GORE TAG Thoracic Branch Endoprosthesis (TBE Device)

P210032 · W. L. Gore & Associates, Inc. · MIH · May 13, 2022 · Cardiovascular

Device Facts

• Record ID: P210032
• Device Name: GORE TAG Thoracic Branch Endoprosthesis (TBE Device)
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: MIH · Cardiovascular
• Decision Date: May 13, 2022
• Decision: APPR
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The GORE® TAG® Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery, in patients who are at high risk for debranching subclavian procedures and have: Adequate iliac/femoral access Proximal Aortic Landing Zones: For Isolated Lesion Patients: Proximal landing zone cannot be aneurysmal, dissected, heavily calcified, or heavily thrombosed For Dissection Patients: Primary entry tear must be distal to the left subclavian artery and the proximal extent of the landing zone must not be dissected Aortic inner diameter range 16-42 mm Proximal segment length (length from distal edge of left subclavian artery to mid left common carotid ostium) of at least 2.0-4.0 cm, depending on Aortic Component selection Proximal covered length (measured from distal edge of left subclavian artery to distal edge of left common carotid artery ostium) of at least 15–36 mm, depending on Aortic Component selection For patients with prior ascending aorta or aortic arch repair with a surgical graft: at least 2 cm landing zone proximal to the distal anastomosis Left Subclavian Landing Zone: Landing zone cannot be aneurysmal, dissected, heavily thrombosed and severely tortuous (180 degree turn within the treated length) Left subclavian artery inner diameter of 6–18 mm, depending on Side Branch Portal diameter selected Left subclavian artery minimum length of 2.5–3.0 cm, depending on Side Branch Portal diameter selected Distal Landing Zone (Isolated Lesion Patients only) Outer curve length must be ≥ 2 cm proximal to celiac artery Aortic inner diameter range 16-42 mm Non aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone Native Aorta or previously placed GORE® TAG® Conformable Thoracic Stent Graft

Device Story

Modular endovascular graft system for descending thoracic aorta repair; preserves left subclavian artery (LSA) flow. Components: Aortic Component (AC), Side Branch (SB) Component, optional Aortic Extender (AE). AC incorporates internal portal for SB seal/fixation. System delivered via single distal access site over 0.035" guidewires. Components consist of ePTFE/FEP graft supported by nitinol wire frame; radiopaque gold bands for imaging. SB component features CBAS® Heparin Surface. Used in hospital setting by vascular surgeons. Device isolates aortic lesions; maintains LSA perfusion; reduces need for high-risk open surgical debranching. Clinical decision-making guided by imaging (CTA/MRA) and procedural success metrics.

Clinical Evidence

Prospective, multicenter, non-randomized pivotal study (SSB 11-02) of 238 patients (Aneurysm, Dissection, Traumatic Transection, Other Isolated Lesions). Primary endpoint: composite of device technical success and absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia/paraparesis, renal failure, or unanticipated reintervention through 12 months. Aneurysm cohort (n=74 eligible) met performance goal of 64% with 83.8% success (95% LCL 75.1%). Dissection cohort (n=103) showed 88.3% success. Traumatic Transection (n=6) 100% success. Other Isolated Lesions (n=8) 87.5% success.

Technological Characteristics

Modular endovascular graft; ePTFE/FEP graft material; nitinol wire frame (stent). Radiopaque gold bands for imaging. CBAS® Heparin Surface on SB component. Delivery system compatible with 0.035" guidewires; 20-26 Fr profile. Sterilized by Ethylene Oxide (EO). MRI safe (1.5T/3.0T).

Indications for Use

Indicated for endovascular repair of descending thoracic aortic lesions in patients at high risk for surgical debranching, requiring left subclavian artery flow preservation. Applicable to patients with aneurysms, dissections, traumatic transections, or other isolated lesions meeting specific anatomical landing zone criteria (16-42 mm aortic diameter). Contraindicated in patients with device material sensitivities, infection, or heparin hypersensitivity (HIT Type II).

Predicate Devices

• GORE® TAG® Conformable Thoracic Endoprosthesis (P040043)

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: GORE® TAG® Thoracic Branch Endoprosthesis

Procode: MIH

Applicant’s Name and Address: W. L. Gore & Associates, Inc.
3450 W. Kiltie
Lane
Flagstaff, AZ
86005, USA

Date of Panel Recommendation: None

Premarket Approval Application (PMA) Number: P210032

Date of FDA Notice of Approval: May 13, 2022

Priority Review: Granted priority review status on July 17, 2015 because the device is intended to treat a potentially life threatening disease and because of reasonable expectation that the device represents a breakthrough technology with the potential to provide a clinically meaningful advantage over existing legally marketed technology, offers significant, clinically meaningful advantages over existing legally marketed alternatives and the availability of the device is in the best interest of patients.

II. INDICATIONS FOR USE

The GORE® TAG® Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery, in patients who are at high risk for debranching subclavian procedures and have:

- Adequate iliac/femoral access
- Proximal Aortic Landing Zones:
- For Isolated Lesion Patients: Proximal landing zone cannot be aneurysmal, dissected, heavily calcified, or heavily thrombosed
- For Dissection Patients: Primary entry tear must be distal to

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the left subclavian artery and the proximal extent of the landing zone must not be dissected

○ Aortic inner diameter range 16-42 mm
Proximal segment length (length from distal edge of left subclavian artery to mid left common carotid ostium) of at least 2.0-4.0 cm, depending on Aortic Component selection
○ Proximal covered length (measured from distal edge of left subclavian artery to distal edge of left common carotid artery ostium) of at least 15–36 mm, depending on Aortic Component selection
For patients with prior ascending aorta or aortic arch repair with a surgical graft: at least 2 cm landing zone proximal to the distal anastomosis

Left Subclavian Landing Zone:

○ Landing zone cannot be aneurysmal, dissected, heavily thrombosed and severely tortuous (180 degree turn within the treated length)
○ Left subclavian artery inner diameter of 6–18 mm, depending on Side Branch Portal diameter selected
○ Left subclavian artery minimum length of 2.5–3.0 cm, depending on Side Branch Portal diameter selected

Distal Landing Zone (Isolated Lesion Patients only)

○ Outer curve length must be ≥ 2 cm proximal to celiac artery
○ Aortic inner diameter range 16-42 mm
Non aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone
Native Aorta or previously placed GORE® TAG® Conformable Thoracic Stent Graft

## III. CONTRAINDICATIONS

The GORE® TAG® Thoracic Branch Endoprosthesis is contraindicated in:

Patients with known sensitivities or allergies to the device materials
- Patients who have a condition that threatens to infect the graft
- Patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) Type II

## IV. WARNINGS AND PRECAUTIONS

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The warnings and precautions can be found in the GORE® TAG® Thoracic Branch Endoprosthesis Device labeling.

## V. DEVICE DESCRIPTION

The GORE® TAG® Thoracic Branch Endoprosthesis provides endovascular repair of pathologies of the descending thoracic aorta requiring a proximal landing zone including the left subclavian artery. The GORE® TAG® Thoracic Branch Endoprosthesis is a modular device consisting of the Aortic Component (AC), the Side Branch (SB) Component, and an optional Aortic Extender (AE), as shown in Figure 1, and their respective delivery systems. These components may be used together as a stand-alone device or in conjunction with the GORE® TAG® Conformable Thoracic Endoprosthesis (P040043) to accommodate the intended treatment site.

Each component of the endoprosthesis consists of an ePTFE/FEP graft supported over its entire length by a nitinol wire frame (stent). Radiopaque gold bands are embedded in the graft material for device imaging. For delivery, all device components are constrained on the leading end of a delivery catheter compatible with 0.035" guidewires and are delivered through a single distal access site. All device components are intended to be delivered through an appropriately sized GORE® DrySeal Flex Sheath family of devices.

Figure 1: GORE® TAG® Thoracic Branch Endoprosthesis System and Key Features

## Aortic Component (AC)

The Aortic Component (see Figure 2) incorporates an internal portal that opens to the outer device surface, allowing for seal and fixation of the SB Component. Embedded in both ends of the Aortic Component and the internal portal are radiopaque gold bands that provide radiographic visibility. The leading end of the endoprosthesis consists of partially uncovered stent apices, while the trailing end of the stent is in line with the graft material.

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This component is mounted onto a catheter delivery system for delivery from a distal access site over a primary aortic guidewire. A Removable Guidewire Tube is provided to facilitate loading of the constrained device over a secondary branch guidewire that is prepositioned from the distal access site to the left subclavian artery (LSA). The constrained profile on the delivery catheter ranges from 20 to 26 Fr.

Figure 2: Aortic Component and Aortic Component Delivery System

# Side Branch Component (SB)

The SB Component (see Figure 3) includes the CBAS® Heparin Surface which consists of stable, covalent, end-point attached heparin of porcine origin. A radiopaque gold band is embedded in the graft material at each end of the device. A third embedded radiopaque band is located $5\mathrm{mm}$ from the trailing end of the device. This inner radiopaque marker facilitates alignment of the SB Component with the Aortic Component internal portal. The SB Component is mounted onto a catheter delivery system and constrained by a deployment sleeve. The SB Component should be selected such that the diameter of the trailing portion of the graft is the same as the portal diameter of the chosen Aortic Component. The diameter of the leading portion of the SB Component should be selected such that it is compatible with the branch vessel diameter.

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Figure 3: Side Branch (SB) Component and SB Component Delivery System

## Aortic Extender (AE)

The Aortic Extender (see Figure 4) is a short, tubular device with radiopaque gold bands at each end for radiographic visibility. Both the leading and trailing ends consist of partially uncovered stent apices. This device is intended to be used to improve sealing of the Aortic Component and/or add seal length proximally within the aorta, if necessary. The compressed profile of these devices on the delivery catheter ranges from 20 to 26Fr. The device is mounted onto a catheter delivery system. A longitudinal radiopaque marker is embedded in the deployment sleeve to allow visualization during delivery catheter withdrawal.

