            |   |               | l |                                        |
|            |   |               | l |                                        |
|            |   |               | b |                                        |
|            |   |               | u |                                        |
|            |   |               | r |                                        |
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|            |   |               | t |                                        |
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|            |   |               | n |                                        |
|            |   |               | g |                                        |
|            |   |               | t |                                        |
|            |   |               | h |                                        |
|            |   |               | s |                                        |
|            |   |               | e |                                        |
|            |   |               | x |                                        |
|            |   |               | c |                                        |
|            |   |               | e |                                        |
|            |   |               | e |                                        |
|            |   |               | d |                                        |
|            |   |               | e |                                        |
|            |   |               | d |                                        |
|            |   |               | t |                                        |
|            |   |               | h |                                        |
|            |   |               | e |                                        |
|            |   |               | m |                                        |
|            |   |               | i |                                        |
|            |   |               | n |                                        |
|            |   |               | i |                                        |
|            |   |               | m |                                        |
|            |   |               | u |                                        |
|            |   |               | m |                                        |
|            |   |               | d |                                        |
|            |   |               | e |                                        |
|            |   |               | s |                                        |
|            |   |               | i |                                        |
|            |   |               | g |                                        |
|            |   |               | n |                                        |
|            |   |               | r |                                        |
|            |   |               | e |                                        |
|            |   |               | q |                                        |
|            |   |               | u |                                        |
|            |   |               | i |                                        |
|            |   |               | r |                                        |
|            |   |               | e |                                        |
|            |   |               | m |                                        |
|            |   |               | e |                                        |
|            |   |               | n |                                        |
|            |   |               | t |                                        |
|            |   |               | s |                                        |
|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| S          | - |               | T |                                        |
| tent-Graft |   |               | h |                                        |
| Diameter   |   |               | e |                                        |
| and Wall   |   |               | o |                                        |
| Thickness  | T |               | u |                                        |
| Test       | e |               | t |                                        |
|            | s |               | e |                                        |
|            | t |               | r |                                        |
|            | i |               | d |                                        |
|            | n |               | i |                                        |
|            | g |               | a |                                        |
|            |   |               | m |                                        |
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|            |   |               | a |                                        |
|            |   |               | n |                                        |
|            |   |               | d |                                        |
|            |   |               | w |                                        |
|            | t |               | a |                                        |
|            | h |               | l |                                        |
|            | e |               | l |                                        |
|            |   |               | t |                                        |
|            |   |               | h |                                        |
|            |   |               | i |                                        |
|            |   |               | c |                                        |
|            | m |               | k |                                        |
|            | o |               | n |                                        |
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|            | i |               | t |                                        |
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|            | y |               | e |                                        |
|            |   |               | d |                                        |
|            |   |               | e |                                        |
|            |   |               | p |                                        |
|            |   |               | l |                                        |
|            | o |               | o |                                        |
|            | f |               | y |                                        |
|            |   |               | e |                                        |
|            |   |               | d |                                        |
|            |   |               | E |                                        |
|            |   |               | B |                                        |
|            | t |               | E |                                        |
|            | h |               | c |                                        |
|            | e |               | o |                                        |
|            |   |               | m |                                        |
|            |   |               | p |                                        |
|            |   |               | o |                                        |
|            |   |               | n |                                        |
|            | e |               | e |                                        |
|            | n |               | n |                                        |
|            | d |               | t |                                        |
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|            | v |               | w |                                        |
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|            | s |               | r |                                        |
|            | c |               | e |                                        |
|            | u |               | c |                                        |
|            | l |               | h |                                        |
|            | a |               | a |                                        |
|            | r |               | r |                                        |
|            |   |               | a |                                        |
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|            | s |               | z |                                        |
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|            |   |               | v |                                        |
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|            | p |               | f |                                        |
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|            | p |               | . |                                        |
|            | r |               | A |                                        |
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|            | z |               | t |                                        |
|            | i |               | s |                                        |
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|            |   |               | s |                                        |
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|            |   |               | d |                                        |
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|            | t |               | a |                                        |
|            | h |               | p |                                        |
|            | e |               | p |                                        |
|            |   |               | r |                                        |
|            |   |               | o |                                        |
|            |   |               | p |                                        |
|            |   |               | r |                                        |
|            | i |               | i |                                        |
|            | m |               | a |                                        |
|            | p |               | t |                                        |
|            | l |               | e |                                        |
|            | a |               | d |                                        |
|            | n |               | e |                                        |
