Summary of Safety and Effectiveness Data

*ANCURE^^ Aortoiliac System*

*Guidant Corporation*

Table of Contents

1\. General Information [2](#general-information)

2\. Indications and Usage [2](#indications-and-usage)

3\. Contraindications [2](#contraindications)

4\. Warnings and Precautions [2](#warnings-and-precautions)

5\. Device Description [3](#device-description)

6\. Alternative Practices or Procedures
[7](#alternative-practices-or-procedures)

7\. Marketing History [7](#marketing-history)

8\. Adverse Events [7](#adverse-events)

8.1 Observed Adverse Events [7](#observed-adverse-events)

8.2 Potential Adverse Events [9](#potential-adverse-events)

9\. Summary of Pre-Clinical Studies
[10](#summary-of-pre-clinical-studies)

9.1 Laboratory Studies [10](#laboratory-studies)

9.1.1 Biocompatibility, Immunology, and Toxicology Studies
[10](#biocompatibility-immunology-and-toxicology-studies)

9.1.2 Graft Mechanical Testing [11](#graft-mechanical-testing)

9.1.3 Graft Durability Testing [12](#graft-durability-testing)

9.1.4 Aortoiliac Graft Attachment System Studies
[12](#aortoiliac-graft-attachment-system-studies)

9.1.5 Delivery System Mechanical Testing
[14](#delivery-system-mechanical-testing)

9.2 Animal Studies [14](#animal-studies)

9.3 Additional Studies [16](#additional-studies)

10\. Summary of Clinical Studies [16](#summary-of-clinical-studies)

10.1 Description of Patients Studied and Gender Bias
[17](#description-of-patients-studied-and-gender-bias)

10.1.1 Evaluation of Gender Bias [17](#evaluation-of-gender-bias)

10.1.2 Aneurysm Diameter Distribution
[18](#aneurysm-diameter-distribution)

10.2 Summary of the Aortoiliac EGS Study
[19](#summary-of-the-aortoiliac-egs-study)

11\. Conclusions Drawn from the Studies
[23](#conclusions-drawn-from-the-studies)

12\. FDA Decision [23](#fda-decision)

13\. Approval Specifications [23](#approval-specifications)

*Summary of Safety and Effectiveness Data*

*ANCURE^^ Aortoiliac System*

*Guidant Corporation*

# General Information

> Device Generic Name: Endovascular Aortoiliac Grafting System
>
> Device Trade Name: ANCURE^^ Aortoiliac System
>
> Applicant's Name and Address: Guidant Corporation\
> 1525 O'Brien Drive\
> Menlo Park, CA 94025
>
> PMA Application Number: P990017/S30
>
> Date of Notice of Approval to the Applicant April 24, 2002

# Indications and Usage

The ANCURE Aortoiliac System is indicated for the endovascular treatment
of infrarenal abdominal aortic aneurysms or aortoiliac aneurysms (AAA)
in patients whose anatomy does not allow the use of a tube or bifurcated
device and having:

-   adequate iliac/femoral access,

-   infrarenal non-aneurysmal neck length of at least 15 mm and a
    diameter of no greater than 26 mm,

-   [one]{.underline} distal segment length of at least 20 mm and
    diameters no greater than 13.4 mm, and

-   morphology suitable for endovascular repair.

# Contraindications

There are no identified contraindications for this device.

# Warnings and Precautions

See Final Draft Labeling

# Device Description

The ANCURE Aortoiliac System consists of a graft, which is housed within
a delivery catheter. The ANCURE Aortoiliac configuration contains a
graft with a single iliac limb segment. The graft is a woven polyester
vascular graft with attachment systems affixed to the ends. Each
attachment system consists of angled metal attachment hooks and a
self-expanding cylindrical metal frame. The attachment systems create an
anastomosis between the graft and the vessel wall. Radiopaque markers on
the graft assist with the visualization under fluoroscopy. The
attachment systems and radiopaque markers are made from metallic alloys.

An earlier version of the ANCURE System, called the EGS System, was used
in the clinical trial to support this submission. The EGS and ANCURE
grafts are identical except that the aortoiliac ANCURE grafts have
suture loops on the superior and inferior attachment systems. These
suture loops on the outside of the graft accommodate the deployment
mechanism of the ANCURE delivery catheter. In addition, the fuzzy
polyester tufts on the superior and inferior ends of the graft which are
used to promote attachment site healing were moved slightly closer to
the ANCURE graft ends and cut slightly shorter. Pre-clinical testing was
used to qualify the new graft design.

The delivery catheter houses the compressed graft and is used to deploy
the graft. The delivery catheter consists of 1) a multi-lumen balloon
catheter that is used to guide the device over a guidewire and secure
the attachment system, 2) a deployment system that controls deployment
of the attachment systems, and 3) a jacket that houses the compressed
graft. See Figures 1 and 2 for depictions of the ANCURE delivery
catheter.

The aortoiliac graft is provided in a range of lengths and diameters to
accommodate variations in patient anatomy. Table 1 lists the sizes and
model numbers available for the Aortoiliac Endograft prosthesis sizes.

Figure 1. ANCURE Delivery Catheter Handle

![](media/image1.wmf)

Figure 2. ANCURE Aortoiliac Delivery System

![](media/image2.wmf)

Figure 3. Illustration of ANCURE Aortoiliac Delivery System

![](media/image3.png)

Table 1. ANCURE Aortoiliac System Model Numbers

  -----------------------------------------------------------------------
  **DESCRIPTION**            **MODEL NUMBER**       **SIZE**
  -------------------------- ---------------------- ---------------------
  **AORTOILIAC**             01201210               20 mm X 12.0 cm

