TREO® Abdominal Stent-Graft System

P190015 · Bolton Medical, Inc. · MIH · May 4, 2020 · Cardiovascular

Device Facts

• Record ID: P190015
• Device Name: TREO® Abdominal Stent-Graft System
• Applicant: Bolton Medical, Inc.
• Product Code: MIH · Cardiovascular
• Decision Date: May 4, 2020
• Decision: APPR
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The TREO® Abdominal Stent-Graft System is indicated for use in the endovascular treatment of patients with infrarenal abdominal aortic and aorto-iliac aneurysms with the following characteristics: - Adequate iliac or femoral access compatible with the required delivery systems and accessories - Proximal aortic landing zone with: - Infrarenal landing neck length of ≥ 15 mm - Aortic neck diameters ≥ 17 mm and ≤ 32 mm - Suprarenal neck angle of ≤ 45 degrees - Infrarenal neck angle of ≤ 60 degrees - Distal iliac landing zone with: - an inside diameter of 8 mm – 13 mm and a length of ≥ 10 mm or - an inside diameter of > 13 mm – 20 mm and a length of ≥ 15 mm - Minimum overall AAA treatment length (proximal landing location to distal landing location) of 13 cm - Minimum overall length from the lowest renal artery to the aortic bifurcation of 9 cm

Device Story

TREO is a modular endovascular stent-graft system for treating infrarenal abdominal aortic and aorto-iliac aneurysms. It comprises a Main Bifurcated Stent-Graft, Leg Extension Stent-Grafts, Proximal Cuff Stent-Grafts, and Straight Iliac Extension Stent-Grafts. Implants consist of self-expanding Nitinol stents sutured to woven polyester fabric. The system is delivered endovascularly via a hydrophilic-coated sheath. Radiopaque platinum-iridium markers aid visualization. The main body features suprarenal fixation barbs and an infrarenal lock stent to secure leg extensions. Used in clinical settings by vascular specialists; output is the exclusion of the aneurysm sac from systemic blood flow. Benefits include minimally invasive repair compared to open surgery, reducing surgical trauma. Clinical decision-making relies on pre-operative CT imaging to confirm anatomical suitability (landing zones, neck angles, diameters). Post-procedure, clinicians monitor patency, endoleaks, and sac diameter via follow-up imaging to ensure long-term aneurysm exclusion.

Clinical Evidence

Pivotal prospective, multi-center, single-arm study (IDE #G100200) of 150 patients. Primary safety endpoint: 30-day MAE rate (0.7%), meeting 19% performance goal. Primary effectiveness endpoint: successful aneurysm treatment at 12 months (93.13%), meeting 88% performance goal. Secondary endpoints included technical success (100% at procedure), migration, endoleaks, and stent integrity. No aneurysm-related mortality or rupture observed through 4 years. Stent strut/barb fractures observed in bare proximal stent; no clinical sequelae reported.

Technological Characteristics

Modular system; self-expanding Nitinol stents (laser-cut and wire); woven polyester fabric; platinum-iridium radiopaque markers (90% Pt, 10% Ir). Delivery system: 13Fr-19Fr profiles, hydrophilic coating. MR Conditional (1.5T/3T). Sterilization: Gamma irradiation (SAL 10^-6). Design verification per ISO 25539-1.

Indications for Use

Indicated for patients aged 18-85 with infrarenal abdominal aortic or aorto-iliac aneurysms (diameter ≥4.5cm males, ≥4.0cm females, or 0.5cm growth in 6 months). Contraindicated in patients with known allergy to nitinol, polyester, or platinum-iridium; active systemic infection; connective tissue disease; mycotic aneurysm; or those unable to tolerate contrast-enhanced CT.

Submission Summary (Full Text)

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SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

I. GENERAL INFORMATION

Device Generic Name: Endovascular Graft

Device Trade Name: TREO® Abdominal Stent-Graft System

Device Procode: MIH

Applicant’s Name and Address: Bolton Medical, Inc.
799 International Parkway
Sunrise, FL 33325
USA

Date(s) of Panel Recommendation: None

Premarket Approval Application (PMA) Number: P190015

Date of FDA Notice of Approval: May 4, 2020

II. INDICATIONS FOR USE

The TREO® Abdominal Stent-Graft System is indicated for use in the endovascular treatment of patients with infrarenal abdominal aortic and aorto-iliac aneurysms with the following characteristics:

- Adequate iliac or femoral access compatible with the required delivery systems and accessories
- Proximal aortic landing zone with:
- Infrarenal landing neck length of ≥ 15 mm
- Aortic neck diameters ≥ 17 mm and ≤ 32 mm
- Suprarenal neck angle of ≤ 45 degrees
- Infrarenal neck angle of ≤ 60 degrees
- Distal iliac landing zone with:
- an inside diameter of 8 mm – 13 mm and a length of ≥ 10 mm or
- an inside diameter of > 13 mm – 20 mm and a length of ≥ 15 mm
- Minimum overall AAA treatment length (proximal landing location to distal landing location) of 13 cm
- Minimum overall length from the lowest renal artery to the aortic bifurcation of 9 cm

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III. CONTRAINDICATIONS

The TREO® Abdominal Stent-Graft System is contraindicated in the following:

- Patients with a known allergy or intolerance to device materials (nitinol, polyester, platinum-iridium).
- Patients with a condition that threatens to infect the graft.

IV. WARNINGS AND PRECAUTIONS

The warnings and precautions can be found in the TREO® Abdominal Stent-Graft System labeling.

V. DEVICE DESCRIPTION

The TREO® Abdominal Stent-Graft System (referred to as TREO hereafter) is a modular system designed to treat abdominal aortic and aorto-iliac aneurysms. The TREO consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft.

Each patient receives at least a TREO Main Bifurcated Stent-Graft and two Leg Extension Stent-Grafts (see Figure 1), each delivered via an endovascular approach using their own separate delivery system. Patients may also receive Proximal Cuff Stent-Grafts and Straight Iliac Extension Stent-Grafts. All stent-grafts are comprised of self-expanding Nitinol stents sutured to woven polyester fabric. The stent scaffold is a series of sinusoidal springs stacked in a tubular configuration. These stents are spaced along the length of the graft fabric to provide radial support and allow for the self-expansion of the stent-grafts. Radiopaque markers are placed on the stent-graft to aid visualization and accurate placement.

Stent-grafts

The Main Bifurcated Stent-Graft has an uncovered proximal stent that includes fixation barbs (suprarenal) for migration resistance. A second row of barbs are also located distally to the start of the covered section, approximately at the middle of the first covered stent, to help provide infrarenal fixation. Each gate of the Main Bifurcated Stent-Graft is designed to accept a Leg Extension Stent-Graft. The diameter of each gate of the Main Bifurcated Stent-Graft is always the same size (14 mm), regardless of proximal diameter or length. Each leg gate of the Main Bifurcated Stent-Graft also includes a Nitinol lock stent that is sewn on the inside of the graft fabric. The lock stent contains dull barbs that are intended to engage the Leg Extension Stent-Graft in-situ and help prevent separation of the Leg Extension Stent-Graft from the Main Bifurcated Stent-Graft.

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Figure 1. TREO® Abdominal Stent-Graft Components

The proximal end of all Leg Extension Stent-Grafts is always of the same diameter (15 mm) to allow coupling with any Main Bifurcated Stent-Graft. In addition, the amount that each Leg Extension Stent-Graft is inserted into the gate of the Main Bifurcated Stent-Graft is adjustable.

Additional ancillary endovascular stent-grafts are also available. Proximal Cuff Stent-Grafts are available for all Main Bifurcated Stent-Grafts if proximal extension is needed. The proximal end of the Proximal Extensions (Cuff Stent-Grafts) is configured identically to the proximal ends of the Main Bifurcated Stent-Grafts.

Radiopaque markers are sewn onto all stent-grafts to aid in the visualization and placement of the device. The markers are made of a platinum iridium alloy that is $90\%$ Platinum and $10\%$ Iridium. The suture that is used to attach the marker bands is the same as that used for the stents. Radiopaque markers are identified in Figure 2.

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Figure 2. Minimum Overlap Markers

The bare stent and lock stent of the TREO stent-grafts are produced from laser cut Nitinol tubing while all of the remaining Nitinol components used in the device are produced from shape-set Nitinol wire.

# Product Size Availability

The TREO® Abdominal Stent-Graft System is intended to be used as a three-piece modular system consisting of a Main Bifurcated Stent-Graft and two Leg Extension Stent-Grafts. Each stent-graft is available as follows:

- The Main Body Bifurcated Stent-Grafts are available in proximal diameters ranging from $20~\mathrm{mm}$ to $30~\mathrm{mm}$ in $2\mathrm{mm}$ increments, $33~\mathrm{mm}$ , and $36~\mathrm{mm}$ with the corresponding vessel size requirement. Each proximal diameter is available in 3 body lengths.
- Each leg gate of the Main Bifurcated Stent-Graft is always the same diameter (14 mm), regardless of the proximal diameter size. This allows using any Leg Extension Stent-Graft with any Main Body Bifurcated Stent-Graft.
- The proximal diameter of every Leg Extension Stent-Graft is always $15 \mathrm{~mm}$ . Leg Extension Stent-Grafts are available in distal diameters of 9, 11, 13, 15, 17, 20, and $24 \mathrm{~mm}$ . Available lengths range from $80 \mathrm{~mm}$ to $160 \mathrm{~mm}$ .
- The Proximal Cuff Extensions are available in proximal diameters ranging from 20 mm to 30 mm in 2 mm increments, 33 mm, and 36 mm. Each is available in 3 body lengths of 40 mm, 55 mm, and 70 mm.