|            | t |               | s |                                        |
|            |   |               | i |                                        |
|            |   |               | g |                                        |
|            |   |               | n |                                        |
|            |   |               | r |                                        |
|            |   |               | e |                                        |
|            |   |               | q |                                        |
|            |   |               | u |                                        |
|            |   |               | i |                                        |
|            |   |               | r |                                        |
|            |   |               | e |                                        |
|            |   |               | m |                                        |
|            |   |               | e |                                        |
|            |   |               | n |                                        |
|            |   |               | t |                                        |
|            |   |               | s |                                        |
|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| S          | - |               | T |                                        |
| tent-Graft |   |               | h |                                        |
| Length     |   |               | e |                                        |
| Test       |   |               | l |                                        |
|            | A |               | e |                                        |
|            | b |               | n |                                        |
|            | i |               | g |                                        |
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|            | c |               | n |                                        |
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|            | a |               | s |                                        |
|            | t |               | , |                                        |
|            | e |               | m |                                        |
|            | l |               | o |                                        |
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|            | e |               | n |                                        |
|            | p |               | t |                                        |
|            | l |               | h |                                        |
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|            | y |               | d |                                        |
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|            | - |               | l |                                        |
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|            |   |               | v |                                        |
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|            | p |               | y |                                        |
|            | p |               | c |                                        |
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|            | i |               | a |                                        |
|            | z |               | s |                                        |
|            | i |               | u |                                        |
|            | n |               | r |                                        |
|            | g |               | e |                                        |
|            |   |               | d |                                        |
|            |   |               | a |                                        |
|            |   |               | n |                                        |
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|            | f |               | o |                                        |
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|            |   |               | a |                                        |
|            |   |               | r |                                        |
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|            | h |               | d |                                        |
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|            |   |               | o |                                        |
|            |   |               | r |                                        |
|            |   |               | e |                                        |
|            |   |               | l |                                        |
|            | i |               | e |                                        |
|            | m |               | v |                                        |
|            | p |               | a |                                        |
|            | l |               | n |                                        |
|            | a |               | t |                                        |
|            | n |               | d |                                        |
|            | t |               | e |                                        |
|            |   |               | s |                                        |
|            |   |               | i |                                        |
|            |   |               | g |                                        |
|            |   |               | n |                                        |
|            |   |               | s |                                        |
|            |   |               | p |                                        |
|            |   |               | e |                                        |
|            |   |               | c |                                        |
|            |   |               | i |                                        |
|            |   |               | f |                                        |
|            |   |               | i |                                        |
|            |   |               | c |                                        |
|            |   |               | a |                                        |
|            |   |               | t |                                        |
|            |   |               | i |                                        |
|            |   |               | o |                                        |
|            |   |               | n |                                        |
|            |   |               | s |                                        |
|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| S          | - |               | T |                                        |
| tent-Graft |   |               | h |                                        |
| Profile    |   |               | e |                                        |
| Test       |   |               | p |                                        |
|            | A |               | r |                                        |
|            | p |               | o |                                        |
|            | p |               | f |                                        |
|            | r |               | i |                                        |
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|            | p |               | e |                                        |
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|            | t |               | t |                                        |
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|            |   |               | B |                                        |
|            |   |               | E |                                        |
|            | s |               | m |                                        |
|            | i |               | o |                                        |
|            | z |               | u |                                        |
|            | i |               | n |                                        |
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|            | g |               | e |                                        |
|            |   |               | d |                                        |
|            |   |               | o |                                        |
|            |   |               | n |                                        |
|            |   |               | d |                                        |
|            | o |               | e |                                        |
|            | f |               | l |                                        |
|            |   |               | i |                                        |
|            |   |               | v |                                        |
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|            | t |               | y |                                        |
|            | h |               | c |                                        |
|            | e |               | a |                                        |
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|            |   |               | m |                                        |
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|            |   |               | e |                                        |
|            |   |               | n |                                        |
|            |   |               | d |                                        |
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|            |   |               | z |                                        |
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|            |   |               | s |                                        |
|            |   |               | . |                                        |
+------------+---+---------------+---+----------------------------------------+
| Wear and   | - |               | E |                                        |
| Migration  |   |               | n |                                        |
| Test       |   |               | d |                                        |
|            |   |               | o |                                        |
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+------------+---+---------------+---+----------------------------------------+

