← Product Code MIH · P990020 # ANEURX STENT GRAFT SYSTEM (P990020) _Medtronic Vascular · MIH · Sep 28, 1999 · Cardiovascular · APWD_ **Canonical URL:** https://fda.innolitics.com/device/P990020 ## Device Facts - **Applicant:** Medtronic Vascular - **Product Code:** MIH - **Decision Date:** Sep 28, 1999 - **Decision:** APWD - **Device Class:** Class 3 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic, Expedited Review ## Intended Use The AneuRx Stent Graft System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms having: Adequate iliac/femoral access; Infrarenal non-aneurysmal neck length of at least 1 cm at the proximal and distal ends of the aneurysm and a vessel diameter 10-20 percent smaller than the labeled device diameter; Morphology suitable for endovascular repair; One of the following: A diameter > 5 cm; A diameter of 4-5 cm and has increased in size by 0.5 cm in the last 6 months; or Twice the diameter of the normal infrarenal aorta. ## Device Story The AneuRx Stent Graft System is a modular endovascular device used to treat infrarenal abdominal aortic or aorto-iliac aneurysms. It consists of a bifurcated stent graft, iliac stent grafts, and optional aortic/iliac extender cuffs, all preloaded into delivery catheters. The device is constructed from laser-cut Nitinol stent rings sewn to woven polyester graft tubes. A reusable deployment handle is used to deploy the system via the femoral or iliac arteries under fluoroscopic guidance. The device reinforces the arterial wall and redirects blood flow, excluding the aneurysm. It is used in a clinical setting by physicians. The modular design allows for customization to patient anatomy. By providing a less invasive alternative to open surgical repair, the device aims to reduce procedural morbidity, blood loss, and hospital stay duration. ## Clinical Evidence Prospective, non-randomized, multicenter study (n=416 treatment, n=66 surgical control). Primary endpoints included delivery/deployment success, morbidity/mortality, migration, aneurysm exclusion, and patency. Results showed 97.6% delivery/deployment success. At 1 year, 1.6% migration rate, 17.4% endoleak rate, and 97.1% patency. Stent graft patients showed significantly lower blood loss, shorter ICU/hospital stays, and faster recovery compared to open surgery (p<0.001). ## Technological Characteristics Materials: Nickel-Titanium (Nitinol) alloy stent rings, woven polyester graft tubes, braided polyester thread, tantalum markers. Principle: Self-expanding stent graft providing friction-fit anchoring. Form factor: Modular bifurcated design with delivery catheters (16F/21F). Connectivity: None. Sterilization: Steam sterilization for reusable handle; single-use components supplied sterile. Standards: ANSI/AAMI VP20-1994, ISO 10993-1. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 14 # Summary of Safety and Effectiveness ## The AneuRx Stent Graft System ### Table of Contents 1. GENERAL INFORMATION ... 1 2. INDICATIONS AND USAGE ... 1 3. CONTRAINDICATIONS ... 1 4. WARNINGS AND PRECAUTIONS ... 2 5. DEVICE DESCRIPTION ... 2 6. ALTERNATIVE PRACTICES OR PROCEDURES ... 6 7. MARKETING HISTORY ... 6 8. ADVERSE EVENTS ... 7 9. SUMMARY OF PRECLINICAL STUDIES ... 8 9.1 LABORATORY STUDIES ... 8 9.2 ANIMAL STUDIES ... 16 9.3 BIOCOMPATIBILITY STUDIES ... 17 9.4 ADDITIONAL STUDIES ... 23 10. SUMMARY OF CLINICAL STUDIES ... 25 10.1 OBJECTIVES ... 25 10.2 STUDY DESIGN ... 25 10.3 DESCRIPTION OF PATIENTS AND GENDER BIAS ... 28 10.4 RESULTS ... 29 10.5 DEVICE FAILURES AND REPLACEMENTS ... 46 11. CONCLUSIONS DRAWN FROM THE STUDIES ... 47 12. PANEL RECOMMENDATION ... 47 13. FDA DECISION ... 47 14. APPROVAL SPECIFICATIONS ... 47 {1} # Summary of Safety and Effectiveness Data ## The AneuRx Stent Graft System ### 1. General Information Device Generic Name: Endovascular Stent Graft and Delivery Catheter Device Trade Name: AneuRx Stent Graft System Applicant's Name and Address: Medtronic AVE, Inc. 2330 Circadian Way Santa Rosa, CA 95407 PMA Application Number: P990020 Date of Panel Recommendation: June 23, 1999 Date of Notice of Approval to the Applicant: September 28, 1999 ### 2. Indications and Usage The AneuRx Stent Graft System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms having: - Adequate iliac/femoral access; - Infrarenal non-aneurysmal neck length of at least 1 cm at the proximal and distal ends of the aneurysm and a vessel diameter 10-20 percent smaller than the labeled device diameter; - Morphology suitable for endovascular repair; - One of the following: - A diameter > 5 cm; - A diameter of 4-5 cm and has increased in size by 0.5 cm in the last 6 months; or - Twice the diameter of the normal infrarenal aorta. ### 3. Contraindications There are no known contraindications currently associated with this device. The AneuRx Stent Graft System SSED P990020 09/27/99 {2} # 4. Warnings and Precautions See WARNINGS AND PRECAUTIONS in the labeling (Instructions for Use) # 5. Device Description The AneuRx Stent Graft System consists of the AneuRx Stent Graft (bifurcated design) and Delivery Catheter, the AneuRx Iliac Stent Graft and Delivery Catheter and the AneuRx Deployment Handle. Two additional system components, the AneuRx Iliac Extender Cuff and Delivery Catheter and the AneuRx Aortic Extender Cuff and Delivery Catheter, may be used to modify the length and/or diameter of the implanted AneuRx Stent Graft. ![img-0.jpeg](img-0.jpeg) Figure 1: AneuRx Bifurcated and Iliac Stent Grafts The bifurcated device is tube-shaped at the top and bifurcated at the bottom. When placed within the aneurysm, the device reinforces the wall of the diseased artery and directs blood flow into the iliac arteries. As shown in Figure 1, the Bifurcated Stent Graft consists of the Bifurcation Body and the Integral Iliac Leg. The Iliac Stent Graft (Inserted Iliac Leg) is a separate component which is positioned following placement of the Bifurcated Stent Graft shown in Figure 2. Radiopaque markers are located at the ends of each device to aid in proper positioning within the aneurysm. The AneuRx Stent Graft System SSED page 2 P990020 09/27/99 {3} ![img-1.jpeg](img-1.jpeg) Figure 2: AneuRx Bifurcated Stent Graft The additional system components, the Iliac Extender Cuff and Delivery Catheter and the Aortic Extender Cuff and Delivery Catheter, are designed to be positioned (overlapping) inside of the implanted Stent Graft in the iliac or aortic sections. Placement of these additional devices modifies the implanted Stent Graft by increasing the length and/or diameter of the Stent Graft at either end. This modular design allows the physician to customize the length and/or diameter of the Stent Graft to fit various anatomies and aneurysm morphologies. Both modular components are manufactured from the same polyester graft material, Nitinol stent rings and polyester thread used to manufacture the AneuRx Bifurcated Stent Graft. All Stent Grafts are available in a range of sizes. ![img-2.jpeg](img-2.jpeg) Figure 3: AneuRx Iliac Stent Graft The AneuRx Stent Graft System SSED ...page 3 P990020 09/27/99 {4} The AneuRx Stent Graft is constructed from self-expanding Nickel-Titanium (Nitinol, NiTi) alloy stent rings and woven polyester graft tubes. Each stent ring consists of a series of diamond-shaped segments connected side-to-side in the circumferential direction to form a ring (see Figure 4). The diamond-shaped segments are cut, using a laser, from a single piece of Nitinol tubing. No joints or welds are necessary to form a stent ring. ![img-3.jpeg](img-3.jpeg) Figure 4: A Single Stent Ring (not to scale) The stent rings are individually sewn using braided polyester thread, along the entire length of the graft, end to end in a circumferential direction (not overlapping) to form a fully supported structure on the exterior of the graft. This configuration is designed to provide column strength (resistance to deflection in the axial direction), and hoop strength (resistance to deflection in the circumferential direction), while providing the flexibility necessary to conform to the individual patient's anatomy. The Nitinol stents allow the graft to be self-anchoring, adhering to the internal surface of the vessel wall by friction fit. ![img-4.jpeg](img-4.jpeg) Figure 5: AneuRx Stent Graft Delivery Catheter Each individual Stent Graft component is preloaded inside an AneuRx Delivery Catheter shown in Figure 5. The Delivery Catheter, supplied sterile for single use only, allows endovascular placement of the AneuRx Bifurcated Stent Graft, Iliac Stent Graft (same as Inserted Iliac Leg) and Iliac and Aortic Extender Cuff Stent Grafts via the arterial vasculature (e.g., femoral or iliac arteries). Using fluoroscopic guidance, the Delivery Catheter is properly positioned within the patient's vasculature. The Stent Graft is then deployed from the Delivery Catheter using the AneuRx Deployment Handle shown in The AneuRx Stent Graft System SSED page 4 P990020 09/27/99 {5} ![img-5.jpeg](img-5.jpeg) Figure 6. The Deployment Handle is a reusable device that may be attached to both the 16 French and 21 French Delivery Catheters to assist in deployment. The Deployment Handle is supplied non-sterile and must be steam sterilized prior to each use. Figure 6: AneuRx Stent Graft System Deployment Handle The AneuRx Stent Grafts are available in the following sizes: Bifurcated Stent Graft | Model Number | Diameter (Proximal/Distal) | Lengths | | --- | --- | --- | | YRBR2012 | 20 mm x 12 mm | 13.5 cm/16.5 cm | | YRBR2213 | 22 mm x 13 mm | 13.5 cm/16.5 cm | | YRBR2414 | 24 mm x 14 mm | 13.5 