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Figure 4: Aortic Extender (AE) Component and AE Component Delivery System

VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are several other alternatives for the treatment of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery including:

Medical management
- Open surgical repair
- Thoracic endovascular aortic repair (TEVAR) using other endovascular devices
- Hybrid surgery with TEVAR

Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with their physician to select the method that best meets expectations and lifestyle.

VII. MARKETING HISTORY

The GORE® TAG® Thoracic Branch Endoprosthesis has not been marketed in the United States or any foreign country.

VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

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

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Table 1: List of Potential Adverse Effects

| access, delivery and deployment events (e.g. access failure; deployment difficulties/failures; failure to deliver the stent graft; and insertion or removal difficulty), | fever and localized inflammation, |
| --- | --- |
| adynamic ileus, | fistula (e.g., aortoenteric, arteriovenous, aortoesophageal, aortobronchial), |
| allergic reaction (to contrast, anti-platelet therapy, stent graft material), | genitourinary (e.g., ischemia, erosion, fistula, incontinence, hematuria, infection), |
| amputation, | hematoma, |
| anesthetic complications, | heparin-induced thrombocytopenia (HIT), infection (e.g., aortic, device, or access sites), |
| aortic expansion, | lymphocele / lymph fistula, |
| aortic rupture, | myocardial infarction, |
| angina, | neurologic damage, local or systemic (e.g., stroke, paraplegia, paraparesis), |
| atelectasis / pneumonia, | nerve injury, |
| bleeding (procedural and post-treatment), | peripheral malperfusion or ischemia, |
| bowel complications (e.g., ileus, transient ischemia, infarction, necrosis), | persistent false lumen flow, |
| branch vessel occlusion or obstruction, | post-implant syndrome, |
| cardiac complications (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension or hypertension), | prosthesis dilatation / rupture, |
| catheter breakage, | prosthetic thrombosis, |
| change in mental status, | pseudoaneurysm, |
| coagulopathy, | pulmonary complications (e.g., pneumonia, respiratory failure), pulmonary embolism, |
| contrast toxicity, | radiation injury, |
| death, | renal complications (e.g., artery occlusion, contrast toxicity, insufficiency, failure), |
| dissection, perforation, or rupture of the aortic vessel and / or surrounding vasculature, | reoperation, |
| edema (e.g., leg), | stenosis, |
| embolism (micro and macro) with transient | surgical conversion, |

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| or permanent ischemia, | |
| --- | --- |
| endoleak, | thrombosis, |
| endoprosthesis: collapse, improper placement; incomplete deployment; migration; material failure; occlusion; infection; stent fracture; dilatation; perigraft flow, | transient ischemic attack, |
| erectile dysfunction, | vascular spasm, |
| erosion, | vascular trauma (e.g., ilio-femoral vessel dissection, bleeding, rupture), |
| extension of dissection, | wound (e.g., infection, dehiscence) |
| femoral neuropathy | fever and localized inflammation, |

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

## IX. SUMMARY OF NONCLINICAL STUDIES

Nonclinical studies were completed to evaluate the GORE® TAG® Thoracic Branch Endoprosthesis including non-clinical bench testing, biocompatibility, sterilization, packaging, shelf-life, and animal studies. These are described in detail in the following sections.

## A. In Vitro Engineering Testing

In vitro bench testing to support the GORE® TAG® Thoracic Branch Endoprosthesis is summarized in Table 2. It was developed based on the device risk assessment and is consistent with FDA's Guidance Document Non-Clinical Tests and Recommended Labeling of Intravascular Stents and Associated Delivery Systems, April 18, 2010, its addendum, Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, August 18, 2015, and BS EN ISO 25539-1.

Table 2: Summary of In Vitro Test Results

| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Endoprosthesis System (Aortic Component (AC), Aortic Extender (AE) and Side Branch (SB)) | | | |
| Post-Deployment Inspections* | This test evaluates various post deployment inspections including, general visual, device integrity, contamination, dimensional inspection. | AC/AE/SB: The GORE® TAG® Thoracic Branch Endoprosthesis system components must meet required inspections (including measurement of length, inner diameter, and portal to leading end stent length (AC)) and be free of damage (e.g., broken struts, delamination, obstructions to the lumen) or unacceptable contamination post-deployment. | PASS |

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| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Deployment Reliability* | This test is to evaluate the deployment reliability of the device in a clinically relevant anatomical model. | AC/AE/SB: Deployment success is the ability of the deployment system to: • Reliably access the treatment site • Reliably deploy the endoprosthesis • Reliably withdraw the delivery catheter through the deployed device and remove from the patient. The device must have acceptable introducer sheath compatibility, pushability and trackability, torqueability, device expansion, deployment force (AC and AE ≤ 7.0 lbs; SB ≤ 5.0 lbs), removal of deployment line system, catheter extraction, and balloon compatibility. | PASS |
| Deployment Accuracy | This test evaluates the ability of the device to deploy accurately at the intended deployment site during simulated in-vitro test conditions. Deployment accuracy is the ability of the device to accurately deploy at its target (intended) location. | AC/AE/SB: The difference between the intended in-vitro deployment location (target) in the appropriate model and the actual deployed location must be within ± 5 mm. Deployment accuracy of the SB and Extender components applies to the proximal and distal target locations. Deployment accuracy of the Aortic Component only applies to the proximal target location. The Aortic Component portal must intersect the ostium of the intended branch vessel. The criterion for ostium intersection is the ability to access the branch with the SB component. | PASS |
| Radiopacity | This test evaluates the radiopacity of the endoprosthesis system. | AC/AE/SB: The loaded endoprosthesis and delivery catheter must demonstrate sufficient radiopacity for clinical use. AE sleeve radiopaque marker: the sleeve of the AE shall have a radiopaque marker for identification during catheter removal post deployment. AE Olive radiopaque marker: the leading olive of the AE shall have a radiopaque marker to facilitate rotational positioning of the AE prior to deployment. Leading olive radiopacity: the leading olive of the AC, AE, and SB shall be radiopaque to identify the leading end of the delivery system. | PASS |

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| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Modular Component Compatibility | This test evaluates device shortening, dislodgement, and modular separation due to deployment of additional modular devices. | AC/AE/SB: The Aortic Component must demonstrate acceptable modular compatibility with the Aortic Extender and the Side Branch component. Compatibility must also be demonstrated for configurations that include both GORE® TAG® Conformable Thoracic Endoprosthesis and TAG® Devices. | PASS |
| Catheter Sleeve Attachment Strength* | This test evaluates the attachment strength of the sleeve to the delivery catheter. | AC/AE: The tensile force required to separate the sleeve from the AC and AE catheter transition shall be ≥ 2.25 lbs. | PASS |
| Docking Separation Force | This test evaluates the force required to separate components within an endoprosthesis system. | AC/SB: The mean force to separate the SB component from the AC shall be greater than or equal to the mean separation force between the GORE® EXCLUDER® trunk and contralateral limb devices. | PASS |
| Particulate Evaluation | This test evaluates the particle counts expressed from simulated device use and provide a particle composition analysis. | SB: The loaded SB device must not release a clinically relevant amount of particulates. | PASS |
| Sewn Sleeve Function* | This test evaluates the ability of the sewn sleeve to constrain, torque, and deploy the device, and be removed with the catheter (AC and AE) in an anatomical model. | AC/AE/SB: The sewn sleeve must constrain the device with an outer diameter capable of being passed through the introducer sheath. The sewn sleeve must prevent premature deployment of the device when protected by the packaging sheath. After removal of the packaging sheath, the sewn sleeve must also be capable of fully opening at the time of clinical deployment. For the AC and SB components, the sleeve is secured to the stent-graft and remains implanted between the endoprosthesis and the vessel wall. The AC torque sleeve and the AE sleeve shall be secured to the delivery catheter and removed with the catheter following deployment. The AC torque sleeve and AE sleeve must couple the device to the catheter to facilitate device torquing pre-deployment. | PASS |
| Deployment Lumen Patency | This test evaluates the patency of the deployment line lumen. | AC/AE/SB: The deployment line lumen must allow passage of the deployment line(s). | PASS |

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| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Acute Angle Access | This test evaluates the ability of the loaded SB to access the branch vessel in a tortuous simulated use environment. | SB: The SB shall track through the portal of a deployed AC device without sustaining visible damage in order to treat branch vessel angles. | PASS |
| Stent Graft | | | |
| Nitinol Material Analysis | This test evaluates the chemical elements present in the bulk and on the surface of the wire and examines the wire surface for contamination and/or defects. | AC/AE/SB: Chemically analyze and quantify the elements present in the bulk and on the surface of the wire. Examine the wire surface for contamination and/or defects. The wire surface must be adequately free of anomalies or contaminants under examination with SEM. Anomalies would include large pits or cracks on the wire surface. | PASS** |
| Nitinol Corrosion | This test evaluates the corrosion resistance of the endoprosthesis. | AC/AE/SB: Characterize the corrosion resistance of the Nitinol wire used to wind the stent. Results must be comparable to an appropriate predicate device. | Characterization ** |
| Nickel Leachability | This test evaluates the nickel leachability of the device. | AC/AE/SB: The results from the worst case configuration, one TBE 53 mm x 20 cm Aortic Component (AC), one 12 mm x 20 mm Side Branch (SB), one 53 mm Aortic Extender (AE), and three 45 mm x 20 cm CTAG devices, must be less than or equal to the acute nickel limit of 290 μg/day during the first 24 hours and chronic nickel limit of 29 μg/day during the duration of the 60 day testing. | PASS |
| Thermo-mechanical Properties | This test evaluates the thermo-mechanical properties of the device. | AC/AE/SB: When deployed at 37 +/- 2°C, the device must open without excessive invagination or any unacceptable obstruction to the flow in order to confirm the superelastic property of the Nitinol material in a final device configuration. Excessive invagination is defined as infolding of the stent frame or infolding of the graft material beyond that expected in the maximum oversizing condition for the respective device size. | PASS |