##  {#section-7 .unnumbered}

## A robust test and analysis regimen was constructed to characterize the mechanical attributes of the EBE. The results of the *in vitro* testing, taken as a whole, demonstrate that the EBE system meets established functional requirements for aortic endovascular devices. Furthermore, these data substantiate the safety and effectiveness of the EBE system by providing evidence that the mechanical attributes of the device have met design goals appropriate for the repair of abdominal aortic aneurysms. {#a-robust-test-and-analysis-regimen-was-constructed-to-characterize-the-mechanical-attributes-of-the-ebe.-the-results-of-the-in-vitro-testing-taken-as-a-whole-demonstrate-that-the-ebe-system-meets-established-functional-requirements-for-aortic-endovascular-devices.-furthermore-these-data-substantiate-the-safety-and-effectiveness-of-the-ebe-system-by-providing-evidence-that-the-mechanical-attributes-of-the-device-have-met-design-goals-appropriate-for-the-repair-of-abdominal-aortic-aneurysms. .unnumbered}

**9.4 Additional Studies**

This device contains no software or electrical components.

10. **Summary of Clinical Studies**

**10.1 Objectives**

The primary objective of the clinical study was to demonstrate that the
EXCLUDER Bifurcated Endoprosthesis is a safe and effective alternative
to open surgical repair in the primary treatment of infrarenal abdominal
aortic aneurysms. Safety was determined by demonstrating that the
EXCLUDER Bifurcated Endoprosthesis subjects would have a total
proportion of major adverse events that is less that the subjects
treated with open repair as evaluated through one year follow-up.
Effectiveness was based on exclusion of the aneurysm including the
absence of an endoleak, the absence of aneurysm enlargement
([\>]{.underline} 5 mm), and the absence of major device efficacy
adverse events evaluated through one year follow-up. Secondary
objectives included an assessment of clinical benefit and
quality-of-life measures.

**10.2 Study Design**

This prospective, non-randomized, multi-center clinical study was
designed to compare patients treated with endovascular repair to an open
surgical repair control group. The control group included patients whose
vascular anatomy (proximal aortic neck length, proximal neck angulation,
and arterial implantation site condition) may not have been suitable for
endovascular AAA repair. The planned ratio of EXCLUDER Bifurcated
Endoprosthesis to control patients was 2:1. Follow-up evaluations were
scheduled for pre-discharge, 1-month, 3-months (if endoleak at 1-month),
6‑months, 12-months and annually thereafter. An independent Core Lab
facility reviewed CT scans and abdominal x‑rays to assess aneurysm
diameter changes, device and relative component migration, device
integrity (wire and graft) and the presence and type of endoleaks.

**10.3 Description of Subjects**

Nineteen U.S. sites enrolled 235 EXCLUDER Bifurcated Endoprosthesis and
99 control subjects. Given the epidemiology of AAA and surgical repair,
males predominated over females (83% compared to 17%). The selection
criteria for the study were based on enrolling subjects with the
appropriate anatomy for endovascular repair. A total of 31 females were
treated with EXCLUDER Bifurcated Endoprosthesis and 26 with open
surgical repair. For subjects treated with EXCLUDER Bifurcated
Endoprosthesis, there were no differences between males and females for
results through one year for survival, freedom from major adverse events
and cumulative adverse events. For open surgical repair subjects,
females compared to males as follows: results at one year showed that
females had a lower rate of cumulative adverse events (0.4 vs 0.8 with p
= 0.003), comparable freedom from major adverse events, and a slightly
lower survival rate (87% vs 97% with p = 0.07).

**10.4 Results**

Tables 10.1 and 10.2 compare the subject characteristics and initial
aneurysm size diameter of the EXCLUDER Bifurcated Endoprosthesis and
open surgical population, respectively.

