ANCURE/AORTOILIAC ENDOGRAFT SYSTEM

{0} # Summary of Safety and Effectiveness Data # ANCURE® Aortoiliac System # Guidant Corporation # Table of Contents | 1. | General Information | 2 | | --- | --- | --- | | 2. | Indications and Usage | 2 | | 3. | Contraindications | 2 | | 4. | Warnings and Precautions | 2 | | 5. | Device Description | 3 | | 6. | Alternative Practices or Procedures | 7 | | 7. | Marketing History | 7 | | 8. | Adverse Events | 7 | | 8.1 | Observed Adverse Events | 7 | | 8.2 | Potential Adverse Events | 9 | | 9. | Summary of Pre-Clinical Studies | 10 | | 9.1 | Laboratory Studies | 10 | | 9.1.1 | Biocompatibility, Immunology, and Toxicology Studies | 10 | | 9.1.2 | Graft Mechanical Testing | 11 | | 9.1.3 | Graft Durability Testing | 12 | | 9.1.4 | Aortoiliac Graft Attachment System Studies | 12 | | 9.1.5 | Delivery System Mechanical Testing | 14 | | 9.2 | Animal Studies | 14 | | 9.3 | Additional Studies | 16 | | 10. | Summary of Clinical Studies | 16 | | 10.1 | Description of Patients Studied and Gender Bias | 17 | | 10.1.1 | Evaluation of Gender Bias | 17 | | 10.1.2 | Aneurysm Diameter Distribution | 18 | | 10.2 | Summary of the Aortoiliac EGS Study | 19 | | 11. | Conclusions Drawn from the Studies | 23 | | 12. | FDA Decision | 23 | | 13. | Approval Specifications | 23 | Ancure® Aortoiliac System – P990017/S30 Page 1 of 23 {1} # Summary of Safety and Effectiveness Data # ANCURE® Aortoiliac System # Guidant Corporation # 1. 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 # 2. 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 distal segment length of at least 20 mm and diameters no greater than 13.4 mm, and - morphology suitable for endovascular repair. # 3. Contraindications There are no identified contraindications for this device. # 4. Warnings and Precautions See Final Draft Labeling Ancure® Aortoiliac System – P990017/S30 Page 2 of 23 {2} ## 5. 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. Ancure® Aortoiliac System – P990017/S30 Page 3 of 23 {3} **Figure 1. ANCURE Delivery Catheter Handle**  **Figure 2. ANCURE Aortoiliac Delivery System**  **Figure 3. Illustration of ANCURE Aortoiliac Delivery System**  Ancure® Aortoiliac System – P990017/S30 Page 4 of 23 {4} **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 | Ancure® Aortoiliac System – P990017/S30 Page 5 of 23 {5} | DESCRIPTION | MODEL NUMBER | SIZE | | --- | --- | --- | | 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 | Ancure® Aortoiliac System – P990017/S30 Page 6 of 23 {6} ## **6. 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. ## **7. 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. ## **8. Adverse Events** ### **8.1 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. ---Ancure® Aortoiliac System – P990017/S30 Page 7 of 23 {7} 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 Aborted | 5.8% | (7/121) | N/A | | | Deep Vein Thrombosis | 1.7% | (2/118) | 0.9% | (1/111) | | Embolism – Lower Extremity Ischemia | 1.7% | (2/118) | 0.9% | (1/111) | | 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. Ancure® Aortoiliac System – P990017/S30 Page 8 of 23 {8} 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. ### 8.2 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 failure/atelectasis/pneumonia | | Deep vein thrombosis | Spasm | | Drug reactions to antiplatelet 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 | | Ancure® Aortoiliac System – P990017/S30 Page 9 of 23 {9} Hematoma ## 9. Summary of Pre-Clinical Studies ### 9.1 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. #### 9.1.1 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/ Mammalian Microsome Mutagenicity Assay | 0.9% USP Sodium Chloride for injection and DMSO extracts | Material is non-mutagenic. | | Sister Chromatid Exchange | McCoy's 5A medium | Material is non-genotoxic. | | Chromosomal Aberration | McCoy's 5A medium | Material is non-genotoxic. | | In Vitro Hemolysis | 0.9% Sodium Chloride USP | Material is non-hemolytic. | | C3a Complement