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- Straight Extensions are available in diameters of 9, 11 and 13 mm. The proximal and distal diameters are the uniform along the length of each Straight Extension Stent-Graft. Straight Extension Stent-Grafts come in one length of 80 mm. Straight Extension Stent-Grafts are only intended for extending a previously placed Leg Extension Stent-Graft that has an identical distal diameter. Straight Extensions are not intended for use directly with a Main Bifurcated Stent-Graft.

## Delivery Systems

The TREO Main Bifurcated Stent-Graft and Proximal Cuff Stent-Graft use the same delivery system, consisting of an introducer sheath attached to a main handle assembly. The handle assembly includes a Black Stationary Grip and Gray Turn Knob control system for accurate placement of the Main Bifurcated or Proximal Cuff Stent-Graft.

The introducer sheath and tip are hydrophilically coated. The sheath can be detached from the handle assembly and left in place while removing the rest of the delivery system, so the introducer sheath can then be used as a vascular introducer for the ipsilateral Leg Extension Stent-Graft and/or other devices. The tip of the delivery system and end of the introducer sheath are radiopaque for visibility during use. The delivery systems profiles are 18Fr or 19Fr depending on the proximal diameter of the Main Bifurcated or Proximal Cuff Stent-Graft. See Figure 3 below.

Figure 3. TREO Main Body and Cuff Delivery System

The TREO Leg Extension and Straight Extension Stent-Grafts use a similar version of the Delivery System as the Main Bifurcated and Proximal Cuff Stent-Grafts. The differences between the Delivery System for the Leg Extension and Straight Extensions and the Main Bifurcate and Proximal Cuff delivery systems are the absence of the clasp release mechanism at the proximal end of the delivery system next to the guidewire flush port, sheath and tip diameter, and usable length. The delivery systems profiles are 13Fr or 14Fr. depending on the distal diameter of the Leg Extension or Straight Extension Stent-Graft. See Figure 4 below.

Figure 4. TREO Leg Extension and Straight Extension Stent-Graft Delivery System

Additional details can be found in the TREO® Abdominal Stent-Graft System Instructions for Use.

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VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are several other alternatives for the treatment of infrarenal abdominal aortic and aorto-iliac aneurysms, including endovascular repair using other endovascular grafts, medical management, and open surgical repair. Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle.

VII. MARKETING HISTORY

The TREO® Abdominal Stent-Graft System is commercially available within the European Union (Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden). In addition, TREO is commercially available Argentina, Brazil, Chile, Hong Kong, Israel, Jordan, Lebanon, Norway, Palestine, Singapore, South Africa, Switzerland, Thailand, Uruguay and Vietnam.

TREO has not been withdrawn from any market for reasons related to safety or effectiveness.

VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

Below is a list of the potential adverse effects (e.g. complications) associated with use of the device:

| Table 1. Potential Adverse Events | |
| --- | --- |
| Amputation | Hemorrhage |
| Anesthetic reactions/complications (e.g., aspiration) | Hepatic failure |
| Aneurysm Sac Enlargement | Impotence |
| Aneurysm / Lesion Rupture | Infection |
| Aortic damage (perforation, dissection, bleeding, rupture) | Ischemia (spinal cord, perfusion pathways) |
| Arteriovenous fistula / aorto-duodenal fistula | Limb ischemia |
| Blood Loss | Open surgical conversion |
| Bowel complications (e.g., adynamic ileus, transient ischemia, infarction, necrosis) | Paralysis/Paresthesia/Paraparesis |
| Cardiac events (e.g., arrhythmia, congestive heart failure, myocardial infarction, hypotension, hypertension) | Post Implantation Syndrome |
| Cerebral vascular accident (stroke) | Pseudoaneurysm |

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| Table 1. Potential Adverse Events | |
| --- | --- |
| Claudication (e.g., buttock, lower limb) | Radiation overexposure or reaction |
| Coagulopathy | Renal failure or Complications |
| Contrast toxicity / anaphylaxis | Stenosis of native vessel |
| Death | Stent fracture / break |
| Delivery system failure | Stent-Graft failure (e.g., improper component placement, graft material wear, suture break, dilatation, erosion, graft twisting or kinking, puncture, perigraft flow) |
| Deployment failure (partial or inaccurate deployment) | Stent-Graft migration |
| Embolism (micro and macro) with transient or permanent ischemia or infarction | Transient Ischemic Attack |
| Endoleak | Vascular Trauma (perforation / dissection) |
| Fever and localized inflammation | Vessel Damage |
| Gastrointestinal complications | Vessel Dissection |
| Genitourinary complications (e.g., ischemia, erosion, femoral-femoral artery thrombosis, fistula, incontinence, hematuria, infection) | Vessel Occlusion/Thrombosis |
| Hematoma (surgical) | Wound complications (dehiscence, infection, hematoma, seroma, cellulitis) |

For the specific adverse events that occurred in the clinical study, see Section X below.

## IX. SUMMARY OF NONCLINICAL STUDIES

Nonclinical studies were completed to evaluate the TREO device, including non-clinical bench testing, biocompatibility, sterilization, packaging, shelf-life, and animal studies. These are described in detail in the following sections.

## A. Laboratory Studies

TREO underwent testing for design verification and validation, including long-term durability and corrosion testing. Testing was performed in accordance with ISO 25539-1:2017, “Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses” and ISO 25539-1:2003/A1, “Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses, Amendment 1: Test Methods.” For the evaluation of TREO, a subset of device components and sizes were used for each test or alternatively, the worst-case configuration/size was selected. This sample selection represented the full size range available for TREO. A summary of this testing is provided in Table 2 and Table 3.

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Asterisk (*) indicates that the testing was performed at baseline and after aging (accelerated or real time to the shelf life duration).

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Table 2. Non-Clinical Testing: Delivery System

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Dimensional verification of the endovascular system* | To evaluate the conformance of the TREO’s dimensions to their design specifications, and to evaluate the compatibility of the TREO with its accessory devices listed in the IFU. Also, to determine the TREO’s maximum diameter at the loaded stent-graft section (largest profile) in order to evaluate the dimensional compatibility between the aged delivery system and the vasculature. | System must be compatible with 0.035” guidewire and 0.036” mandrel. | Pass |
| | | Delivery system sheath outer diameter (O.D.) must meet pre-determined tolerances.
- 14Fr = 0.183” ±0.002” (4.65mm ± .05mm)
- 13Fr = 0.170” ±0.002” (4.32mm ± .05mm)
- 18Fr = 0.239” ±0.002” (6.07mm ± .05mm)
- 19Fr = 0.252” ±0.002” (6.40mm ± .05mm) | Pass |
| | | All test samples must meet the nominal labeled profile. | Pass |
| | | Useable length:
- Main Body = 52.2 cm ± 1.6 cm
- Leg System = 84.2 cm ± 0.5cm | Pass |
| Simulated Use (Including Force to Deploy)* | An overall assessment of the TREO was conducted during which qualitative assessments are made as well as quantitative measurements. The TREO was prepared, deployed and the delivery system is then removed from an anatomical model. The anatomical model was designed to challenge both access as well as implant site requirements. Assessments included:
• Ability to prepare system.
• Ability to track system to landing zone, while ensuring direct assessment of attributes such as kink resistance, pushability and torquability.
• Forces required to deploy system at each step, including the stent-graft as well as the proximal clasp, if applicable.
• Ability to accurately deploy the stent-graft at the target landing zone.
• Ability to successfully withdraw the delivery system.
Other assessments included: sheath stretching, stent-graft twisting, ability to re-position the device prior to final deployment, tip re-seating, insertion of leg device into main sheath (if applicable) and valve hemostasis. | Bifurcated & Cuff Graft Deployment Force: < 45lbs. (200.2N) | Pass |
| | | Leg Graft Deployment Force: ≤ 38lbs | Pass |
| | | Clasp Release: ≤ 10lbs. (44.5 N) | Pass |
| | | Leg Clasp Release from sheath: ≤ 10lbs. (44.5 N) | Pass |
| | | All qualitative assessments must meet acceptance criteria:
• System must be able to be prepped with saline passing through guidewire lumen and out the distal end of the sheath.
• Device must successfully track to deployment site while assessing for the ability to torque the device.
• Device must not kink prior to or during deployment.
• Device must deploy at designated landing zone.
• Delivery system must be withdrawn without catching on deployed stent-graft.
• Sheath hemostasis valve must not leak > 15cc in one minute. | Pass |

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Table 2. Non-Clinical Testing: Delivery System

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Tensile Bond Strength* | To determine the bond strength of the joints and/or fixed connections of the TREO. | Sub-assemblies tested must meet pre-determined pull forces depending on the bond or tubing requirements.
Acceptance criteria ranged from 5 lbs to 50 lbs (22.2 N to 222.4N). | Pass |
| Torsional Bond Strength | To determine the torque required to cause failure of the bonded joints of the TREO. | The delivery system sheath introducer must be torqued at 180 degrees without any damage to the sheath bond. | Pass |
| Hemostasis* | To evaluate the TREO’s ability of any seals or valves to maintain adequate hemostasis for the Bifurcated and Leg system. | Amount of water obtained through leaking in 1 minute should be < 15 cc. | Pass |
| Lubricity Test | To determine the lubricity of the hydrophilically coated Tip and Introducer Sheath. | The force must meet the current specification for acceptable lubricity tests with 95/90 confidence/reliability:
- Sheath Spec: = 400g (3.9N)
- Tip Spec: = 800g (7.8N) | Pass |