**Table 10.1. Comparison of Subject Characteristics**

+----------------------------+-------+-------+-------+-------+--------+
| **Characteristic**         | **EBE |       | **Co  |       | **p-V  |
|                            | (N =  |       | ntrol |       | alue** |
|                            | 2     |       | (N =  |       |        |
|                            | 35)** |       | 99)** |       |        |
|                            |       |       |       |       |        |
|                            | **N   |       | **N   |       |        |
|                            | (%)** |       | (%)** |       |        |
+============================+=======+=======+=======+=======+========+
| Average Age (range in      | 73.0  |       | 70.1  |       | 0.002  |
| years)                     | (4    |       | (5    |       |        |
|                            | 8-91) |       | 1-87) |       |        |
+----------------------------+-------+-------+-------+-------+--------+
| Gender:                    | 204   | 87%   | 73    | 74%   | 0.004  |
|                            |       |       |       |       |        |
| Male                       | 31    | 13%   | 26    | 26%   |        |
|                            |       |       |       |       |        |
| Female                     |       |       |       |       |        |
+----------------------------+-------+-------+-------+-------+--------+
| Coronary Artery Disease    | 145   | 62%   | 53    | 54%   | 0.165  |
+----------------------------+-------+-------+-------+-------+--------+
| Arrhythmia                 | 56    | 24%   | 21    | 21%   | 0.591  |
+----------------------------+-------+-------+-------+-------+--------+
| Valvular Heart Disease     | 18    | 8%    | 7     | 7%    | 0.852  |
+----------------------------+-------+-------+-------+-------+--------+
| Congestive Heart Failure   | 22    | 9%    | 8     | 8%    | 0.708  |
+----------------------------+-------+-------+-------+-------+--------+
| Stroke                     | 26    | 11%   | 10    | 10%   | 0.818  |
+----------------------------+-------+-------+-------+-------+--------+
| Aneurysm Symptomatic       | 11    | 5%    | 15    | 15%   | \      |
|                            |       |       |       |       | <0.001 |
+----------------------------+-------+-------+-------+-------+--------+
| Inflammatory AAA           | 2     | 1%    | 1     | 1%    | 1.00   |
+----------------------------+-------+-------+-------+-------+--------+
| Family History of AAA      | 14    | 6%    | 9     | 9%    | 0.307  |
+----------------------------+-------+-------+-------+-------+--------+
| Other Concomitant          | 18    | 8%    | 13    | 13%   | 0.116  |
| Aneurysms                  |       |       |       |       |        |
+----------------------------+-------+-------+-------+-------+--------+
| Peripheral Arterial        | 38    | 16%   | 14    | 14%   | 0.640  |
| Occlusive Disease          |       |       |       |       |        |
+----------------------------+-------+-------+-------+-------+--------+
| Prior Vascular             | 26    | 11%   | 10    | 10%   | 0.796  |
| Intervention               |       |       |       |       |        |
+----------------------------+-------+-------+-------+-------+--------+
| Long Term Use of Steroids  | 8     | 3%    | 1     | 1%    | 0.290  |
+----------------------------+-------+-------+-------+-------+--------+
| Thrombotic Event           | 17    | 7%    | 4     | 4%    | 0.332  |
+----------------------------+-------+-------+-------+-------+--------+
| COPD                       | 62    | 26%   | 25    | 25%   | 0.830  |
+----------------------------+-------+-------+-------+-------+--------+
| Smoking History            | 208   | 89%   | 84    | 85%   | 0.357  |
+----------------------------+-------+-------+-------+-------+--------+
| Renal Dialysis             | 0     | 0     | 0     | 0     | NA     |
+----------------------------+-------+-------+-------+-------+--------+
| Paraplegia                 | 0     | 0     | 0     | 0     | NA     |
+----------------------------+-------+-------+-------+-------+--------+
| Erectile Dysfunction       | 33    | 16%   | 10    | 14%   | 0.616  |
| (males only)               |       |       |       |       |        |
+----------------------------+-------+-------+-------+-------+--------+
| Hepatic Dysfunction        | 6     | 3%    | 1     | 1%    | 0.679  |
+----------------------------+-------+-------+-------+-------+--------+
| Bleeding Disorder          | 11    | 5%    | 1     | 1%    | 0.119  |
+----------------------------+-------+-------+-------+-------+--------+
| Cancer                     | 59    | 25%   | 19    | 19%   | 0.243  |
+----------------------------+-------+-------+-------+-------+--------+

**Table 10.2. Aneurysm Diameter Distribution**

+-------------------+-----------+-----------+-----------+-----------+
| **Diameter        | **EBE (N  |           | **Control |           |
| Range**           | = 235)**  |           | (N =      |           |
|                   |           |           | 98)**     |           |
|                   | **N (%)** |           |           |           |
|                   |           |           | **N (%)** |           |
+-------------------+-----------+-----------+-----------+-----------+
| \< 30 mm          | 0         | 0%        | 0         | 0%        |
+-------------------+-----------+-----------+-----------+-----------+
| 30-39 mm          | 0         | 0%        | 0         | 0%        |
+-------------------+-----------+-----------+-----------+-----------+
| 40-49 mm          | 61        | 26%       | 15        | 15.3%     |
+-------------------+-----------+-----------+-----------+-----------+
| 50-59 mm          | 109       | 46.4%     | 46        | 46.9%     |
+-------------------+-----------+-----------+-----------+-----------+
| 60-69 mm          | 44        | 18.7%     | 21        | 21.4%     |
+-------------------+-----------+-----------+-----------+-----------+
| 70-79 mm          | 15        | 6.4%      | 10        | 10.2%     |
+-------------------+-----------+-----------+-----------+-----------+
| 80-89 mm          | 4         | 1.7%      | 5         | 5.1%      |
+-------------------+-----------+-----------+-----------+-----------+
| [\>]{.underline}  | 2         | 0.9%      | 1         | 1.0%      |
| 90 mm             |           |           |           |           |
+-------------------+-----------+-----------+-----------+-----------+

**10.4.1 Primary Outcomes: Safety and Effectiveness**

Data gathered in Tables 10.3 to 10.13 were collected by either the Core
Lab or the clinical study sites. Table 10.3 compares the safety and
efficacy measures between the EXCLUDER Bifurcated Endoprosthesis and
control subjects as reported by the clinical sites through the primary
end point of 12 months.