  **AORTOILIAC**             01201310               20 mm X 13.0 cm

  **AORTOILIAC**             01201410               20 mm X 14.0 cm

  **AORTOILIAC**             01201510               20 mm X 15.0 cm

  **AORTOILIAC**             01201610               20 mm X 16.0 cm

  **AORTOILIAC**             01201710               20 mm X 17.0 cm

  **AORTOILIAC**             01201810               20 mm X 18.0 cm

  **AORTOILIAC**             01201910               20 mm X 19.0 cm

  **AORTOILIAC**             01202010               20 mm X 20.0 cm

  **AORTOILIAC**             01202110               20 mm X 21.0 cm

  **AORTOILIAC**             01202210               20 mm X 22.0 cm

  **AORTOILIAC**             01202310               20 mm X 23.0 cm

  **AORTOILIAC**             01202410               20 mm X 24.0 cm

  **AORTOILIAC**             01202510               20 mm X 25.0 cm

  **AORTOILIAC**             01221211               22 mm X 12.0 cm

  **AORTOILIAC**             01221311               22 mm X 13.0 cm

  **AORTOILIAC**             01221411               22 mm X 14.0 cm

  **AORTOILIAC**             01221511               22 mm X 15.0 cm

  **AORTOILIAC**             01221611               22 mm X 16.0 cm

  **AORTOILIAC**             01221711               22 mm X 17.0 cm

  **AORTOILIAC**             01221811               22 mm X 18.0 cm

  **AORTOILIAC**             01221911               22 mm X 19.0 cm

  **AORTOILIAC**             01222011               22 mm X 20.0 cm

  **AORTOILIAC**             01222111               22 mm X 21.0 cm

  **AORTOILIAC**             01222211               22 mm X 22.0 cm

  **AORTOILIAC**             01222311               22 mm X 23.0 cm

  **AORTOILIAC**             01222411               22 mm X 24.0 cm

  **AORTOILIAC**             01222511               22 mm X 25.0 cm

  **AORTOILIAC**             01241212               24 mm X 12.0 cm

  **AORTOILIAC**             01241312               24 mm X 13.0 cm

  **AORTOILIAC**             01241412               24 mm X 14.0 cm

  **AORTOILIAC**             01241512               24 mm X 15.0 cm

  **AORTOILIAC**             01241612               24 mm X 16.0 cm

  **AORTOILIAC**             01241712               24 mm X 17.0 cm

  **AORTOILIAC**             01241812               24 mm X 18.0 cm

  **AORTOILIAC**             01241912               24 mm X 19.0 cm

  **AORTOILIAC**             01242012               24 mm X 20.0 cm

  **AORTOILIAC**             01242112               24 mm X 21.0 cm

  **AORTOILIAC**             01242212               24 mm X 22.0 cm

  **AORTOILIAC**             01242312               24 mm X 23.0 cm

  **AORTOILIAC**             01242412               24 mm X 24.0 cm

  **AORTOILIAC**             01242512               24 mm X 25.0 cm

  **AORTOILIAC**             01261213               26 mm X 12.0 cm

  **AORTOILIAC**             01261313               26 mm X 13.0 cm

  **AORTOILIAC**             01261413               26 mm X 14.0 cm

  **AORTOILIAC**             01261513               26 mm X 15.0 cm

  **AORTOILIAC**             01261613               26 mm X 16.0 cm

  **AORTOILIAC**             01261713               26 mm X 17.0 cm

  **AORTOILIAC**             01261813               26 mm X 18.0 cm

  **AORTOILIAC**             01261913               26 mm X 19.0 cm

  **AORTOILIAC**             01262013               26 mm X 20.0 cm

  **AORTOILIAC**             01262113               26 mm X 21.0 cm

  **AORTOILIAC**             01262213               26 mm X 22.0 cm

  **AORTOILIAC**             01262313               26 mm X 23.0 cm

  **AORTOILIAC**             01262413               26 mm X 24.0 cm

  **AORTOILIAC**             01262513               26 mm X 25.0 cm
  -----------------------------------------------------------------------

# Alternative Practices or Procedures

Currently, the most widely accepted treatment for AAA repair is surgical
repair utilizing aneurysmorrhaphy and prosthetic graft interposition
through a transperitoneal or retroperitoneal incision.

# Marketing History

The ANCURE Aortoiliac System has been commercially available in Sweden,
France, Australia, Belgium, Greece, Canada, Austria, Spain, United
Kingdom, Netherlands, Italy, Germany, Switzerland, Finland, and Israel.

# Adverse Events

## Observed Adverse Events

A total of 232 patients were enrolled in the EGS clinical study (121
aortoiliac and 111 surgical control). Adverse event data from this study
are summarized in alphabetical order in Tables 2 and 3.

In the EGS clinical study, the operative mortality rate was less than
five percent in both treatment groups (4.2 % aortoiliac and 2.7% control
subjects; not statistically significantly different). In the aortoiliac
clinical study, five operative deaths occurred. The 5 operative (defined
as \< 30 days) deaths are all aortoiliac EGS subjects, 4/5 were male.
The causes of the 5 aortoiliac operative deaths are: cardio-respirator
failure with pulmonary hypertension (died prior to discharge),
exsanguination (died intra-op), cardiac arrest (died 4 days
post-discharge), arrhythmia (died prior to discharge), and tension
pneumothorax (female subject, died prior to discharge).

In the aortoiliac clinical study, nine late deaths (defined as \< 1 year
and \> 30 days) occurred. Of these nine late deaths, four were cardiac
related, three were respiratory related, one was the result of stroke
and one was the result of cancer.

Table 2. Adverse Events ≤ 30 days (Listed Alphabetically)

+-------------------------------+-----------------+--------------------+
| Event                         | Aortoiliac ^1^  | Surgical Control   |
|                               |                 | ^2^                |
|                               | \% (n/N)        |                    |
|                               |                 | \% (n/N)           |
+-------------------------------+-----------------+--------------------+
| Deaths -- Operative           | 4.2% (5/118)    | 2.7% (3/111)       |
+-------------------------------+-----------------+--------------------+
| Other Adverse Events          |                 |                    |
+-------------------------------+-----------------+--------------------+
| > Arterial Trauma             | 9.3% (11/118)   | 0.0% (0/111)       |
+-------------------------------+-----------------+--------------------+
| > Bleeding                    | 15.3% (18/118)  | 39.6% (44/111)     |
+-------------------------------+-----------------+--------------------+
| > Bowel                       | 5.9% (7/118)    | 8.1% (9/111)       |
+-------------------------------+-----------------+--------------------+
| > Cardiac                     | 22.0% (26/118)  | 20.7% (23/111)     |
+-------------------------------+-----------------+--------------------+
| > Coagulopathy                | 1.7% (2/118)    | 4.5% (5/111)       |
+-------------------------------+-----------------+--------------------+
| > Conversions^3^ / Cases      | 5.8% (7/121)    | N/A                |
| > Aborted                     |                 |                    |
+-------------------------------+-----------------+--------------------+
| > Deep Vein Thrombosis        | 1.7% (2/118)    | 0.9% (1/111)       |
+-------------------------------+-----------------+--------------------+
| > Embolism -- Lower Extremity | 1.7% (2/118)    | 0.9% (1/111)       |
| > Ischemia                    |                 |                    |
+-------------------------------+-----------------+--------------------+
| > Hematoma                    | 8.5% (10/118)   | 1.8% (2/111)       |
+-------------------------------+-----------------+--------------------+
| > Impotence                   | 0.0% (0/118)    | 1.8% (2/111)       |
+-------------------------------+-----------------+--------------------+
| > Paraplegia/Paraparesis      | 0.8% (1/118)    | 0.0% (0/111)       |
+-------------------------------+-----------------+--------------------+
| > Perigraft Flow, Discharge   | 51.8% (58/112)  | N/A                |
+-------------------------------+-----------------+--------------------+
| > Prosthetic Thrombosis       | 1.7% (2/118)    | 0.0% (0/111)       |
+-------------------------------+-----------------+--------------------+
| > Reduced Limb Flow ^4^       | 28.3% (32/113)  | N/A                |
+-------------------------------+-----------------+--------------------+
| > Renal Insufficiency         | 6.8% (8/118)    | 1.8% (2/111)       |
+-------------------------------+-----------------+--------------------+
| > Respiratory                 | 11.9% (14/118)  | 22.5% (25/111)     |
+-------------------------------+-----------------+--------------------+
| > Stroke                      | 0.8% (1/118)    | 0.9% (1/111)       |
+-------------------------------+-----------------+--------------------+
| > TIA                         | 0.8% (1/118)    | 0.0% (0/111)       |
+-------------------------------+-----------------+--------------------+
| > Wound                       | 7.6% (9/118)    | 1.8% (2/111)       |
+-------------------------------+-----------------+--------------------+

> 1\. Of the total 121 aortoiliac subjects, three discontinued their
> participation at discharge and were alive at that time. These subjects
> are included in the analysis only through surgical implantation.
>
> 2\. 94 of the Control subjects were tube subjects and 17 were
> bifurcated subjects.
>
> 3\. Three aortoiliac subjects had the treatment abandoned without
> conversion to open repair.
>
> 4\. These analyses included only implanted patients.

Table 3. Adverse Events at 12 months (Listed Alphabetically) ^1^

  -------------------------- ---------------------- ----------------------
  **Event**                  **Aortoiliac (%)**     **Surgical Control ^2^
                                                    (%)**

  Deaths                     11.9%                  5.4%

  Other Adverse Events                              

  Arterial Trauma            10.2%                  1.0%

  Bleeding                   16.1%                  39.6%

  Bowel                      6.8%                   11.0%

  Cardiac                    38.1%                  24.6%

  Graft Migration ^3^        0.0%                   N/A

  Perigraft Flow ^3^         33.0%                  N/A

  Renal Insufficiency        8.5%                   1.8%

  Respiratory                19.5%                  24.3%

  Wound                      9.3%                   1.9%
  -------------------------- ---------------------- ----------------------

> 1\. Event rates are based on Kaplan Meier methodology.
>
> 2\. 94 of the Control subjects were tube subjects and 17 were
> bifurcated subjects.
>
> 3\. These events were assessed at discrete time points (discharge, 6
> mos., 12 mos.), therefore Kaplan Meier estimates of the rates were not
> performed.