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| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Radial Outward Force | This test evaluates the radial outward force of the GORE® TAG® Thoracic Branch Endoprosthesis. | AC/AE: For each device diameter, radial force of the AC and AE must be comparable to that of the GORE® TAG® Conformable Thoracic Stent Graft.SB: Leading End Radial Force: The radial force of the leading end of the SB must be comparable to that of the minimum GORE® TAG® Conformable Thoracic Stent Graft radial force. | PASS |
| Durability Testing – Pulsatile Fatigue | This test evaluates durability through accelerated testing. Finite Element Analysis was used to determine the strains present in the wire stent structure under specific loading conditions for each size. | AC/AE/SB: The GORE® TAG® Thoracic Branch Endoprosthesis components must withstand simulated physiologic pulsatile loading for ten years without wire fractures, failure of the graft material, or failure of the graft material/Nitinol endoprosthesis composite that would compromise device function.Devices were evaluated in single and overlapped configurations. | PASS |
| Durability Testing – Aortic Bending Fatigue | This test evaluates durability through accelerated testing. | AC: The Aortic Component shall be evaluated in accelerated alternating-bending testing motion in a modular configuration. Wire fractures and/or ePTFE wear shall be equivalent to or better than the GORE® TAG® Conformable Thoracic Endoprosthesis device design. | PASS |
| Durability Testing – Side Branch Bending Fatigue | This test evaluates durability through accelerated testing. | SB: The SB device was evaluated in clinically relevant accelerated alternating-bending testing in a modular configuration with the Aortic component. The rate of wire fractures and/or ePTFE wear to the SB shall be better than state-of-the-art arch repair therapies and equivalent to or better than the GORE® TAG® Device design. The Aortic component portal was also evaluated for wire fractures and/or ePTFE wear. The results were interpreted with respect to GORE® TAG® Device historical clinical performance and expected clinical use. | PASS |
| MRI Safety and Compatibility | This test evaluates the safety of the device in an MR environment using 1.5 and 3.0 Tesla magnetic fields. | AC/AE/SB: The endoprosthesis shall not present an additional hazard or risk when implanted in a patient undergoing a MRI procedure or who may be present in a MRI environment of ≤ 3.0 Tesla. The device may affect MRI quality depending on the pulse sequence that is used and the imaging area of interest. | PASS |

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| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Sealing | This test evaluates the ability of the stent-graft to seal an aneurysm in a simulated use environment. | AC/AE/SB: The overall rate of fluid loss, due to the sealing of the device and the water permeability of the graft material, shall be no worse than the amount of fluid lost through the GORE® TAG® Thoracic Endoprosthesis Device design. | PASS |
| Acute Anchoring | This test evaluates the ability of the device to remain at the target deployment location over time or with increased flow velocity. | AC/AE/SB: Migration of the leading and trailing ends of the device must be ≤ 5 mm. | PASS |
| Compression Resistance | This test evaluates the compression resistance of the device in a simulated use environment. | AC: The device must be resistant to compression when subjected to increased physiologically relevant pulsatile flow rates in an appropriate in vitro model. | PASS |
| Conformability | This test evaluates the ability of the device to conform in a specific anatomy. Conformance is defined as the minimum amount of surface contact between the graft material and an inner curve of a transection model that is acceptable to maintain compression resistance when subjected to increased physiologically relevant pulsatile flow rates. | AC: The device must conform to the inner curve of a transection model when deployed under simulated physiological flow rates. | PASS |

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| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Bend Radius | This test evaluates the minimum radius that the endovascular prosthesis can bend without kinking. Bend radius is defined as the minimum radius at which the device does not kink. | AC/AE: The allowable bend radius must be ≤ 12.6 mm. SB: The SB bend radius must be ≤ 2.5 mm. | PASS |
| Heparin Activity | This test evaluates the heparin activity of the side branch. | SB: The heparin activity must be at a sufficient level to ensure lasting thromboresistance. | PASS |
| Side Branch Flow | This test evaluates the mean perfusion rates (mL/min) of fluid through the SB in a simulated use environment. | SB: The flow rate through the SB shall be characterized before, during, and after system deployment during simulated use testing. | Characterization |
| Pressure Drop | This test evaluates the pressure drop across the SB in a simulated use environment. | SB: In-vitro testing must demonstrate that the mean pressure drop shall be < 15 mmHg. | PASS |
| Sleeve Overhang | This test evaluates the amount of sleeve overhang at the proximal and distal ends of the device post-deployment. | AC/SB: The deployment sleeve overhang (length of the sleeve beyond the strut) for the Aortic and SB components shall be ≤ to 5 mm at each end of the stent-graft. In addition, the AC sleeve must not prohibit delivery and deployment of the SB component. | PASS |
| Transmural Leakage | This test determines the porosity of the graft material for an endovascular prosthesis constructed of non-textile materials. | AC/AE: The device must demonstrate no visible leakage of serous fluid when pressurized to 200 mmHg. | PASS |
| Water Permeability | This test evaluates the ability to resist water leakage through holes in the graft material under pressure. | AC/AE/SB: Characterize the water permeability of the devices. Refer to sealing for appropriate acceptance criteria. | Characterization |
| Device Luminal Surface | This test evaluates the structure of the inside lumen of the final deployed device. | AC/AE/SB: The average fibril length of the graft must meet specification. | PASS |

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| Test | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Delivery System | | | |
| Catheter Shaft to Hub Bond Strength* | Evaluate the bond strength of the catheter shaft to the deployment hub. | AC/AE/SB: The catheter shaft to hub assembly must have tensile bond strengths ≥ 7.0 lbs. | PASS |
| Olive and Transition Attachment Strength * | Evaluate the bond strength of the catheter leading olive and transition attachment. | AC/AE/SB: The bond strength of the olive-to-distal catheter shaft, transition-to-distal catheter shaft, and transition-to- catheter shaft shall be ≥ 7.0 lbs. | PASS |
| Deployment System Tensile Strength* | This test evaluates the strength of the bond between the deployment line and the deployment knob. | AC/AE: The tensile strength of the catheter deployment system must be > 7.0 lbs.
SB: The tensile strength of the catheter deployment system must be > 5.0 lbs. | PASS |
| Catheter Leak | This test evaluates the leak resistance of the catheter. | AC/AE/SB: Pressure at which leakage of the delivery catheter guidewire lumen occurs shall be ≥ 300 kPa for all devices. | PASS |
| Catheter Torque | This test evaluates the torque strength of the catheter. | AC/AE/SB: The torque required to break the hub assembly to catheter bond shall be ≥ 13 in-oz. | PASS |
| Catheter Rotation | This test evaluates the ability of the catheter to rotate 360° without mechanical damage or failure. | AC/AE: The hub of the AC and AE catheter must rotate 360° without mechanical damage or failure when the leading end is fixed. | PASS |
| Retraction Force | This test evaluates the ability to safely withdraw the delivery system. | AC/AE/SB: The force to retract the catheter through the introducer sheath post-deployment must be < 7.0 lbs. for all sizes. | PASS |
| Guidewire Compatibility* | This test evaluates the device compatibility with the specified guidewire. | AC/AE/SB: The catheter and removable guidewire tube must be compatible with a 0.035” or smaller guidewire. The guidewire shall pass freely through the catheter without obstruction. | PASS |
| Flushable Guidewire Lumen* | This test evaluates the flushability of the guidewire lumen. | AC/AE/SB: The guidewire lumen of the catheter must be flushable with water or saline whereby fluid enters at the guidewire/flush port and exist at the leading end of the catheter through the guidewire lumen. | PASS |
| *Testing was also completed to support the 36-month shelf-life study (See Section IX-D). | | | |
| ** GORE® TAG® Conformable Thoracic Endoprosthesis device testing leveraged due to similarities in processing and design. | | | |

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B. Animal Studies

The GORE® TAG® Thoracic Branch Endoprosthesis was subjected to 2 (two) GLP animal studies to evaluate the safety and performance of the device. The GLP in vivo animal study demonstrated the safety and overall product performance of the GORE® TAG® Thoracic Branch Endoprosthesis in vivo in a total of 13 domestic swine. Table 3 summarizes the result of the GLP study conducted on finished, sterile devices.

Table 3: Summary Result of the GLP Animal Study

| Study Description | Study Overview | Purpose | Summary of Test Results |
| --- | --- | --- | --- |
| #2156SC
An acute evaluation of the GORE® TAG® Thoracic Branched Endoprosthesis in the swine model | - Animal Model: 3 Domestic swine
- Anatomical Deployment Location: Thoracic aorta/left subclavian artery
- Responses Evaluated: Assessed delivery system performance and functional performance (at 0 days) assessed against acceptance criteria | To evaluate the delivery system performance and functional performance of the GORE® TAG® Thoracic Branch Endoprosthesis (AC, SB, AE) and accessory devices. | Delivery performance: Passing scores for all delivery performance attributes.
Functional performance: Passing scores for all functional performance attributes. No abnormal necropsy findings were observed. |
| #2155SC*
GORE® TAG® Thoracic Branched Endoprosthesis evaluation in the porcine left subclavian artery | - Animal Model: Domestic swine (10 at day 0, 6 at 90 days and 3 at 180 days)
- Anatomical Deployment Location: Thoracic aorta/left subclavian artery
- Responses Evaluated: Delivery system performance (n=10) and functional performance (n=6 at 90 days, n=3 at 180 days) | To evaluate the delivery system and the long-term functional performance of the GORE® TAG® Thoracic Branch Endoprosthesis (AC/SB) in the left subclavian artery position. | Delivery performance: Passing scores for all attributes.
Functional performance: Passing scores for all attributes. No abnormal necropsy findings were observed. |

*#2155 was also used to assess the biocompatibility endpoint for in vivo thrombogenicity for the SB and AC.

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# C. Biocompatibility Studies

Biocompatibility testing was conducted on the GORE® TAG® Thoracic Branch Endoprosthesis in accordance with applicable Good Laboratory Practices (21 CFR §58) and ISO 10993-1: 2009, Biological Evaluation of Medical Devices.

The GORE® TAG® Thoracic Branch Endoprosthesis delivery systems are classified as externally communicating in limited contact (&lt; 24 hrs) with circulating blood. The stent-grafts are classified as an implant device in permanent contact (&gt; 30 days) with circulating blood.

All testing performed met the pre-specified acceptance criteria. A summary of the biocompatibility testing conducted can be found in Table 4.