The study design is based on one-year safety and effectiveness outcomes.
Subject follow-up is continuing and two-year data are also presented.

**Table 10.3. Principal Safety Results**

+----------------------------+----+----+----+----+------------------+
| **Outcome Measures**       | *  |    | *  |    | **p-Value**      |
|                            | *E |    | *C |    |                  |
|                            | BE |    | on |    |                  |
|                            | ** |    | tr |    |                  |
|                            |    |    | ol |    |                  |
|                            | *  |    | ** |    |                  |
|                            | *N |    |    |    |                  |
|                            | (  |    | *  |    |                  |
|                            | %) |    | *N |    |                  |
|                            | ** |    | (  |    |                  |
|                            |    |    | %) |    |                  |
|                            |    |    | ** |    |                  |
+----------------------------+----+----+----+----+------------------+
| Early ([\<]{.underline}    | 3  | 1% | 0  | 0  | p = 0.56         |
| 30-day) Mortality          |    |    |    |    |                  |
+----------------------------+----+----+----+----+------------------+
| Early ([\<]{.underline}    | 32 | 1  | 56 | 5  | p \<0.0001       |
| 30-day) Adverse Events     |    | 4% |    | 7% |                  |
+----------------------------+----+----+----+----+------------------+
| Early Conversion           | 0  | 0  | 0  | 0  | NA               |
+----------------------------+----+----+----+----+------------------+
| Late Conversion            | 0  | 0  | 0  | 0  | NA               |
+----------------------------+----+----+----+----+------------------+
| Rupture                    | 0  | 0  | 0  | 0  | NA               |
+----------------------------+----+----+----+----+------------------+

Three conversions have occurred \>24 months postoperative due to
aneurysm enlargement and/or endoleak.

Tables 10.4 to 10.11 describe results of the EXCLUDER Bifurcated
Endoprosthesis subjects as reported by the Core Lab. Device performance
factors analyzed by the Core Lab included device integrity (Table 10.4),
device patency (Table 10.5), migration (Tables 10.6 and 10.7), and
aneurysm exclusion (Tables 10.8 to 10.11). For device performance
factors, more than one incident can occur to one subject and incidents
are not necessarily viewed at every time point for one subject. Device
integrity encompasses the structural findings of the wire-form via KUB
images at the corresponding follow-up time points.

**Table 10.4. Device Integrity Assessment by KUB Imaging Data**

+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **Device        | *   |     | **6 |     | *   |     | *   |     |
| Integrity:      | *Di |     | Mo  |     | *12 |     | *24 |     |
| KUB**           | sch |     | nth |     | Mo  |     | Mo  |     |
|                 | arg |     | s** |     | nth |     | nth |     |
|                 | e** |     |     |     | s** |     | s** |     |
|                 |     |     | *   |     |     |     |     |     |
|                 | *   |     | *(N |     | *   |     | *   |     |
|                 | *(N |     | =   |     | *(N |     | *(N |     |
|                 | =   |     | 156 |     | =   |     | =   |     |
|                 | 171 |     | )** |     | 140 |     | 117 |     |
|                 | )** |     |     |     | )** |     | )** |     |
|                 |     |     | **N |     |     |     |     |     |
|                 | **N |     | %** |     | **N |     | **N |     |
|                 | %** |     |     |     | %** |     | %** |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| Subjects Free   | 170 | 99% | 156 | 1   | 140 | 1   | 117 | 1   |
| From Device     |     |     |     | 00% |     | 00% |     | 00% |
| Integrity       |     |     |     |     |     |     |     |     |
| Issues          |     |     |     |     |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| Fracture        | 1   | 0   | 0   | 0%  | 0   | 0%  | 0   | 0%  |
|                 |     | .6% |     |     |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+

**Table 10.5. Narrowing of the Flow Channel by CT Imaging Data\***

+------------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **Narrowing**    | **1 |     | **6 |     | *   |     | *   |     |
|                  | M   |     | Mo  |     | *12 |     | *24 |     |
|                  | ont |     | nth |     | Mo  |     | Mo  |     |
|                  | h** |     | s** |     | nth |     | nth |     |
|                  |     |     |     |     | s** |     | s** |     |
|                  | *   |     | *   |     |     |     |     |     |
|                  | *(N |     | *(N |     | *   |     | *   |     |
|                  | =   |     | =   |     | *(N |     | *(N |     |
|                  | 212 |     | 193 |     | =   |     | =   |     |
|                  | )** |     | )** |     | 185 |     | 148 |     |
|                  |     |     |     |     | )** |     | )** |     |
|                  | **N |     | **N |     |     |     |     |     |
|                  | %** |     | %** |     | **N |     | **N |     |
|                  |     |     |     |     | %** |     | %** |     |
+------------------+-----+-----+-----+-----+-----+-----+-----+-----+
| EXCLUDER         | 3   | 1   | 0   | 0%  | 2   | 1   | 2   | 1   |
| Bifurcated       |     | .5% |     |     |     | .1% |     | .4% |
| Endoprosthesis   |     |     |     |     |     |     |     |     |
+------------------+-----+-----+-----+-----+-----+-----+-----+-----+

\*None affected device patency.