cm/16.5 cm | | YRBR2615 | 26 mm x 15 mm | 13.5 cm/16.5 cm | | YRBR2816 | 28 mm x 16 mm | 13.5 cm/16.5 cm | Iliac Stent Grafts | Model Number | Diameter | Lengths | | --- | --- | --- | | YRIR12 | 12 mm | 8.5 cm/11.5 cm | | YRIR13 | 13 mm | 8.5 cm/11.5 cm | | YRIR14 | 14 mm | 8.5 cm/11.5 cm | | YRIR15 | 15 mm | 8.5 cm/11.5 cm | | YRIR16 | 16 mm | 8.5 cm/11.5 cm | Extender Cuff Stent Grafts | Model Number | Diameter | Lengths | | --- | --- | --- | | YREC12 | 12 mm | 5.5 cm | | YREC13 | 13 mm | 5.5 cm | | YREC14 | 14 mm | 5.5 cm | | YREC15 | 15 mm | 5.5 cm | | YREC16 | 16 mm | 5.5 cm | | YREC20 | 20 mm | 3.75 cm | | YREC22 | 22 mm | 3.75 cm | | YREC24 | 24 mm | 3.75 cm | | YREC26 | 26 mm | 3.75 cm | | YREC28 | 28 mm | 3.75 cm | The AneuRx Stent Graft System SSED P990020 09/27/99 {6} Deployment Handle Model Number YR5100 # 6. Alternative Practices or Procedures The generally accepted standard of care for the treatment of AAA’s involves dissecting the aneurysm and placing a synthetic graft inside the diseased tissue. Surgical repair of AAA’s is indicated when the risk of rupture is believed to exceed the risks of open surgery. Due to the high risk of rupture for AAA’s greater than 5 cm in diameter, and the mortality associated with rupture, surgical repair of such aneurysms is the standard of care. # 7. Marketing History The AneuRx Stent Graft System is available in many countries throughout the world including Europe, Asia, and Australia. The AneuRx Stent Graft System has not been withdrawn from marketing in any country for any reason related to safety or effectiveness. 'Zarins, C.K., Harris, E.J. (1997) “Operative Repair for Aortic Aneurysms: The Gold Standard.” Journal of Endovascular Surgery, 4: 232-241. The AneuRx Stent Graft System SSED ... page 6 P990020 09/27/99 20 {7} # 8. Adverse Events | Adverse Event | Early ≤30 Days Stent Graft % (n/N) | | Early ≤30 Days Control % (n/N) | | Late >30 Days Stent Graft % (n/N) | | Late >30 Days Control % (n/N) | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Deaths | 2% | (7/416) | 0% | (0/66) | 5% | (416)^{7} | 9% | (6/66) | | Other Adverse Events | | | | | | | | | | AAA Rupture | 0.2% | (1/416) | 0% | (0/66) | 0.2% | (1/416) | 0% | (0/66) | | Bleeding^{1} | 4% | (18/416) | 3% | (2/66) | 0.2% | (1/416) | 0% | (0/66) | | Cardiac Failure/Infarction | 2% | (7/416) | 6% | (4/66) | 0.7% | (3/416) | 0% | (0/66) | | Edema^{2} | 1% | (5/416) | 0% | (0/66) | <1% | (2/416) | 0% | (0/66) | | Wound Healing Complications^{3} | 4% | (17/416) | 5% | (3/66) | 1% | (4/416) | 0% | (0/66) | | Impotence | 0% | (0/416) | 0% | (0/66) | 0.2% | (1/416) | 0% | (0/66) | | Pulmonary Complications^{4} | 2% | (7/416)^{8} | 8% | (5/66)^{8} | <1% | (2/416)^{9} | 5% | (3/66)^{9} | | Renal Failure^{5} | 4% | (15/416) | 0% | (0/66) | 1% | (3/416) | 0% | (0/66) | | Gastrointestinal Complications^{6} | 3% | (4/416)^{10} | 14% | (9/66)^{10} | 1% | (5/416) | 0% | (0/66) | | Vascular Occlusion (includes thrombosis and thromboembolism) | | | | | | | | | | Arterial | 2% | (8/416) | 2% | (1/66) | 0.5% | (2/416) | 0% | (0/66) | | Venous | 0% | (0/416) | 0% | (0/66) | 0.5% | (2/416) | 0% | (0/66) | 1 Includes: hematuria, brachial and femoral hematomas, elevated PT/INR, groin hemorrhage, retroperitoneal bleed, urethral bleeding 2 Includes: scrotal and foreskin edema, lower extremity swelling 3 Includes: delayed wound healing, lymphatic leak, seroma 4 Includes: bilateral pleural effusions, shortness of breath, respiratory failure/arrest, atelectasis, pneumonia 5 Includes: renal insufficiency/failure, dialysis, elevated creatinine 6 Includes: angiodysplasia of stomach, bowel ischemia, ileus, constipation, nausea/vomiting, ulcers, rectal bleeding, cholecystitis, diarrhea, bowel obstruction, GI bleed, small bowel mesentery bleed, sigmoid colon necrosis 7 Four (1%, 4/416) late deaths (>30 days post-procedure) occurred that were classified as device related. One (≤1%, 1/416) death had an unknown cause at the time of the data analysis. One death was undetermined but possibly occurred by cerebral embolism. One death was due to renal failure and pulmonary complications. One death was due to neurological complications. 8 p = 0.015 9 p = 0.02 10 p = 0.002 The AneuRx Stent Graft System SSED P990020 09/27/99 {8} # 9. Summary of Preclinical Studies ## 9.1 Laboratory Studies The following *in vitro* tests were performed in accordance with consensus documents. Since no single standard or guidance document has yet been developed for stent grafts, two documents were “merged” and have become the basis for tests presented in this summary. The two documents are: - Association for the Advancement of Cardiovascular Instrumentation, Cardiovascular Implants – Vascular Prostheses (ANSI/AAMI VP20-1994) - Interventional Cardiology Devices Branch, Division of Cardiovascular, Respiratory and Neurological Devices, Office of Device Evaluation, Guidance for the Submission of Research and Marketing Application for Interventional Cardiology Devices, May 1994 The AneuRx Stent Graft System SSED ...page 8 P990020 09/27/99 {9} Table 1: Summary of Finished Device Testing | Test | Samples Tested | Specification | Results | | --- | --- | --- | --- | | Stent Graft Expansion Integrity - To show that the Stent Graft maintains its integrity upon deployment from a compressed state. | • (10) 20x12mm (16.5cm length) Bifurcated Stent Grafts • (10) 28x16mm (16.5cm length) Bifurcated Stent Grafts • (10) 16mm (11.5cm length) Iliac Stent Grafts • (10) 12mm (11.5cm length) Iliac Stent Grafts | Following compression, sterilization and deployment into 37°C water, the Stent Graft shall have: The sum total of broken stitches per Stent Ring cannot include the top stitch (crown or junction), central (node) and lower stitch patterns(junction or crown) with: *Bifur, long* - No more than 7 broken sutures total; *Bifur, short* - No more than 6 broken sutures total, *Iliac, long* - No more than 4 broken sutures total, *Iliac, short* - No more than 3 broken sutures total, *Cuff* - No more than 2 broken sutures total Example: a single Stent Ring cannot have a top broken junction stitch, a bottom broken junction stitch and a broken central (node) stitch but may have any combination (a single broken junction and node or two broken junctions, top and bottom) provided the total number does not exceed the limit for the device. No holes with area >0.2mm². Graft runs with a maximum dimension <1.5mm are acceptable, but the quantity is limited to not more than 5 per cm of Stent Graft length. | All devices met the acceptance criteria and passed the test. | The AneuRx Stent Graft System SSED P990020 09/27/99 {10} The AneuRx Stent Graft System SSED P990020 09/27/99 | Test | Samples Tested | Specification | Results | | --- | --- | --- | --- | | Stent Graft Internal Pressure vs. External Diameter - To determine the static external diameter of the Stent Graft (as a function of internal pressure) by measuring the change in diameter directly under static internal pressure loading. | • (10) 20x12mm (16.5cm length) Bifurcated Stent Grafts • (10) 28x16mm (16.5cm length) Bifurcated Stent Grafts • (10) 16mm (11.5cm length) Iliac Stent Grafts • (10) 12mm (11.5cm length) Iliac Stent Grafts | The Stent Graft diameter must not change more than 10% in response to an internal pressure of 100mm Hg. | The greatest percent diameter change noted during this test was 7%. All Stent Grafts met the acceptance criteria, indicating that the AneuRx Stent Graft diameter does not change more than 10% in diameter in response to human physiologic pressures. | | Stent Graft Dimensional Verification - To verify the Stent Graft expands to its labeled diameter. | • (10) 20x12mm (16.5cm length) Bifurcated Stent Grafts • (10) 28x16mm (16.5cm length) Bifurcated Stent Grafts • (10) 16mm (11.5cm length) Iliac Stent Grafts • (10) 12mm (11.5cm length) Iliac Stent Grafts | Iliac and Bifurcated Stent Grafts shall expand to full diameter following compression, loading, sterilization, and deployment in 37°C water. The tolerance for the 12-16mm sizes is ±1.0mm. The tolerance for the 20-28mm sizes is +1.5/-1.0mm. | All Stent Grafts met the acceptance criteria. | | Stent Graft Dynamic Compliance - To determine the dynamic compliance of the AneuRx Stent Graft by measuring the change in external diameter in response to a pressure pulse. | • (10) 20x12mm (16.5cm length) Bifurcated Stent Grafts • (10) 28x16mm (16.5cm length) Bifurcated Stent Grafts • (10) 16mm (11.5cm length) Iliac Stent Grafts • (10) 12mm (11.5cm length) Iliac Stent Grafts | The stent graft shall have a minimum dynamic compliance of 0.1% per 100mmHg. | All Stent Grafts had a mean compliance of 0.2% to 3.1% at 100mm Hg. All Stent Grafts met the acceptance criteria. | | Stent Graft Joint Strength - To determine the force necessary to pull one stent graft or modular component from another following implantation. | • (10) 20x12mm (16.5cm length) Bifurcated Stent Grafts • (10) 28x16mm (16.5cm length) Bifurcated Stent Grafts • (10) 16mm (11.5cm length) Iliac Stent Grafts • (10) 12mm (11.5cm length) Iliac Stent Grafts | Stent Graft joint strength must be in excess of 40 grams of force at 1cm overlap. | All Stent Grafts met the acceptance criteria of a minimum joint strength greater than 40 grams at 1cm overlap. | | Stent Graft Kink Radius - To determine the radius of curvature to which the Stent Graft can conform before a kink initiates. | • (10) 20x12mm (16.5cm length) Bifurcated Stent Grafts • (10) 28x16mm (16.5cm length) Bifurcated Stent Grafts • (10) 16mm (11.5cm length) Iliac Stent Grafts • (10) 