Table 3. Non-Clinical Testing: Implant

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| MR Compatibility | To provide the recommended scan conditions for use with the device. | Non-clinical testing completed at worst-case conditions for displacement & deflection force, torque force, RF heating, and MRI artifact demonstrated that the TREO is MR Conditional. A person with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5-Tesla and 3-Tesla
• Maximum spatial gradient magnetic field of 4,000-Gauss/cm (40 T/m) or less
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4-W/kg (First Level Controlled Operating Mode) | Pass |
| Leakage at Seal Zone | To determine if the fixation points are against the mock artery completely in order to address the sealing characteristics. | Lack of voids in contact between the stent-graft and model wall. | Pass |

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Table 3. Non-Clinical Testing: Implant

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Migration Resistance | To determine the force required to displace the stent-graft in a mock artery. This test provided an indication of the resistance to migration provided by the fixation mechanisms of the stent-graft. | Migration Specification: ≥ 25N | Pass |
| Separation Force for Overlapping Endovascular Prostheses | To determine the force required to separate the modular components of the stent-graft or to separate overlapping stent-grafts in the deployed state | Modular junction force: ≥ 4N | Pass |
| Compression Resistance
Flat Plate Full Length Crush Resistance | To determine the force required to cause buckling and permanently radially deform or fully collapse the stent-graft and to determine if it recovers to its original geometry after testing. | Observations were documented as pass/fail. If any permanent deformation occurred to the stent-graft, the test was considered a failure. The force used to crush the stent-graft at 50% diameter and full collapse as well as the deflection was recorded. | Pass |
| Compression Resistance
Local Compression | To determine the deformation of the stent-graft in response to a localized compressive force, perpendicularly applied to the longitudinal axis of the stent-graft, and to determine if it recovered to its original geometry after testing. | Observations were documented as pass/fail along with the forces used to compress the stent-graft and the deflection observed. Any deformation to the stent-graft was considered a failure. | Pass |
| Radial Force (Self-Expanding Endovascular Prostheses)* | To determine the force exerted by a self-expanding implant as a function of the implant diameter. | Positive radial load. | Pass |
| Resistance to Kinking (Flexibility) | To determine the minimum radius of curvature that the stent-graft can accommodate without kinking and if it can recover to its original geometry. | The stent-graft must bend into various radii without kinking, and/or permanent deformation. Kinking is defined as a reduction in lumen area of greater than approximately 50%. Additionally, the stent-graft must return to its original geometry. | Pass |
| Integral Water Leakage | To determine the rate of water leakage through the entire stent-graft, incorporating all modular components and extension devices. | Stent-graft leakage: < 168 ml / min / cm² | Pass |
| Water Permeability (Textile Materials) | To determine the rate of fluid flow through the wall of the stent-graft as virgin material. | Textile Component Native Permeability: < 120 ml / min / cm² | Pass |

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Table 3. Non-Clinical Testing: Implant

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Dimensional Verification of the Endovascular Prosthesis | To determine the relationship between the AAA stent-graft length and diameter following deployment in order to assess foreshortening. | The length of the stent-graft must be within specification while compressed in the minimum and maximum simulated vessel sized tubes | |
| | | Length = (± 2mm) for Bifurcated and Leg Extension Stent-grafts | Pass |
| | | Length= (± 1mm) for Cuff Stent-grafts | Pass |
| | To determine the outer diameter of the TREO stent-grafts in the deployed state for verification to design specifications. The purpose of this test is to show that the implant can withstand the strains experienced in radial compression during loading / unloading without any significant change to its dimensions or geometry. | Relaxed outer diameter post deployment | |
| | | Outer diameter for cuffs, bifurcates and legs 17mm and larger must be within -1mm / +2mm of the nominal diameter at the proximal, middle and distal ends. | Pass |
| | | Outer diameter must be within 0mm / +2mm for 8mm – 15mm legs. | Pass |
| Burst Strength* | To determine the pressurized burst strength or circumferential strength of the stent-graft if used with an accessory balloon. | The stent-graft must withstand 1.5 ATM of pressure without damage. | Pass |
| Longitudinal Tensile Strength (Stent-Graft)* | To determine the longitudinal tensile strength of the stent-graft. | Textile Component Native Tensile Force: ≥ 150 lbf | Pass |
| Strength of the Connection(s) or Bond(s) Between the Graft material and the stent(s) or attachment system(s) | To determine the strength of the fixation between the graft material and the stent/attachment system. | ≥ 48.5 lbs (215.7 N) for a composite pull test of 5 apexes. | Pass |
| Visibility | To evaluate the ability to visualize the TREO using the imaging techniques specified in the IFU. | Test units must be visible under fluoroscopy. | Pass |
| Corrosion | To evaluate the corrosion resistance properties of the TREO’s (all Nitinol) metallic components. | All samples display breakdown potentials equivalent or better to a comparison device. | Pass |
| Fatigue and Durability — Computational Analyses | Finite element analysis (FEA) was used to compute the maximum strains in all of the TREO design’s sizes when subjected to catheter loading and an in-vivo pulsatile loading environment. | Characterization study. The worst-case component size was identified and used to inform the selection of the worst-case prosthesis size for in vitro fatigue testing. | Pass |

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Table 3. Non-Clinical Testing: Implant

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Fatigue and durability — In-vitro testing | Pulsatile Fatigue Testing: To evaluate the long-term durability of the stent-graft design over 380 million cycles of pulsatile fatigue loading. | The samples must not exhibit physical damage that would represent a failure of their safety or function due to:
1. Component deformation, separation or fractures leading to ineffective proximal or distal seals, migration or severed pieces into the bloodstream
2. Fabric holes larger than 0.5 mm²
3. Modular disjunctions
4. Compromised luminal integrity due to twisting or component collapse
All anomalies must be studied on a case-by-case basis. Anomalies due to test artifacts will not be representative of failure in safety or function of the design. | Pass |
| | Pulsatile Bending Testing: To evaluate the long-term durability of the stent-graft design over 380 million cycles of bending loads. | | Pass |
| | Axial Fatigue Tests: To evaluate the long-term durability of TREO’s bare proximal stent engagement features and the limbs’ modular junction engagement features for 380 million cycles. | The samples must not exhibit physical damage that would represent a failure of their safety or function due to:
1. Component deformation, separation or fractures leading to ineffective proximal seals, migration or severed pieces into the bloodstream
2. Fabric holes larger than 0.5 mm²
3. Modular disjunctions | Pass |

## Fracture Root Cause Investigation

As described below, the TREO was evaluated in a clinical study. During the clinical study, bare proximal stent fractures were observed in three areas of the component: the suprarenal barb, the proximal end of a stent strut, and the distal end of a stent strut (for detailed description, see Section X.D.2.2.8 Stent-Graft Integrity). A root cause analysis and evaluation of the potential impact on device performance was conducted that evaluated materials and components, manufacturing processes, clinical procedure, patient anatomical data, bench top performance testing of fractured test samples, biomechanical analysis, computational modeling, and experimental fatigue testing.

## Root Cause Investigation

Biomechanical analyses of TREO patients identified axial deformation and barb flexion occurring during aortic pulsation. Subsequent computational modeling predicted that axial drag forces from blood flow and barb penetration depth are primary factors impacting fatigue fracture at the suprarenal barbs and struts of the bare proximal stent.

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Experimental fatigue testing was conducted to investigate the learnings from the biomechanical analysis and computational modeling.

Accelerated axial fatigue testing (intended to represent 10 years of physiologic loading) of the bare proximal stent resulted in fractures of the cranial barbs and a strut, which were consistent with the fracture locations and rates reported in the clinical study.

Fatigue-to-fracture testing was also conducted to further characterize the effect of axial loading on device fracture. The test results predicted barb penetration as an important consideration in component fracture. From a mechanics perspective, minimal barb penetration results in a larger bending moment and increased loading on the component. Minimal barb penetration can manifest clinically in patients with less oversizing. Clinical analysis of the study subjects showed that devices with strut fracture tended to be less oversized; however, similarly oversized devices were also not associated with fracture observations. Due to the low sample size of patients with fracture as compared to the overall study sample size, and that patients with devices with similarly less oversizing did not exhibit fractures, no definitive relationship between oversizing and fracture could be confirmed.

In summary, the root cause evaluation identified axial drag forces from blood flow and minimal barb penetration as potential contributing causes of bare proximal stent fracture. The information from the root cause investigation did not identify patient anatomical, demographic, or procedural related factors that may contribute to an increased risk of fracture.

## Evaluation of Potential Impact of Stent Fracture on Device Performance

It was identified that two critical device performance characteristics that may be affected by stent fracture and result in clinical sequelae were stent-graft displacement (migration) resistance and radial force. Comparative testing was conducted to characterize the following conditions:

- "Intended" condition – Test samples with no fractures, representing the control.
- "Beyond-fault" condition – Test samples that consisted of device fracture conditions of multiple stent strut or barb fractures that exceeded the observations from the clinical study (two study subjects had multiple stent fractures of: 4 stent strut fractures in a single device; and 2 barb fractures in a single device). The intent of this testing was to characterize the impact of stent fractures on device performance and the number of fractures that may significantly decrease the device's ability to provide its intended function.

With the exception of test samples with 4 fractured barbs (exceeding the observations from the durability bench testing and the clinical study), all other device conditions met the same pre-defined acceptance criteria for design verification and validation testing of migration resistance and radial force as listed in Table 3. The results support that with respect to the bare proximal stent fractures observed in the durability bench testing and clinical study, fractured TREO devices are expected to still meet their performance requirements in a controlled benchtop setting.

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# B. Animal Studies

In-vivo animal study testing (acute and chronic) was conducted on the TREO® Abdominal Stent-Graft System.