Activation | Normal Human Serum, NHS, certified HIV (1 & 2) and Hepatitis (B & C) negative | Test article represented activation at 18,472 ng/ml. The materials performed as anticipated. | | Determination of Clotting Time using the Lee-White Method | Canis familiaris blood | Material did not have a significant effect on clotting time. | | Cytotoxicity | Single strength MEM supplemented with 5% calf serum and 2% antibiotics | Material showed no evidence of cell lysis or toxicity to L-929 mouse fibroblast cells. The material was non-cytotoxic. | | Acute Intracutaneous Reactivity Study in the Rabbit | 0.9% Sodium Chloride USP Solution and Cottonseed Oil | The Primary Irritation Index Characterization was negligible. There was no evidence of significant irritation or toxicity. | | Magnusson and Kligman Method Delayed Contact Sensitization Study in the Guinea Pig, Maximization | 0.9% Sodium Chloride USP Solution and Cottonseed Oil | There was no evidence of causing delayed dermal contact sensitization in the guinea pig. | Ancure® Aortoiliac System – P990017/S30 Page 10 of 23 {10} | Test Performed | Extract(s) | Findings | | --- | --- | --- | | Magnusson and Kligman Method Delayed Contact Sensitization Study in the Guinea Pig, Maximization Method (Positive Control) | 1-Chloro -2,4-Dinitrobenzene (DNCB) | The known sensitizer DNCB showed significant evidence of causing delayed dermal contact sensitization. | | Rabbit Pyrogen | 0.9% Sodium Chloride USP Solution | Material is non-pyrogenic. | | USP Systemic Toxicity Study in the Mouse | 0.9% Sodium Chloride USP Solution and Cottonseed Oil, NF (CSO) | There was no evidence of significant systemic toxicity. | | Sub-Chronic (14 days) Intravenous Toxicity Study in the Rat | 0.9% Sodium Chloride USP Solution | There was no evidence of significant systemic toxicity | | Muscle Implantation Study in the rabbit with Histopathology (surgical method 13 weeks) | N/A | There was no evidence if material toxicity in the surrounding animal tissues. | ### 9.1.2 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 EndoWeave-65 Graft Material | Source B EndoWeave-65 Graft Material | Guidant Specification (EndoWeave-65) | | --- | --- | --- | --- | | Water Permeability (ml/cm²/min) | Avg: 177 S.D.: 30.8 | Avg.: 186 S.D.: 39.8 | Average must be between 50 and 300 ml/cm²/min | | Modified Tensile Strength (lbs.) | Avg: 112.0 S.D.: 6.91 | Avg.: 112.5 S.D.: 6.27 | Average must be ≥95 lbs. | | Balloon Burst Strength (Hoop Stress) (p.s.i.) | Avg: 9573 S.D.: 557 | Avg.: 10199 S.D.: 665 | ≥5732 PSI | | Compliance (%) | Avg: 0.0100 S.D.: 0.00145 | Avg.: 0.0088 S.D.: 0.00121 | 0.00 – 0.03% | | Longitudinal Tensile Strength (lb./inch) | Avg: 86.1 S.D.: 3.02 | Avg.: 84.5 S.D.: 18.35 | ≥60 lb./in | | Suture Retention Strength (grams-force) | Avg: 1682 S.D.: 366 | Avg.: 2243 S.D.: 166 | ≥800 grams-force | | Suture Hole Elongation (inches) | Avg: 0.006" S.D.: 0.0038 | Avg.: 0.009" S.D.: 0.0038 | ≤0.039" | | Kink Radius (inches) | Avg. Limbs: 0.234" S.D.: 0.010 | Avg. Limbs: 0.235" S.D.: 0.005 | <0.65" | Ancure® Aortoiliac System – P990017/S30 Page 11 of 23 {11} | Crush Resistance (grams) | Avg. Limbs: 52.5 S.D.: 2.5 | Avg. Limbs: 78.3 S.D.: 12.5 | ≥50 grams-force | | --- | --- | --- | --- | | Usable Length (% elongation) | Avg. (100mm Hg): 18.6% S.D.: 3.60 Avg. (full): 22.3% S.D.: 3.28% | Avg. (100mm Hg):15.9% S.D.: 2.0% Avg. (full): 22.1% S.D.: 2.5% | 8 – 20% at 100mm Hg 20 – 27% at full elongation | ### 9.1.3 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 Force (lbf) after 100 Million Cycles (n=2) | Peak Tensile Force (lbf) after 200 Million Cycles (n=2) | Peak Tensile Force (lbf) after 300 Million Cycles (n=2) | Peak Tensile Force (lbf) after 400 Million 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. ### 9.1.4 Aortoiliac Graft Attachment System Studies #### 9.1.4.1 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. Ancure® Aortoiliac System – P990017/S30 Page 12 of 23 {12} 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. ### 