12mm (11.5cm length) Iliac Stent Grafts | The minimum kink radius/diameter for 20x12mm Bifurcated Stent Grafts and 12mm Iliac Stent Grafts must be less than or equal to 6.0cm. The minimum kink radius/diameter for 28x16mm Bifurcated Stent Grafts and 16mm Iliac Stent Grafts must be less than or equal to 8.0cm. | All Stent Grafts met the acceptance criteria. | {11} | Test | Samples Tested | Specification | Results | | --- | --- | --- | --- | | Stent Graft Column Strength - To quantify the longitudinal strength of the Stent Grafts. | (14) 28mm (5.5cm length) Iliac Stent Grafts (10) 12mm (5.5cm length) Iliac Stent Grafts | The Stent Grafts shall have a minimum longitudinal compression strength of 40 grams at 5mm deflection. | The mean column strength for the 28mm Stent Grafts was 1294±754 grams (range 341-3123 grams). The mean column strength for the 12mm Stent Grafts was 341±93 grams (range 173-518 grams). All Stent Grafts met the acceptance criteria. | | Delivery Catheter Deployment Force - To determine the force exerted on the Delivery Catheter during deployment of the AneuRx Stent Graft. | (12) 16 French Delivery Catheters (16mm Iliac) (10) 21 French Delivery Catheters (28x16 Bifurcated) | The 21 French Delivery Catheter deployment force must not exceed 40 lbs. The 16 French Delivery Catheter deployment force must not exceed 30 lbs. | Mean deployment force for the 21 French catheters was 11.5 ±0.9 lbs. (range 10.4-12.8 lbs) and the mean deployment force for the 16 French catheters was 7.3±1.0 lbs. (range 6.0-8.8 lbs). All catheters met the acceptance criteria under simulated clinical conditions. | | Delivery Catheter Flexibility - To demonstrate that the Delivery Catheter is flexible enough to be used in tortuous vessels without kinking. | (15) 16 French Catheters (20) 21 French Catheters | Catheter shall be kink resistant in a 1.0-inch bend radius. | No kinking of the catheters was observed. All catheters met the acceptance criteria. | | Delivery Catheter Tensile Tests - To ensure critical bonds on the Delivery Catheter are adequate in strength and will not fail under normal conditions. | Bond 16 French Catheter 21 French Catheter 15*, 30** 12* 10 12 10 15 12 12 10 15 12 12 12 12 12 12 12 12 12 12 12 | All bonds must have a tensile strength of 5 pounds or greater. The Graft cover to slider bond must have a tensile strength of 30 pounds or greater for the 16 French catheters and 40 pounds or greater for the 21 French catheters. | All critical bonds met the acceptance criteria. The Delivery Catheter will be able to withstand anticipated clinical loads without failure. | The AneuRx Stent Graft System SSED P990020 09/27/99 {12} The AneuRx Stent Graft System SSED P990020 09/27/99 | Test | Samples Tested | Specification | Results | | --- | --- | --- | --- | | Stent Graft Fatigue - To determine the fatigue characteristics of the final Stent Graft product by subjecting the devices to 10 million cycles of simulated implant conditions. Ten million cycles represents three months of pressure waves created by the human heart assuming an average heart rate of 72 beats per minute. The influence of overlapping Stent Grafts on fatigue performance was also examined. | • (10) 12mm (5.5cm length) Extender Cuff Stent Grafts • (10) 28mm (5.5cm length) Extender Cuff Stent Grafts | The Stent Graft shall be able to withstand 10 million cycles in a 5-7% compliant tube (10% undersized) pulsed with a minimum 40mm Hg pressure in 37° C saline with no more than 2 additional broken sutures (based on pre-test inspection) and no broken stents. | The 28mm Extender Cuff Stent Grafts had no broken sutures or stents. The test apparatus containing the 12mm Extender Cuff Stent Grafts experienced an equipment failure 124 hours into testing. A motor speed controller failed, resulting in several of the stent grafts being forced to the end of the tubing by the increased pressure wave. All samples were removed from testing at that time and visually examined. Four of the 10 samples had multiple broken stents and sutures. The four samples with extensive damage were removed from testing and the test was resumed. The remaining six 12mm Extender Cuff Stent Grafts completed the test and met all acceptance criteria. | | Delivery Handle Re-use Testing - To investigate the effect of multiple cleaning and sterilization cycles on the Delivery Handle in order to support the maximum number of recommended re-use sterilization cycles. | • (6) Delivery Handles | The Delivery Handle must pass 20 steam sterilization cycles and function satisfactorily after each one. | All Delivery Handles were functional after 20 steam sterilization cycles. Some separation of a glue joint on the main body of one handle was noticed after 17 cycles, however the handle still functioned through 3 more (20 total) sterilization cycles. All Delivery Handles met the acceptance criteria. | {13} Page 13 The AneuRx Stent Graft System SSED P990020 09/27/99 | Test | Samples Tested | Specification | Results | | --- | --- | --- | --- | | Stent Graft Water Permeability - To determine the rate of water leakage per unit area through the Stent Graft under a pressure of 120mm Hg. | • (10) 12mm (5.5cm length) Extender Cuff Stent Grafts • (13) 28mm (3.75cm length) Extender Cuff Stent Grafts | The Stent Graft must have a water permeability/leakage rate less than 700 ml/min/cm². | The 12mm Extender Cuff Stent Grafts had a mean water permeability of 521 ml/min/cm² and the 28 mm Extender Cuff Stent Grafts had a mean water permeability of 547 ml/min/cm². All Stent Grafts met the acceptance criteria. | | Delivery Catheter Crossing Profile - To ensure the outside diameter of the AneuRx Stent Graft Delivery Catheter is as labeled. | • (10) 16 French Catheters (16mm Iliac) • (10) 21 French Catheters (28x16mm Bifurcated) | The 21 French graft cover must have a maximum outside diameter of 0.277 inches. The 16 French graft cover must have a maximum outside diameter of 0.213 inches. | All ring gauges passed over the Delivery Catheters successfully. All catheters met the acceptance criteria and have a crossing profile within specifications. | | Delivery Catheter Wire Pass - To ensure all delivery catheters can accept a 0.038 inch guidewire with ease. | • (10) 16 French Catheters (16mm Iliac) • (10) 21 French Catheters (28x16mm Bifurcated) | All Delivery Catheters must not exceed a maximum frictional force of 100 grams to pull a stiff 0.038 inch guidewire through its guidewire lumen. | The guidewire passed successfully through all Delivery Catheters. All Delivery Catheters met the acceptance criteria. | | Delivery Catheter Hemostasis - To demonstrate the Delivery Catheter will maintain hemostasis during normal clinical use. | • (10) 16 French Catheters (16mm Iliac) • (10) 21 French Catheters (28x16mm Bifurcated) | The Delivery Catheter must not leak more than 2cc/min. | No leakage or drop in pressure was noted on any Delivery Catheter. All Delivery Catheters met the acceptance criteria. The AneuRx Delivery Catheter provides adequate hemostasis. | {14} | Test | Samples Tested | Specification | Results | | --- | --- | --- | --- | | Shelf-Life Study - To ensure the Stent Grafts, after having been compressed, loaded, packaged, sterilized, and stored on the shelf for one year, will still deploy and meet design specifications. | The following samples were tested for functionality: • (1) 28mm (3.75cm length) Extender Cuff Stent Graft • (2) 26mm (3.75cm length) Extender Cuff Stent Grafts • (1) 24mm (3.75cm length) Extender Cuff Stent Graft • (2) 22mm (3.75cm length) Extender Cuff Stent Grafts • (1) 20mm (3.75cm length) Extender Cuff Stent Graft The following samples were tested for sterility: • (1) 15mm (8.5cm length) Iliac Stent Graft / Delivery Catheter • (1) 12mm (5.5cm length) Extender Cuff Stent Graft / Delivery Catheter • (2) 13mm (5.5cm length) Extender Cuff Stent Graft / Delivery Catheters • (1) 20mm (3.75cm length) Extender Cuff Stent Graft / Delivery Catheter • (1) 22mm (3.75cm length) Extender Cuff Stent Graft / Delivery Catheter • (1) 24mm (3.75cm length) Extender Cuff Stent Graft, Negative Control • (1) 26mm (3.75cm length) Extender Cuff Stent Graft, Positive Control | The AneuRx Stent Graft must have a shelf life of at least one year and perform as intended. | The AneuRx Stent Graft will maintain sterility and will function after an extended shelf life. | | Packaging Performance Testing – To ensure the AneuRx Stent Graft System packaging materials prevent damage to the AneuRx Stent Graft System and maintain sterile barrier properties during shipping to the end user. | • Five stent graft systems in a five-pack shipping carton • Ten stent graft systems in a ten-pack shipping carton | Following completion of all shipping tests, (vehicle stacking, vibration and drop testing) packaging materials must remain intact; labels must remain intact and legible. The pouch material / seals must be undamaged upon visual inspection and confirmed by dye migration testing. | The AneuRx Stent Graft System packaging materials remained intact and all seals and pouch material was undamaged. Sterile barrier integrity was confirmed by dye migration testing. | The AneuRx Stent Graft System SSED P990020 09/27/99 {15} | Test | Samples Tested | Specification | Results | | --- | --- | --- | --- | | Characterization of Stent Performance at Low Temperature - To characterize performance of the Nitinol stents at temperatures below 37 °C in the event an implanted patients core body temperature was to be lowered for a subsequent procedure (e.g., open heart surgery). | • (5) 