## Potential Adverse Events

The following adverse events (in alphabetical order) may be associated
with endovascular AAA repair:

Table 4. Potential Adverse Events

+---------------------------------------+------------------------------+
| Acute myocardial infarction           | Hypotension/Hypertension     |
|                                       |                              |
| Amputation                            | Impotence                    |
|                                       |                              |
| Anastomotic false aneurysm            | Infection and pain at        |
|                                       | insertion site               |
| Aneurysm rupture                      |                              |
|                                       | Infection                    |
| Arrhythmias                           |                              |
|                                       | Lymphatic complications      |
| Arterial trauma/dissection            |                              |
|                                       | Paraplegia/paraparesis       |
| Attachment system fractures           |                              |
|                                       | Perforation                  |
| Bleeding, requiring transfusion       |                              |
|                                       | Perigraft flow               |
| Bowel ischemia/bowel                  |                              |
| obstruction/adynamic ileus            | Prosthesis extrusion/erosion |
|                                       |                              |
| Claudication                          | Prosthetic infection         |
|                                       |                              |
| Coagulopathy                          | Pulmonary embolism           |
|                                       |                              |
| Congestive heart failure              | Reduced limb flow            |
|                                       |                              |
| Conversion to standard AAA surgery    | Renal insufficiency/failure  |
|                                       |                              |
| Death                                 | Respiratory                  |
|                                       | f                            |
| Deep vein thrombosis                  | ailure/atelectasis/pneumonia |
|                                       |                              |
| Drug reactions to antiplatelet        | Spasm                        |
| agents/contrast medium                |                              |
|                                       | Stroke/cerebrovascular event |
| Emboli, distal (air, tissue or        |                              |
| thrombotic emboli)                    | TIA                          |
|                                       |                              |
| Femorofemoral thrombosis              | Thrombosis/occlusion of      |
|                                       | graft                        |
| Fistula (aortoenteric, aortocaval)    |                              |
|                                       | Wound dehiscence             |
| Graft dilatation                      |                              |
|                                       |                              |
| Graft migration                       |                              |
|                                       |                              |
| Hematoma                              |                              |
+---------------------------------------+------------------------------+

# Summary of Pre-Clinical Studies

## Laboratory Studies

The ANCURE System (and the earlier version, the EGS System) was
subjected to a pre-clinical testing program in accordance with the FDA
draft "Guidance for the Preparation of Research and Marketing
Applications for Vascular Graft Prostheses." All test samples were
prepared in the same manner as intended for clinical usage.

### Biocompatibility, Immunology, and Toxicology Studies

Toxicity and biocompatibility studies were conducted for all graft and
delivery catheter materials. The testing was conducted in accordance
with Good Laboratory Practices per 21CFR 58 and ISO 10993. The grafts
were classified by ISO 10993 as implant devices, blood contact, C -
long-term. The delivery catheter was classified as an externally
communicating device with circulating blood contact and limited exposure
of less than 24 hours. The results as shown in Table 5 support the
biocompatibility of the Aortoiliac device for its intended uses.

Table 5. Biocompatibility, Immunology, and Toxicology Studies

  -----------------------------------------------------------------------
  **Test Performed**       **Extract(s)**        **Findings**
  ------------------------ --------------------- ------------------------
  Ames Salmonella/         0.9% USP Sodium       Material is
  Mammalian Microsome      Chloride for          non-mutagenic.
  Mutagenicity Assay       injection and DMSO    
                           extracts              

  Sister Chromatid         McCoy\'s 5A medium    Material is
  Exchange                                       non-genotoxic.

  Chromosomal Aberration   McCoy\'s 5A medium    Material is
                                                 non-genotoxic.

  *In Vitro* Hemolysis     0.9% Sodium Chloride  Material is
                           USP                   non-hemolytic.

  C3a Complement           Normal Human Serum,   Test article represented
  Activation               NHS, certified HIV (1 activation at 18,472
                           & 2) and Hepatitis (B ng/ml. The materials
                           & C) negative         performed as
                                                 anticipated.

  Determination of         Canis familiaris      Material did not have a
  Clotting Time using the  blood                 significant effect on
  Lee-White Method                               clotting time.

  Cytotoxicity             Single strength MEM   Material showed no
                           supplemented with 5%  evidence of cell lysis
                           calf serum and 2%     or toxicity to L-929
                           antibiotics           mouse fibroblast cells.
                                                 The material was
                                                 non-cytotoxic.

  Acute Intracutaneous     0.9% Sodium Chloride  The Primary Irritation
  Reactivity Study in the  USP Solution and      Index Characterization
  Rabbit                   Cottonseed Oil        was negligible. There
                                                 was no evidence of
                                                 significant irritation
                                                 or toxicity.

  Magnusson and Kligman    0.9% Sodium Chloride  There was no evidence of
  Method Delayed Contact   USP Solution and      causing delayed dermal
  Sensitization Study in   Cottonseed Oil        contact sensitization in
  the Guinea Pig,                                the guinea pig.
  Maximization                                   

  Magnusson and Kligman    1-Chloro              The known sensitizer
  Method Delayed Contact   -2,4-Dinitrobenzene   DNCB showed significant
  Sensitization Study in   (DNCB)                evidence of causing
  the Guinea Pig,                                delayed dermal contact
  Maximization Method                            sensitization.
  (Positive Control)                             

  Rabbit Pyrogen           0.9% Sodium Chloride  Material is
                           USP Solution          non-pyrogenic.

  USP Systemic Toxicity    0.9% Sodium Chloride  There was no evidence of
  Study in the Mouse       USP Solution and      significant systemic
                           Cottonseed Oil, NF    toxicity.
                           (CSO)                 

  Sub-Chronic (14 days)    0.9% Sodium Chloride  There was no evidence of
  Intravenous Toxicity     USP Solution          significant systemic
  Study in the Rat                               toxicity

  Muscle Implantation      N/A                   There was no evidence if
  Study in the rabbit with                       material toxicity in the
  Histopathology (surgical                       surrounding animal
  method 13 weeks)                               tissues.
  -----------------------------------------------------------------------

### Graft Mechanical Testing

Although there are no specific applicable standards for endovascular
aortoiliac grafts, mechanical tests were conducted on the EndoWeave-65
tube graft, as representative of the aortoiliac graft. Two sources for
the EndoWeave-65 material were qualified. A summary of the mechanical
testing conducted is presented in Table 6. The data demonstrates the
mechanical properties of the graft are suitable for its intended use and
are within manufacturing capabilities.

Table 6. Graft Mechanical Testing Summary

+-------------------+----------------+----------------+----------------+
| **Attribute**     | **Source A     | **Source B     | **Guidant      |
|                   | EndoWeave-65   | EndoWeave-65   | Specification  |
|                   | Graft          | Graft          | (E             |
|                   | Material**     | Material**     | ndoWeave-65)** |
+-------------------+----------------+----------------+----------------+
| > Water           | > Avg: 177\    | > Avg.: 186\   | > Average must |
| > Permeability\   | > S.D.: 30.8   | > S.D.: 39.8   | > be between   |
| > (ml/cm^2^/min)  |                |                | > 50 and 300   |
|                   |                |                | > ml/cm^2^/min |
+-------------------+----------------+----------------+----------------+
| > Modified        | > Avg: 112.0\  | > Avg.: 112.5\ | > Average must |
| > Tensile         | > S.D.: 6.91   | > S.D.: 6.27   | > be           |
| > Strength\       |                |                | > [\>]         |
| > (lbs.)          |                |                | {.underline}95 |
|                   |                |                | > lbs.         |
+-------------------+----------------+----------------+----------------+
| > Balloon Burst   | > Avg: 9573\   | > Avg.: 10199\ | > [\>]{.       |
| > Strength\       | > S.D.: 557    | > S.D.: 665    | underline}5732 |
| > (Hoop Stress)\  |                |                | > PSI          |
| > (p.s.i.)        |                |                |                |
+-------------------+----------------+----------------+----------------+
| > Compliance\     | > Avg: 0.0100\ | > Avg .:       | > 0.00 --      |
| > (%)             | > S.D.:        | > 0.0088\      | > 0.03%        |
|                   | > 0.00145      | > S.D.:        |                |
|                   |                | > 0.00121      |                |
+-------------------+----------------+----------------+----------------+
| > Longitudinal    | > Avg: 86.1\   | > Avg.: 84.5\  | > [\>]         |
| > Tensile         | > S.D.: 3.02   | > S.D.: 18.35  | {.underline}60 |
| > Strength\       |                |                | > lb./in       |
| > (lb./inch)      |                |                |                |
+-------------------+----------------+----------------+----------------+
| > Suture          | > Avg: 1682\   | > Avg.: 2243\  | > [\>]{        |
| > Retention       | > S.D.: 366    | > S.D.: 166    | .underline}800 |
| > Strength\       |                |                | > grams-force  |
| > (grams-force)   |                |                |                |
+-------------------+----------------+----------------+----------------+
| > Suture Hole     | > Avg: 0.006"\ | > Avg.:        | > [\<]{.un     |
| > Elongation\     | > S.D.: 0.0038 | > 0.009"\      | derline}0.039" |
| > (inches)        |                | > S.D.: 0.0038 |                |
+-------------------+----------------+----------------+----------------+
| > Kink Radius\    | > Avg. Limbs:  | > Avg. Limbs:  | > \<0.65"      |
| > (inches)        | > 0.234"\      | > 0.235"\      |                |
|                   | > S.D.: 0.010  | > S.D.: 0.005  |                |
+-------------------+----------------+----------------+----------------+
| > Crush           | > Avg. Limbs:  | > Avg. Limbs:  | > [\>]         |
| > Resistance\     | > 52.5\        | > 78.3\        | {.underline}50 |
| > (grams)         | > S.D.: 2.5    | > S.D.: 12.5   | > grams-force  |
+-------------------+----------------+----------------+----------------+
| > Usable Length\  | > Avg. (100mm  | > Avg. (100mm  | > 8 -- 20% at  |
| > (% elongation)  | > Hg): 18.6%\  | > Hg):15.9%\   | > 100mm Hg\    |
|                   | > S.D.: 3.60\  | > S.D.: 2.0%\  | > 20 -- 27% at |
|                   | > Avg. (full): | > Avg. (full): | > full         |
|                   | > 22.3%\       | > 22.1%\       | > elongation   |
|                   | > S.D.: 3.28%  | > S.D.: 2.5%   |                |
+-------------------+----------------+----------------+----------------+