- The acute study consisted of 2 animals and was designed to evaluate the intraoperative features of delivery and hemostasis of the TREO® Stent-Graft System. The test articles in the acute study consisted of 14 mm stent-grafts representative of the distal section of the TREO Bifurcated Stent-Graft and 15.3 mm stent-grafts representing the proximal section of the TREO Leg Extension Stent-Graft.

- The chronic study consisted of 21 animals with the objective of evaluating the safety of the device following implantation in ovine aorta and iliac arteries at 6 weeks (7 sheep), 12 weeks (6 sheep) and 26 weeks (8 sheep). The test articles in the chronic study consisted of 14 mm stent-grafts representative of the distal section of the TREO Bifurcated Stent-Graft and 15.3 mm stent-grafts representing the proximal section of the TREO Leg Extension Stent-Graft and 20 mm Main Bifurcated surrogates similar to the Proximal Cuff design. The 20 mm device was placed in an appropriately sized area of the abdominal aorta alone. The 14 mm device was placed in an appropriately sized portion of the abdominal aorta distal to the 20 mm device and then the 15.3 mm device was placed inside of the deployed 14 mm device. The tissue response to TREO was evaluated histologically, and the sealing capability and integrity of the stent-graft were evaluated angiographically and radiographically, respectively.

The results of both the chronic and acute study supported that the TREO is well-tolerated in the ovine model and does not adversely affect the general health of animals. The acute study results support that the TREO can be accurately deployed in the aorta. The results of the chronic animal study showed that the device was successfully deployed, remained intact and patent through study duration, and had appropriate tissue response.

There was no device-related mortality and no evidence of adverse systemic effects in either the acute or chronic animal studies.

See Table 4 below for results of the animal studies.

Table 4. Results of Animal Studies

| Study | # of Animals | Objectives | Results |
| --- | --- | --- | --- |
| GLP Acute Performance Assessment of the Bolton Medical Aortic | 2 | To evaluate the acute performance of the modified TREO to verify the accuracy of deployment, visibility of the device under fluoroscopy, | The Main Bifurcated Stent-Graft, Leg Extension Stent-Grafts and their respective delivery systems were graded |

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Table 4. Results of Animal Studies

| Study | # of Animals | Objectives | Results |
| --- | --- | --- | --- |
| Stent Graft in Ovine Model | | and hemostasis of the sheath valve. | above average overall. Accuracy of deployment of the Leg Extension Stent-Graft was satisfactory.
The radiopacity of the Main Bifurcated and Leg Extension Stent-Grafts was confirmed, and the device was visible under fluoroscopy.
Blood loss through the closed hemostasis valves of the Main Bifurcated and Leg Extension delivery systems was absent or miniscule and, in most cases, minimal with the valve open.
Radiographs of the explanted Main Bifurcated and Leg Extension Stent-Grafts showed the stents were accurately overlapped. The explanted stent pairs were engaged and remained intact when tensile testing was performed. |
| Chronic Evaluation of a Stent-Graft in an Ovine mode | 21 | To evaluate the delivery/deployment associated with the TREO when placed in the thoracic or abdominal aorta and/or iliac artery position, through the femoral artery. | All devices were deployed, and no device-related adverse events occurred during deployment and subsequent recovery. |

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Table 4. Results of Animal Studies

| Study | # of Animals | Objectives | Results |
| --- | --- | --- | --- |
| | | To evaluate the physiological function (e.g., patency, integrity) associated with the TREO when placed in the thoracic or abdominal aorta and/or iliac artery position, through the femoral artery. | Histologic evaluation confirmed the fabric of the device remained intact at all time points and complete tissue incorporation of the fabric was observed at all time points for all devices. |
| | | To evaluate the potential for thrombus associated with the TREO when placed in the thoracic or abdominal aorta and/or iliac artery position, through the femoral artery. | Histologic evaluation confirmed the presence of a complete anti-thrombogenic cell lining on the luminal surface of all devices. |
| | | To evaluate the healing associated with the TREO when placed in the thoracic or abdominal aorta and/or iliac artery position, through the femoral artery. | Tissue analysis indicated no evidence of necrosis and minimal inflammatory response. |

## C. Biocompatibility

The biocompatibility assessment performed on TREO was based on the matrix for body contact and contact duration as specified in ISO 10993-1:2009/(R)2013, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.” The TREO is comprised of an implantable stent-graft and a corresponding delivery system. For purposes of the biocompatibility assessment, the stent-graft was classified as an implant device, permanent contact (&gt; 30 days), while the delivery system was classified as an external communicating device, circulating blood, limited exposure (&lt; 24 hours). All testing was conducted by a qualified contract laboratory in accordance with FDA GLP regulations, 21 CFR 58.

All testing performed met the pre-specified acceptance criteria. The results are results are summarized in Table 5 for the Implant and Table 6 for the delivery system.

Table 5. Biocompatibility Evaluation - TREO Implant

| Biological Effect (Test) | Purpose | Results | Acceptance Criteria Met? |
| --- | --- | --- | --- |
| ISO MEM Elution Cytotoxicity | To determine if stent-graft extracts cause cytotoxicity when exposed to L-929 fibroblast cells. | Non-cytotoxic: Grade 2 (mild reactivity). | Yes |

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Table 5. Biocompatibility Evaluation - TREO Implant

| Biological Effect (Test) | Purpose | Results | Acceptance Criteria Met? |
| --- | --- | --- | --- |
| ISO Guinea Pig Maximization Sensitization | To evaluate the allergenic/sensitization potential of stent-graft extracts in guinea pigs. | Non-sensitizer: All animals scored 0 resulting in 0% sensitization rate. | Yes |
| ISO Intracutaneous Reactivity | To evaluate stent-graft extracts for potential irritation effects after intracutaneous injection in rabbits. | Non-irritant: The difference between the test article extracts overall mean score and corresponding control overall mean score was less than 1.0. | Yes |
| ISO Acute Systemic Toxicity | To evaluate stent-graft extracts for potential toxic effects after single-dose systemic injections in mice. | There was no mortality or evidence of systemic toxicity from the test article extracts. | Yes |
| Material Mediated Pyrogenicity | To evaluate the stent-graft for the potential of inducing a pyrogenic response in rabbits. | Non-pyrogenic: rabbits showed a maximum temperature rise of 0.0, 0.1, and 0.2°C, respectively over the 3 hour test period. | Yes |
| Genotoxicity /Mutagenicity | | | |
| • Ames Assay | To evaluate the mutagenic potential of the stent-graft by measuring its ability to induce back mutations at selected loci of several strains of bacteria. | Non-mutagenic: The stent-graft did not cause an increase in point mutations, exchanges or deletions. | Yes |
| • In vitro Mouse Lymphoma | To evaluate the potential of the stent-graft extracts to induce a forward mutation in the TK locus of L5178Y TK+/- cells. | The stent-graft is considered to be non-mutagenic in the test system. | Yes |
| • In-vivo Mouse Micronucleus | To evaluate the potential of the stent-graft to induce in-vivo clastogenic events or damage to the mitotic spindle in polychromatic erythrocytes obtained from mouse bone marrow. | The stent-graft is considered to be non-mutagenic in the test system. | Yes |
| Hemocompatibility | | | |
| • Hemolysis | To evaluate the potential of the stent-graft to cause hemolysis in direct contact or by extraction. | Non-hemolytic: Percent hemolysis: Direct contact – 0.6% Extract – 0.0% | Yes |
| • Partial Thromboplastin Time (PTT) | To determine the potential of the stent-graft to cause an effect on the coagulation cascade via the intrinsic coagulation pathway. | Minimal activator of intrinsic coagulation pathway: The stent-graft had an average clotting time of 256.9 seconds (86% of the negative control). | Yes |

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Table 5. Biocompatibility Evaluation - TREO Implant

| Biological Effect (Test) | Purpose | Results | Acceptance Criteria Met? |
| --- | --- | --- | --- |
| • Complement Activation | To determine the potential of the stent-graft to activate complement. | C3a – potential activator of the complement system SC5b-9 – not considered to be a potential activator of the complement system | Yes |
| Rabbit Intramuscular Implant | | | |
| • 4 weeks | To evaluate the potential for local and systemic toxic effects of a test article in direct contact with skeletal muscle of the rabbit for 4 weeks. | The macroscopic reaction was not significant as compared to the negative control implant material. Microscopically, the test article was classified as a slight irritant as compared to the negative control article. | Yes |
| • 12 weeks | To evaluate the potential for local and systemic toxic effects of a test article in direct contact with skeletal muscle of the rabbit for 12 weeks. | The macroscopic reaction was not significant as compared to the negative control implant material. Microscopically, the test article was classified as a moderate irritant as compared to the negative control article. | Yes |
| • In-vivo thrombogenicity * | N/A * | N/A * | |
| Chemical Characterization | To assess the exhaustive extractables profile of the stent-graft. | Based on the available toxicity data, exposure estimates, and safety margins, the likelihood of extractable chemicals from the stent-graft producing unacceptable carcinogenic or non-carcinogenic health risks in the adult patient population under the proposed conditions and duration of clinical use (permanent; >30 days) is acceptable. | Yes |
| *In-vivo thrombogenicity of the stent prosthesis was assessed at 6, 12 and 26 weeks as part of the in-vivo safety study summarized in Section IX (B). | | | |