9.1.4.2 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. ### 9.1.4.3 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 Performed | Methods | Findings | | --- | --- | --- | | Fatigue lifetime of the iliac attachment system hook tip bend | Estimations by plotting alternating load versus cycles to failure at several different loads. Results were extrapolated from a fatigue curve and compared to the in vivo force. | The iliac hook tip bend was determined to meet the product requirement of a 15-year in vivo lifetime. | Ancure® Aortoiliac System – P990017/S30 Page 13 of 23 {13} | Test Performed | Methods | Findings | | --- | --- | --- | | *In vivo* life of the iliac frame apex | Estimated using cyclic displacement loading applied to test specimens representing the iliac attachment frame apex in a corrosive environment. A fatigue curve was generated. | The iliac frame apex was determined to meet the product requirement of a 15-year *in vivo* lifetime. | | *In vivo* life of the iliac hook weld | Estimated using cyclic displacement loading applied to test specimens representing the iliac attachment frame hook weld in a corrosive environment at three different test conditions. A fatigue curve was generated. | The iliac hook weld was determined to meet the product requirement of a 15-year *in vivo* lifetime. | | Fatigue of aortic frame closure weld | Cyclic displacement at different loading was applied to test specimens in a corrosive environment using Cantilever Beam Equipment. Results were extrapolated to long term *in vivo* lifetimes. | The aortic frame closure weld was determined to meet the product criteria of a 15-year *in vivo* lifetime. | | Fatigue of iliac frame closure weld | Cyclic displacement at different loading was applied to test specimens in a corrosive environment using Cantilever Beam Equipment. Results were extrapolated to long term *in vivo* lifetimes. | The iliac frame closure weld was determined to meet the product criteria of a 15-year *in vivo* lifetime. | ### 9.1.5 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. ### 9.2 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. Ancure® Aortoiliac System – P990017/S30 Page 14 of 23 {14} **Table 9. Animal Studies Summary** | Animal Study | No./Type Animals Studied | Test Article | Methods | Results/Conclusions | | --- | --- | --- | --- | --- | | Acute and Chronic Study of Tube Graft | 19 sheep | Scaled-down tube EGS system consisting of a delivery catheter with a helically wound, longitudinal flexible capsule containing the compressed graft. | Five animals each implanted for periods of 1, 2, and 6 months, at which time they were sacrificed. Four additional animals were later added to 6-month group. Implant sites were evaluated macro and microscopically. | All grafts successfully deployed. Grafts remained patent with no evidence of thrombosis, migration, twist, or compression. All animals displayed morphologic evidence of normal graft healing. | | Acute Healing Study of Bifurcated Graft | 15 bovine | Full-scale EGS delivery catheters & EGS bifurcated graft. | Fifteen animals assessed for delivery catheter deployment & acute implantation. Chronic evaluation was planned but terminated early due to animal model difficulties resulting from bovine vasculature. See next study for chronic healing. | Excellent acute results of the delivery catheter and graft. All grafts were patent. | | Chronic Healing Study of Bifurcated Graft | 7 sheep | Iliac portion of bifurcated EGS graft | Two animals implanted with the bifurcated graft with a shortened contralateral limb. Five animals were implanted bilaterally with a short tube with iliac attachment system using modified delivery catheters. | Acute implantation was successful in all animals. All grafts were patent with good distal perfusion. There were no signs of twisting, migration, kinks or longitudinal compression. Healing was normal and similar to those found in sheep at one month. | | Acute Evaluation of the