28mm Stent Rings • (5) 20mm Stent Rings • (5) 16mm Stent Rings • (5) 12mm Stent Rings | The radial force at 26 °C must be greater than zero and at least 3 times larger than the sensitivity threshold of the load cell (0.002 lb.). | The radial force delivered by the stents at temperatures below 37°C, stays significantly above zero in a wide temperature range down to 15 °C. The available radial force at 26 °C for all stents was measured to be more than 50% of that at 37 °C, therefore the stent would still be applying an outward pressure at 26°C to keep the stent graft from migrating in the event the body temperature of an implanted patient were to be lowered. | The AneuRx Stent Graft System SSED P990020 09/27/99 {16} # 9.2 Animal Studies AneuRx has conducted three *in-vivo* animal trials to evaluate the performance of the AneuRx Stent Graft System. The *in-vivo* tests were performed using straight Stent Grafts and bifurcated Stent Grafts. The *in-vivo* studies were conducted to evaluate and document the performance of the Stent Graft devices and the delivery system. The clinical performance attributes evaluated include: - The ability of the delivery system to effectively navigate vasculature to deliver the Stent Graft to the proper anatomical location prior to deployment, - The ability of the delivery catheter to adequately and accurately deploy the Stent Graft into the vasculature, - The ability of the Stent Graft to exclude the aneurysm, - Performance of the Stent Graft in high-flow areas, - Adequacy of the friction fit method in attaching the Stent Graft to the aortic wall, and - Feasibility and utility of the modular design. Each of these studies evaluated a different aspect of clinical performance of the AneuRx Stent Graft System. Implantation in the thoracic aorta of sheep demonstrated the performance of the device in a high-flow area, allowing documentation of the lack of migration of the device after implantation, and the ability to deploy one Stent Graft device within another modular unit. Implantation in an *in situ* aortic aneurysm in sheep documented the lack of migration, aneurysm exclusion and outflow patency characteristics. Implantation in *in situ* aortic aneurysms in dogs demonstrated lack of migration, aneurysm exclusion, modularity and flow characteristics for the bifurcated units, and the ability to maneuver the bifurcated delivery system through narrow and tortuous vasculature. By conducting these studies in three different models, substantiation of each of these parameters was often obtainable in more than one model. **Methods:** Straight CVC Endovascular Prostheses were deployed in a total of 36 sheep and 18 dogs. The device was deployed in the thoracic aorta of 18 sheep, and at the site of a surgically fabricated *in situ* infrarenal aortic aneurysm in another 18 sheep. CVC Bifurcated Endovascular Prostheses were deployed within surgically fabricated *in situ* infrarenal aortic aneurysms in 18 dogs. The implanted animals have been sacrificed as summarized below. The AneuRx Stent Graft System SSED P990020 09/27/99 {17} Sacrifice Schedule of Animals Implanted with CVC Endovascular Prostheses | Sacrifice Timepoint | AAA Ovine Straight EP (n=18 implanted) | Thoracic Ovine Straight EP (n=18 implanted) | AAA Canine Bifurcated EP (n=18 implanted) | Total | | --- | --- | --- | --- | --- | | One Week | 3 | 3 | 4 | 10 | | One Month | 3 | 3 | 3 | 9 | | Three Months | 3 | 3 | 4 | 10 | | Six Months | 6 | 7 | 6 | 19 | | One Year | 3 | 2 | 1 | 6 | In these three animal models, each of which tests multiple and different aspects of potential clinical performance, the AneuRx Stent Graft was successfully advanced to the desired location and implanted. When desired, the AneuRx Stent Graft was deployed accurately within another Stent Graft device. In 34 of the 36 animals studied, devices excluded the aneurysm as desired. The Stent Graft generally remained patent, except for some of the iliac legs inserted into the old bifurcated design in the canine model. Clinical complications were rare, and with one exception, were transient and caused no obvious long-term adverse effects. Additionally, the implanted Stent Grafts were well-tolerated by the native vessels indicating an acceptable level of biocompatibility for the AneuRx Stent Graft device. ## 9.3 Biocompatibility Studies AneuRx has conducted biocompatibility testing to establish the safety and biocompatibility of all patient-contacting materials used to manufacture the Medtronic AneuRx Stent Graft and Delivery Catheter. All biocompatibility testing was conducted in compliance with Good Laboratory Practice (GLP) regulations by contract laboratories specializing in the conduct of safety evaluation testing. Tests initiated prior to July 1, 1995 were conducted in accordance with the Tripartite Biocompatibility Guidance for Medical Devices. Tests initiated on or after July 1, 1995, were conducted in accordance with ISO 10993-1 - Biological Evaluation of Medical Devices. Biocompatibility testing was performed on the following patient-contacting materials: The AneuRx Stent Graft System SSED ... page 17 P990020 09/27/99 {18} - Polyester Graft Material with Tantalum Markers - Raw Materials - Nickel Titanium Stent - Raw Material - Stent Graft Devices - Finished Product - Stent Graft Delivery System - Finished Product The Polyester Graft Material with Tantalum Markers (raw materials), the Nickel Titanium Stent (raw material) and the Stent Graft Devices (finished product) successfully passed each individual test. These results indicate that the test articles are biocompatible and safe for use in manufacturing of a permanent implant device designed to come into direct contact with blood. The Stent Graft Delivery System successfully passed each individual test, indicating that the Stent Graft Delivery Catheter - Finished Product is biocompatible and safe for use as an externally communicating device, having limited contact with circulating blood. Overall, results of biocompatibility testing performed confirm that the Medtronic AneuRx Stent Graft and Delivery Catheter are considered to be safe at the cellular, systemic, local and immunological levels. Below are tabulated biocompatibility summaries. ### Table 1 Test Material: Polyester Graft Material with Tantalum Markers (Raw Materials) | Test | Purpose | Results & Conclusions | | --- | --- | --- | | USP Muscle Implantation Test with Histopathology in the Rabbit (90 days) Lot number M950058 | To evaluate the potential for local irritation or a toxic response to material implanted in direct contact with living muscle tissue. | Results: Macroscopic: non-reactive Microscopic: Moderately irritating* Conclusion: Passed | *Histopathology revealed that the test material was moderately irritating when compared to the control material. However, the irritation seen was considered to be a result of the physical structural characteristics of the embedded material and not due to any inherent toxic quality of the test material. The AneuRx Stent Graft System SSED ... page 18 P990020 09/27/99 {19} Table 2 Test Material: Nickel Titanium Stent (Raw Material) | Test | Purpose | Results & Conclusions | | --- | --- | --- | | USP Muscle Implantation Test with Histopathology in the Rabbit (90 days) Lot number M950057 | To evaluate the potential for local irritation or a toxic response to material implanted in direct contact with living muscle tissue. | Results: Macroscopic: non-reactive Microscopic: Moderately irritating* Conclusion: Passed | *Histopathology revealed slight irritation in the test compared to the control groups. Inflammatory reaction and fibrosis around the test implant was extremely minimal. The AneuRx Stent Graft System SSED page 19 P990020 09/27/99 {20} Table 3 Test Material: Stent Graft Devices (Finished Product) | Test | Purpose | Results & Conclusions | | --- | --- | --- | | USP Systemic Injection Test Lot number M950062 | To determine whether leachables extracted from the test article would cause systemic toxicity following injection into mice. | Results: No mortality or toxicity observed Conclusion: Passed | | USP Intracutaneous Test Lot number M950062 | To determine whether leachables extracted from the test article would cause significant irritation or toxicity when injected intracutaneously. | Results: The difference between the mean scores for each of the sample extracts and corresponding blanks was 1.0 or less. Conclusion: Passed | | Guinea Pig Maximization Test Lot number M950062 | To determine to what extent a test material has the potential for acting as a contact sensitizer in guinea pigs. | Results: SCI* and CSO* extractions: None of the test group or negative control animals exhibited scores higher than “1”. Conclusion: Passed | | Cytotoxicity – Elution Test Lot numbers M950063, M950101, M950102, F050056 | To determine the in-vitro biological reactivity of mammalian cell cultures to specific extracts prepared from the test samples in physiological media. | Results: None of the cell cultures treated with the sample extract scored a reactivity grade greater than “1” (mild reactivity) Conclusion: Passed | The AneuRx Stent Graft System SSED page 20 P990020 09/27/99 {21} | Test | Purpose | Results & Conclusions | | --- | --- | --- | | Hemolysis – Direct Contact Lot number M950063 | To determine if the composition of the sample has the ability to cause hemolysis in-vitro. | **Results:** Average hemolysis was 1.9% **Conclusion:** Passed | | Thrombogenicity Lot number M950062 | To quantitate the thrombogenic potential of the test samples | **Results:** No statistically significant difference between the clot time of the sample and the polypropylene negative control. **Conclusion:** Passed | | Salmonella Typhimurium Reverse Mutation Assay (Ames Test) Lot number M950062 | To determine whether a 0.9% saline extract of the test article would cause mutagenic changes in histidine – dependent strains of Salmonella Typhimurium. | **Results:** The extract tested against the five strains did not meet the criteria for a potential mutagen **Conclusion:** Passed | * 0.9% Sodium Chloride for Injection ** Cottonseed Oil The AneuRx Stent Graft System SSED ... page 21 P990020 09/27/99 {22} Table 4 Test Material: Stent Graft Delivery System (Finished Product) | Test | Purpose | Results & Conclusions | | --- | --- | --- | | USP Systemic Injection Test Lot number M950083 | To determine whether leachables extracted from the test article would cause systemic toxicity following injection into mice. | Results: No mortality or toxicity observed. Conclusion: Passed | | USP Intracutaneous Test Lot number M950083 | To determine whether leachables extracted from the test article would cause systemic irritation or toxicity when injected intracutaneously. | Results: The difference between the mean scores for each of the sample extracts and corresponding blanks was 1.0 or less. Conclusion: Passed | | Guinea Pig Maximization Test Lot number M950083 | To determine to what extent a test material has the potential for acting as a contact sensitizer in guinea pigs. | Results: SCI* extractions: None of the test groups or negative control animals exhibited scores higher than “1”. Conclusion: Passed | | Cytotoxicity – Elution Test Lot number M950083 | To determine the in-vitro biological reactivity of mammalian cell cultures to specific extracts prepared from the test samples in physiological media. | Results: None of the cell cultures treated with the sample extract scored a reactivity grade greater than “0” (none). Conclusion: Passed | The AneurRx Stent Graft System SSED page 22 P990020 09/27/99 {23} | Test | Purpose | Results & Conclusions | | --- | --- | --- | | Hemolysis – Direct Contact Lot number M950083 | To determine if the composition of the sample has the ability to cause hemolysis *in-vitro*. | **Results:** Average hemolysis was <1%. **Conclusion:** Passed | | Thrombogenicity Lot number M950097 | To quantitate the thrombogenic potential of the test samples. | **Results:** No statistically significant difference between the clot time of the sample and the polypropylene negative control. **Conclusion:** Passed | * 0.9% Sodium Chloride for Injection ## 9.4 Additional Studies **Magnetic Resonance Imaging (MRI) Safety Testing** - to ensure there will be no adverse effects to the patient in the event a patient requires a MRI procedure after the Stent Graft has been implanted. **Samples Tested** – (1) 28x16mm (16.5cm length) Bifurcated Stent Graft, corresponding 16mm contralateral iliac leg and 28mm (3.75cm length) diameter Extender Cuff Stent Graft. This Stent Graft represents the largest diameter, longest length and greatest mass of metal with an Aortic Extension Cuff added for additional length and mass. **Specification** – A patient with an implanted AneuRx Stent Graft must be able to undergo subsequent MRI procedures without adverse effects to the patient from the Stent Graft (e.g., migration, RF heating). **Results** – The Medtronic AneuRx Stent Graft has been determined to be MRI Safe. When presented in a patient undergoing an MRI procedure, the Medtronic AneuRx Stent Graft will not present additional risk to the patient, but may affect the image quality depending on the pulse sequence that is used and the imaging area of interest evaluated using MRI. Safety information for the use of magnetic resonance imaging (MRI) procedures (i.e., imaging, angiography, functional imaging and spectroscopy) pertains to the The AneuRx Stent Graft System SSED ... page 23 P990020 09/27/99 {24} use of a shielded MRI systems with static magnetic fields of 1.5T or less, spatial gradient of 450 gauss/cm or less, gradient magnetic fields of 10 Tesla/second or less, and a maximum whole body averaged specific absorption rate (SAR) of 1.4 W/kg for 30 minutes of imaging. The effects of performing MRI procedures using MR systems and conditions above these levels have not been determined. The AneuRx Stent Graft System SSED page 24 P990020 09/27/99 38 {25} # 10. Summary of Clinical Studies ## 10.1 Objectives To document the safety and effectiveness of the AneuRx System in the treatment of infrarenal aortic or aorto-iliac AAAs by: - Demonstrating the effectiveness of the Stent Graft through successful deployment and aneurysm exclusion both acutely and long term. - Comparing the relative safety and clinical utility of the endovascular treatment of AAA to open surgical repair. To show that endovascular stent graft repair of abdominal aortic aneurysms using the Medtronic AneuRx Stent Graft System is a safe and effective alternative to conventional open surgical repair of abdominal aortic aneurysms. ## 10.2 Study Design The clinical evaluation for the AneuRx Stent Graft System was a prospective, non-randomized, multicenter clinical study designed to compare endovascular repair to conventional open surgical repair in terms of safety, procedural parameters and hospital activities. The study was initiated in April 1996. Safety comparisons were made by evaluating morbidity and mortality of the surgical and stent graft subjects. Procedural parameters and hospital activities were compared by evaluating factors such as procedural blood loss, duration of procedure and anesthesia times, length of hospital stay, length of time in the intensive care unit, time to resumption of normal diet, etc. Due to the very different nature of the surgical and endovascular approaches, the aneurysm exclusion rate will not be compared, but is presented with descriptive statistics along with other unique endpoints of the endovascular approach such as stent graft migration, and stent graft patency. Thirteen clinical sites were involved in the study. Each of the sites was required to first enroll five control subjects in the Surgical Control Group prior to initiating enrollment of subjects for endovascular stent graft treatment (Stent Graft Treatment Group). ## Follow-up Surgical Control Group subjects and Stent Graft Treatment Group subjects were followed at the same post-operative intervals. Follow-up evaluations were scheduled for pre-discharge, 1 month, 6 month, and 1 year post procedure. A later protocol amendment added 2, 3, 4 and 5 year post-procedure follow-up evaluations for Stent Graft Treatment Group Subjects. At each of these intervals the subject’s health is evaluated, endpoints are recorded and quality of life questionnaires are completed. The only difference in the follow-up regimen between the two groups is the additional imaging procedures necessary to evaluate the effectiveness of the device by measuring endpoints such as migration, aneurysm exclusion and patency (see below for a complete description of each endpoint). The AneuRx Stent Graft System SSED ... page 25 P990020 09/27/99 {26} Primary Outcome Measures ## Delivery Success Vessel access was achieved and the physician was able to insert the delivery catheter and deliver it to the treatment site. If the aneurysm cannot be accessed with the delivery catheter, it is considered a delivery failure. This endpoint is measured only during the procedure. ## Deployment Success The stent graft(s) was advanced through the vasculature to the desired location and fully deployed within 0.5 cm of the intended location. Deployment success is verified during the procedure with fluoroscopy. ## Morbidity and Mortality At each follow-up evaluation and each hospital stay, all complications suffered by both the stent graft treatment group and the surgical control group were collected. Complications will be categorized and reported according to severity. A comparison between the surgical control group and the stent graft treatment group will be made to evaluate the relative safety of the endovascular procedure. ## Stent Graft Migration Post implantation movement of the stent graft relative to the native aorta is considered migration. Migration can be measured by CT, angiography, ultrasound, or pathological analysis and is evaluated at discharge and at all follow-up visits. ## Aneurysm Exclusion An endoleak is defined as evidence of blood flow around or through the stent graft into the aneurysm. All endoleaks are considered an exclusion failure; however, some endoleaks may be tolerated and followed to determine clinical impact. Aneurysm exclusion is measured by CT examination at discharge and at the 6-month, 1, 2, 3, 4, and 5-year follow-up visits, and by color duplex ultrasound or CT at the 1-month follow-up visit. ## Stent Graft Patency Blood flow through the treated vessel and stent graft must be obtained. Core Lab interpretation of non-patency was any occlusion, whether complete or partial. Hospital interpretation of non-patency was complete occlusion of any part of the device requiring interventional treatment. ## Stent Graft Occlusion (Non-Patency) Stent graft occlusion is defined as a complete blockage of the initial implanted lumen diameter of any prosthesis as evidenced by CT, angiography, ultrasound or pathological analysis, and is considered a patency failure. ## Device Integrity The device must remain intact with no visible defects as measured by CT examination or color duplex ultrasound at all