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Table 6. Biocompatibility Evaluation - TREO Delivery System

| Biological Effect (Test) | Purpose | Results | Acceptance Criteria Met? |
| --- | --- | --- | --- |
| ISO MEM Elution Cytotoxicity | To determine if delivery system extracts cause cytotoxicity when exposed to L-929 mammalian cells. | Non-cytotoxic: Grade 0 | Yes |
| ISO Guinea Pig Maximization Sensitization | To evaluate the allergenic/sensitization potential of delivery system extracts in guinea pigs. | The test article did not elicit a sensitization response. | Yes |
| ISO Intracutaneous Reactivity | To determine if any chemicals that may leach or be extracted from the test article were capable of causing local irritation in the dermal tissues of rabbits. | Non-irritant: The difference between the test article extracts overall mean score and corresponding control overall mean score was less than 1.0. | Yes |
| ISO Acute Systemic Toxicity | To evaluate delivery system extracts for potential toxic effects after single-dose systemic injections in mice. | There was no evidence of systemic toxicity from the test article extracts. | Yes |
| Material Mediated Pyrogenicity | To evaluate the delivery system for the potential of inducing a pyrogenic response in rabbits. | Non-pyrogenic: rabbits showed a maximum temperature rise of 0.0, 0.2, and 0.3°C, respectively over the 3 hour test period. | Yes |
| Genotoxicity /Mutagenicity | | | |
| • Ames Assay | To evaluate the mutagenic potential of the delivery system by measuring its ability to induce back mutations at selected loci of several strains of bacteria. | Non-mutagenic: The stent-graft did not cause an increase in point mutations, exchanges or deletions. | Yes |
| • In vitro Mouse Lymphoma | To evaluate the potential of the delivery system extracts to induce a forward mutation in the TK gene of L5178Y TK+/- cells. | Non-genotoxic and non-mutagenic: Mutant frequencies and cloning efficiencies of preparations treated with stent-graft were within the limits defined for a negative response. | Yes |
| Hemocompatibility | | | |
| • Hemolysis | To evaluate the potential of the delivery system to cause hemolysis in direct contact or by extraction. | Non-hemolytic: percent hemolysis: Direct contact – 0.0% Extract – 0.0% | Yes |
| • Partial Thromboplastin Time (PTT) | To determine the time citrated plasma exposed to delivery system takes to form a clot when exposed to a suspension of phospholipid particles and calcium chloride. | The test article results are comparable to the reference control article results and the comparison control article results. | Yes |

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Table 6. Biocompatibility Evaluation - TREO Delivery System

| Biological Effect (Test) | Purpose | Results | Acceptance Criteria Met? |
| --- | --- | --- | --- |
| • Platelet and Leukocyte count | To determine if the delivery system exposed to human whole blood in vitro would adversely affect the platelet and leukocyte ratios in whole blood. | The platelet and leukocyte counts of the test article sample were comparable to the reference and comparison controls. | Yes |
| • In-vivo thrombogenicity | To evaluate the potential of the test device to resist thrombus formation when placed in the vasculature. | No thrombus was observed on the delivery device. | Yes |

D. Sterilization, Packaging and Shelf-Life

TREO is sterilized via gamma irradiation resulting in a sterility assurance level (SAL) of $10^{-6}$. The production dose of $25\mathrm{kGy}$ is supported by a validation study that was executed in accordance with ISO 11137-2.

Packaging validation was executed successfully per AAMI/ANSI/ISO 11607-1:2006: Packaging for terminally sterilized devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems. All packaging and shelf life validation testing was performed as per current standards and Terumo Aortic procedures. The TREO packaging configuration used in these studies reflects the final package configuration.

Specific engineering testing completed to support shelf life are denoted by an asterisk (*) in Table 2 and 3. Accelerated and real time shelf-life product testing conducted on the TREO supports a 2-year shelf-life claim for the Main Bifurcated Stent-Grafts, the Proximal Cuff and the Straight Extension Stent-Grafts and a 3 year shelf life for the Leg Extension Stent-Grafts.

X. SUMMARY OF PRIMARY CLINICAL STUDY

The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of endovascular repair of infrarenal abdominal aortic and aorto-iliac aneurysms with the TREO in the US under IDE #G100200. Data from this clinical study were the basis for the PMA approval decision. A summary of the clinical study is presented below.

A. Study Design

Patients were treated between November 25, 2013 and February 10, 2016. The database for this PMA reflected data collected through February 14, 2019 and included 150 patients. There were 29 US investigational sites.

The study was a multi-center, prospective, single-arm, non-randomized, non-blinded clinical study.

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The primary safety endpoint was defined as the proportion of patients with a major adverse event (MAE) at 30 days post-procedure. The results were tested against a performance goal of 19%, derived from published data on open surgical controls.

The hypothesis tested for the primary safety endpoint at a one-sided alpha level of 0.025 was:

Null hypothesis (H₀): p_saf ≥ 0.19

Alternative hypothesis (H₁): p_saf &lt; 0.19,

where p_saf was the proportion of patients with at least one major adverse event through 30 days post implant procedure.

The proportion of patients in the safety sample with composite MAE at 30 days post procedure was summarized as a number, percentage and an exact 95% confidence interval (Clopper-Pearson method). The probability of experiencing at least one MAE in the 30 days post procedure was tested versus the performance goal for the endpoint using an exact binomial test. In addition, the probability of experiencing at least one MAE in the 30 days post procedure was estimated using Kaplan-Meier method. Time to MAE was calculated by determining the number of days between the date of the procedure and the date of the first MAE. Patients without events (within the first 30 days post procedure) were censored at 30 days (for the primary safety analysis). Patients who withdrew from the study after device implantation were censored at the time of early discontinuation (if it occurred prior to 30 days).

The primary effectiveness endpoint was defined as the proportion of patients with successful aneurysm treatment after use of TREO through 1-year post implant procedure. The results were tested against a performance goal of 88%, derived from the clinical study data of commercially available endovascular grafts.

The hypothesis tested for the primary effectiveness endpoint at a one-sided level of 0.025 was:

Null hypothesis (H₀): p_eff ≤ 0.88

Alternative hypothesis (H₁): p_eff &gt; 0.88,

where p_eff was the proportion of TREO patients with successful aneurysm treatment at 12 months post implant procedure.

The hypothesis of the primary safety endpoint was that the 30-day MAE rate in the Pivotal Study was lower than the performance goal of 19%. Assuming that the proportion of patients with at least one adverse event included in the definition of the composite MAE up to 30 days post-implant was 10.2%, 150 endovascular patients (receiving the TREO device) provided 80% power for an exact binomial test at a one-sided alpha level of 0.025 against the performance goal of 19%.

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The hypothesis of the primary effectiveness endpoint was that the proportion of patients with the composite endpoint of successful aneurysm treatment at 12 months post-implant is at least 88% (estimated performance goal), and 127 endovascular patients (receiving TREO device and with 12 month follow-up) will provide better than 80% power for an exact binomial test at an one-sided alpha level of 0.025 against an alternative of 95.6% success rate. The goal of 127 patients with 12 months follow-up can be achieved with 150 enrolled patients assuming 15% attrition rate.

External evaluation groups were used during the course of the Pivotal Study, which are described below:

- Independent Imaging Review Committee: An independent imaging review committee, made up of a team of vascular surgeons, assessed each patient for anatomical approval for enrollment. This panel of physicians performed a concurrent review of the screening imaging after initial prescreening by the site. The investigators were ultimately responsible for considering both medical and anatomic criteria and determining patient's eligibility for the study based on the complete selection criteria.
- Imaging Core Laboratory: Following a patient's enrollment in the study, the Cleveland Clinic Peripheral Vascular Core Laboratory evaluated all imaging obtained during the course of the study. This review included confirmation of anatomical requirements for enrollment, along with assessment of follow-up imaging endpoints.
- Clinical Events Committee and Data Safety Monitoring Board: An independent Clinical Events Committee (CEC) and a separate, independent Data Safety Monitoring Board (DSMB) were responsible for assuring the study was conducted ethically, and that the health and welfare of each study patient was protected. The CEC adjudicated all major adverse events reported by the site and classified them as related or not related to the device or the procedure. The DSMB met separately to review the safety data in aggregate and assess the overall safety of the study. The DSMB also assessed whether the continuation of enrollment was appropriate, and, if not, whether protocol modifications were necessary or whether the study should be halted.

1. Clinical Inclusion and Exclusion Criteria

Enrollment in the Pivotal Study was limited to patients who met the following inclusion criteria:

- Age between 18 and 85
- Infrarenal AAA with or without iliac artery involvement, with contrast CT performed within 4 months of planned implant procedure
- Infrarenal AAA:

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○ ≥ 4.5 cm in diameter for males, or ≥ 4.0 cm in diameter for females, or
○ increased in diameter by 0.5 cm in the last 6 months

- AAA anatomy including:
○ infrarenal landing neck length of 10mm or greater and an angle of less than 60 degrees relative to the long axis of the aneurysm (centerline at lowest renal to centerline at bifurcation) and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an outside diameter of 17mm – 32mm, or
○ infrarenal landing neck length of 15mm or greater and an angle of between 60 and 75 degrees relative to the long axis of the aneurysm and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an outside diameter of 16mm – 30mm

- Infrarenal landing neck meeting the vessel size requirements specified in the Instructions for Use (IFU) for the corresponding devices
- Lowest renal artery at least 9 cm from the aortic bifurcation
- Distal iliac landing neck with
○ an inside diameter of 8 mm – 13 mm and a length of at least 10 mm, or
○ an inside diameter of &gt;13 mm – 20 mm and a length of at least 15 mm

- Distal iliac landing neck meeting the vessel size requirements specified for the corresponding devices in the IFU
- Total treatment length of at least 13 cm
- A distal aortic diameter above the iliac bifurcation ≥70% of the sum of the selected leg graft diameters that would pass through the same
- Patient was willing and able to comply with 1-month, 6-month, and 12-month follow-up visits, as well as annual visits out to 5 years
- Adequate renal function to tolerate required follow-up contrast enhanced CTs
- Adequate vascular access (e.g., patent iliac or femoral arteries) for introduction of the delivery system, which is 18F (6.0 mm) or 19F (6.3 mm) outer diameter, based on size of device used. Alternatively, patient’s anatomy was suitable for creation of an iliac conduit
- Patient or Legally Authorized Representative agreed to sign Informed Consent Form