**Table 10.6. CT Findings -- Trunk Migration\***

+----------------------+-------+-------+-------+-------+-------+-------+
| **CT -- Trunk        | **6   |       | **12  |       | **24  |       |
| Migration**          | Mon   |       | Mon   |       | Mon   |       |
|                      | ths** |       | ths** |       | ths** |       |
|                      |       |       |       |       |       |       |
|                      | **(N  |       | **(N  |       | **(N  |       |
|                      | =     |       | =1    |       | =     |       |
|                      | 1     |       | 75)** |       | 1     |       |
|                      | 71)** |       |       |       | 44)** |       |
|                      |       |       | **N   |       |       |       |
|                      | **N   |       | %**   |       | **N   |       |
|                      | %**   |       |       |       | %**   |       |
+----------------------+-------+-------+-------+-------+-------+-------+
| Trunk Migration      | 5     | 3.0%  | 4     | 2.3%  | 2     | 1.4%  |
+----------------------+-------+-------+-------+-------+-------+-------+

\*None resulted in clinical sequelae.

**Table 10.7. KUB Findings -- Component Migration\***

+--------------------------+------+------+------+------+------+------+
| **KUB -- Component       | **6  |      | **12 |      | **24 |      |
| Migration**              | Mont |      | Mont |      | Mont |      |
|                          | hs** |      | hs** |      | hs** |      |
|                          |      |      |      |      |      |      |
|                          | **(N |      | **(N |      | **(N |      |
|                          | =    |      | =    |      | =    |      |
|                          | 13   |      | 13   |      | 12   |      |
|                          | 9)** |      | 9)** |      | 2)** |      |
|                          |      |      |      |      |      |      |
|                          | **N  |      | **N  |      | **N  |      |
|                          | %**  |      | %**  |      | %**  |      |
+--------------------------+------+------+------+------+------+------+
| Component Migration      | 2    | 1.4% | 1    | 1.0% | 1    | 1.0% |
+--------------------------+------+------+------+------+------+------+

\*None resulted in clinical sequelae.

**Table 10.8. Endoleak Status according to Evaluation Interval**

<table style="width:100%;">
<colgroup>
<col style="width: 24%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 9%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2"><strong>Type Endoleak<sup>1,2</sup></strong></td>
<td colspan="12"><strong>Evaluation Interval</strong></td>
</tr>
<tr class="even">
<td colspan="3"><p><strong>1-month</strong></p>
<p><strong>(N = 180)</strong></p>
<p><strong>N (%)</strong></p></td>
<td colspan="3"><p><strong>6-months</strong></p>
<p><strong>(N = 177)</strong></p>
<p><strong>N (%)</strong></p></td>
<td colspan="3"><p><strong>12-months</strong></p>
<p><strong>(N = 156)</strong></p>
<p><strong>N (%)</strong></p></td>
<td colspan="3"><p><strong>24-months</strong></p>
<p><strong>(N=119)</strong></p>
<p><strong>N %</strong></p></td>
</tr>
<tr class="odd">
<td colspan="2">Type I</td>
<td>7</td>
<td colspan="2">4%</td>
<td>3</td>
<td colspan="2">2%</td>
<td>2</td>
<td colspan="2">1%</td>
<td>3</td>
<td>3%</td>
</tr>
<tr class="even">
<td colspan="2">Type II</td>
<td>21</td>
<td colspan="2">12%</td>
<td>19</td>
<td colspan="2">11%</td>
<td>19</td>
<td colspan="2">12%</td>
<td>16</td>
<td>13%</td>
</tr>
<tr class="odd">
<td colspan="2">Type III</td>
<td>0</td>
<td colspan="2">0%</td>
<td>0</td>
<td colspan="2">0%</td>
<td>0</td>
<td colspan="2">0%</td>
<td>0</td>
<td>0%</td>
</tr>
<tr class="even">
<td colspan="2">Type IV</td>
<td>0</td>
<td colspan="2">0%</td>
<td>0</td>
<td colspan="2">0%</td>
<td>0</td>
<td colspan="2">0%</td>
<td>0</td>
<td>0%</td>
</tr>
<tr class="odd">
<td colspan="2">Indeterminate</td>
<td>11</td>
<td colspan="2">6%</td>
<td>14</td>
<td colspan="2">8%</td>
<td>6</td>
<td colspan="2">4%</td>
<td>5</td>
<td>4%</td>
</tr>
<tr class="even">
<td colspan="2">Total</td>
<td>39</td>
<td colspan="2">22%</td>
<td>36</td>
<td colspan="2">20%</td>
<td>27</td>
<td colspan="2">17%</td>
<td>24</td>
<td>20%</td>
</tr>
</tbody>
</table>