Aortoiliac EGS System | 3 bovine | Aortoiliac EGS delivery catheter and aortoiliac EGS graft | Animals implanted with aortoiliac EGS graft. Following implantation each animal was sacrificed and a necropsy of the graft was performed. | Acute implantation successful with unobstructed flow through the graft. While the catheters performed flawlessly, some refinements were later 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 Evaluation of ANCURE System | 5 bovine | ANCURE delivery catheter w/ ANGIOSCALE catheter | Grafts were deployed using ANCURE tube, bifurcated, and aortoiliac delivery catheters. A necropsy was performed following animal sacrifice. | Acute implantation was successful and all grafts were patent, with no evidence of migration, twist, or compression. Minor technical issues encountered with the delivery catheter, which were corrected by subsequent device changes. | Ancure® Aortoiliac System – P990017/S30 Page 15 of 23 {15} ### 9.3 Additional Studies This device contains no software or electrical components. ## 10. 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. ---Ancure® Aortoiliac System – P990017/S30 Page 16 of 23 {16} ## 10.1 Description of Patients Studied and Gender Bias Table 10. Demographics | Variable | Aortoiliac (N=121) | | Surgical Control (N=111)^{1} | | | --- | --- | --- | --- | --- | | | n | % | 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 | | | | | | I | 0 | (0.0%) | 1 | (0.9%) | | II | 16 | (13.2%) | 14 | (12.6%) | | III | 86 | (71.1%) | 79 | (71.2%) | | IV | 19 | (15.7%) | 17 | (15.3%) | 1. 94 of the Control subjects were tube subjects and 17 were bifurcated subjects. 2. N=119 3. N=120 ### 10.1.1 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. Ancure® Aortoiliac System – P990017/S30 Page 17 of 23 {17} 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 Group | Males | | Females | | Difference: [95% CI] | | --- | --- | --- | --- | --- | --- | | | (%) | n/N | (%) | n/N | | | Aortoiliac | (92.6%) | 112/121 | (7.4%) | 9/121 | 16.0% [6.8, 25.2]^{1} | | Sx Control | (76.6%) | 85/111 | (23.4%) | 26/111 | -- | 1. p<0.01 ### 10.1.2 Aneurysm Diameter Distribution Table 12. Aneurysm Diameter Distribution | Diameter Range | Aortoiliac (N=121) | | Surgical Control^{1} (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. Ancure® Aortoiliac System – P990017/S30 Page 18 of 23 {18} ## 10.2 Summary of the Aortoiliac EGS Study Table 13. Principle Safety and Effectiveness Results (Comparison Measures) | Outcome Measure | Treatment Group | % | (n/N) | Aortoiliac EGS-Control^{1} Difference [95% CI] | | --- | --- | --- | --- | --- | | Operative Mortality (≤ 30 days) | Aortoiliac^{2} | 4.2% | (5/118) | 1.5% [-5.7, 9.8] | | | Sx Control | 2.7% | (3/111) | -- | | Major Complications^{3} (≤ 30 days) | Aortoiliac^{2} | 35.6% | (42/118) | -8.6% [-21, 4.0] | | | 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 (cc) | Aortoiliac^{2} | 400 | (118) | -400 [-500, -300] | | | 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. Ancure® Aortoiliac System – P990017/S30 Page 19 of 23 {19} 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 mm) | 4/98 | 4.1% [0.2, 8.0] | | Decreased Aneurysm Size, (≥ 5 mm) | 46/98 | 46.9% [37.1, 56.8] | | 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 Claudication | | Buttock/Thigh Claudication | | | --- | --- | --- | --- | --- | --- | | | | n | % | n | % | | Landing zone in common, contra occlusion in common; fem-fem; both internal iliac arteries remain patent. | 54 | 0 | 0% | 1 | 1.9% | | Landing zone in common, contra. occlusion in external and internal, fem-fem; the ipsilateral internal iliac artery remains patent. | 13 | 0 | 0% | 1 | 7.7% | | Landing zone in external, contra. occlusion in common, fem-fem; the contralateral internal iliac artery remains patent. | 32 | 0 | 0% | 7 | 21.9% | | Landing zone in external, contra. occlusion in external and internal, fem-fem. | 6 | 0 | 0% | 0 | 0% | | Any landing zone, preexisting contra. occlusion | 5 | 0 | 0% | 0 | 0% | 1. 