follow-up examinations. This applies to the integrity of the device as it relates to the stent (all struts intact, no kinks or breaks) as well as to the graft material (no tears or holes). The AneuRx Stent Graft System SSED ... page 26 P990020 09/27/99 {27} Additional primary endpoints have been added as a result of recent discussions with FDA. They are as follows: ## Aneurysm Rupture Rupture of the abdominal aortic aneurysm during attempted endovascular repair or subsequent to successful stent graft delivery and deployment, due to any possible cause at any point in time. ## Expansion of the AAA by >0.5 cm Increase of the maximum AAA diameter by more than 0.5 cm from pre-discharge imaging (or baseline imaging if no pre-discharge imaging is available) to any time during the follow-up interval or between any two consecutive follow-up intervals as determined by core lab interpretation of the CT scan imaging. ## Conversion to surgical repair Conversion to open surgical repair of the AAA due to unsuccessful delivery or deployment of the stent graft, due to complications or other clinical situations which precluded successful endovascular treatment, or at any time following initial successful endovascular treatment for any reason. ## Additional procedure required Number of patients in which more than one procedure was required to successfully treat the patient (i.e. an additional stent graft procedure for placement of extension cuffs to treat endoleak or migration, or treatment for graft non-patency). These patients may be evaluated for secondary success. ## Secondary Outcome Measures ### Duration of Surgical Procedure The time from which the first incision is made to the time the last suture is completed. ### Time Spent in the ICU Number of days spent in the intensive care unit following the procedure. ### Days of Hospitalization Number of days spent in the hospital post-procedure. ### Amount of Blood Loss Blood lost during the procedure that could not be returned to the patient by autotransfusion. ### Number of Patients Requiring Transfusion of Stored Blood The percentage of patients that required any blood transfusion with stored blood or blood-products. ### Time to Extubation The AneuRx Stent Graft System SSED ... page 27 P990020 09/27/99 {28} Expressed as days until patient is extubated post-procedure. ## Time to Unassisted Ambulation Number of days until patient is able to ambulate from bed on his/her own. ## Time to Resumption of Normal Diet Number of days until patient is prescribed a regular diet (e.g. solid food) ## Quality of Life Assessments Both groups answered a Quality of Life questionnaire pre and post procedure as well as at all follow-up evaluations. These assessments were designed to help determine the impact on the patient (both physically and mentally) of surgical treatment compared to endovascular treatment. ## 10.3 Description of Patients and Gender Bias ### Subjects At the time of this analysis a total of 416 subjects were enrolled into the Phase II study. Subjects were enrolled into two groups, the Surgical Control Group and the Stent Graft Treatment Group. A total of 66 subjects were enrolled in the Surgical Control Group. ### Surgical Control Group Sixty-six subjects were enrolled in the Surgical Control Group of the Phase II study. The Phase II protocol called for five control patients to have surgical repair of their abdominal aortic aneurysms at each clinical site prior to initiating enrollment of patients in the Phase II Stent Graft Treatment Group. One site enrolled an additional Surgical Control Group subject bringing the total number of Surgical Control Group patients to 66, instead of 65. ### Stent Graft Treatment Group There were 13 investigational sites involved in enrollment of patients in the Phase II Stent Graft Treatment Group. As of December 7, 1998, 416 patients were enrolled in the Phase II Stent Graft Treatment Group. Patients enrolled in the study were implanted with a Bifurcated Stent Graft and Iliac Stent Graft (inserted iliac leg). See Device Description for a detailed description of the device. ### Gender Bias There were a total of 416 subjects enrolled in the Stent Graft Treatment Group of the study, 89% were male and 11% were female. In comparison, there were 66 subjects enrolled in the Surgical Control Group, 85% were male and 15% were female. The results of the clinical study indicate that women treated with this device may have a higher incidence of mortality compared to their male counterparts. A review of the literature reveals that the gender of patients undergoing conventional abdominal aortic aneurysm repair are 82% male and 18% female.²,³,⁴,⁵,⁶,⁷,⁸,⁹ The AneurRx Stent Graft System SSED ... page 28 P990020 09/27/99 42 {29} # 10.4 Results ## Enrollment by Center | Institution | Principal Investigator | Location | Surgical Patients | Stent Graft Patients | | --- | --- | --- | --- | --- | | Harbor - UCLA | Rodney White, MD | Torrance, CA | 5 | 66 | | Baptist East Hospital | Edward Kinney, MD | Louisville, KY | 5 | 31 | | Stanford Univ. Medical Ctr | Christopher Zarins, MD | Stanford, CA | 5 | 46 | | Northside Cardiology | Donald Schwarten, MD | Indianapolis, IN | 5 | 49 | | Northwestern Univ. Medical School | Jon Matsumura, MD | Chicago, IL | 5 | 10 | | Cleveland Clinic Foundation | Timothy Sullivan, MD | Cleveland, OH | 5 | 41 | | Ochsner Clinic | Samuel Money, MD | New Orleans, LA | 6 | 26 | | Sanger Clinic | Robert Bersin, MD | Charlotte, NC | 5 | 28 | | Springfield Memorial Hospital | Kim Hodgson, MD | Springfield, IL | 5 | 52 | | Washington Hospital Center | John Laird, MD | Washington, DC | 5 | 18 | | Arizona Heart Institute | Edward Diethrich, MD | Phoenix, AZ | 5 | 30 | | West Columbia Hospital | William Moore, MD | West Columbia, SC | 5 | 9 | | Pittsburgh Vascular Center | Mark Wholey, MD | Pittsburgh, PA | 5 | 10 | | | | Total | 66 | 416 | The AneuRx Stent Graft System SSED ... page 29 P990020 09/27/99 {30} # Demographics (66 Surgical Control Group Subjects, 416 Stent Graft Treatment Group Subjects, unless otherwise noted) | Demographic | Stent Graft (N = 416)^{1} | Control (N = 66) | | --- | --- | --- | | Age (years) | 73 (45-93) | 69 (49-85) | | Alcoholism | 3% | 5% | | Angina pectoris | 18% | 23% | | Cancer | 26% | 26% | | Cerebrovascular disease | 14% | 12% | | Chronic obstructive pulmonary disease^{2} | 24% | 36% | | Chronic renal failure | 2% | 6% | | Diabetes | 12% | 9% | | Family history of aneurysm disease | 10% (n=415) | 14% | | Gender | | | | Female | 11% | 15% | | Male | 89% | 85% | | History of CVA (n=49) | 11% | 8% | | Hypertension | 64% | 56% | | Immunodeficiency | 0% | 2% | | Myocardial infarction prior to last 6 months | 33% | 24% | | Myocardial infarction within previous 6 months | 4% | 3% | | Obesity | 18% | 18% | | Peripheral vascular disease | 20% (n=415) | 24% | | Previous surgery in affected area^{3} | 26% | 14% | | Prior coronary intervention procedure | 45% (n=415) | 53% | | Radiation of the affected area | 3% | 2% | | Symptomatic cardiac arrhythmia^{4} | 12% | 3% | | Symptomatic congestive heart failure | 8% | 3% | | Systemic infection - current | 0% | 0% | | Thromboembolic events | 4% (n=413) | 6% | | Tobacco use | 86% (n=414) | 82% | 1 Unless otherwise noted, N = 416 2 p = 0.037 3 p = 0.027 4 p = 0.029 The AneuRx Stent Graft System SSED ... page 30 P990020 09/27/99 {31} # Aneurysm Diameter Distribution | Diameter Range | Stent Graft | | | | Control | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Neck N=346 n | Neck N=390 % | Aneurysm N=390 n | Neck N=47 % | Aneurysm N=47 n | Neck N=53 % | Aneurysm N=53 n | Neck N=53 % | | <20 | 16 | 4.6 | 0 | 0 | 2 | 4.3 | 0 | 0 | | 20 – 29 mm | 325 | 93.9 | 0 | 0 | 41 | 87.2 | 0 | 0 | | 30 – 39 mm | 5 | 1.5 | 6 | 1.5 | 3 | 6.4 | 1 | 1.9 | | 40 – 49 mm | 0 | 0 | 68 | 17.4 | 0 | 0 | 8 | 15.1 | | 50 – 59 mm | 0 | 0 | 199 | 51.0 | 1 | 2.1 | 25 | 47.2 | | 60 – 69 mm | 0 | 0 | 80 | 20.5 | 0 | 0 | 9 | 17.0 | | 70 – 79 mm | 0 | 0 | 25 | 6.4 | 0 | 0 | 4 | 7.6 | | 80 – 89 mm | 0 | 0 | 9 | 2.3 | 0 | 0 | 4 | 7.6 | | ≥90 mm | 0 | 0 | 3 | 0.8 | 0 | 0 | 2 | 3.8 | # Aneurysm Length Distribution | Length Range | Stent Graft | | | | Control | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Neck N=360 n | Neck N=333 % | Aneurysm N=333 n | Neck N=46 % | Aneurysm N=46 n | Neck N=44 % | Aneurysm N=44 n | Neck N=44 % | | <20 | 100 | 27.8 | 3 | 0.9 | 14 | 30.4 | 0 | 0 | | 20 – 29 mm | 126 | 35.0 | 1 | 0.3 | 24 | 52.2 | 0 | 0 | | 30 – 39 mm | 71 | 19.7 | 5 | 1.5 | 4 | 8.7 | 2 | 4.6 | | 40 – 49 mm | 40 | 11.1 | 8 | 2.4 | 2 | 4.4 | 1 | 2.3 | | 50 – 59 mm | 10 | 2.8 | 19 | 5.7 | 1 | 2.2 | 4 | 9.1 | | 60 – 69 mm | 10 | 2.8 | 41 | 12.3 | 0 | 0 | 8 | 18.2 | | 70 – 79 mm | 2 | 0.6 | 58 | 17.4 | 1 | 2.2 | 7 | 15.9 | | 80 – 89 mm | 1 | 0.3 | 70 | 21.0 | 0 | 0 | 0 | 0 | | ≥90 mm | 0 | 0 | 128 | 38.4 | 0 | 0 | 22 | 50.0 | # ASA Grades (66 Surgical Control Group Subjects, 416 Stent Graft Treatment Group Subjects) | ASA Grade | Surgical Control Group | Stent Graft Treatment Group | Difference [95% CI] | | --- | --- | --- | --- | | 1 | 0% | 1.0% | -1.0%[-2.8%, 0.9%] | | 2 | 7.6% | 9.6% | -2.0%[-9.1%, 5.0%] | | 3 | 68.2% | 64.4% | 3.8%[-8.5%,16.0%] | | 4 | 24.2% | 25.0% | -0.4%[-11.6%,10.9%] | The Aneurx Stent Graft System SSED page 31 P990020 09/27/99 {32} # AAA Classification (64 Surgical Control Group Subjects, 416 Stent Graft Treatment Group Subjects) | AAA Classification | Surgical Control Group | Stent Graft Treatment Group | Difference [95% CI] | | --- | --- | --- | --- | | A | 14.1% | 19.5% | -5.5% [-14.8%, 3.9%] | | B | 34.4% | 