### Graft Durability Testing

**Objective:** Testing was conducted on the EndoWeave-65 graft material
to evaluate its mechanical integrity.

**Methods:** Testing was completed on graft material samples to an
equivalent of 10 years or 400 million cycles. A cycle is considered a
simulation of pulsatile blood flow. A modified tensile test was
performed on one sample each following 100 million, 200 million, 300
million and 400 million cycles. Following cycling, the samples were cut
into two pieces and pulled to failure.

**Results:** Durability results are shown in Table 7.

Table 7. Graft Durability Testing Summary

  ----------------- ----------------- ----------------- -----------------
  **Peak Tensile    **Peak Tensile    **Peak Tensile    **Peak Tensile
  Force (lbf) after Force (lbf) after Force (lbf) after Force (lbf) after
  100 Million       200 Million       300 Million       400 Million
  Cycles (n=2)**    Cycles (n=2)**    Cycles (n=2)**    Cycles (n=2)**

  113.2 ± 2.33      99.3 ± 7.92       102 ± 1.06        81.83 ± 16.65
  ----------------- ----------------- ----------------- -----------------

Theoretical burst strength was calculated from the tensile force data.
After the equivalent of 10 years *in vivo* the EndoWeave-65 graft
material exhibited a theoretical burst strength of 106.5 psi, which far
exceeds the estimated *in vivo* loads of 2 -- 5 psi. The compliance of
the Endo-Weave-65 graft material before and after 400 million cycles was
0.0100% and 0.0083%, respectively.

**Conclusions:** These data indicate the EndoWeave-65 graft material has
sufficient strength and compliance for its intended use throughout its
intended lifetime.

### Aortoiliac Graft Attachment System Studies

#### Estimation of In vivo Loads

Although there are no specific applicable standards for endovascular
aortoiliac grafts, three estimation methods (clinical extrapolation, a
flow model, and a fluid mechanics model) were used to model the
aortoiliac graft *in vivo* axial loads. Aortic axial loads experienced
in an aortoiliac graft were found to be similar to axial loads in the
tube and bifurcated grafts.

The iliac attachment system mean diameter *in vivo* was determined for
all sizes of graft diameters. Radial loads were estimated based on the
cyclic diameter change experienced by the iliac arteries. The *in vivo*
mean diameters and cyclic diameter changes were used in combination with
finite element analysis to determine the *in vivo* mean and alternating
stresses of the aortic and iliac attachment systems due to arterial
diameter change loading.

#### Finite Element Analysis

Results from the finite element analysis for the tube EGS graft
attachment system were used to represent the aortoiliac EGS graft aortic
attachment system frame, since the aortic end of the aortoiliac EGS
graft attachment system is identical to that of the tube EGS graft
attachment system. A finite element analysis was used to estimate the
*in vivo* stresses of the aortoiliac EGS V-hooks. The V-hook model
showed stress as linearly proportional to the attachment system diameter
change over the *in vivo* diameter range. Stresses were dominated by
bending stresses. Axial and torsional stresses were low.

Finite element analysis was used to estimate the *in vivo* mean and
alternating stresses of the attachment system frame and V-hook. Two
analyses were conducted on the bifurcated EGS graft iliac attachment
system to estimate hook stresses using elastic finite element analysis.
The results from these tests were used to represent the aortoiliac EGS
graft, since the iliac attachment systems for these two devices are
identical. In the first analysis, the iliac attachment system frame
stresses were estimated using a radially loaded model that was
compressed from a 15mm-free diameter to the estimated *in vivo* systolic
and diastolic diameters. A second analysis was conducted to estimate
hook stresses using a radially and axially loaded model that was
compressed from a 15mm-free diameter to the estimated *in vivo* systolic
and diastolic changes. The results for both analyses showed that
stresses are linearly proportional to attachment system diameter changes
over the *in vivo* diameter range. Stresses were dominated by bending
stresses. Axial and torsional stresses were low. A similar analysis was
performed on each diameter for iliac attachment systems yielding similar
results.

#### Fatigue Testing

The estimated *in vivo* mean and alternating stresses and R-ratios in
the aortic attachment systems and V-hooks for the tube graft attachment
systems were utilized to represent the aortoiliac graft aortic
attachment system frame and V-hooks, with one exception. While the
V-hook design on the aortoiliac graft is identical to the tube design,
the estimated *in vivo* stress for the aortoiliac V-hook tip is slightly
higher. A fatigue test was therefore conducted on the aortoiliac V-hook.
These data were used in estimating fatigue life using the Goodman
fatigue diagrams.

Table 8. Aortoiliac Attachment System Fatigue Analyses

  ------------------------------------------------------------------------
  **Test            **Methods**                  **Findings**
  Performed**                                    
  ----------------- ---------------------------- -------------------------
  Fatigue lifetime  Estimations by plotting      The iliac hook tip bend
  of the iliac      alternating load versus      was determined to meet
  attachment system cycles to failure at several the product requirement
  hook tip bend     different loads. Results     of a 15-\
                    were extrapolated from a     year *in vivo* lifetime.
                    fatigue curve and compared   
                    to the *in vivo* force.      

  *In vivo* life of Estimated using cyclic       The iliac frame apex was
  the iliac frame   displacement loading applied determined to meet the
  apex              to test specimens            product requirement of a
                    representing the iliac       15-\
                    attachment frame apex in a   year *in vivo* lifetime.
                    corrosive environment. A     
                    fatigue curve was generated. 

  *In vivo* life of Estimated using cyclic       The iliac hook weld was
  the iliac hook    displacement loading applied determined to meet the
  weld              to test specimens            product requirement of a
                    representing the iliac       15-\
                    attachment frame hook weld   year *in vivo* lifetime.
                    in a corrosive environment   
                    at three different test      
                    conditions. A fatigue curve  
                    was generated.               

  Fatigue of aortic Cyclic displacement at       The aortic frame closure
  frame closure     different loading was        weld was determined to
  weld              applied to test specimens in meet the product criteria
                    a corrosive environment      of a 15-year *in vivo*
                    using Cantilever Beam        lifetime.
                    Equipment. Results were      
                    extrapolated to long term    
                    *in vivo* lifetimes.         