Patients were not permitted to enroll in the TREO Pivotal Study if they met any of the following exclusion criteria:

- Patient was pregnant or lactating
- Dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
- Patient had a patent inferior mesenteric artery that could not be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery
- Implant procedure as planned did not allow for at least one patent hypogastric artery left intact, unless both were occluded on pre-op imaging

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- Lesion that could not be crossed by a guide wire
- Proximal neck could not increase by more than 10% over 15mm or more than 7% over 10mm (i.e., no trapezoidal necks)
- Patient had severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction &lt; 20%, or recent diagnosis of CHF
- Stroke or myocardial infarction within 6 months of the planned treatment date
- Patient had chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
- Patient had an active systemic infection or was suspected of having an active systemic infection (e.g., AIDS/HIV, sepsis)
- Morbidly obesity (more than 100% over the ideal body weight or as defined by institutional standards) or other clinical conditions that had the potential to severely compromise or impair x-ray visualization of the aorta
- Connective tissue disease (e.g., Marfan syndrome)
- Mycotic aneurysm
- Significant or circumferential calcification or mural thrombus in the proximal aortic neck or distal landing zone.
- Significant or circumferential calcification or mural thrombus within the treatment length, which could have adversely impacted device patency
- Patient had a blood coagulation disorder or bleeding diathesis, the treatment for which could not be suspended pre- and post-repair
- Patient was in acute or chronic renal failure (creatinine ≥ 2.5 mg/dL), unless patient was stable on dialysis
- Patient had less than two-year life expectancy as evidenced by factors prohibiting major medical intervention (e.g., presence of malignancy, severe cardiopulmonary disease)
- Patient was participating in another research study, had received investigational study drug within 30 days of planned procedure, or had received an investigational device within one year of planned procedure
- Patient was confronted with other medical, social or psychological issues that the investigator believed could have interfered with study treatment or follow-up. These reasons had to be documented. An example included adherence to a theological or personal doctrine with aversion or opposition to blood transfusion
- Patient had a prior AAA repair (endovascular or surgical)
- Patient had an untreatable allergy or sensitivity to contrast media, Nitinol/nickel, or polyester
- Patient had undergone other major surgical or medical intervention within 45 days of the planned procedure or was planning to undergo other major surgical or medical intervention within 45 days post implantation (e.g., coronary artery bypass grafting, organ transplantation, renal stenting)

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# 2. Follow-up Schedule

All patients were scheduled to return for follow-up examinations at 30 days (+/- 4 weeks), 6 months (+/- 8 weeks), 12 months (+/- 8 weeks), and annually through 5 years (+/- 12 weeks) postoperatively. Additional annual follow-up examinations through 10 years will be conducted for patients who experienced a stent-strut or barb fracture within the first 5 years of study participation. Adverse events and complications were recorded at all visits.

Preoperatively – Each patient was required to have a CT with contrast, a physical examination and ankle-brachial index (ABI), coagulation (PT &amp; APTT), chemistry (BUN &amp; creatinine), and urine human chorionic gonadotropin (hCG) (if applicable).

Treatment and discharge – During the implant procedure, each patient was to have an intraoperative angiogram. Device assessment by the investigator was collected, including: device delivery, deployment, patency, and integrity. At the time of the procedure and prior to hospital discharge, clinical utility data was documented, consisting of: type of anesthesia, duration of procedure, amount of contrast administered, total fluoroscopy time, estimated blood loss, vascular access site, duration of hospitalization, duration of ICU stay. Prior to hospital discharge, each patient was to have a physical examination and ABI.

Post-operative follow-up visits – Assessments during the study included CT with and without contrast and x-rays. At follow-up visits through 12 months, patients were to also have a physical examination and ABI.

Additional assessments that were collected at each follow-up visit included:

- Adverse events, including:
- Serious adverse events
- Major adverse events
- Procedure-related adverse events
- Device-related adverse events
- Aneurysm sac rupture
- Stent graft migration, assessed by an Independent Core Lab
- Endoleak, assessed by an Independent Core Lab
- AAA enlargement
- Stent-graft integrity, assessed by an Independent Core Lab
- Loss of stent-graft patency
- Conversion to open surgery
- Secondary interventions
- AAA-related mortality

Pre-operative and post-operative parameters measured for all visits are presented in Table 7.

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The key timepoints are shown below in the tables summarizing safety and effectiveness.

Table 7. Schedule of Activities

| Assessment | Screening/ Baseline | Treatment | Hospital Discharge | 1, 6, & 12 Month Follow-up | Annual Follow-up Visits (Years 2-5 for all patients, and Years 6-10 for patients with Core Lab-confirmed fracture) |
| --- | --- | --- | --- | --- | --- |
| Obtain Informed Consent/ Screening Consent | X | | | | |
| Review Medical History and Risk Factors, CT, and Physical Assessment | X^{a} | | | | |
| Lab Evaluations | X | | | | |
| Concomitant meds | X | X | | | |
| Physical Exam including Femoral & Pedal Pulses, Ankle-Brachial Index | X | | X | X^{b} | |
| CT with and without contrast | | | | X^{c} | X^{c} |
| Cardiac-gated CT (optional) | X | | | X | X |
| Angiogram | | X | | | |
| Device Assessment | | X | | | |
| Document clinical utilities | | X | X | | |
| Document ICU time and hospital time | | | X | | |
| AE observation, evaluation, and treatment | | X | X | X | X |
| X-ray (KUB, 3-4 view) | | | | X | X |
| a Screening CT may be used as the Baseline CT as long as the Screening CT was performed within 4 months of the planned procedure date and includes contrast imaging. If the procedure is delayed and the CT is older than 4 months, or it does not include contrast imaging, an additional CT must be performed for the Baseline evaluation.
b Incision site assessment only required to be performed at the 1-month follow-up visit
c Patients with renal insufficiency may be followed with unenhanced CT combined with duplex ultrasound or MRI | | | | | |

3. Clinical Endpoints

With regard to safety, the primary safety endpoint was the incidence of major adverse events (MAEs) at 30 days post-implant. A major adverse event was defined as any one of the following:

- All-cause mortality
- Myocardial infarction
- Stroke
- Renal failure
- Respiratory failure
- Paraplegia
- Bowel ischemia
- Procedural blood loss of 1,000 cc or greater

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The primary safety endpoint was compared to a performance goal of 19%.

With regard to effectiveness, the primary effectiveness endpoint, was successful aneurysm treatment, which was a composite endpoint defined as the following:

- Technical success at the conclusion of the procedure, where the endovascular graft must be patent, with absence of Type I/III endoleak, or treated aneurysm sac rupture
- Absence of aneurysm enlargement (&gt;5 mm) or stent-graft migration (&gt;10 mm) through 12 months (compared to 30-day imaging)
- Absence of fracture, conversion to open surgical repair, treated aneurysm rupture, Type I/III endoleak, or treated stent-graft occlusion through 12 months

The primary effectiveness endpoint was compared to a performance goal of 88%.

With regard to success/failure criteria, the TREO Pivotal Study was considered successful if both the primary safety and effectiveness goals were met.

The following secondary analyses were completed using descriptive statistics:

The secondary safety endpoints included the following:

- The rate of each individual component of the composite MAE, determined at 30 days, 6 months, and 12 months
- The composite MAE rate at 12 months and annually to 5 years
- Procedure-related complications through 30 days, 6 months, 12 months, and annually to 5 years

The secondary effectiveness endpoints included the following:

- Technical success at 30 days confirmed by an imaging modality
- Clinical utility measures (type of anesthesia, procedure duration, time in the intensive care unit and length of hospital stay)
- Aneurysm-related Mortality (ARM) at 12 months and annually through 5 years
- Secondary interventions through 12 months, and annually through 5 years
- Major device-related events through 30 days, 12 months, and annually through 5 years

## B. Accountability of PMA Cohort

At the time of database lock, of 150 patients enrolled in the PMA study, 96% (144) of patients were available for analysis at the completion of the study, the 12-month postoperative visit. Of the 144, a total of 131 (91.0%) patients had follow-up imaging deemed evaluable for endovascular graft parameters.

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One hundred and fifty patients (150) were implanted with the TREO Abdominal Stent-Graft System and seen through discharge. All of these patients completed the 1-month follow-up visit (minimum of 97% of patients had imaging adequate to evaluate endovascular graft parameters). The follow-up compliance rate of patients with imaging adequate to evaluate endovascular graft parameters at 6 months and 1 year was at least 89.3% and 88.9%, respectively. There were four patients that died within the first year; none of these deaths were aneurysm-related.

Beyond the 1-year visit, there was at least 83% of patients with imaging adequate to assess endovascular graft parameters at 2-years, 71% at 3 years (with 5.8% of patients still in the follow-up window with visit not yet completed), and 40.6% at 4 years (with approximately 31.9% of patients still in the follow-up window with a visit not yet completed). Compliance and imaging follow-up are provided in Table 8.