Table 4: Summary of GORE® TAG® Thoracic Branch Endoprosthesis Implant Biocompatibility Testing

| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Cytotoxicity | To determine if device extracts cause cytotoxicity | Test article extract cytotoxicity score is ≤ 2. | PASS |
| Sensitization | To evaluate the allergenic potential or sensitizing capacity of device extracts | Test article extracts do not elicit a dermal observation grade > 1 at the challenge provided the control group did not also receive grades > 1. | PASS |
| Irritation / Intracutaneous Reactivity | To determine if any chemicals that may leach or be extracted from the test article were capable of causing local irritation | The difference in the average scores between test and control extracts is ≤ 1. | PASS |
| Acute Systemic Toxicity | To screen device extracts for potential toxic effects as a result of single-dose systemic injections | None of the animals treated with test extracts exhibit significantly greater biological reactions than control animals. | PASS |
| Pyrogenicity | To determine if a saline extract of the device causes a febrile response | Temperature increases in individual animals treated with test article extract are each ≤ 0.5°C. | PASS |

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| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Implantation | Evaluate the local effects of a device in direct contact with living skeletal muscle tissue | Histological evaluation of implant sites, aided by gross observation at necropsy, indicate that tissue responses surrounding test article implants are not significantly greater than those associated with the negative control article. | PASS |
| Hemocompatibility Hemolysis | To evaluate the hemolytic potential of the device | Hemolytic indices above the negative controls for the direct contact and extraction evaluations are both ≤ 2%. | PASS |
| Hemocompatibility Complement | To measure complement activation when serum is exposed to a device which indicates whether a device is capable of generating activation fragment SC5b-9, which contributes to the inflammatory immune response | The test article is not considered to have a clinically relevant effect on SC5b-9 complement activation. | PASS* |
| Hemocompatibility Thrombogenicity | To evaluate the potential of the test device to resist thrombus formation when placed in the vasculature as evaluated in an animal study. | SB and AC: Characterization only
AE: Thrombus and patency scores for the test article are not substantially worse than those for the commercial, control article (≤ 2 point difference). | PASS |
| Genotoxicity | To determine whether long-term (>30 days) patient exposure to levels of exhaustively extracted chemicals from the test articles could produce unacceptable human health risks, including carcinogenic and systemic non-carcinogenic risks. | Refer to Chemical characterization and Toxicological Risk Assessment | PASS |
| Carcinogenicity | | | |
| Reproductive and Developmental Toxicity | | | |
| Subchronic/Chronic Toxicity | | | |

* The AC and AE components did not activate SC5b-9 fragments in vitro. The SB implant generated statistically significant levels of SC5b-9 fragments in the in vitro complement activation assay compared to a negative reference material. All final SC5b-9 concentrations recorded in the complement activation assay of the SB component, including those for all control articles except for Normal Human Serum at rest, are on the high end of historical ranges of this study and, thus, strongly suggest non-specific signal elevation in this particular assay.

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Neither a 180-day preclinical porcine study nor a human clinical trial spanning 8 years have revealed any evidence of complement activation. Furthermore, all of the materials comprising the SB implant are used in commercial GORE medical devices with successful clinical histories. Therefore, the results for SB complement activation were determined to be acceptable.

Table 5: Summary of GORE® TAG® Thoracic Branch Endoprosthesis Delivery System Biocompatibility Testing

| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Cytotoxicity | To determine if device extracts cause cytotoxicity | Test article extract cytotoxicity score is ≤ 2. | PASS |
| Sensitization | To evaluate the allergenic potential or sensitizing capacity of delivery system extracts | Test article extracts do not elicit a dermal observation grade > 1 at the challenge provided the control group did not also receive grades > 1. | PASS |
| Irritation / Intracutaneous Reactivity | To determine if any chemicals that may leach or be extracted from the test article were capable of causing local irritation | The difference in the average scores between test and control extracts is ≤ 1. | PASS |
| Acute Systemic Toxicity | To screen delivery system extracts for potential toxic effects as a result of single-dose systemic injections | None of the animals treated with test extracts exhibit significantly greater biological reactions than control animals. | PASS |
| Pyrogenicity | To determine if a saline extract of the delivery system causes a febrile response | Temperature increases in individual animals treated with test article extract are each ≤ 0.5°C. | PASS |
| Hemocompatibility Hemolysis | To evaluate the hemolytic potential of the delivery system | Hemolytic indices above the negative controls for the direct contact and extraction evaluations are both ≤ 2%. | PASS |
| Hemocompatibility Complement | To measure complement activation when serum is exposed to a delivery system which indicates whether a delivery system is capable of generating activation fragment SC5b-9, which contributes to the inflammatory immune response | The test article is considered to have no effect on complement activation if the SC5b-9 concentration is not statistically different than the negative reference material or if the test article results are statistically significantly less than the negative reference material. | PASS |

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| Test Performed | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Hemocompatibility
Thrombogenicity | To evaluate the potential of the test delivery system to resist thrombus formation when placed in the vasculature as evaluated in an animal study. | All animals survived the general anesthesia and study observation interval, and the patency and thrombus scores were not subjectively different between the test and control articles. | PASS |

## D. Sterilization, Packaging, and Shelf-Life

The GORE® TAG® Thoracic Branch Endoprosthesis is sterilized by Ethylene Oxide (EO). Validation of the sterilization method to ensure a Sterility Assurance Level (SAL) of 10⁻⁶ has been conducted in accordance with ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

Packaging Validation demonstrated the ability of the packaging to protect the product and maintain a sterile barrier through shipping and shelf life.

A shelf life of three (3) years has been established for the GORE® TAG® Thoracic Branch Endoprosthesis based on product and package shelf-life testing. The specific engineering tests completed to support the shelf-life are denoted by an asterisk (*) in Table 2.

## X. SUMMARY OF PRIMARY CLINICAL STUDY

The applicant performed a clinical study (SSB 11-02) to establish a reasonable assurance of safety and effectiveness of the GORE® TAG® Thoracic Branch Endoprosthesis for endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery in the US under IDE # G130120. 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 September 2016 and October 2019. The database for this PMA reflected data collected through April 12, 2021 and included 238 patients. There were 40 investigational sites in the US.

The study was a prospective, multicenter, non-randomized clinical study with two (2) study arms specific to proximal placement of the device in Zone 2 with a total of four (4) cohorts. The arms are described as follows:

- Zone 2 – Aneurysm Arm/Cohort: Primary enrollment cohort with hypothesis-driven analysis

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- Zone 2 – Non-aneurysm Arm: Descriptive analysis
- Dissection Cohort
- Traumatic Transection Cohort
- Other isolated lesion types (Other Isolated Lesions are Non-Aneurysm, Non-Traumatic Transection, or Non-Dissection lesions with non-diseased proximal and distal landing zones for example intramural hematomas, aortic ulcers etc.)

Each cohort was analyzed separately by lesion type.

The primary endpoint was a composite of the following events from the time of enrollment through 12 months:

- Device Technical Success
- Absence of the following:
- Aortic rupture;
- Lesion-related mortality;
- Disabling stroke (within 30 days);
- Permanent paraplegia (within 30 days);
- Permanent paraparesis (within 30 days);
- New onset renal failure requiring permanent dialysis (within 30 days);
- Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system.

Primary endpoint (mixture of safety and effectiveness) success was defined as the proportion of analysis-eligible subjects without a primary endpoint event that met all of the endpoint components (described above) and with 12-Month imaging performed. The Aneurysm Cohort was the only cohort with a performance goal to be tested. The results were tested against a performance goal of 64%, derived from historical GORE TAG® Thoracic Endoprosthesis and Conformable GORE® TAG® Thoracic Endoprosthesis study data (P040043). The hypothesis tested against a one-sided alpha level of 0.05 was:

Null hypothesis (H₀): p ≤ 0.64

Alternative hypothesis (Hₐ): p &gt; 0.64

Where p is the proportion of Subjects with primary endpoint success, as described above.

No hypothesis tests were planned for the Non-Aneurysm Cohorts.

GORE® TAG® Thoracic Branch Endoprosthesis Aneurysm feasibility data (G130120) was used to estimate primary endpoint success to be 78% in Aneurysm. Using the Exact Binomial Test and assuming a one-sided alpha of 0.05, a performance goal of 64%, and power of at least 80%, the sample size needed was 70 patients. Assuming 18% attrition, the sample size required was 85 patients.

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Evaluation groups used during the course of the pivotal study are described below:

- During the screening process, all patients who were assessed by an Investigator to meet all inclusion / exclusion criteria were submitted to Gore for review and case approval. At the conclusion of the process, the site was notified by Gore on the patient’s eligibility (Accept / Reject).
- An independent external Core Laboratory (Core Lab) was used to perform evaluations on all medical imagery submitted by clinical sites. The Core Lab reported all measurements and device assessments to Gore.
- An external Clinical Events Committee (CEC) adjudicated safety and certain effectiveness endpoint events for the study as well as reviewed inclusion / exclusion violations for potential impact on subject safety. Effectiveness endpoint events not adjudicated by the CEC were determined by the Core Lab.
- An independent Data Safety Monitoring Board (DSMB) reviewed all available safety data on a regular basis and provided recommendations on the continuing safety, validity and scientific merit of the study.

1. Clinical Inclusion and Exclusion Criteria

Enrollment in the SSB 11-02 study arms described above was limited to patients who met the following inclusion criteria:

- Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 2.
- Age ≥18 years at time of informed consent signature
- Subject is capable of complying with protocol requirements, including follow-up.
- Informed Consent Form (ICF) is signed by Subject or legal representative
- Must have appropriate proximal aortic landing zone.
- Must have appropriate target branch vessel landing zone.
- For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.

Patients were not permitted to enroll in the SSB11-02 study arms described above if they met any of the following exclusion criteria:

- Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
- Previous endovascular repair of the ascending aorta
- Previous endovascular repair of the DTA with a non-Gore device
- Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access, or surgery to treat any other presenting injuries in Traumatic Transection Subjects only.