  Fatigue of iliac  Cyclic displacement at       The iliac frame closure
  frame closure     different loading was        weld was determined to
  weld              applied to test specimens in meet the product criteria
                    a corrosive environment      of a 15-year *in vivo*
                    using Cantilever Beam        lifetime.
                    Equipment. Results were      
                    extrapolated to long term    
                    *in vivo* lifetimes.         
  ------------------------------------------------------------------------

### Delivery System Mechanical Testing

Mechanical joint and component testing was conducted on the ANCURE
delivery catheter. Deflation rate and burst testing was conducted for
the balloon and balloon catheter components of the delivery catheter.
The maximum anticipated *in vivo* loads for the delivery catheter was
estimated and used as conservative design criteria for mechanical
testing. The early estimates were found to be appropriate during the
clinical trials.

All of the bonded joints and engagements were tested for the ANCURE
delivery catheter. All results indicated that at a 95% confidence level
that 99.9% of the bonded strength joints were greater than the expected
maximum *in vivo* forces. The burst strength of the balloons was
determined to be at least 51 psi, which compared favorably with the
rated burst pressure of 30 psi.

## Animal Studies

A series of animal studies were conducted to evaluate the tube,
bifurcated and aortoiliac EGS and ANCURE Systems. Both EGS and ANCURE
animal data are presented since the EGS and ANCURE grafts are nearly
identical in design making both relevant to an evaluation of the ANCURE
graft.

Table 9. Animal Studies Summary

  ---------------------------------------------------------------------------------------
  **Animal     **No./Type   **Test         **Methods**          **Results/Conclusions**
  Study**      Animals      Article**                           
               Studied**                                        
  ------------ ------------ -------------- -------------------- -------------------------
  Acute and    19 sheep     Scaled-down    Five animals each    All grafts successfully
  Chronic                   tube EGS       implanted for        deployed. Grafts remained
  Study of                  system         periods of 1, 2, and patent with no evidence
  Tube Graft                consisting of  6 months, at which   of thrombosis, migration,
                            a delivery     time they were       twist, or compression.
                            catheter with  sacrificed. Four     All animals displayed
                            a helically    additional animals   morphologic evidence of
                            wound,         were later added to  normal graft healing.
                            longitudinal   6-month group.       
                            flexible       Implant sites were   
                            capsule        evaluated macro and  
                            containing the microscopically.     
                            compressed                          
                            graft.                              

  Acute        15 bovine    Full-scale EGS Fifteen animals      Excellent acute results
  Healing                   delivery       assessed for         of the delivery catheter
  Study of                  catheters &    delivery catheter    and graft. All grafts
  Bifurcated                EGS bifurcated deployment & acute   were patent.
  Graft                     graft.         implantation.        
                                           Chronic evaluation   
                                           was planned but      
                                           terminated early due 
                                           to animal model      
                                           difficulties         
                                           resulting from       
                                           bovine vasculature.  
                                           See next study for   
                                           chronic healing.     

  Chronic      7 sheep      Iliac portion  Two animals          Acute implantation was
  Healing                   of bifurcated  implanted with the   successful in all
  Study of                  EGS graft      bifurcated graft     animals. All grafts were
  Bifurcated                               with a shortened     patent with good distal
  Graft                                    contralateral limb.  perfusion. There were no
                                           Five animals were    signs of twisting,
                                           implanted            migration, kinks or
                                           bilaterally with a   longitudinal compression.
                                           short tube with      Healing was normal and
                                           iliac attachment     similar to those found in
                                           system using         sheep at one month.
                                           modified delivery    
                                           catheters.           

  Acute        3 bovine     Aortoiliac EGS Animals implanted    Acute implantation
  Evaluation                delivery       with aortoiliac EGS  successful with
  of the                    catheter and   graft. Following     unobstructed flow through
  Aortoiliac                aortoiliac EGS implantation each    the graft. While the
  EGS System                graft          animal was           catheters performed
                                           sacrificed and a     flawlessly, some
                                           necropsy of the      refinements were later
                                           graft was performed. incorporated to the
                                                                jacket lock and inferior
                                                                control handle. A
                                                                swing-lock, jacket lock
                                                                design was implemented.
                                                                The prosthesis was patent
                                                                and free from thrombus.
                                                                The aortic attachment
                                                                system hooks all
                                                                penetrated the aortic
                                                                arterial wall with
                                                                effective results. The
                                                                current iliac attachment
                                                                system hooks all
                                                                penetrated the iliac
                                                                arterial wall with
                                                                effective results.

  Acute        5 bovine     ANCURE         Grafts were deployed Acute implantation was
  Evaluation                delivery       using ANCURE tube,   successful and all grafts
  of ANCURE                 catheter w/    bifurcated, and      were patent, with no
  System                    ANGIOSCALE     aortoiliac delivery  evidence of migration,
                            catheter       catheters. A         twist, or compression.
                                           necropsy was         Minor technical issues
                                           performed following  encountered with the
                                           animal sacrifice.    delivery catheter, which
                                                                were corrected by
                                                                subsequent device
                                                                changes.
  ---------------------------------------------------------------------------------------

## Additional Studies

This device contains no software or electrical components.

# Summary of Clinical Studies

**Purpose:** The Aortoiliac EGS clinical study compared the rates of
(proportions of patients with) major complications for patients treated
with the Aortoiliac EGS system to the standard surgical treatment for
AAA. Primary outcome measures were: 1) the rate of complications; 2) the
length of hospital stay; and 3) the rate of aneurysm enlargement and
rupture in the first 12 months.

**Study Design:** This prospective, multi-center, non-randomized
clinical study compared patients treated with the Aortoiliac EGS system
to a concurrent surgical control group. All patients had an infrarenal
AAA and were candidates for surgical treatment of AAA. The concurrent
surgical control group included patients whose vascular anatomy may not
have been suitable for endovascular AAA repair based on arterial access
size and proximal and distal neck lengths. Patients were followed at 6
weeks and 6 and 12 months from surgery. Aneurysm diameter changes and
graft patency were evaluated by core laboratory assessment of contrast
enhanced CT scans, abdominal ultrasounds, and x-rays. A total of 15
centers participated in the Aortoiliac EGS study. The study enrolled 121
Aortoiliac and 111 Surgical Control patients.

Vascular surgeons, as well as an interventional radiologist, served as
principal investigators in the clinical study. When the interventional
radiologist performed the procedure, a vascular surgeon performed the
cutdown and closure and was available during the procedure in the event
that conversion to standard surgical repair was necessary.

## Description of Patients Studied and Gender Bias

Table 10. Demographics

+---------------------------+---------------------+--------------------+
| **Variable**              | **Aortoiliac\       | **Surgical         |
|                           | (N=121)\            | Control\           |
|                           | n %**               | (N=111) ^1^\       |
|                           |                     | n %**              |
+---------------------------+---------------------+--------------------+
| Male                      | 112 (92.6%)         | 85 (76.6%)         |
+---------------------------+---------------------+--------------------+
| Age (yrs) Mean ±SD        | 73.2 ± 7.1          | 71.6 ± 7.0         |
+---------------------------+---------------------+--------------------+
| Race (Caucasian)          | 113 (93.4%)         | 108 (97.3%)        |
+---------------------------+---------------------+--------------------+
| CAD                       | 79 (65.3%)          | 68 (61.3%)         |
+---------------------------+---------------------+--------------------+
| MI                        | 56 (46.3%)          | 43 (38.7%)         |
+---------------------------+---------------------+--------------------+
| Arrhythmia ^2^            | 45 (37.8%)          | 21 (18.9%)         |
+---------------------------+---------------------+--------------------+
| Valvular Heart Disease    | 14 (11.6%)          | 10 (9.0%)          |
+---------------------------+---------------------+--------------------+
| CHF                       | 21 (17.4%)          | 8 (7.2%)           |
+---------------------------+---------------------+--------------------+
| Stroke                    | 11 (9.1%)           | 13 (11.7%)         |
+---------------------------+---------------------+--------------------+
| Hypertension              | 76 (62.8%)          | 79 (71.2%)         |
+---------------------------+---------------------+--------------------+
| PAOD                      | 31 (25.6%)          | 12 (10.8%)         |
+---------------------------+---------------------+--------------------+
| COPD                      | 48 (39.7%)          | 33 (29.7%)         |
+---------------------------+---------------------+--------------------+
| Smoking ^3^               | 109 (90.8%)         | 100 (90.1%)        |
+---------------------------+---------------------+--------------------+
| Diabetes                  | 15 (12.4%)          | 11 (9.9%)          |
+---------------------------+---------------------+--------------------+
| Anesthesia Risk           | 0 (0.0%)            | 1 (0.9%)           |
|                           |                     |                    |
| I                         | 16 (13.2%)          | 14 (12.6%)         |
|                           |                     |                    |
| II                        | 86 (71.1%)          | 79 (71.2%)         |
|                           |                     |                    |
| III                       | 19 (15.7%)          | 17 (15.3%)         |
|                           |                     |                    |
| IV                        |                     |                    |
+---------------------------+---------------------+--------------------+