**Table 10.9. Change in Aneurysm Size by Interval**

+------------+--------+--------+--------+--------+--------+--------+
| **Change   | **1    |        | **1    |        | **1    |        |
| in         | month  |        | month  |        | month  |        |
| Aneurysm   | to 6   |        | to 12  |        | to 24  |        |
| Size**     | mo     |        | mo     |        | mo     |        |
|            | nths** |        | nths** |        | nths** |        |
|            |        |        |        |        |        |        |
|            | **(N = |        | **(N = |        | **(N = |        |
|            | 182)** |        | 181)** |        | 146)** |        |
|            |        |        |        |        |        |        |
|            | **N    |        | **N    |        | **N    |        |
|            | %**    |        | %**    |        | %**    |        |
+------------+--------+--------+--------+--------+--------+--------+
| Decrease   | 18     | 10%    | 26     | 14%    | 28     | 19%    |
+------------+--------+--------+--------+--------+--------+--------+
| No Change  | 159    | 87%    | 142    | 78%    | 97     | 67%    |
+------------+--------+--------+--------+--------+--------+--------+
| Increase   | 5      | 3%     | 13     | 8%     | 21     | 14%    |
+------------+--------+--------+--------+--------+--------+--------+

**Table 10.10. Maximum Aneurysm Diameter and Endoleaks at 12-Months**

+-----------------------------------+-------+-------+-------+-------+
| **Aneurysm Change from 1 to 12    | **N** | **End |       | *     |
| Months\***                        |       | oleak |       | *p-Va |
|                                   |       | at**  |       | lue** |
|                                   |       |       |       |       |
|                                   |       | **12  |       |       |
|                                   |       | Month |       |       |
|                                   |       | s\*** |       |       |
+-----------------------------------+-------+-------+-------+-------+
|                                   |       | N     | \%    |       |
+-----------------------------------+-------+-------+-------+-------+
| Increase ([\>]{.underline} 5 mm)  | 10    | 4     | 40%   |       |
+-----------------------------------+-------+-------+-------+-------+
| No Change                         | 118   | 19    | 16%   |       |
+-----------------------------------+-------+-------+-------+-------+
| Decrease ([\<]{.underline} 5 mm)  | 18    | 2     | 11%   |       |
+-----------------------------------+-------+-------+-------+-------+
| Total                             | 146   | 25    | 17%   | 0.12  |
+-----------------------------------+-------+-------+-------+-------+

\*Only includes patients with interpretable films (endoleak) and
measurements of aneurysm change from 1 to 12 months.

**Table 10.11. Maximum Aneurysm Diameter and Endoleaks at 24-Months**

+---------------------+-----------+-----------+-----------+-----------+
| **1-month to        | **N**     | *         |           | **        |
| 24-month Aneurysm   |           | *Endoleak |           | p-Value** |
| Change\***          |           | at        |           |           |
|                     |           | 24-m      |           |           |
|                     |           | onths\*** |           |           |
|                     |           |           |           |           |
|                     |           | **N %**   |           |           |
+---------------------+-----------+-----------+-----------+-----------+
| Increase            | 15        | 7         | 47%       | 0.004     |
| ([\>]{.underline}5  |           |           |           |           |
| mm)                 |           |           |           |           |
+---------------------+-----------+-----------+-----------+-----------+
| No change           | 74        | 10        | 14%       |           |
+---------------------+-----------+-----------+-----------+-----------+
| Decrease            | 23        | 2         | 9%        |           |
| ([\<]{.underline}5  |           |           |           |           |
| mm)                 |           |           |           |           |
+---------------------+-----------+-----------+-----------+-----------+
| Total               | 112       | 19        | 17%       |           |
+---------------------+-----------+-----------+-----------+-----------+

\*includes subjects with interpretable films for endoleaks and
measurements for aneurysm change from 1 to 24 months.

Secondary interventions within the first and second year each were
performed in 6% of the EXCLUDER Bifurcated Endoprosthesis subjects as
shown in Table 10.11. All interventions were catheter-based. Subjects
may have a single intervention for an endoleak and an aneurysm
enlargement.