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Table 8. Summary of Compliance and Core Lab Imaging Follow-Up

| Analysis Window | Patient Follow-Upc | | | | Imaging Performedc | | Imaging Adequate to Assess the Parameterd | | | | Events Occurring Within Windowe | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | No Visit, Still in Windowb | Missed Visit | Performed | CT Scan | X-Ray | Sac Diameter | Endoleak | Migration | Fracture | Death | Surgical Conversion | LTFU | Withdrawal | Not Due for Next Visit | |
| Proc | 150 | 0 | 0 | 150/150 (100.0%) | NA | NA | NA | NA | NA | 0 | 0 | 0 | 0 | 0 | |
| 1 Mo | 150 | 0 | 0 | 150/150 (100.0%) | 150/150 (100.0%) | 147/150 (98.0%) | NAd | 146/150 (97.3%) | NAd | 148/150 (98.7%) | 1 | 0 | 0 | 0 | |
| 6 Mos | 149 | 0 | 10/149 (6.7%) | 139/149 (93.3%) | 138/149 (92.6%) | 133/149 (89.3%) | 137/149 (91.9%) | 134/149 (89.9%) | 134/149 (89.9%) | 133/149 (89.3%) | 2 | 0 | 0 | 3 | |
| 1 Yr | 144 | 0 | 7/144 (4.9%) | 137/144 (95.1%) | 137/144 (95.1%) | 131/144 (91.0%) | 136/144 (94.4%) | 133/144 (92.4%) | 128/144 (88.9%) | 131/144 (91.0%) | 7 | 0 | 2 | 3 | |
| 2 Yrs | 132 | 0 | 13/132 (9.8%) | 119/132 (90.2%) | 119/132 (90.2%) | 113/132 (85.6) | 116/132 (87.9%) | 113/132 (85.6%) | 111/132 (84.1%) | 110/132 (83.3%) | 6 | 0 | 1 | 5 | |
| 3 Yrs | 120 | 7/120 (5.8%) | 15/120 (12.5%) | 98/120 (81.7%) | 95/120 (79.2%) | 88/120 (73.3%) | 94/120 (78.3) | 94/120 (78.3%) | 91/120 (75.8%) | 86/120 (71.7%) | 2 | 0 | 2 | 3 | |
| 4 Yrs | 69 | 22/69 (31.9%) | 8/69 (11.6%) | 39/69 (56.5%) | 32/69 (46.4%) | 30/69 (43.5) | 30/69 (43.5) | 31/69 (44.9%) | 28/69 (40.6%) | 30/69 (43.5%) | 0 | 0 | 2 | 5 | |
| 5 Yrs | 13 | 10/13 (76.9%) | 2/13 (15.4%) | 1/13 (7.7%) | 1/13 (7.7%) | 1/13 (7.7%) | 1/13 (7.7%) | 1/13 (7.7%) | 1/13 (7.7%) | 1/13 (7.7%) | 0 | 0 | 0 | 1 | |
| NA - Not Applicable a Eligible for Visit reflects those patients eligible for follow-up calculated as: (previous eligible for follow-up) - (previous death + conversion + lost to follow-up + early withdrawal + not due for follow-up) b Patients who did not have a visit within the window but who had not yet reached the end of the analysis window. This value is used for the denominator for calculating the percentage of visits performed. c Based on site-reported data d Based on Core Laboratory analysis. Sac Diameter and Migration assessments use 1 month as baseline, and are therefore not reported at 1 month. Eligible patients require valid value at 1 month and at the specified time point. e These columns reflect patients who had visits within the specified window but were not eligible at the start of the next window due to death, surgical conversion, lost to follow-up or early withdrawal. | | | | | | | | | | | | | | | |

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# C. Study Population Demographics and Baseline Parameters

# Demographics

The demographics of the study population are typical for an EVAR pivotal study performed in the US. In the study, $88\%$ (132/150) of patients were male. The mean age was 71.7 years and approximately one-half of the patients were between 65 and 74 years of age. Almost all patients were Caucasian, $98.0\%$ (147/150). Patient demographics for the study are provided in Table 9.

Table 9. Summary of Patient Demographics

| Characteristic | Statistics | Pivotal |
| --- | --- | --- |
| Sex | | |
| Female | % (n/N) | 12.0% (18/150) |
| Male | % (n/N) | 88.0% (132/150) |
| Age (years) | Mean ± SD (N) Median (IQR) Min - Max | 71.7 ± 7.4 (150) 72.0 (67.0, 78.0) 52 - 85 |
| Age Groups | | |
| 18-64 years | % (n/N) | 16.7% (25/150) |
| 65-74 years | % (n/N) | 48.0% (72/150) |
| 75-80 years | % (n/N) | 24.7% (37/150) |
| 81-85 years | % (n/N) | 10.7% (16/150) |
| Ethnic Group | | |
| Hispanic or Latino | % (n/N) | 1.3% (2/150) |
| Not Hispanic or Latino | % (n/N) | 96.7% (145/150) |
| Not Reported | % (n/N) | 1.3% (2/150) |
| Unknown | % (n/N) | 0.7% (1/150) |
| Race | | |
| American Indian/Alaskan Native | % (n/N) | 0.7% (1/150) |
| Black or African American | % (n/N) | 1.3% (2/150) |
| White | % (n/N) | 98.0% (147/150) |

# Baseline Medical History

The baseline clinical history for the study patients is summarized in Table 10. Most of the patients in the study had a history of hypertension (90.0%, 135/150) or received treatment for hypertension (73.3%, 110/150). A history of hyperlipidemia was reported in 73.3% (110/150) and smoking in 85.3% (128/150).

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Table 10. Summary of Patient Medical History

| Comorbidity | Pivotal |
| --- | --- |
| Peripheral Vascular Disease | 25.3% (38/150) |
| Documented Coronary Artery Disease | 56.0% (84/150) |
| Myocardial Infarction | 18.0% (27/150) |
| Stable Angina | 0.7% (1/150) |
| Unstable Angina | 6.0% (9/150) |
| Arrhythmias | 24.0% (36/150) |
| Congestive Heart Failure | 8.7% (13/150) |
| Other | 32.2% (48/149) |
| Diabetes Mellitus | 28.0% (42/150) |
| Hypertension (HTN) and/or Treatment of HTN | 90.0% (135/150) |
| Hypercholesterolemia | 44.7% (67/150) |
| Hyperlipidemia | 73.3% (110/150) |
| Smoking | 85.3% (128/150) |
| Current | 31.3% (40/128) |
| Former | 68.8% (88/128) |
| Renal Insufficiency | 13.3% (20/150) |
| Currently on Antiplatelet/Anticoagulant Medications | 78.7% (118/150) |
| Limb Ischemia | 7.3% (11/150) |
| Limb Ischemia: Left Claudication | 6.0% (9/150) |
| Limb Ischemia: Left Ischemic Rest Pain | 0.7% (1/150) |
| Limb Ischemia: Left Asymptomatic | 2.0% (3/150) |
| Limb Ischemia: Right Claudication | 5.3% (8/150) |
| Limb Ischemia: Right Ischemic Rest Pain | 0.7% (1/150) |
| Limb Ischemia: Right Asymptomatic | 2.7% (4/150) |
| Vascular Intervention | 18.0% (27/150) |
| Gastrointestinal | 20.0% (30/150) |
| Cholecystitis | 4.0% (6/150) |
| Ischemic Colitis | 0% (0/150) |
| Complications: Small Bowel Ischemia | 0.7% (1/150) |
| GI Bleed | 4.7% (7/150) |
| Impotence | 16.0% (24/150) |

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| Comorbidity | Pivotal |
| --- | --- |
| All values expressed as % (n/N) | |

## Baseline Vessel Measurements

A comparison of the Core Laboratory and site reported baseline aneurysm and anatomical measurements are provided in Table 11. Patients with aortic or aortoiliac aneurysms were enrolled in the study. All patients met the inclusion criteria for study entry, with the exception of one who had pre-existing chronic obstructive lung disease for which he denied daily oxygen use prior to enrollment, as he used oxygen only as needed during the day. However, following enrollment, the patient clarified that he used oxygen every night, which constituted routine oxygen use, and was an exclusion criterion. Of the 150 patients enrolled in the study, 19 (12.7%) had iliac artery involvement.

Table 11. Comparison of Core Laboratory and Site Reported Anatomic Characteristics