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- Infected aorta
- Life expectancy &lt;2 years
- Myocardial infarction within 6 weeks prior to treatment
- Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.
- Patient has a systemic infection and may be at increased risk of endovascular graft infection
- Pregnant female at time of informed consent signature
- Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
- Participation in another drug or medical device study within one year of study enrollment
- Known history of drug abuse within one year of treatment
- Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
- Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
- Planned coverage of celiac artery
- Patient has known sensitivities or allergies to the device materials
- Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
- Previous instance of Heparin Induced Thrombocytopenia Type 2 (HIT-2) or known hypersensitivity to heparin
- Patient with a history of a hypercoagulability disorder and/or hypercoagulability state
- Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper
- Mycotic aneurysm
- Persistent refractory shock (systolic blood pressure &lt;90 mm Hg)
- Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
- Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) &lt;30 or currently requiring dialysis

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2. Follow-up Schedule

All patients were required to return for follow-up examinations at 1, 6, 12, 24, 36, 48 and 60 months. Table 6 outlines the required screening evaluations and follow-up visit procedures for subjects.

Table 6: Schedule of Events
| | Pre-Treatment | Treatment | Discharge | 1 month | 6 months | Annually for up to 5 years |
| --- | --- | --- | --- | --- | --- | --- |
| Physical examination | X | | X | X | X | X |
| Serum Creatinine Concentration | X | | | | | |
| Spiral CTA (contrast) | X | | | X | X | X |
| Spiral CT (non-contrast) | | | | X | | |
| Angiogram | | X | | | | |

3. Clinical Endpoints

With regards to safety and effectiveness, the primary endpoint for all cohorts was a composite of the following events through 12 months:

- Device Technical Success
- Successful access and delivery to the intended implantation site, and retrieval of the device delivery system, and;
- Patency of the graft, and;
- The absence of unanticipated additional procedure related to the device, procedure, or withdrawal of the delivery system

- Absence of the following:
- Aortic rupture
- Lesion-related mortality
- Disabling stroke
- Stroke was assessed using the Modified Rankin Scale (mRS). Stroke identified as having occurred within 30 days of the index endovascular procedure, combined with mRS≥2 with an increase from baseline of at least one grade due to neurological deficits at no more than 120 days post index endovascular procedure.
- Permanent paraplegia
- Paraplegia secondary to Spinal Cord Ischemia (SCI) identified within 30 days of the index endovascular procedure combined with SCI scale grade = 3 at the one month follow-up visit.
- Permanent paraparesis
- Paraparesis secondary to SCI identified within 30 days of the index endovascular procedure, combined with SCI scale grade = 2 at the one month follow-up visit.

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○ New onset renal failure requiring permanent dialysis
▪ New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with need/requirement for dialysis at the one month follow-up visit.

○ Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system

With regard to overall study success, the primary endpoint performance goal of 64% for the Aneurysm cohort needed to be met in order to achieve study success. The primary endpoint analysis for the other cohorts (Dissection, Traumatic Transection and Other Isolated Lesion) was analyzed for each cohort and was reported descriptively (no hypothesis tests).

In addition to the primary endpoint analysis, Procedural and Treatment Success data was collected and analyzed for each cohort and were reported descriptively and independent of the performance goal.

- Procedural Success - defined as Device Technical Success, with absence of the following from the initiation of the endovascular procedure through the one month follow-up window (59 days) unless otherwise noted below:

○ Death (Through 30 days only)
○ Aortic rupture (Through 30 days only)
○ Disabling stroke (Through 30 days only)
○ Paraplegia (Through 30 days only)
○ Paraparesis (Through 30 days only)
○ New onset renal failure requiring dialysis (Through 30 days only)
○ Additional unanticipated surgical (including conversion to open surgery) or interventional (placement of additional unanticipated endovascular devices) procedure related to the device, procedure, or withdrawal of the delivery system
○ New ischemia
○ Distal device-related thromboembolic adverse event requiring intervention or surgery
○ Extension of a dissection (proximally or distally) (Dissection cohort only)
○ New dissection
○ Life-threatening bleed (Through 30 days only)
○ Myocardial infarction (Through 30 days only)
○ Prolonged intubation
○ Laryngeal or Phrenic Nerve injury (Through 30 days only)
○ Renal dysfunction or volume overload requiring ultrafiltration
○ Severe Heart Failure/Hypotension

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- Treatment Success- defined as Device Technical Success with absence of the following events occurring from the initiation of the index endovascular procedure and at all appropriate follow-up windows:
- Aortic enlargement in the region encompassed by the initial lesion
- Aortic rupture
- Extension of a dissection (proximally or distally) (Dissection cohort only)
- New dissection
- False lumen perfusion through the primary entry tear (Dissection cohort only)
- False lumen perfusion through an aortic arch branch vessel (Dissection cohort only)
- Type I or III endoleak
- Fistula formation
- Lesion-related mortality
- Loss of device integrity
- Loss of aortic or aortic branch patency
- Migration
- Disabling stroke within 30 days of the index endovascular procedure only
- Paraplegia within 30 days of the index endovascular procedure only
- Paraparesis within 30 days of the index endovascular procedure only
- New ischemia
- Additional unanticipated surgical (including conversion to open surgery) or interventional (placement of additional unanticipated endovascular devices) procedure related to the device, procedure, or withdrawal of the delivery system

The following outcomes, which were not components of Procedural or Treatment Success, were pre-defined as additional outcomes within the study protocol and collected:
- Type II endoleak
- Type IV endoleak
- Significant Blood Loss
- False Lumen Status in treated and untreated segments (Dissection cohort only)
- False Lumen perfusion through a non-aortic arch branch vessel (Dissection cohort only)

## B. Accountability of PMA Cohort

At the time of database lock, 238 patients were eligible and included for analysis. Two patients were excluded from analysis due to a major protocol deviation. Table 7 and Table 8 summarize compliance with the follow-up visit and imaging requirements directed by the investigational plan for enrolled Aneurysm and Dissection Subjects.

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Table 7: Subject Disposition and Compliance by Study Period for Aneurysm Cohort

| | | Subjects with Data for Visit | | | | | Adequate Imaging to Assess Parameter2 | | | | | Subject Status | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Visit | Eligible for Follow-Up | Subjects with Data for that Visit | Physical Exam | CT | MRA | Subjects with Follow-Up Pending1 | Size Increase (Aortic Enlargement) | Endoleak | Device Migration | Wire Fracture | Device Patency | Death | Conversion | LTF3 | Not Due for Next Visit4 |
| Endovascular Procedure | 84 | 84 (100.0%) | - | - | - | 0 (0%) | - | - | - | - | 84 (100.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Post-Procedure | 84 | 82 (97.6%) | 80 (95.2%) | 13 (15.5%) | 0 (0%) | 0 (0%) | - | 12 (14.3%) | 13 (15.5%) | 13 (15.5%) | 13 (15.5%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| 1 Month | 84 | 79 (94.0%) | 78 (92.9%) | 72 (85.7%) | 1 (1.2%) | 0 (0%) | - | 69 (82.1%) | 72 (85.7%) | 72 (85.7%) | 70 (83.3%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| 6 Months | 84 | 76 (90.5%) | 72 (85.7%) | 74 (88.1%) | 0 (0%) | 0 (0%) | 62 (73.8%) | 72 (85.7%) | 73 (86.9%) | 73 (86.9%) | 72 (85.7%) | 3 (3.6%) | 0 (0%) | 1 (1.2%) | 0 (0%) |
| 12 Months | 80 | 74 (92.5%) | 69 (86.3%) | 68 (85.0%) | 1 (1.3%) | 0 (0%) | 57 (71.3%) | 66 (82.5%) | 67 (83.8%) | 66 (82.5%) | 67 (83.8%) | 2 (2.5%) | 0 (0%) | 2 (2.5%) | 0 (0%) |
| 24 Months | 76 | 64 (84.2%) | 55 (72.4%) | 53 (69.7%) | 0 (0%) | 0 (0%) | 47 (61.8%) | 51 (67.1%) | 53 (69.7%) | 53 (69.7%) | 51 (67.1%) | 5 (6.6%) | 0 (0%) | 3 (3.9%) | 0 (0%) |
| 36 Months | 68 | 37 (54.4%) | 29 (42.6%) | 33 (48.5%) | 0 (0%) | 24 (35.3%) | 25 (36.8%) | 26 (38.2%) | 28 (41.2%) | 28 (41.2%) | 27 (39.7%) | 1 (1.5%) | 0 (0%) | 2 (2.9%) | 33 (48.5%) |
| 48 Months | 32 | 4 (12.5%) | 2 (6.3%) | 4 (12.5%) | 0 (0%) | 28 (87.5%) | 1 (3.1%) | 1 (3.1%) | 1 (3.1%) | 1 (3.1%) | 1 (3.1%) | 0 (0%) | 0 (0%) | 0 (0%) | 32 (100.0%) |
| 1Subjects still within follow-up window, but data not yet available.2Not the number of Subjects with these reported events, but rather, the number with adequate imaging as assessed by Core Lab, such as paired size data to evaluate aneurysm growth. Wire fracture is if at least partially evaluable.3In this table, lost to follow-up (LTF) includes all other reasons for study discontinuation including Subjects that have withdrawn from the study.4Those Subjects that are “Not due for next visit” are those subjects that are not within the follow-up window for the next interval.Study period definitions: Endovascular Procedure (0 days) Post-Procedure (1-14 days) 1 Month (15-59 days) 6 Months (60-242 days) 12 Months (243-546 days) 24 Months (547-911 days) 36 Months (912-1275 days) 48 Months (1276-1640 days) 60 Months (1641-2006 days) | | | | | | | | | | | | | | | |