Table 10.12. Interventions for Endoleak and Aneurysm Size Increases

+------------------------------------+-------+-------+-------+-------+
| **Intervention**                   | **P   |       | **\>  |       |
|                                    | ost-p |       | 12-m  |       |
|                                    | roced |       | onths |       |
|                                    | ure** |       | to    |       |
|                                    |       |       | 2     |       |
|                                    | **to  |       | 4-mon |       |
|                                    | 1     |       | ths** |       |
|                                    | 2-mon |       |       |       |
|                                    | ths** |       | **(N  |       |
|                                    |       |       | =     |       |
|                                    | **(N  |       | 2     |       |
|                                    | = 235 |       | 03)** |       |
|                                    | )**   |       |       |       |
|                                    |       |       | **N   |       |
|                                    | **N   |       | (%)** |       |
|                                    | (%)** |       |       |       |
+------------------------------------+-------+-------+-------+-------+
| Number subjects with               | 15    | 6%    | 12    | 6%    |
| [\>]{.underline} 1 Intervention    |       |       |       |       |
+------------------------------------+-------+-------+-------+-------+
| Treatment of Endoleaks:            | 16    | 7%    | 10    | 5%    |
+------------------------------------+-------+-------+-------+-------+
| Embolization                       | 15    |       | 9     |       |
+------------------------------------+-------+-------+-------+-------+
| Ligation                           | 1     |       | 0     |       |
+------------------------------------+-------+-------+-------+-------+
| Conversion                         | 0     |       | 1\*   |       |
+------------------------------------+-------+-------+-------+-------+
| Treatment of Aneurysm Enlargement  | 1     | 0.4%  | 8\*\* | 4%    |
+------------------------------------+-------+-------+-------+-------+
| Embolization                       | 0     |       | 5     |       |
+------------------------------------+-------+-------+-------+-------+
| Ligation                           | 1     |       | 0     |       |
+------------------------------------+-------+-------+-------+-------+
| Conversion                         | 0     |       | 3\*   |       |
+------------------------------------+-------+-------+-------+-------+

> \*Total of three conversions
>
> \*\*Six of the subjects also had endoleak.

10.4.2 Secondary Outcomes

As described in Table 10.13, treatment of AAA with EXCLUDER Bifurcated
Endoprosthesis compared to the control group demonstrated significant
benefits in recovery and quality of life measures.

**Table 10.13. Secondary Outcomes by Treatment Group**

+-----------------------------+------------+------------+------------+
| **Secondary Outcomes**      | **EBE**    | *          | *          |
|                             |            | *Control** | *p-Value** |
+-----------------------------+------------+------------+------------+
| Blood Loss (ml)             | 310        | 1590       | \<0.0001   |
|                             |            |            |            |
| Mean (range)                | (50-2160)  | (100-7000) |            |
+-----------------------------+------------+------------+------------+
| Procedure Transfusion (%)   | 14%        | 89%        | \<0.0001   |
+-----------------------------+------------+------------+------------+
| Procedure Time (minutes)    | 144        | 196        | \<0.0001   |
|                             |            |            |            |
| Mean (range)                | (51-320)   | (67-420)   |            |
+-----------------------------+------------+------------+------------+
| ICU Stay (%)                | 24%        | 87%        | \<0.0001   |
+-----------------------------+------------+------------+------------+
| Hospital Length of Stay     | 2          | 9.8        | \<0.0001   |
| (days)                      |            |            |            |
|                             | (1-11)     | (3-114)    |            |
| Mean (range)                |            |            |            |
+-----------------------------+------------+------------+------------+
| Time to First Oral Intake   | 0.5        | 2.6        | \<0.0001   |
| (days)                      |            |            |            |
|                             | (0.-2.1)   | (0.07-9.5) |            |
| Mean (range)                |            |            |            |
+-----------------------------+------------+------------+------------+
| Time to Ambulation (days)   | 1.0        | 2.6        | \<0.0001   |
|                             |            |            |            |
| Mean (range)                | (0-5.0)    | (0-18)     |            |
+-----------------------------+------------+------------+------------+
| Time to Return to Normal    | 42         | 92         | 0.002      |
| Activities (Days)           |            |            |            |
+-----------------------------+------------+------------+------------+

**11.0 Conclusions Drawn from the Studies**

As compared to conventional open surgery, the clinical benefits of the
EXCLUDER Bifurcated Endoprosthesis are a lower rate of major
complications, reduced blood loss and blood replacement volume, reduced
need for an ICU stay, shorter hospitalization and faster return to
normal activities. The risks include procedure- and/or device-related
phenomenon, which include but are not limited to endoleaks and increase
in aneurysm size.

^1^ White GH, May J, Waugh RC, et al. Type II and Type IV endoleak:
Toward a complete definition of blood flow in the sac after AAA
endoluminal repair. J Endovasc Surg 5:305-309, 1998.

^2^ White GH, Yu W, May J, et al. Endoleak as a complication of
endoluminal grafting of abdominal aortic aneurysms: Classification,
incidence, diagnosis and management. J Endovasc Surg 4:152-168, 1997.