56.3% | -21.9% [-34.4%, -9.3%] | | C | 34.4% | 13.0% | 21.4% [9.3%, 33.4%] | | D | 9.4% | 7.0% | 2.4% [-5.2%, 9.9%] | | E | 7.8% | 4.3% | 3.5% [-3.4%, 10.3%] | # Type of Anesthesia Used (66 Surgical Control Group Subjects, 415 Stent Graft Treatment Group Subjects) | Anesthesia Type | Surgical Control Group | Stent Graft Treatment Group | Difference [95% CI] | | --- | --- | --- | --- | | General | 100% | 67% | 33% [28%, 38%] | | Epidural | 0 | 22% | -22% [-27%, -17%] | | Local | 0 | 11% | -11% [-15%, -7%] | # Adverse Events See Section 8 above. The AneuRx Stent Graft System SSED P990020 09/27/99 {33} # Principal Safety Results (N=416) The time intervals capture the events between the follow up time periods. Denominators that are < 416 reflect patients that were successfully treated with the Stent Graft, measures that are determined by cine, and the actual readable images sent to the corelab by the investigational sites. The denominators are determinable measures based on the image quality. Five of 415 (1.2%) patients underwent open surgical repair due to iliac access difficulty or due to the unsuccessful delivery, deployment or positioning of at least one of the stent graft components. One patient (0.2%) refused placement of an Extender Cuff for treatment of endoleak and instead opted for open surgical repair. Two patients (0.5%) were converted to open surgical repair following rupture of the AAA. Patients with technical success underwent an additional procedure(s): 19 patients for Extender Cuff placement due to endoleak, with or without migration, and 8 for non-patent endovascular grafts. | Safety Measures and other Clinical Events | Pre-discharge to six months | Pre-discharge to one year | | --- | --- | --- | | Aneurysm Rupture | 1/405 (0.2%) | 1/405 (0.2%) | | Conversion to Surgical Repair | 7/415 (1.7%) | 8/415(1.9%) | | Additional Procedure Required | 16/405 (3.9%) | 27/405 (6.7%) | The AneuRx Stent Graft System SSED P990020 09/27/99 {34} # Principal Effectiveness Results 416 patients were enrolled in the study. Denominators that are < 416 reflect a subset of the patients implanted with a Stent Graft and with readable images sent to the corelab by the investigational sites. ## Principal Effectiveness Results | Efficacy Measures | Pre-discharge N=416² | Pre-discharge N=189 | 6 months N=189 | 1 year N=189 | | --- | --- | --- | --- | --- | | Delivery Success/ Deployment Success | 405/415 (97.6%) | —— | —— | —— | | Stent Graft Migration | Baseline | Baseline | 3/173 (1.7%) 16 patients did not have a KUB or CT corelab evaluation. | 3/187 (1.6%) 1 patient did not have a readable KUB or CT. 1 patient refused return visit. | | Aneurysm non-Exclusion (evidence of endoleak) | 165/354 (46.6%) | 74/169 (43.8%) 20 patients did not have a CT corelab evaluation. | 38/162 (24.0%) 27 patients did not have a CT corelab evaluation. | 30/172 (17.4%) 17 patients did not have a CT corelab evaluation. | | Stent Graft Patency | 352/352 (100%) | 167/168 (99.4%) 20 patients did not have a CT corelab evaluation. 1 patient did not have a readable CT. | 156/162 (96.3%) 27 patients did not have a CT corelab evaluation. | 166/171 (97.1%) 18 patients did not have a CT corelab evaluation. 1 patient did not have a readable CT. | | Device Integrity¹ 1. Stent graft fractures | 1. 0/383 (0%) | 1. 0/137 (0%) 51 patients did not have a KUB corelab evaluation. 1 patient did not have a readable KUB. | 1. 0/113 (0%) 76 patients did not have a KUB evaluation. | 1. 0/133 (0%) Read by KUB only. 56 patients did not have a KUB evaluation. | | 2. Kinking and/or twisting | 2. 14/351 (3.9%) | 2. 11/186 (5.9%) 3 patients did not have a KUB or CT corelab evaluation. | 2. 3/174 (1.7%) 15 patients did not have a CT or KUB evaluation. | 2. 5/188 (2.6%) 1 patient refused return visit. | | Morbidity and Mortality | Contained in Section 5. ADVERSE EVENTS | | | | ¹No patient with a device kink or twist had nonpatency, migration, or required additional procedures for correction. The AneuRx Stent Graft System SSED page 34 P990020 09/27/99 {35} Secondary Outcome: Surgical Control vs. Stent Graft | Endpoint | Surgical Control Mean (range) | Stent Graft Mean (range) | Difference [95% CI] | | --- | --- | --- | --- | | Duration of Anesthesia (min)^{1} | 293 (125-623) N=65 | 255 (110-814) N=415 | 38 [14, 62] | | Duration of Procedure (min)^{2} | 210 (90-498) N=65 | 174 (71-680) N=415 | 36 [16, 56] | | Blood Loss (cc)^{2} | 1617 (200-8000) N=65 | 544 (0-3500) N=410 | 1073 [886,1261] | | Patients Requiring Blood Transfusion (%)^{2} | 55 N=65 | 24 N=410 | 31 [18, 44] | | Days to Endotracheal Extubation^{2} | 1.3 N=60 | 0.2 N=374 | 1.1 [0.6, 1.5] | | Days to Unassisted Ambulation^{2} | 3.6 N=65 | 1.4 N=392 | 2.2 [1.8, 2.5] | | Days to Resumption of Normal Diet^{2} | 4.9 N=60 | 1.3 N=389 | 3.6 [3.2, 3.9] | | Days in ICU^{2} | 3.5 (0-72) N=66 | 0.9 (0-83) N=396 | 2.5 [1.1, 3.9] | | Hospital Length of Stay (LOS, days)^{2} | 9.3 (3-72) N=50 | 3.4 (0.8-84) N=406 | 5.9 [4.3, 7.6] | 1. p < 0.002 2. p < 0.001 The AneuRx Stent Graft System SSED page 35 P990020 09/27/99 {36} # Successful Delivery and Deployment (Stent Graft Treatment Group, n=415) | Prosthesis Type | Devices Attempted | Successful Delivery | 95% Confidence Interval | Successful Deployment | 95% Confidence Interval | | --- | --- | --- | --- | --- | --- | | Bifurcated Device | 416 | 98.1% | [96.8%, 99.4%] | 97.8% | [96.4%, 99.2%] | | Contralateral Limb | 465 | 99.8% | [98.6%, 100%] | 99.6% | [98.3%, 99.9%] | | Extension Cuff | 237 | 98.7% | [96%, 99.7%] | 98.7% | [96.0%, 99.7%] | ## Additional Procedures: Type of Cuff Place for Each Type of Endoleak | Leak Location* | Number of Patients | Therapy / Number of Patients | | --- | --- | --- | | Proximal | 7 | Proximal Cuff / 7 | | Junction | 5 | Iliac Leg Cuff / 5 | | Collateral Vessel | 2 | Proximal Cuff / 1 Distal Cuff / 1 | | Distal | 5 | Distal Cuff / 5 | | Indeterminate | 1 | Proximal and Distal Cuff / 1 | *One patient had both a proximal and distal leak ## Additional Procedures: Non-Patent Stent Graft Therapies | Number of Patients with Non-Patent Stent Graft | Therapy | | --- | --- | | 3 | Femoral-Femoral Bypass | | 2 | Thrombectomy | | 1 | Embolectomy | | 1 | Axillary-Popliteal Bypass | | 1 | Angioplasty with Stent Placement | The AneuRx Stent Graft System SSED ... page 36 P990020 09/27/99 {37} # Aneurysm Expansion by Follow-up Period¹ | Type | Pre-discharge N=416 | Pre-discharge N=158 | 6 months N=158 | 1 year N=158 | | --- | --- | --- | --- | --- | | Expansion of the AAA by >5mm | Baseline evaluation | Baseline evaluation | 4/147² (2.7%) | 6/158 (3.8%) | ¹ 416 patients were enrolled in the study. Denominators that are < 416 reflect the number of patients implanted with a Stent Graft and the actual readable images sent to the corelab by the investigational sites. The denominators are determinable measures based on the image quality. One patient suffered an MI after enrollment and prior to implantation. ² Patients required to have both predischarge and 6 month data for determination. 11 patients did not have both values. # Aneurysm Growth in the Presence of Endoleaks at 12 months (N = 172) | Location | Enlarged¹ | Unchanged | Decreased² | Unknown³ | | --- | --- | --- | --- | --- | | Proximal Attachment Site | 0 | 1 | 0 | 0 | | Distal Attachment Site | 0 | 2 | 0 | 0 | | Junctional (modular) | 0 | 2 | 0 | 1 | | Collateral | 1 | 15 | 0 | 0 | | Unknown | 1 | 6 | 0 | 1 | | Total | 2 | 26 | 0 | 2 | ¹ Defined as size change of >5 mm. ² Defined as size change of <5 mm. ³ No data or no conclusion regarding aneurysm size changes. The AneurRx Stent Graft System SSED ... page 37 P990020 09/27/99 {38} Elective Conversions, by Primary Cause of Failure | Cause | During procedure | Before 30 days | 1 month | 6 months | 1 year | | --- | --- | --- | --- | --- | --- | | AAA Rupture | 0 | 0 | 0 | 0 | 0 | | Leak: Collateral Vessels Filling Aneurysm | 0 | 0 | 1 | 0 | 0 | | Unsuccessful vessel access or device malposition | 0 | 0 | 0 | 0 | 0 | | Total | 0 | 0 | 1 | 0 | 0 | Emergent Conversions, by Primary Cause of Failure | Cause | During procedure | Before 30 days | 1 month | 6 months | 1 year | | --- | --- | --- | --- | --- | --- | | AAA Rupture | 0 | 1 | 0 | 0 | 1 | | Leak: Collateral Vessels Filling Aneurysm | 0 | 0 | 0 | 0 | 0 | | Unsuccessful vessel access or device malposition | 4 | 1 | 0 | 0 | 0 | | Total | 4 | 2 | 0 | 0 | 1 | The AneuRx Stent Graft System SSED page 38 P990020 09/27/99 {39} # Freedom from Cardiac Events (66 Surgical Control Group Subjects, 415 Stent Graft Treatment Group Subjects) | Interval | Treatment | 1 Month | 6 Month | 12 Month | | --- | --- | --- | --- | --- | | Stent Graft | | | | | | # Patients | 415 | 402 | 353 | 274 | | # Censored | 2 | 25 | 72 | 267 | | # Patients with Cardiac Events | 11 | 24 | 7 | 7 | | Kaplan-Meier Estimated Probability of Freedom from Cardiac Events | 97% | 92% | 90% | 86% | | Surgical | | | | | | # Patients | 66 | 64 | 58 | 53 | | # Censored | 0 | 2 | 4 | 53 | | # Patients with Cardiac Events | 2 | 4 | 1 | 0 | | Kaplan-Meier Estimated Probability of Freedom from Cardiac Events | 97% | 91% | 89% | 89% | ![img-6.jpeg](img-6.jpeg) $p = 0.588$ (log-rank test) The Aneurx Stent Graft System SSED page 39 P990020 09/27/99 {40} # Freedom from Neurological Events (66 Surgical Control Group Subjects, 415 Stent Graft Treatment Group Subjects) | Interval | Treatment | 1 Month | 6 Month | 12 Month | | --- | --- | --- | --- | --- | | Stent Graft | | | | | | # Patients | 415 | 408 | 371 | 293 | | # Censored | 1 | 24 | 72 | 289 | | # Patients with Neurological Events | 6 | 13 | 6 | 4 | | Kaplan-Meier Estimated Probability of Freedom from Neurological Events | 99% | 95% | 94% | 92% | | Surgical | | | | | | # Patients | 66 | 66 | 57 | 54 | | # Censored | 0 | 0 | 2 | 54 | | # Patients with Neurological Events | 0 | 7 | 1 | 0 | | Kaplan-Meier Estimated Probability of Freedom from Neurological Events | 100% | 89% | 88% | 88% | ![img-7.jpeg](img-7.jpeg) Freedom From Neurological Events (Kaplan-Meier estimates) p= 0.202 (log-rank test) The AneuRx Stent Graft System SSED page 40 P990020 09/27/99 {41} # Freedom from Pulmonary Events (66 Surgical Control Group Subjects, 415 Stent Graft Treatment Group Subjects) | Interval | Treatment | 1 Month | 6 Month | 12 Month | | --- | --- | --- | --- | --- | | Stent Graft | | | | | | # Patients | 415 | 412 | 381 | 302 | | # Censored | 2 | 25 | 79 | 300 | | # Patients with Pulmonary Events | 1 | 6 | 0 | 2 | | Kaplan-Meier Estimated Probability of Freedom from Pulmonary Events | 100% | 98% | 98% | 97% | | Surgical | | | | | | # Patients | 66 | 65 | 59 | 55 | | # Censored | 0 | 2 | 4 | 54 | | # Patients with Pulmonary Events | 1 | 4 | 0 | 1 | | Kaplan-Meier Estimated Probability of Freedom from Pulmonary Events | 99% | 92% | 92% | 90% | ![img-8.jpeg](img-8.jpeg) Freedom From Pulmonary Events (Kaplan-Meier estimates) p= 0.006 (log-rank test) The AneuRx Stent Graft System SSED P990020 09/27/99 {42} # Freedom from Gastrointestinal Events (66 Surgical Control Group Subjects, 415 Stent Graft Treatment Group Subjects) | Interval | Treatment | 1 Month | 6 Month | 12 Month | | --- | --- | --- | --- | --- | | Stent Graft | | | | | | # Patients | 415 | 413 | 378 | 297 | | # Censored | 1 | 22 | 76 | 297 | | # Patients with Gastrointestinal Events | 1 | 13 | 5 | 0 | | Kaplan-Meier Estimated Probability of Freedom from Gastrointestinal Events | 100% | 97% | 95% | 95% | | Surgical | | | | | | # Patients | 66 | 66 | 55 | 52 | | # Censored | 0 | 2 | 3 | 52 | | # Patients with Gastrointestinal Events | 0 | 9 | 0 | 0 | | Kaplan-Meier Estimated Probability of Freedom from Gastrointestinal Events | 100% | 86% | 86% | 86% | ## Freedom From Gastrointestinal Events (Kaplan-Meier estimates) ![img-9.jpeg](img-9.jpeg) p= 0.004 (log-rank test) The AneuRx Stent Graft System SSED ... page 42 P990020 09/27/99 {43} # Freedom from Thromboembolic Events (66 Surgical Control Group Subjects, 415 Stent Graft Treatment Group Subjects) | Interval | Treatment | 1 Month | 6 Month | 12 Month | | --- | --- | --- | --- | --- | | Stent Graft | | | | | | # Patients | 415 | 408 | 371 | 292 | | # Censored | 1 | 25 | 75 | 291 | | # Patients with Thromboembolic Events | 6 | 12 | 4 | 1 | | Kaplan-Meier Estimated Probability of Freedom from Thromboembolic Events | 99% | 96% | 95% | 94% | | Surgical | | | | | | # Patients | 66 | 65 | 63 | 59 | | # Censored | 0 | 2 | 4 | 59 | | # Patients with Thromboembolic Events | 1 | 0 | 0 | 0 | | Kaplan-Meier Estimated Probability of Freedom from Thromboembolic Events | 99% | 99% | 99% | 99% | ## Freedom From Thrombotic/Embolic Events (Kaplan-Meier estimates) ![img-10.jpeg](img-10.jpeg) p= 0.153 (log-rank test) The Aneurx Stent Graft System SSED ... page 43 P990020 09/27/99 {44} # Survival (66 Surgical Control Group Subjects, 415 Stent Graft Treatment Group Subjects) | Interval | Treatment | 1 Month | 6 Month | 12 Month | | --- | --- | --- | --- | --- | | Stent Graft | | | | | | # Patients | 415 | 415 | 391 | 307 | | # Censored | 0 | 17 | 76 | 296 | | # Patients Dead | 0 | 7 | 8 | 11 | | Kaplan-Meier Estimated Probability of Survival | 100% | 98% | 96% | 91% | | Surgical | | | | | | # Patients | 66 | 66 | 65 | 61 | | # Censored | 0 | 1 | 3 | 56 | | # Patients Dead | 0 | 0 | 1 | 5 | | Kaplan-Meier Estimated Probability of Survival | 100% | 100% | 98% | 89% | ![img-11.jpeg](img-11.jpeg) Kaplan-Meier Survival Curve p= 0.900 (log-rank test) The Aneurx Stent Graft System SSED page 44 P990020 09/27/99 {45} # Quality of Life Survey Results Quality of Life (QOL) surveys were completed by patients as a clinical utility endpoint only and were not a study endpoint. QOL data were available for 427 patients total (398 were from the Stent Graft Treatment Group and 29 were from the Surgical Control Group). 50% of the patients in each group completed QOL surveys at baseline, discharge, and one month. Overall, the QOL survey demonstrated good psychometric properties, and Cronbach’s alpha was greater than 0.70 for all scales. At discharge and one month, Stent Graft patients had more favorable scores than the Surgery group for all QOL scales. By the sixth month, differences in QOL scale scores between groups were resolved. In regard to patient satisfaction, 60% of patients in the Stent Graft group evaluated their treatment at discharge as “excellent” compared to 35% in the Surgery group. The results support the hypotheses that patients undergoing the less invasive AneuRx Stent Graft procedure experience faster return to normal functioning and are more satisfied with their treatment than the group undergoing open surgical repair. The study findings, however, must be considered cautiously in light of the small sample of surgery patients. The AneuRx Stent Graft System SSED page 45 P990020 09/27/99 {46} # 10.5 Device Failures and Replacements The tables below summarize all complaints received from the investigational centers, for all cases reported in this summary including high risk cases. Also included is the corrective action taken to address each issue. Complaints have been categorized by whether they involved the Stent Graft, the Delivery Catheter, or the Deployment Handle. | Complaint Description | # | Corrective Action | | --- | --- | --- | | **Delivery Catheter** | | | | Quick Disconnect Detached from Catheter and Inner Assembly | 5 | Devices examined. Manufacturing change improved bond joint strength. | | Difficulty Deploying | 7 | Devices examined. Surgical procedures reviewed. Customers contacted. Customers retrained that the reusable handle life is limited to 20 uses. | | Safety Clip Missing | 2 | Inspection procedure reviewed. Operators retrained. | | Slider Pull Out | 2 | Devices examined. Manufacturing change improved the molded slider. | | Non-Deployment | 4 | Devices examined. Surgical procedures reviewed. Customers contacted. Engineering testing performed. Design change made to improve the slider mechanism. Action request opened to resolve the quick disconnect mechanism inadvertently unlocking. | | **Stent Graft** | | | | Radiopaque markers were mismounted | 2 | Operators and inspectors retrained. Verification step added to manufacturing procedure. Action request opened to investigate marker design system in process of design review. | | Stent Graft was Loaded Incorrectly | 1 | Action request opened to evaluate marker placement. | | **Deployment Handle** | | | | Inoperable Crank | 1 | Device examined. Inspection procedures for handle revised. Clinical staff retrained. | | Knob Melted During Sterilization | 2 | Devices examined. Customers reminded of re-sterilization procedures. | In all cases where failure of the device resulted in a damage or a destroyed device an alternate device was available to complete the procedure. The AneuRx Stent Graft System SSED page 46 P990020 09/27/99 {47} # 11. Conclusions Drawn from the Studies The clinical benefits associated with this system are a lower rate of severe, treatment-related complications as compared to open surgery, significantly fewer days in the ICU and in the hospital, and less blood loss and blood replacement. The risks associated with the device include perigraft flow and endoleaks, an increase in aneurysm size, and aneurysm rupture. # 12. Panel Recommendation The Circulatory Devices Panel met on June 23, 1999 to discuss the Medtronic AneuRx Stent Graft System for abdominal aortic and aorto-iliac aneurysms. The Panel recommended approval with the following conditions: 1. The sponsor should perform a post-approval study to assess the long-term effects of the device over a 5 year period. 2. Additional information should be collected on women in order to further assess/evaluate the differences (e.g. mortality) found between men and women entered into the study. The data currently collected will be sufficient to support labeling that identifies these differences. 3. The sponsor should develop an in-depth Physician Training Plan. # 13. FDA Decision CDRH concurs with the recommendation made by the Circulatory Devices Panel for the AneuRx Stent Graft System indicated in the treatment of abdominal aortic and aorto-iliac aneurysms (AAA), i.e., approval with conditions as noted above. This PMA was reviewed under the modular PMA process, and was granted expedited review status due to the unique, less-invasive technology proposed for the repair if abdominal aortic aneurysms. FDA has also required tracking (21 CFR 821) for endovascular grafting systems due to the limited experience with these devices, the lack of long-term data, and the potential for catastrophic failure leading to a significant adverse clinical outcome. # 14. Approval Specifications Directions for Use: See Labeling. Hazards to Health from Use of the Device: See Indications, Contraindications, Warnings, Precautions and Adverse Events in the Labeling. Post-Approval Requirements and Restrictions: See Approval Order. The AneuRx Stent Graft System SSED ... page 47 P990020 09/27/99 --- **Source:** [https://fda.innolitics.com/device/P990020](https://fda.innolitics.com/device/P990020) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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