Table 8: Subject Disposition and Compliance by Study Period for Dissection Cohort

| | | Subjects with Data for Visit | | | | | Adequate Imaging to Assess Parameter2 | | | | | Subject Status | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Visit | Eligible for Follow-Up | Subjects with Data for that Visit | Physical Exam | CT | MRA | Subjects with Follow-Up Pending1 | Size Increase (Aortic Enlargement) | Endoleak | Device Migration | Wire Fracture | Device Patency | Death | Conversion | LTF3 | Not Due for Next Visit4 |
| Endovascular Procedure | 132 | 132 (100.0%) | - | - | - | 0 (0%) | - | - | - | - | 132 (100.0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Post-Procedure | 132 | 129 (97.7%) | 124 (93.9%) | 17 (12.9%) | 0 (0%) | 0 (0%) | - | 17 (12.9%) | 16 (12.1%) | 17 (12.9%) | 16 (12.1%) | 4 (3.0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| 1 Month | 128 | 119 (93.0%) | 118 (92.2%) | 109 (85.2%) | 0 (0%) | 0 (0%) | - | 106 (82.8%) | 109 (85.2%) | 104 (81.3%) | 107 (83.6%) | 2 (1.6%) | 0 (0%) | 0 (0%) | 0 (0%) |
| 6 Months | 126 | 113 (89.7%) | 97 (77.0%) | 108 (85.7%) | 1 (0.8%) | 0 (0%) | 95 (75.4%) | 103 (81.7%) | 107 (84.9%) | 102 (81.0%) | 106 (84.1%) | 5 (4.0%) | 0 (0%) | 0 (0%) | 0 (0%) |

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| | | Subjects with Data for Visit | | | | | Adequate Imaging to Assess Parameter² | | | | | Subject Status | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Visit | Eligible for Follow-Up | Subjects with Data for that Visit | Physical Exam | CT | MRA | Subjects with Follow-Up Pending¹ | Size Increase (Aortic Enlargement) | Endoleak | Device Migration | Wire Fracture | Device Patency | Death | Conversion | LTF³ | Not Due for Next Visit⁴ |
| 12 Months | 121 | 103 (85.1%) | 99 (81.8%) | 98 (81.0%) | 0 (0%) | 1 (0.8%) | 90 (74.4%) | 94 (77.7%) | 97 (80.2%) | 94 (77.7%) | 95 (78.5%) | 3 (2.5%) | 0 (0%) | 3 (2.5%) | 2 (1.7%) |
| 24 Months | 113 | 76 (67.3%) | 64 (56.6%) | 68 (60.2%) | 0 (0%) | 24 (21.2%) | 59 (52.2%) | 60 (53.1%) | 64 (56.6%) | 60 (53.1%) | 61 (54.0%) | 4 (3.5%) | 0 (0%) | 2 (1.8%) | 32 (28.3%) |
| 36 Months | 75 | 35 (46.7%) | 29 (38.7%) | 32 (42.7%) | 0 (0%) | 30 (40.0%) | 29 (38.7%) | 25 (33.3%) | 29 (38.7%) | 28 (37.3%) | 25 (33.3%) | 0 (0%) | 0 (0%) | 1 (1.3%) | 38 (50.7%) |
| 48 Months | 36 | 6 (16.7%) | 5 (13.9%) | 6 (16.7%) | 0 (0%) | 28 (77.8%) | 3 (8.3%) | 4 (11.1%) | 4 (11.1%) | 4 (11.1%) | 4 (11.1%) | 1 (2.8%) | 0 (0%) | 2 (5.6%) | 33 (91.7%) |
| ¹Subjects still within follow-up window, but data not yet available.
²Not the number of Subjects with these reported events, but rather, the number with adequate imaging as assessed by Core Lab, such as paired size data to evaluate aneurysm growth. Wire fracture is if at least partially ev
³In this table, lost to follow-up (LTF) includes all other reasons for study discontinuation including subjects that have withdrawn from the study.
⁴Those Subjects that are “Not due for next visit” are those Subjects that are not within the follow-up window for the next interval.
Study period definitions: Endovascular Procedure (0 days) Post-Procedure (1-14 days) 1 Month(15-59 days) 6 Months(60-242 days) 12 Months(243-546 days) 24 Months(547-911 days) 36 Months(912-1275 days) 48 Months(1276-1640 days) 60 Months(1641-2006 days) | | | | | | | | | | | | | | | |

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Subject compliance with follow-up visits and imaging requirements for the Traumatic Transection and Other Isolated Lesion Cohorts is summarized below:

- Traumatic Transection Cohort: All nine (100%) eligible Subjects in this cohort had a 1-Month visit and imaging. Seven (77.8%) Subjects had their 12-Month visit (66.7% had imaging). All nine Subjects were through the 12-Month follow-up window, with four Subjects in the 24-Month window and five in the 36-Month window. There have been no deaths or discontinuations in this cohort.
- Other Isolated Lesion Cohort: Twelve (92.3%) of the 13 Subjects in this cohort had a 1-Month visit and imaging. Eleven Subjects were eligible for a 12-Month follow-up visit, and 9 (81.8%) Subjects had their 12-Month visit (72.7% had imaging). Two Subjects were still in the 12-Month window, with four in the 24-Month window, one in the 36-Month window, and one in the 48-Month window. There have been four deaths and one non-death discontinuation in this cohort.

## C. Study Population Demographics and Baseline Parameters

### 1. Demographics

The demographics of the study population are typical for a thoracic endovascular graft study performed in the US.

A summary of Subject demographics can be found in Table 9. The majority of Subjects were male (63.1% for Aneurysm, 75.0% for Dissection, 88.9% for Traumatic Transection, and 46.2% for Other Isolated Lesion). Most Subjects also specified white as their race (79.8% for Aneurysm, 72.7% for Dissection, 55.6% for Traumatic Transection, and 69.2% for Other Isolated Lesion). The median ages reported were 72 years for Aneurysm, 64 years for Dissection, 43 years for Traumatic Transection, and 67 years for Other Isolated Lesion.

Table 9: Baseline Demographics

| | Aneurysm Arm | Non-Aneurysm Arm | | | Total |
| --- | --- | --- | --- | --- | --- |
| | Zone 2 Aneurysm | Zone 2 Dissection | Zone 2 Traumatic Transection | Zone 2 Other Isolated Lesion | Zone 2 |
| Number of Enrolled Subjects | 84 | 132 | 9 | 13 | 238 |
| | | | | | |
| Sex | | | | | |
| Male | 53 (63.1%) | 99 (75.0%) | 8 (88.9%) | 6 (46.2%) | 166 (69.7%) |
| Female | 31 (36.9%) | 33 (25.0%) | 1 (11.1%) | 7 (53.8%) | 72 (30.3%) |
| | | | | | |
| Ethnicity | | | | | |
| Not Hispanic or Latino | 82 (97.6%) | 123 (93.2%) | 5 (55.6%) | 10 (76.9%) | 220 (92.4%) |
| Hispanic or Latino | 2 (2.4%) | 7 (5.3%) | 4 (44.4%) | 3 (23.1%) | 16 (6.7%) |
| Unknown | 0 (0%) | 2 (1.5%) | 0 (0%) | 0 (0%) | 2 (0.8%) |
| | | | | | |

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| | Aneurysm Arm | Non-Aneurysm Arm | | | Total |
| --- | --- | --- | --- | --- | --- |
| | Zone 2 Aneurysm | Zone 2 Dissection | Zone 2 Traumatic Transection | Zone 2 Other Isolated Lesion | Zone 2 |
| Race1 | | | | | |
| White | 67 (79.8%) | 96 (72.7%) | 5 (55.6%) | 9 (69.2%) | 177 (74.4%) |
| Black or African American | 12 (14.3%) | 29 (22.0%) | 0 (0%) | 2 (15.4%) | 43 (18.1%) |
| Asian | 4 (4.8%) | 3 (2.3%) | 0 (0%) | 0 (0%) | 7 (2.9%) |
| American Indian or Alaska Native | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Hawaiian or Pacific Islander | 2 (2.4%) | 1 (0.8%) | 0 (0%) | 0 (0%) | 3 (1.3%) |
| Other | 0 (0%) | 3 (2.3%) | 4 (44.4%) | 2 (15.4%) | 9 (3.8%) |
| | | | | | |
| Age (yrs) | | | | | |
| N | 84 | 132 | 9 | 13 | 238 |
| Mean (Std Dev) | 70.3 (11.11) | 62.5 (11.29) | 42.4 (18.95) | 64.8 (13.28) | 64.6 (12.93) |
| Median | 72.0 | 64.0 | 43.0 | 67.0 | 67.0 |
| Range | (33, 87) | (23, 88) | (22, 76) | (30, 79) | (22, 88) |
| | | | | | |
| BMI | | | | | |
| N | 84 | 132 | 9 | 13 | 238 |
| Mean (Std Dev) | 28.8 (6.30) | 30.5 (6.47) | 29.5 (5.03) | 25.8 (5.33) | 29.6 (6.39) |
| Median | 28.3 | 29.5 | 29.1 | 25.8 | 29.0 |
| Range | (18.9, 51.7) | (16.0, 53.9) | (23.8, 38.8) | (18.9, 38.4) | (16.0, 53.9) |
| 1One Zone 2 Aneurysm Subject had two races selected (Asian and Pacific Islander) | | | | | |

# 2. Subject Baseline Medical History

A summary of the Subject baseline medical history is provided in Table 10. The majority of Subjects had a medical history of hypertension (89.9%).

Table 11 summarizes Subject risk factors prior to enrollment. Most Subjects (70.2% for Aneurysm, 66.7% for Dissection, 44.4% for Traumatic Transection, and 69.3% for Other Isolated Lesion) had an American Society of Anesthesiologists (ASA) classification of III or higher. The majority of Subjects were classified as NYHA I or higher (62.6%), with only 37.4% of Subjects having no cardiac disease. The median Society of Vascular Surgeon's (SVS) risk score was 4.9 for the Aneurysm cohort, 5.3 for Dissection, 1.6 for Traumatic Transection, and 5.2 for Other Isolated Lesions. Approximately one third of the Subjects had a history of previous aortic surgery (38.1% for Aneurysm, 27.3% for Dissection, and 53.8% for Other Isolated Lesions), most commonly of the ascending aorta (56.0%).