> 1\. 94 of the Control subjects were tube subjects and 17 were
> bifurcated subjects.
>
> 2\. N=119
>
> 3\. N=120

### Evaluation of Gender Bias

Study inclusion and exclusion criteria were designed and the study was
conducted in a manner to avoid gender bias in the subject population.
The selection criteria in the study were based on identifying subjects
with the appropriate anatomy for endovascular surgery.

Table 11 displays the percentage of males and females in each study and
the differences between groups. Overall, more men were enrolled in both
treatment groups. This finding reflects the actual incidence of AAA in
the general population; men are more likely to have AAAs than women. The
Control group included a statistically significantly (p=0.0008) higher
percentage of female subjects (23.4%) compared to the Aortoiliac group
(7.4%). This finding was anticipated as women tend to have smaller
peripheral vasculature than men and Aortoiliac subjects were required to
have a femoral artery of sufficient size to accommodate the 23 French
EGS System Delivery Catheter. There were no other statistically
significant differences between the treatment groups in regard to
demographic characteristics.

Table 11. Comparison of Gender Between the Aortoiliac and Control Groups

+-----------------+--------+--------+--------+--------+-----------------+
| **Treatment     | **M    |        | **Fem  |        | **Difference:   |
| Group**         | ales** |        | ales** |        | \[95% CI\]**    |
+=================+========+========+========+========+=================+
|                 | *      | *      | *      | *      |                 |
|                 | *(%)** | *n/N** | *(%)** | *n/N** |                 |
+-----------------+--------+--------+--------+--------+-----------------+
| > Aortoiliac    | (      | 1      | (7.4%) | 9/121  | 16.0% \[6.8,    |
|                 | 92.6%) | 12/121 |        |        | 25.2\] ^1^      |
+-----------------+--------+--------+--------+--------+-----------------+
| > Sx Control    | (      | 85/111 | (      | 26/111 | \--             |
|                 | 76.6%) |        | 23.4%) |        |                 |
+-----------------+--------+--------+--------+--------+-----------------+

> 1\. p\<0.01

### Aneurysm Diameter Distribution

Table 12. Aneurysm Diameter Distribution

+-------------------------+---------------------+----------------------+
| **Diameter Range**      | **\                 | **Surgical Control   |
|                         | Aortoiliac\         | ^1^\                 |
|                         | (N=121)\            | (N=102)\             |
|                         | n %**               | n %**                |
+-------------------------+---------------------+----------------------+
| > \< 30 mm              | > 0 (0.0%)          | > 0 (0.0%)           |
+-------------------------+---------------------+----------------------+
| > 30 mm -- 39 mm        | > 2 (1.7%)          | > 2 (2.0%)           |
+-------------------------+---------------------+----------------------+
| > 40 mm -- 49 mm        | > 24 (19.8%)        | > 28 (27.5%)         |
+-------------------------+---------------------+----------------------+
| > 50 mm -- 59 mm        | > 50 (41.3%)        | > 42 (41.2%)         |
+-------------------------+---------------------+----------------------+
| > 60 mm -- 69 mm        | > 29 (24.0%)        | > 21 (20.6%)         |
+-------------------------+---------------------+----------------------+
| > 70 mm -- 79 mm        | > 15 (12.4%)        | > 6 (5.9%)           |
+-------------------------+---------------------+----------------------+
| > 80 mm -- 89 mm        | > 1 (0.8%)          | > 3 (2.9%)           |
+-------------------------+---------------------+----------------------+
| > ≥ 90 mm               | > 0 (0.0%)          | > 0 (0.0%)           |
+-------------------------+---------------------+----------------------+

1.  Of the total 111 surgical control subjects, data is missing for nine

> subjects. These subjects were not included in the distribution of
> aneurysm
>
> diameter above.

## Summary of the Aortoiliac EGS Study

Table 13. Principle Safety and Effectiveness Results (Comparison
Measures)

  ---------------------- -------------- ---------------- --------------------
  Outcome Measure        Treatment      \% (n/N)         Aortoiliac
                         Group                           EGS-Control ^1^\
                                                         Difference \[95%
                                                         CI\]

  Operative Mortality\   Aortoiliac ^2^ 4.2% (5/118)     1.5% \[-5.7, 9.8\]
  (≤ 30 days)                                            

                         Sx Control     2.7% (3/111)     \--

  Major Complications    Aortoiliac ^2^ 35.6% (42/118)   -8.6% \[-21, 4.0\]
  ^3^\                                                   
  (≤ 30 days)                                            

                         Sx Control     44.1% (49/111)   \--

  Need for ICU Stay (%)  Aortoiliac     38.9% (44/113)   -57.7% \[-59.1,
                                                         -55.6\]

                         Sx Control     96.3% (104/108)  \--

  Thrombosis/Occlusion   Aortoiliac ^2^ 1.7% (2/118)     1.7% \[-3.6, 9.8\]

                         Sx Control     0.0% (0/111)     \--

                                        **Median (N)**   

  Hospital Stay (days)   Aortoiliac ^2^ 3 (113)          -3.0 \[-3.0, -2.0\]

                         Sx Control     6 (108)          \--

  ICU Stay (hours) ^4^   Aortoiliac ^2^ 24.0 (44)        -6.0 \[-12.2, -1.0\]

                         Sx Control     27.0 (104)       \--

  Operative Time (min)   Aortoiliac ^2^ 240.0 (118)      77.0 \[62.0, 92.0\]

                         Sx Control     167.0 (111)      \--

  Operative Blood Loss   Aortoiliac ^2^ 400 (118)        -400 \[-500, -300\]
  (cc)                                                   

                         Sx Control     800 (111)        \--
  ---------------------- -------------- ---------------- --------------------

1\. Confidence intervals for differences in percentages were calculated
by the exact (binomial) method; confidence intervals for differences in
medians center on the Hodges-Lehmann estimator.

2\. Of the total 121 aortoiliac subjects, three discontinued their
participation at discharge and were alive at that time. These subjects
are included in the analysis only through surgical implantation.

3\. Major Complications = significant respiratory, cardiac, bleeding,
bowel, wound, renal, arterial trauma, neurological and ischemic
complications, and death.

4\. ICU Stay duration includes only subjects who went to the ICU.

Table 14. Principle Safety and Effectiveness Results for Aortoiliac EGS
System\
at 12 months (Other Measures)

  ------------------------------- ---------------- -----------------------
  Outcome Measure                 n/N              \% \[95% CI\]

  Intraop Conversions ^1^         7/121            5.8% \[ 2.4, 11.6\]

  Postop Conversions              0/113            0.0% \[0, 0.03\]

  Aneurysm Rupture                0/113            0.0% \[0, 0.03\]

  Reduced Limb Flow ^3^           34/113           30.1% \[21.6 38.5\]

  Perigraft Flow, Discharge       58/112           51.8% \[45.2, 61.0\]

  Perigraft Flow                  33/100           33.0% \[23.8, 42.2\]

  Increased Aneurysm Size (≥ 5    4/98             4.1% \[0.2, 8.0\]
  mm)                                              

  Decreased Aneurysm Size, (≥ 5   46/98            46.9% \[37.1, 56.8\]
  mm)                                              

  Graft Migration                 0/113            0.0% \[0, 0.03\]
  ------------------------------- ---------------- -----------------------

> 1\. Intraop Conversions = access failure or failure to deploy.
> Protocol required these subjects to undergo standard AAA repair.
>
> 2\. There were four aortoiliac intraoperative conversions; in three
> subjects the implant procedure was abandoned.
>
> 3\. Reduced Limb Flow = intraoperative or postoperative intervention
> during the first 12 mos. to treat reduced limb patency.