| Characteristic | Statistics | Core Laboratory | Site Reported |
| --- | --- | --- | --- |
| Angle between Suprarenal Aorta and Proximal AAA Neck (degrees) (Suprarenal Neck Angle) | Mean ± SD (N) | 18.6 ± 11.1 (149) | 13.0 ± 11.1 (149) |
| | Median (IQR) | 16.4 (10.1, 25.8) | 10.0 (3.0, 20.0) |
| | Min - Max | 0.0 - 51.9 | 0.0 - 40.0 |
| Angle between Proximal AAA Neck and Main Axis of AAA (degrees) (Infrarenal Neck Angle) | Mean ± SD (N) | 35.8 ± 13.2 (149) | 25.0 ± 16.5 (149) |
| | Median (IQR) | 35.4 (27.2, 42.0) | 22.0 (12.0, 35.0) |
| | Min - Max | 5.2 - 72.2 | 0.0 - 70.0 |
| Diameter of Proximal Neck (mm) | Mean ± SD (N) | 23.0 ± 3.1 (150) | 23.7 ± 3.0 (150) |
| | Median (IQR) | 22.3 (21.0, 24.7) | 24.0 (21.5, 25.0) |
| | Min - Max | 15.0 - 33.5 | 17.0 - 32.0 |
| Length of Infrarenal Proximal Neck (mm) (Proximal Landing Zone) | Mean ± SD (N) | 43.1 ± 13.0 (150) | 28.4 ± 11.2 (150) |
| | Median (IQR) | 43.1 (33.9, 50.7) | 27.8 (20.0, 34.0) |
| | Min - Max | 14.4 - 80.4 | 10.0 - 60.0 |
| Length from Lowest Renal Artery to Aortic Bifurcation (mm) | Mean ± SD (N) | 119.5 ± 14.2 (150) | 116.8 ± 16.0 (150) |
| | Median (IQR) | 118.5 (110.6, 127.5) | 114.0 (107.5, 124.0) |
| | Min - Max | 85.1 - 160.8 | 90.0 - 200.0 |
| Length from Aortic Bifurcation to Right Internal Iliac Artery (mm) | Mean ± SD (N) | 59.4 ± 15.3 (150) | 64.1 ± 30.4 (150) |
| | Median (IQR) | 59.5 (47.9, 71.8) | 58.2 (46.0, 73.0) |
| | Min - Max | 25.9 - 95.5 | 25.0 - 185.0 |
| Length from Aortic Bifurcation to Left Internal Iliac Artery (mm) | Mean ± SD (N) | 58.5 ± 15.7 (149) | 64.5 ± 29.4 (149) |
| | Median (IQR) | 57.7 (48.8, 66.7) | 58.0 (47.0, 71.0) |
| | Min - Max | 26.9 - 107.9 | 30.0 - 192.0 |
| Length of Right Iliac/Femoral Landing Zone (mm) | Mean ± SD (N) | 48.9 ± 19.8 (136) | 37.6 ± 21.6 (136) |
| | Median (IQR) | 48.6 (33.5, 63.8) | 30.0 (20.0, 50.5) |
| | Min - Max | -14.9 - 94.0 | 4.0 - 120.0 |
| Length of Left Iliac/Femoral Landing Zone (mm) | Mean ± SD (N) | 50.6 ± 19.1 (140) | 38.6 ± 21.3 (140) |
| | Median (IQR) | 51.3 (35.8, 61.8) | 37.5 (20.0, 50.0) |
| | Min - Max | 13.7 - 107.9 | 6.0 - 120.0 |
| Total Treatment Length (Core Lab = One Measure, Site = Left) (mm) | Mean ± SD (N) | 187.9 ± 20.2 (150) | 181.0 ± 32.8 (150) |
| | Median (IQR) | 186.9 (172.9, 202.6) | 174.0 (158.0, 194.0) |
| | Min - Max | 139.3 - 265.4 | 137.0 - 336.0 |

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Table 11. Comparison of Core Laboratory and Site Reported Anatomic Characteristics

| Characteristic | Statistics | Core Laboratory | Site Reported |
| --- | --- | --- | --- |
| Total Treatment Length (Core Lab = One Measure, Site = Right) (mm) | Mean ± SD (N) | 187.9 ± 20.2 (150) | 181.0 ± 33.8 (150) |
| | Median (IQR) | 186.9 (172.9, 202.6) | 174.0 (160.0, 198.0) |
| | Min - Max | 139.3 - 265.4 | 130.0 - 329.0 |
| Maximum Aneurysm Diameter (mm) | Mean ± SD (N) | 54.0 ± 7.7 (150) | 54.4 ± 6.6 (150) |
| | Median (IQR) | 52.8 (50.0, 56.4) | 53.2 (51.0, 57.0) |
| | Min - Max | 39.2 - 113.3 | 42.4 - 108.0 |
| Diameter of Distal Aorta (mm) (Aortic Diameter at Bifurcation) | Mean ± SD (N) | 30.4 ± 9.5 (150) | 26.5 ± 6.3 (150) |
| | Median (IQR) | 28.2 (23.3, 35.7) | 25.0 (22.0, 30.0) |
| | Min - Max | 16.7 - 72.1 | 15.0 - 47.0 |
| Diameter of Right Iliac Landing Zone Neck (mm) | Mean ± SD (N) | 16.9 ± 3.0 (145) | 14.1 ± 2.8 (145) |
| | Median (IQR) | 16.6 (14.7, 18.7) | 14.0 (12.0, 16.0) |
| | Min - Max | 9.6 - 27.3 | 9.0 - 23.0 |
| Diameter of Left Iliac Landing Zone Neck (mm) | Mean ± SD (N) | 17.4 ± 3.8 (145) | 13.7 ± 2.6 (145) |
| | Median (IQR) | 16.4 (15.0, 19.1) | 14.0 (12.0, 15.0) |
| | Min - Max | 11.1 - 36.1 | 8.0 - 20.0 |

The distribution of baseline aneurysm diameters as measured by the Imaging Core Laboratory is presented in Table 12. The majority of patients (100/150, 66.7%) had aneurysms with maximum sac diameter ranging from 50-59 mm.

Table 12. Distribution of Baseline Aneurysm Diameters – Core Lab Reported

| Maximum Aneurysm Diameter (mm) | Pivotal Study N = 150 |
| --- | --- |
| <45 mm | 3/150 (2.0%) |
| 45-49 mm | 27/150 (18.0%) |
| 50-59 mm | 100/150 (66.7%) |
| 60-69 mm | 15/150 (10.0%) |
| 70-79 mm | 4/150 (2.7%) |
| 80-89 mm | 0 |
| ≥90 mm | 1/150 (0.7%) |

## TREO Devices Implanted

A total of 565 TREO Stent-Grafts were implanted in the Pivotal Study. The number and types of TREO Stent-Grafts implanted in the initial procedure are shown in Tables 13 and 14. No competitor devices were implanted during any of the initial procedures. All patients received at least 3 TREO Stent-Grafts; namely, a single Main Bifurcated Stent-Graft and 2 Leg Extension Stent-Grafts. Ten percent of patients received additional stent-grafts (13 patients received 1 additional stent-graft, 1 patient received 2 additional stent-grafts and 1 patient received 3 additional stent-grafts). Overall, 98.7% of the patients were treated with 3 or 4 total TREO Stent-Grafts.

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The diameters of the devices implanted in the Pivotal Study are show in Table 15.

Table 13. TREO Stent-Grafts Implanted

| TREO Components | Pivotal Study N = 150* |
| --- | --- |
| Main Bifurcated Stent-Graft | 150/150 (100.0%) |
| Proximal Cuff Stent-Graft | 6/150 (4.0%) |
| Ipsilateral Leg Extension Stent-Graft | 150/150 (100.0%) |
| Ipsilateral Leg/Straight Extension Stent-Graft | 3/150 (2.0%) |
| Contralateral Leg Extension Stent-Graft | 150/150 (100.0%) |
| Contralateral Leg/Straight Extension Stent-Graft | 7**/150 (4.7%) |
| *Denominator includes all patients who received the test device.** Seven patients received 9 contralateral Leg Extension Stent-Grafts / Straight Extension Stent-Grafts | |

Table 14. Number of Devices Implanted During the Index Procedure

| Number of Devices Implanted | Pivotal Cohort
N = 150* |
| --- | --- |
| 1 | NA |
| 2 | NA |
| 3 | 135/150 (90.0%) |
| 4 | 13/150 (8.7%) |
| 5 | 1/150 (0.7%) |
| 6 | 1/150 (0.7%) |
| *Denominator includes all patients who received the TREO device. | |

Table 15. Diameter of TREO Devices Implanted During the Index Procedure

| TREO Stent-Graft Type | Outer Diameter (mm) | Pivotal Study
N = 150* |
| --- | --- | --- |
| Main Bifurcated Stent-Graft | | 150/150 (100.0%) |
| | 20 | 1/150 (0.7%) |
| | 22 | 5/150 (3.3%) |
| | 24 | 12/150 (8.0%) |
| | 26 | 34/150 (22.7%) |
| | 28 | 48/150 (32.0%) |
| | 30 | 24/150 (16.0%) |
| | 33 | 19/150 (12.7%) |
| | 36 | 7/150 (4.7%) |
| Proximal Cuff Stent-Graft | | 6/150 (4.0%) |
| | 20 | 0/150 (0.0%) |
| | 22 | 0/150 (0.0%) |
| | 24 | 0/150 (0.0%) |
| | 26 | 2/150 (1.3%) |
| | 28 | 2/150 (1.3%) |

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Table 15. Diameter of TREO Devices Implanted During the Index Procedure

| TREO Stent-Graft Type | Outer Diameter (mm) | Pivotal Study N = 150* |
| --- | --- | --- |
| | 30 | 0/150 (0.0%) |
| | 33 | 2/150 (1.3%) |
| | 36 | 0/150 (0.0%) |
| Ipsilateral Leg Extension Stent-Graft | | 150/150 (100%) |
| | 9 | 2/150 (1.3%) |
| | 11 | 4/150 (2.7%) |
| | 13 | 23/150 (15.3%) |
| | 15 | 45/150 (30.0%) |
| | 17 | 36/150 (24.0%) |
| | 20 | 26/150 (17.3%) |
| | 24 | 14/150 (9.3%) |
| Contralateral Leg Extension Stent-Graft | | 150/150 (100%) |
| | 9 | 1/150 (0.7%) |
| | 11 | 12/150 (8.0%) |
| | 13 | 25/150 (16.7%) |
| | 15 | 39/150 (26.0%) |
| | 17 | 34/150 (22.7%) |
| | 20 | 17/150 (11.3%) |
| | 24 | 12/150 (8.0%) |
| Ipsilateral Leg/Straight Extension Stent-Graft | | 3/150 (2.0%) |
| | 9 | 0/150 (0.0%) |
| | 11 | 1/150 (0.7%) |
| | 13 | 1/150 (0/7%) |
| | 15 | 0/150 (0.0%) |
| | 17 | 0/150 (0.0%) |
| | 20 | 1/150 (0.7%) |
| | 24 | 0/150 (0.0%) |
| Contralateral Leg/Straight Extension Stent-Graft | | 7**/150 (4.7%) |
| | 9 | 1/150 (0.7%) |
| | 11 | 0/150 (0.0%) |
| | 13 | 0/1…