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Table 10: Baseline Medical History

| | Aneurysm Arm | Non-Aneurysm Arm | | | Total |
| --- | --- | --- | --- | --- | --- |
| | Zone 2 Aneurysm | Zone 2 Dissection | Zone 2 Traumatic Transection | Zone 2 Other Isolated Lesion | Zone 2 |
| Number of Enrolled Subjects | 84 | 132 | 9 | 13 | 238 |
| | | | | | |
| Atrial fibrillation | 16/83 (19.3%) | 25/132 (18.9%) | 0/9 (0%) | 4/13 (30.8%) | 45/237 (19.0%) |
| Cancer | 21/83 (25.3%) | 20/130 (15.4%) | 1/9 (11.1%) | 1/13 (7.7%) | 43/235 (18.3%) |
| Cardiac arrhythmia | 15/83 (18.1%) | 46/132 (34.8%) | 0/9 (0%) | 5/13 (38.5%) | 66/237 (27.8%) |
| Chronic obstructive pulmonary disease | 16/84 (19.0%) | 16/131 (12.2%) | 0/9 (0%) | 3/13 (23.1%) | 35/237 (14.8%) |
| Congestive heart failure | 14/84 (16.7%) | 11/132 (8.3%) | 0/9 (0%) | 0/13 (0%) | 25/238 (10.5%) |
| Coronary artery bypass graft | 12/83 (14.5%) | 7/132 (5.3%) | 0/9 (0%) | 0/13 (0%) | 19/237 (8.0%) |
| Coronary artery disease | 27/83 (32.5%) | 19/126 (15.1%) | 1/9 (11.1%) | 3/13 (23.1%) | 50/231 (21.6%) |
| Diabetes mellitus | 14/84 (16.7%) | 19/132 (14.4%) | 1/9 (11.1%) | 2/13 (15.4%) | 36/238 (15.1%) |
| Erectile dysfunction (males only) | 7/27 (25.9%) | 4/44 (9.1%) | 1/5 (20.0%) | 0/3 (0%) | 12/79 (15.2%) |
| Great vessel stenosis | 1/83 (1.2%) | 1/129 (0.8%) | 0/9 (0%) | 0/11 (0%) | 2/232 (0.9%) |
| Hypercholesterolemia | 44/84 (52.4%) | 55/127 (43.3%) | 1/9 (11.1%) | 6/13 (46.2%) | 106/233 (45.5%) |
| Hypertension | 72/84 (85.7%) | 127/132 (96.2%) | 4/9 (44.4%) | 11/13 (84.6%) | 214/238 (89.9%) |
| Myocardial infarction | 14/83 (16.9%) | 10/127 (7.9%) | 0/9 (0%) | 2/12 (16.7%) | 26/231 (11.3%) |
| Nicotine use | 30/84 (35.7%) | 47/132 (35.6%) | 2/9 (22.2%) | 7/13 (53.8%) | 86/238 (36.1%) |
| Other vascular intervention | 11/83 (13.3%) | 8/131 (6.1%) | 0/9 (0%) | 2/13 (15.4%) | 21/236 (8.9%) |
| Paraplegia | 1/84 (1.2%) | 0/132 (0%) | 0/9 (0%) | 0/13 (0%) | 1/238 (0.4%) |
| Percutaneous coronary intervention | 14/82 (17.1%) | 3/132 (2.3%) | 0/9 (0%) | 2/13 (15.4%) | 19/236 (8.1%) |
| Peripheral vascular disease | 11/83 (13.3%) | 8/128 (6.3%) | 1/9 (11.1%) | 1/13 (7.7%) | 21/233 (9.0%) |
| Prior aortic surgery | 32/84 (38.1%) | 36/132 (27.3%) | 0/9 (0%) | 7/13 (53.8%) | 75/238 (31.5%) |
| Renal dialysis | 0/83 (0%) | 2/132 (1.5%) | 1/9 (11.1%) | 0/13 (0%) | 3/237 (1.3%) |
| Renal insufficiency | 14/84 (16.7%) | 24/132 (18.2%) | 1/9 (11.1%) | 0/13 (0%) | 39/238 (16.4%) |
| Stroke | 12/84 (14.3%) | 12/132 (9.1%) | 1/9 (11.1%) | 1/13 (7.7%) | 26/238 (10.9%) |
| Subclavian steal | 0/82 (0%) | 0/126 (0%) | 0/9 (0%) | 0/9 (0%) | 0/226 (0%) |
| Thromboembolic event | 7/83 (8.4%) | 10/132 (7.6%) | 0/9 (0%) | 0/13 (0%) | 17/237 (7.2%) |
| Transient ischemic attack | 6/84 (7.1%) | 2/132 (1.5%) | 0/9 (0%) | 0/13 (0%) | 8/238 (3.4%) |
| Valvular heart disease | 20/83 (24.1%) | 21/131 (16.0%) | 0/9 (0%) | 3/13 (23.1%) | 44/236 (18.6%) |

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Table 11: Baseline Risk Factors

| | Aneurysm Arm | Non-Aneurysm Arm | | | Total |
| --- | --- | --- | --- | --- | --- |
| | Zone 2 Aneurysm | Zone 2 Dissection | Zone 2 Traumatic Transection | Zone 2 Other Isolated Lesion | Zone 2 |
| Number of Enrolled Subjects | 84 | 132 | 9 | 13 | 238 |
| | | | | | |
| Dominant left vertebral artery1 | 5/65 (7.7%) | 5/105 (4.8%) | 0/7 (0%) | 1/6 (16.7%) | 11/183 (6.0%) |
| Occluded/stenosed right vertebral artery1 | 1/69 (1.4%) | 2/108 (1.9%) | 0/7 (0%) | 0/7 (0%) | 3/191 (1.6%) |
| Aberrant right subclavian artery1 | 1/83 (1.2%) | 4/128 (3.1%) | 0/9 (0%) | 3/12 (25.0%) | 8/232 (3.4%) |
| Bilateral carotid artery disease1 | 5/73 (6.8%) | 3/118 (2.5%) | 0/8 (0%) | 1/9 (11.1%) | 9/208 (4.3%) |
| Presence of a left internal mammary artery graft1 | 5/82 (6.1%) | 0/129 (0%) | 0/9 (0%) | 0/12 (0%) | 5/232 (2.2%) |
| Incomplete circle of willis1 | 0/49 (0%) | 0/78 (0%) | 0/6 (0%) | 0/6 (0%) | 0/139 (0%) |
| Left vertebral artery ending in posterior inferior cerebellar artery1 | 0/47 (0%) | 0/76 (0%) | 0/5 (0%) | 0/5 (0%) | 0/133 (0%) |
| | | | | | |
| Clinical Frailty Scale Score (1-9, higher is more frail) | | | | | |
| n | 83 | 131 | 8 | 13 | 235 |
| Median | 3.0 | 3.0 | 2.0 | 3.0 | 3.0 |
| | | | | | |
| SVS Score (0-24, higher is worse) | | | | | |
| n | 84 | 132 | 9 | 13 | 238 |
| Median | 5.0 | 5.0 | 0.0 | 4.0 | 5.0 |
| | | | | | |
| ASA Classification | | | | | |
| I | 5/84 (6.0%) | 8/132 (6.1%) | 2/9 (22.2%) | 1/13 (7.7%) | 16/238 (6.7%) |
| II | 20/84 (23.8%) | 36/132 (27.3%) | 3/9 (33.3%) | 3/13 (23.1%) | 62/238 (26.1%) |
| III | 39/84 (46.4%) | 43/132 (32.6%) | 0/9 (0%) | 4/13 (30.8%) | 86/238 (36.1%) |
| IV | 20/84 (23.8%) | 44/132 (33.3%) | 4/9 (44.4%) | 4/13 (30.8%) | 72/238 (30.3%) |
| V | 0/84 (0%) | 1/132 (0.8%) | 0/9 (0%) | 1/13 (7.7%) | 2/238 (0.8%) |
| | | | | | |
| NYHA Classification | | | | | |
| No cardiac disease | 28/84 (33.3%) | 48/132 (36.4%) | 8/9 (88.9%) | 5/13 (38.5%) | 89/238 (37.4%) |
| I | 31/84 (36.9%) | 55/132 (41.7%) | 1/9 (11.1%) | 3/13 (23.1%) | 90/238 (37.8%) |
| II | 22/84 (26.2%) | 24/132 (18.2%) | 0/9 (0%) | 5/13 (38.5%) | 51/238 (21.4%) |
| III | 3/84 (3.6%) | 5/132 (3.8%) | 0/9 (0%) | 0/13 (0%) | 8/238 (3.4%) |
| IV | 0/84 (0%) | 0/132 (0%) | 0/9 (0%) | 0/13 (0%) | 0/238 (0%) |
| 1Restricted to those with information known | | | | | |

# 3. Subject Baseline Treated Anatomy Information

A summary of the Subject baseline (Core Lab pre-imaging) aneurysm/lesion/treated segment diameters are provided in Table 12. Aneurysm Subjects had a median aneurysm diameter of $56.6\mathrm{mm}$ , Dissection Subjects had a median treated segment diameter of $47.2\mathrm{mm}$ , Traumatic Transection Subjects had a median lesion diameter of $34.8\mathrm{mm}$ , and Other Isolated Lesion Subjects had a median lesion diameter of $42.2\mathrm{mm}$ .

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Table 12: Baseline Core Lab Aortic Treated (Aneurysm/Lesion/Treated Segment) Diameters

| | Aneurysm Arm | Non-Aneurysm Arm | | | Total |
| --- | --- | --- | --- | --- | --- |
| | Zone 2 Aneurysm | Zone 2 Dissection | Zone 2 Traumatic Transection | Zone 2 Other Isolated Lesion | Zone 2 |
| Number of Enrolled Subjects | 84 | 132 | 9 | 13 | 238 |
| | | | | | |
| Maximum Transverse Aortic Diameter of Aneurysm/Lesion1 (mm) | | | | | |
| n | 84 | 123 | 9 | 13 | 229 |
| Median | 56.6 | 47.2 | 34.8 | 42.2 | 50.2 |
| 1Maximum Aortic Diameter in Treated Segment for Dissection Subjects. | | | | | |

Table 13 summarizes the baseline (Core Lab) description of the extent of the Dissection treated in the Dissection cohort. For the majority of the Dissection Subjects, proximal extent of Dissection was Zone 2 (70.5%), although all of the Dissection Subjects required the device to be proximally landed in Zone 2. The distal extent of the treated dissection extended to the iliac arteries in the majority of Subjects (56.8%), followed by the abdominal aorta (12.9%), and then the DTA (12.1%, Zone 3-5).