113 patients successfully implanted; missing data for three subjects. Ancure® Aortoiliac System – P990017/S30 Page 20 of 23 {20} **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% CI] | n/N | % [95% CI] | n/N | % [95% CI] | | Attachment Site Flow | 8/112 | 7.1 [2.4, 11.9] | 6/88 | 6.8% [2.5, 14.37] | 4/100 | 4.0% [0.2, 7.8] | | Branch Flow | 35/112 | 31.3% [22.7, 39.8] | 23/88 | 26.1% [17.3, 36.6] | 19/100 | 19.0% [11.3, 26.7] | | Contralateral Occlusion Site Flow | 8/112 | 7.1% [2.4, 11.9] | 10/88 | 11.4% [5.6, 19.9] | 7/100 | 7.0% [2.0, 12.0] | | Source Unknown | 7/112 | 6.3% [1.8, 10.7] | 3/88 | 3.4% [0.7, 9.6] | 3/100 | 3.0% [0.0, 6.3] | | | 24 Months | | 36 Months | | 48 Months | | | | n/N | % | n/N | % | n/N | % | | Attachment Site Flow | 1/67 | 1.5% | 0/37 | 0.0% | 0/12 | 0.0% | | Branch Flow | 18/67 | 26.9% | 6/37 | 16.2% | 3/12 | 25.0% | | Contralateral Occlusion Site Flow | 2/67 | 3.0% | 0/37 | 0.0% | 0/12 | 0.0% | | 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. Ancure® Aortoiliac System – P990017/S30 Page 21 of 23 {21} **Table 18. Change in Aneurysm Diameter $^{1}$** | | Aortoiliac (N=98) Discharge to 12 months | | | Aortoiliac (N=65) Discharge to 24 months | | | | --- | --- | --- | --- | --- | --- | --- | | | n | % [95% CI] | Mean Change (mm) | n | % | Mean Change (mm) | | Increase (+ ≥5 mm) | 4 | 4.1% [0.2, 8.0] | +8.7 | 2 | 3.1% | +15.8 | | No Change (± <5 mm) | 48 | 49.0% [39.1, 58.9] | -1.4 | 22 | 33.8% | -1.5 | | Decrease (- ≥5 mm) | 46 | 46.9% [37.1, 56.8] | -11.3 | 41 | 63.1% | -14.1 | | | Aortoiliac (N=36) Discharge to 36 months | | | Aortoiliac (N=11) Discharge to 48 months | | | | | n | % | Mean Change (mm) | n | % | Mean Change (mm) | | Increase (+ ≥5 mm) | 2 | 5.6% | +17.9 | 1 | 9.1% | +6.6 | | No Change (± <5 mm) | 12 | 33.3% | -2.0 | 2 | 18.2% | -2.6 | | Decrease (- ≥5 mm) | 22 | 61.1% | -16.9 | 8 | 72.7% | -16.3 | 1. Includes implanted subjects who have follow-up data at each time period. **Table 19. Aneurysm Diameter by Perigraft Flow Status** | Perigraft Flow Status | Aneurysm Diameter Change | | | | | | | --- | --- | --- | --- | --- | --- | --- | | | Decrease (≥5 mm) | | No Change (± <5 mm) | | Increase (≥5 mm) | | | | n/N | % [95% CI] | n/N | % [95% CI] | n/N | % [95% CI] | | **12 months** | | | | | | | | No Perigraft Flow | 33/62 | 53.2% [40.8, 65.6] | 29/62 | 46.8% [34.4, 59.2] | 0/62 | 0.0% [0.0, 0.05] | | Perigraft Flow | 12/33 | 36.4% [20.0, 52.8] | 17/33 | 51.5% [24.5, 68.6] | 4/33 | 12.1% [1.0, 23.3] | | **24 months** | | | | | | | | No Perigraft Flow | 29/37 | 78.4 % | 8/37 | 21.6 % | 0/37 | 0.0 % | | Perigraft Flow | 9/23 | 39.1 % | 12/23 | 52.2 % | 2/23 | 8.7 % | | **36 months** | | | | | | | | No Perigraft Flow | 17/22 | 77.3 % | 5/22 | 22.7 % | 0/22 | 0.0 % | | Perigraft Flow | 2/8 | 25.0 % | 4/8 | 50.0 % | 2/8 | 25.0 % | Ancure® Aortoiliac System – P990017/S30 Page 22 of 23 {22} **Table 20. Types of Interventions to Optimize Aortoiliac Graft Limb Flow** | | Intraoperative | | Postoperative | | Total | | | --- | --- | --- | --- | --- | --- | --- | | | n/N | % [95% CI] | n/N | % [95% CI] | n/N | % [95% CI] | | Stent^{1} | 19/113 | 16.8% [9.9, 23.7] | 12^{2}/113 | 10.6% [4.9, 16.3] | 31/113 | 27.4% [19.2, 35.7] | | PTA only | 4/113 | 3.5% [0.1, 6.9] | 0/113 | 0.0% [0, 0.03] | 4/113 | 3.5% [0.1, 6.9] | | Surgical^{3} | 1/113 | 0.9% [0.0, 2.6] | 2/113 | 1.8% [0, 4.2] | 3/113 | 2.7% [0.0, 5.6] | | Other | 0/113 | 0.0% [0, 0.03] | 0/113 | 0.0% [0, 0.03] | 0/113 | 0.0% [0, 0.03] | | **(Total)** | **24/113** | **21.2%** | **14/113** | **12.4%** | **38/113** | **33.6%** | 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. ## 11. 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. ## 12. 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. ## 13. 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, and ADVERSE EVENTS in the Final Draft Labeling (Instructions for Use). **Post-approval Requirements and Restrictions:** See Approval Order Ancure® Aortoiliac System – P990017/S30 Page 23 of 23