^Table\ 15.\ Claudication\ Complications\ versus\ Site\ of\ Distal\ Attachment\ and\ Contralateral\ Occlusion\ for\ Aortoiliac\ Subjects\ at\ ≤\ 30\ days^
1

+-------------------------------+------------+-----------+------------+
| Configuration                 | N=110      | Leg       | But        |
|                               |            | Cla       | tock/Thigh |
|                               |            | udication | Cl         |
|                               |            |           | audication |
|                               |            | n %       |            |
|                               |            |           | n %        |
+-------------------------------+------------+-----------+------------+
| Landing zone in common,       | 54         | 0 0%      | 1 1.9%     |
| contra occlusion in common;   |            |           |            |
| fem-fem; both internal iliac  |            |           |            |
| arteries remain patent.       |            |           |            |
+-------------------------------+------------+-----------+------------+
| Landing zone in common,       | 13         | 0 0%      | 1 7.7%     |
| contra. occlusion in external |            |           |            |
| and internal, fem-fem; the    |            |           |            |
| ipsilateral internal iliac    |            |           |            |
| artery remains patent.        |            |           |            |
+-------------------------------+------------+-----------+------------+
| Landing zone in external,     | 32         | 0 0%      | 7 21.9%    |
| contra. occlusion in common,  |            |           |            |
| fem-fem; the contralateral    |            |           |            |
| internal iliac artery remains |            |           |            |
| patent.                       |            |           |            |
+-------------------------------+------------+-----------+------------+
| Landing zone in external,     | 6          | 0 0%      | 0 0%       |
| contra. occlusion in external |            |           |            |
| and internal, fem-fem.        |            |           |            |
+-------------------------------+------------+-----------+------------+
| Any landing zone, preexisting | 5          | 0 0%      | 0 0%       |
| contra. occlusion             |            |           |            |
+-------------------------------+------------+-----------+------------+

1\. 113 patients successfully implanted; missing data for three
subjects.

##  {#section .unnumbered}

Table 16. Conversions to Standard Surgical Repair

  --------------------------------------- -------------- --------------------
  Reason for Conversion                   Aortoiliac\    
                                          Conversions\   
                                          (N=121)\       
                                          n % \[95% CI\] 

  **Conversion (Total)**                  **7**          **5.8% \[2.9,
                                                         11.6\]**

  Failure to Access                       4              3.3% \[1.4, 8.3\]

  **Failure to Accurately Place (Total)** **2**          **1.7% \[0.5,
                                                         5.8\]**

  Arterial Trauma                         0              0.0% \[0.0, 3.0\]

  Failure to Retract Jacket               0              0.0% \[0.0, 3.0\]

  Improper Graft Position                 0              0.0% \[0.0, 3.0\]

  Perigraft Flow                          0              0.0% \[0.0, 3.0\]

  Twist                                   0              0.0% \[0.0, 3.0\]

  Unable to Remove Delivery Catheter      2              1.7% \[0.5, 5.8\]

  Change in anatomy                       1              0.8% \[0.2, 4.5\]

  **Late Conversion (Total)**             **2**          **1.7% \[0.5,
                                                         5.8\]**

  Perigraft Flow and Aneurysm Enlargement 1              0.8% \[0.0, 4.5\]

  Reduced Limb Flow                       1              0.8% \[0.0, 4.5\]
  --------------------------------------- -------------- --------------------

Table 17. Perigraft Flow for Aortoiliac EGS Subjects Over Time^1^

+-----------------+----------------+-----------------+----------------+
|                 | **Discharge**  | **6 Months**    | **12 Months**  |
|                 |                |                 |                |
|                 | **n/N % \[95%  | **n/N % \[95%   | **n/N % \[95%  |
|                 | CI\]**         | CI\]**          | CI\]**         |
+-----------------+----------------+-----------------+----------------+
| Attachment Site | 8/112 7.1      | 6/88 6.8%       | 4/100 4.0%     |
| Flow            | \[2.4, 11.9\]  | \[2.5, 14.37\]  | \[0.2, 7.8\]   |
+-----------------+----------------+-----------------+----------------+
| Branch Flow     | 35/112 31.3%   | 23/88 26.1%     | 19/100 19.0%   |
|                 | \[22.7, 39.8\] | \[17.3, 36.6\]  | \[11.3, 26.7\] |
+-----------------+----------------+-----------------+----------------+
| Contralateral   | 8/112 7.1%     | 10/88 11.4%     | 7/100 7.0%     |
| Occlusion Site  | \[2.4, 11.9\]  | \[5.6, 19.9\]   | \[2.0, 12.0\]  |
| Flow            |                |                 |                |
+-----------------+----------------+-----------------+----------------+
| Source Unknown  | 7/112 6.3%     | 3/88 3.4%       | 3/100 3.0%     |
|                 | \[1.8, 10.7\]  | \[0.7, 9.6\]    | \[0.0, 6.3\]   |
+-----------------+----------------+-----------------+----------------+
| []{.mark}       | **24 Months**  | **36 Months**   | **48 Months**  |
|                 |                |                 |                |
|                 | **n/N %**      | **n/N %**       | **n/N %**      |
+-----------------+----------------+-----------------+----------------+
| Attachment Site | 1/67 1.5%      | 0/37 0.0%       | 0/12 0.0%      |
| Flow            |                |                 |                |
+-----------------+----------------+-----------------+----------------+
| Branch Flow     | 18/67 26.9%    | 6/37 16.2%      | 3/12 25.0%     |
+-----------------+----------------+-----------------+----------------+
| Contralateral   | 2/67 3.0%      | 0/37 0.0%       | 0/12 0.0%      |
| Occlusion Site  |                |                 |                |
| Flow            |                |                 |                |
+-----------------+----------------+-----------------+----------------+
| Source Unknown  | 3/67 4.5%      | 2/37 5.4%       | 0/12 0.0%      |
+-----------------+----------------+-----------------+----------------+

1\. Includes implanted subjects with data available at each time period.

Table 18. Change in Aneurysm Diameter ^1^

  ----------- -------------- ---- --------------- --------- -------------- ---- ---------------- ---------
              Aortoiliac                                    Aortoiliac                           
              (N=98)                                        (N=65)                               
              Discharge to                                  Discharge to                         
              12 months                                     24 months                            

                             n    \% \[95% CI\]   Mean                     n    \%               Mean
                                                  Change                                         Change
                                                  (mm)                                           (mm)

  Increase\                  4    4.1% \[0.2,     +8.7                     2    3.1%             +15.8
  (+ ≥5 mm)                       8.0\]                                                          

  No Change\                 48   49.0% \[39.1,   -1.4                     22   33.8%            -1.5
  (± \<5 mm)                      58.9\]                                                         

  Decrease\                  46   46.9% \[37.1,   -11.3                    41   63.1%            -14.1
  (- ≥5 mm)                       56.8\]                                                         

              **Aortoiliac                                  **Aortoiliac                         
              (N=36)                                        (N=11)                               
              Discharge to                                  Discharge to                         
              36 months**                                   48 months**                          

                             n    \%              Mean                     n    \%               Mean
                                                  Change                                         Change
                                                  (mm)                                           (mm)

  Increase\                  2    5.6%            +17.9                    1    9.1%             +6.6
  (+ ≥5 mm)                                                                                      

  No Change\                 12   33.3%           -2.0                     2    18.2%            -2.6
  (± \<5 mm)                                                                                     

  Decrease\                  22   61.1%           -16.9                    8    72.7%            -16.3
  (- ≥5 mm)                                                                                      
  ----------- -------------- ---- --------------- --------- -------------- ---- ---------------- ---------

> 1\. Includes implanted subjects who have follow-up data at each time
> period.