Table 13: Baseline Core Lab Treated Dissection Extent for Zone 2 Dissection Cohort

| | Zone 2 Dissection |
| --- | --- |
| Number of Enrolled Subjects | 132 |
| | |
| Proximal Extent of Dissection (Pre-Imaging, Core Lab)1 | |
| Zone 0/1 | 0 (0%) |
| Zone 2 | 93 (70.5%) |
| Zone 3 | 26 (19.7%) |
| Zone 4 | 5 (3.8%) |
| Zone 5 | 0 (0%) |
| | |
| Distal Extent of Dissection (Pre-Imaging, Core Lab)2 | |
| Aortic Arch (Zone 0,1,2) | 0 (0%) |
| Descending Thoracic (Zone 3,4,5) | 16 (12.1%) |
| Celiac (Zone 6) | 4 (3.0%) |
| SMA (Zone 7) | 3 (2.3%) |
| Renal(s) (Zone 8) | 5 (3.8%) |
| Abdominal (Zone 9) | 17 (12.9%) |
| Iliac(s) (Zone 10,11) | 75 (56.8%) |
| 1Eight subjects did not have this information reported and were not included in the table. Therefore, the total percentages do not equal 100%1Twelve Subjects did not have this information reported and were not included in the table missing this information, therefore this does not add up to 100%. | |

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# 4. Device Usage

Table 14 describes the initial treatment devices implanted in Subjects enrolled in the study. Table 15 shows a summary of GORE® TAG® Thoracic Branch Endoprosthesis Aortic Component sizes implanted in the index procedure. Table 16 and Table 17 show a summary of the GORE® TAG® Thoracic Branch Endoprosthesis Side Branch Sizing and Aortic Extender Sizing.

Table 14: Treatment Devices Implanted

| | Aneurysm Arm | | Non-Aneurysm Arm | | Total |
| --- | --- | --- | --- | --- | --- |
| | Zone 2 Aneurysm | Zone 2 Dissection | Zone 2 Traumatic Transection | Zone 2 Other Isolated Lesion | Zone 2 |
| Number of Enrolled Subjects | 84 | 132 | 9 | 13 | 238 |
| | | | | | |
| Number of Subjects with Both GORE® TAG® Thoracic Branch EndoprosthesesImplanted1 | 84 (100.0%) | 131 (99.2%) | 9 (100.0%) | 13 (100.0%) | 237 (99.6%) |
| | | | | | |
| Subjects with >1 Aortic Component Implanted | 3 (3.6%) | 1 (0.8%) | 0 (0%) | 0 (0%) | 4 (1.7%) |
| Subjects with Aortic Extender Implanted | 18 (21.4%) | 13 (9.8%) | 0 (0%) | 1 (7.7%) | 32 (13.4%) |
| Subjects with Other Devices Implanted2 | 2 (2.4%) | 1 (0.8%) | 0 (0%) | 1 (7.7%) | 4 (1.7%) |
| Subjects with CTAG as Distal Extension Implanted | 43 (51.2%) | 90 (68.2%) | 0 (0%) | 4 (30.8%) | 137 (57.6%) |
| | | | | | |
| SB Components Implanted Per Subject2 | | | | | |
| 1 SB Component Implanted | 76 (90.5%) | 130 (98.5%) | 9 (100.0%) | 12 (92.3%) | 227 (95.4%) |
| 2 SB Components Implanted | 8 (9.5%) | 1 (0.8%) | 0 (0%) | 1 (7.7%) | 10 (4.2%) |
| | | | | | |
| Aortic Extenders Implanted Per Subject | | | | | |
| 0 Aortic Extenders | 66 (78.6%) | 119 (90.2%) | 9 (100.0%) | 12 (92.3%) | 206 (86.6%) |
| 1 Aortic Extender | 15 (17.9%) | 12 (9.1%) | 0 (0%) | 1 (7.7%) | 28 (11.8%) |
| 2 Aortic Extenders | 3 (3.6%) | 1 (0.8%) | 0 (0%) | 0 (0%) | 4 (1.7%) |

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| | Aneurysm Arm | | Non-Aneurysm Arm | | Total |
| --- | --- | --- | --- | --- | --- |
| | Zone 2 Aneurysm | Zone 2 Dissection | Zone 2 Traumatic Transection | Zone 2 Other Isolated Lesion | Zone 2 |
| | | | | | |
| CTAG Devices Implanted Per Subject | | | | | |
| 0 CTAGs | 41 (48.8%) | 42 (31.8%) | 9 (100.0%) | 9 (69.2%) | 101 (42.4%) |
| 1 CTAG | 30 (35.7%) | 80 (60.6%) | 0 (0%) | 2 (15.4%) | 112 (47.1%) |
| 2 CTAGs | 11 (13.1%) | 9 (6.8%) | 0 (0%) | 2 (15.4%) | 22 (9.2%) |
| 3+ CTAGs | 2 (2.4%) | 1 (0.8%) | 0 (0%) | 0 (0%) | 3 (1.3%) |
| 1This includes both the aortic and side branch components.2Other devices implanted included the following: One Subject used a GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis device to extend/reinforce the SB Component, another Subject had a GORE® VIABAHN® Endoprosthesis device plus a GORE® EXCLUDER® AAA Endoprosthesis device to treat an access related complication (iliac rupture), a third Subject had two GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis devices used as the SB Component (physician choice, due to difficulty advancing SB Component), and the last Subject had two GORE® VIABAHN® Endoprosthesis devices implanted to treat access related complications (iliac rupture). | | | | | |

Table 15: GORE® TAG® Thoracic Branch Endoprosthesis Aortic Component Sizing

| Device Diameter (mm) | SB Portal Diameter (mm) | Device Length (cm) | Subjects (N=238) | Devices (N=242) |
| --- | --- | --- | --- | --- |
| 21 | 8 | 10 | 2 (0.8%) | 2 (0.8%) |
| 26 | 8 | 10 | 3 (1.3%) | 3 (1.2%) |
| 26 | 8 | 15 | 1 (0.4%) | 1 (0.4%) |
| 28 | 8 | 10 | 5 (2.1%) | 5 (2.1%) |
| 28 | 8 | 15 | 3 (1.3%) | 3 (1.2%) |
| 31 | 8 | 15 | 16 (6.7%) | 16 (6.6%) |
| 31 | 8 | 20 | 11 (4.6%) | 11 (4.5%) |
| 34 | 8 | 15 | 37 (15.5%) | 37 (15.3%) |
| 34 | 8 | 20 | 17 (7.1%) | 17 (7.0%) |
| 34 | 12 | 15 | 1 (0.4%) | 1 (0.4%) |
| 34 | 12 | 20 | 9 (3.8%) | 9 (3.7%) |
| 37 | 8 | 10 | 3 (1.3%) | 3 (1.2%) |
| 37 | 8 | 15 | 28 (11.8%) | 28 (11.6%) |
| 37 | 8 | 20 | 17 (7.1%) | 17 (7.0%) |
| 37 | 12 | 15 | 4 (1.7%) | 4 (1.7%) |
| 37 | 12 | 20 | 12 (5.0%) | 12 (5.0%) |
| 40 | 8 | 15 | 13 (5.5%) | 13 (5.4%) |
| 40 | 8 | 20 | 29 (12.2%) | 31 (12.8%) |
| 40 | 12 | 20 | 3 (1.3%) | 3 (1.2%) |
| 45 | 8 | 15 | 11 (4.6%) | 11 (4.5%) |
| 45 | 8 | 20 | 9 (3.8%) | 9 (3.7%) |
| 45 | 12 | 15 | 3 (1.3%) | 3 (1.2%) |
| 45 | 12 | 20 | 2 (0.8%) | 3 (1.2%) |

Table 16: GORE® TAG® Thoracic Branch Endoprosthesis Side Branch Sizing

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| Device Diameter (mm) | SB Portal Diameter (mm) | Device Length (cm) | Subjects (N=237) | Devices (N=247) |
| --- | --- | --- | --- | --- |
| 8 | 8 | 6 | 3 (1.3%) | 4 (1.6%) |
| 10 | 8 | 6 | 22 (9.3%) | 22 (8.9%) |
| 12 | 8 | 6 | 100 (42.2%) | 103 (41.7%) |
| 15 | 8 | 6 | 66 (27.8%) | 69 (27.9%) |
| 15 | 12 | 6 | 25 (10.5%) | 27 (10.9%) |
| 17 | 8 | 6 | 13 (5.5%) | 13 (5.3%) |
| 17 | 12 | 6 | 8 (3.4%) | 9 (3.6%) |

Table 17: Initial Treatment GORE® TAG® Thoracic Branch Endoprosthesis Aortic Extender Sizing

| Device Diameter (mm) | Device Length (cm) | Subjects (N=32) | Devices (N=36) |
| --- | --- | --- | --- |
| 34 | 4.2 | 10 (31.3%) | 12 (33.3%) |
| 37 | 4.2 | 10 (31.3%) | 11 (30.6%) |
| 40 | 4.3 | 9 (28.1%) | 10 (27.8%) |
| 45 | 4.6 | 3 (9.4%) | 3 (8.3%) |

## 5. Procedure Characteristics

Table 18, Table 19, and Table 20 summarize the endovascular procedure information by cohort. The majority of Subjects' (87.4%) proximal landing zone was within native aortic tissue, and 12.6% landed in a surgical graft (25 dissections subjects, four aneurysm subjects, and one was an other isolated lesion subject). The median procedure time was 132.5 minutes (154.5 minutes for the Aneurysm Cohort, 129 minutes for the Dissection Cohort, 109 minutes for the Traumatic Transection Cohort, and 142 minutes for the Other Isolated Lesion cohort). The access method for 69.7% of all Subjects was percutaneous, primarily through the right femoral artery (62.6%). Cut-down was used for 63 (26.…