##  {#section-1 .unnumbered}

Table 19. Aneurysm Diameter by Perigraft Flow Status

<table style="width:100%;">
<colgroup>
<col style="width: 28%" />
<col style="width: 6%" />
<col style="width: 0%" />
<col style="width: 17%" />
<col style="width: 0%" />
<col style="width: 6%" />
<col style="width: 0%" />
<col style="width: 18%" />
<col style="width: 0%" />
<col style="width: 5%" />
<col style="width: 0%" />
<col style="width: 16%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="3"><strong>Perigraft Flow Status</strong></td>
<td colspan="11"><strong>Aneurysm Diameter Change</strong></td>
</tr>
<tr class="even">
<td colspan="3"><strong>Decrease (≥5 mm)</strong></td>
<td colspan="5"><strong>No Change (± &lt;5 mm)</strong></td>
<td colspan="3"><strong>Increase (≥5 mm)</strong></td>
</tr>
<tr class="odd">
<td colspan="2"><strong>n/N</strong></td>
<td><strong>% [95% CI]</strong></td>
<td colspan="2"><strong>n/N</strong></td>
<td colspan="3"><strong>% [95% CI]</strong></td>
<td colspan="2"><strong>n/N</strong></td>
<td><strong>% [95% CI]</strong></td>
</tr>
<tr class="even">
<td><blockquote>
<p><strong>12 months</strong></p>
</blockquote></td>
<td></td>
<td colspan="3"></td>
<td colspan="2"></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>No Perigraft Flow</p>
</blockquote></td>
<td>33/62</td>
<td colspan="3">53.2% [40.8, 65.6]</td>
<td colspan="2">29/62</td>
<td>46.8% [34.4, 59.2]</td>
<td colspan="2">0/62</td>
<td colspan="2">0.0% [0.0, 0.05]</td>
</tr>
<tr class="even">
<td><blockquote>
<p>Perigraft Flow</p>
</blockquote></td>
<td>12/33</td>
<td colspan="3">36.4% [20.0, 52.8]</td>
<td colspan="2">17/33</td>
<td>51.5% [24.5, 68.6]</td>
<td colspan="2">4/33</td>
<td colspan="2">12.1% [1.0, 23.3]</td>
</tr>
<tr class="odd">
<td colspan="12"><blockquote>
<p><strong>24 months</strong></p>
</blockquote></td>
</tr>
<tr class="even">
<td><blockquote>
<p>No Perigraft Flow</p>
</blockquote></td>
<td>29/37</td>
<td colspan="3">78.4 %</td>
<td colspan="2">8/37</td>
<td>21.6 %</td>
<td colspan="2">0/37</td>
<td colspan="2">0.0 %</td>
</tr>
<tr class="odd">
<td><blockquote>
<p>Perigraft Flow</p>
</blockquote></td>
<td>9/23</td>
<td colspan="3">39.1 %</td>
<td colspan="2">12/23</td>
<td>52.2 %</td>
<td colspan="2">2/23</td>
<td colspan="2">8.7 %</td>
</tr>
<tr class="even">
<td colspan="12"><blockquote>
<p><strong>36 months</strong></p>
</blockquote></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>No Perigraft Flow</p>
</blockquote></td>
<td>17/22</td>
<td colspan="3">77.3 %</td>
<td colspan="2">5/22</td>
<td>22.7 %</td>
<td colspan="2">0/22</td>
<td colspan="2">0.0 %</td>
</tr>
<tr class="even">
<td><blockquote>
<p>Perigraft Flow</p>
</blockquote></td>
<td>2/8</td>
<td colspan="3">25.0 %</td>
<td colspan="2">4/8</td>
<td>50.0 %</td>
<td colspan="2">2/8</td>
<td colspan="2">25.0 %</td>
</tr>
</tbody>
</table>

Table 20. Types of Interventions to Optimize Aortoiliac Graft Limb Flow

<table style="width:100%;">
<colgroup>
<col style="width: 16%" />
<col style="width: 0%" />
<col style="width: 10%" />
<col style="width: 0%" />
<col style="width: 18%" />
<col style="width: 0%" />
<col style="width: 8%" />
<col style="width: 0%" />
<col style="width: 18%" />
<col style="width: 0%" />
<col style="width: 8%" />
<col style="width: 0%" />
<col style="width: 18%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="2" rowspan="2"></td>
<td colspan="4"><strong>Intraoperative</strong></td>
<td colspan="4"><strong>Postoperative</strong></td>
<td colspan="3"><strong>Total</strong></td>
</tr>
<tr class="even">
<td><strong>n/N</strong></td>
<td colspan="3"><strong>% [95% CI]</strong></td>
<td>n/N</td>
<td colspan="3"><strong>% [95% CI]</strong></td>
<td colspan="2"><strong>n/N</strong></td>
<td><strong>% [95% CI]</strong></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>Stent<sup>1</sup></p>
</blockquote></td>
<td colspan="3">19/113</td>
<td>16.8% [9.9, 23.7]</td>
<td colspan="3">12<sup>2</sup>/113</td>
<td>10.6% [4.9, 16.3]</td>
<td colspan="2">31/113</td>
<td colspan="2">27.4% [19.2, 35.7]</td>
</tr>
<tr class="even">
<td><blockquote>
<p>PTA only</p>
</blockquote></td>
<td colspan="3">4/113</td>
<td>3.5% [0.1, 6.9]</td>
<td colspan="3">0/113</td>
<td>0.0% [0, 0.03]</td>
<td colspan="2">4/113</td>
<td colspan="2">3.5% [0.1, 6.9]</td>
</tr>
<tr class="odd">
<td><blockquote>
<p>Surgical<sup>3</sup></p>
</blockquote></td>
<td colspan="3">1/113</td>
<td>0.9% [0.0, 2.6]</td>
<td colspan="3">2/113</td>
<td>1.8% [0, 4.2]</td>
<td colspan="2">3/113</td>
<td colspan="2">2.7% [0.0, 5.6]</td>
</tr>
<tr class="even">
<td><blockquote>
<p>Other</p>
</blockquote></td>
<td colspan="3">0/113</td>
<td>0.0% [0, 0.03]</td>
<td colspan="3">0/113</td>
<td>0.0% [0, 0.03]</td>
<td colspan="2">0/113</td>
<td colspan="2">0.0% [0, 0.03]</td>
</tr>
<tr class="odd">
<td><blockquote>
<p><strong>(Total)</strong></p>
</blockquote></td>
<td colspan="3"><strong>24/113</strong></td>
<td><strong>21.2%</strong></td>
<td colspan="3"><strong>14/113</strong></td>
<td><strong>12.4%</strong></td>
<td colspan="2"><strong>38/113</strong></td>
<td colspan="2"><strong>33.6%</strong></td>
</tr>
</tbody>
</table>

1\. Includes some subjects who had PTA or thrombolysis and stent.

2\. One of these subjects had one stent placed intraoperatively. Another
subject had a surgical limb attachment intraoperatively.

3\. Includes Femoro-Femoral Bypass and surgical revision. Includes some
subjects who may have had stents, PTA, or other non-surgical
interventions.

# Conclusions Drawn from the Studies

The data establish that all delivery catheter components will withstand
the expected *in vivo* loads and the implants have at least a 15-year
useful life. The clinical benefits of these systems are the reduced risk
of several serious complications including bleeding, cardiac,
respiratory, and bowel, and the less invasive nature of the devices
which lead to reduced need for post-operative care and shorter
hospitalization. The risks include the increased risk of renal and
arterial trauma complications and device-related phenomenon such as
perigraft flow and increases in aneurysm size. FDA determined that the
data provide valid scientific evidence of reasonable assurance of safety
and clinical benefit to the patient when used as indicated.

# FDA Decision

FDA determined that this PMA supplement did not require a panel meeting.
FDA also determined that the application was approvable with the
condition that all patients in the original PMA cohort be followed for
five years after implantation. CDRH issued an approval order on April
24, 2002.

# Approval Specifications

**Directions for Use:** See Final Draft Labeling (Instructions for Use)

**Hazards to Health from Use of the Device**: See [Indications,
Contraindications, Warnings and Precautions,]{.smallcaps} and [Adverse
Events]{.smallcaps} in the Final Draft Labeling (Instructions for Use).

**Post-approval Requirements and Restrictions**: See Approval Order