RelayPro Thoracic Stent-Graft System

P200045 · Bolton Medical, Inc. · MIH · Aug 5, 2021 · Cardiovascular

Device Facts

• Record ID: P200045
• Device Name: RelayPro Thoracic Stent-Graft System
• Applicant: Bolton Medical, Inc.
• Product Code: MIH · Cardiovascular
• Decision Date: Aug 5, 2021
• Decision: APPR
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Relay®Pro Thoracic Stent-Graft System is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy, including: - Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; - Non-aneurysmal aortic neck diameter in the range of 20 – 42 mm; - Non-aneurysmal proximal aortic neck lengths of: - 15 mm for the 24 – 28 mm device diameters (Bare Stent Configuration) - 20 mm for the 30 – 38 mm device diameters (Bare Stent Configuration) - 25 mm for the 40 – 46 mm device diameters (Bare Stent Configuration) - 25 mm for the 24 – 38 mm device diameters (Non-Bare Stent Configuration) - 30 mm for the 40 – 46 mm device diameters (Non-Bare Stent Configuration) - Non-aneurysmal distal aortic neck lengths of: - 25 mm for the 24 – 38 mm device diameters - 30 mm for the 40 – 46 mm device diameters

Device Story

RelayPro Thoracic Stent-Graft System treats descending thoracic aortic aneurysms/ulcers. Device consists of self-expanding Nitinol stents sutured to woven polyester fabric, preloaded into a coaxial delivery system. Physician advances delivery system under fluoroscopy to lesion site; deploys stent-graft to create blood flow channel, excluding lesion from pressure/flow. Available in proximal bare stent or non-bare stent (NBS) configurations. Delivery system features hydrophilic-coated sheaths, apex release mechanism, and (for NBS) support wires to control expansion. Output is visual confirmation of graft placement via radiopaque markers. Benefits include minimally invasive aneurysm exclusion, reducing need for open surgical repair. Used in hospital settings by vascular surgeons/interventionalists.

Clinical Evidence

Prospective, multi-center, non-randomized, single-arm study (IDE# G040175) of 110 patients. Primary safety endpoint: 30-day MAE rate (6.4%, 95% CI 11.6%, p=0.0002 vs 20% PG). Primary effectiveness endpoint: 12-month successful aneurysm treatment (89.2%, 95% CI 81.8%, p=0.0185 vs 80% PG). Technical success at 24 hours was 100%. No stent fractures or conversions to open surgery reported through 12 months.

Technological Characteristics

Implant: Self-expanding Nitinol stents, woven polyester fabric, platinum-iridium radiopaque markers. Configurations: Proximal bare stent or non-bare stent (NBS). Diameters: 24-46mm. Delivery system: Coaxial sheaths/catheters, 19-23Fr, 90cm length, hydrophilic coating. Sterilization: Gamma irradiation (SAL 10^-6). MR Conditional (1.5T/3T).

Indications for Use

Indicated for endovascular repair of fusiform aneurysms, saccular aneurysms, and penetrating atherosclerotic ulcers (PAU) in the descending thoracic aorta in patients ≥18 years with appropriate iliac/femoral access and specific aortic neck dimensions. Contraindicated in patients with known allergy to Nitinol, polyester, or platinum-iridium, or conditions threatening graft infection.

Predicate Devices

• RelayPlus Thoracic Stent-Graft System (P110038)

Reference Devices

• Treovance (P190015)
• TREO (P190015)

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: Relay®Pro Thoracic 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: P200045

Date of FDA Notice of Approval:

II. INDICATIONS FOR USE

The Relay®Pro Thoracic Stent-Graft System is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy, including:

- Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;
- Non-aneurysmal aortic neck diameter in the range of 20 – 42 mm;
- Non-aneurysmal proximal aortic neck lengths of:
- 15 mm for the 24 – 28 mm device diameters (Bare Stent Configuration)
- 20 mm for the 30 – 38 mm device diameters (Bare Stent Configuration)
- 25 mm for the 40 – 46 mm device diameters (Bare Stent Configuration)
- 25 mm for the 24 – 38 mm device diameters (Non-Bare Stent Configuration)
- 30 mm for the 40 – 46 mm device diameters (Non-Bare Stent Configuration)
- Non-aneurysmal distal aortic neck lengths of:
- 25 mm for the 24 – 38 mm device diameters
- 30 mm for the 40 – 46 mm device diameters

III. CONTRAINDICATIONS

The Relay®Pro Thoracic Stent-Graft System is contraindicated in the following:

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- 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 Relay®Pro Thoracic Stent-Graft System labeling.

V. DEVICE DESCRIPTION

The Relay®Pro Thoracic Stent-Graft System (referred to as RelayPro hereafter) is designed to treat fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers in the descending thoracic aorta. The RelayPro consists of two types of implants, namely the proximal bare stent configuration and the non-bare stent (NBS) configuration. The RelayPro is a next generation endovascular graft of the currently marketed existing RelayPlus Thoracic Stent-Graft System (P110038).

Each patient receives at least one RelayPro Stent-Graft (Figure 1). Each implant configuration is preloaded into its own RelayPro delivery system that is advanced under fluoroscopy to the location of the lesion. Upon deployment, the stent-graft creates a blood flow channel, excluding the lesion from blood pressure and flow.

RelayPro Stent-Grafts

All stent-grafts are comprised of self-expanding Nitinol stents sutured to a 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. A spiraled ("S" shaped) Nitinol strut is sewn to the proximal section of the fabric to provide longitudinal support. The stents and the curved wire are sewn to the graft fabric with polyester suture. Radiopaque markers (platinum-iridium) are placed on the stent-graft to aid in visualization and accurate placement.

The RelayPro Stent-Graft is available in two proximal configurations: the proximal bare stent and non-bare stent (NBS). Other than the proximal configuration, the two implants are identical in design as described above.

The proximal bare stent configuration incorporates a bare stent that is mostly uncovered and is made of a slightly larger Nitinol wire than the other stents in the implant. The proximal apexes are designed with larger radii of curvature as compared to all other apexes on all other stents. Additionally, the bare stent has the lowest radial load of all stents on the RelayPro stent-graft. The combination of the large apexes and low radial force of the bare stent is intended to minimize the stress on the aortic wall. There is one bare stent per implant. The proximal stent (just distal to the bare stent) has the highest radial load and is designed to seal with the aortic wall. There are two proximal stents per implant.

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The NBS configuration incorporates a crown stent that consists of a series of apices that are connected by flat sections. The crown stent is designed to support the edge of the graft to appose the vessel wall and to minimize graft infolding. There is one crown stent per implant. The NBS proximal stent (just distal to the crown stent) has the same design intent as proximal stent in the proximal bare stent configuration and has a slightly modified design. There are two NBS proximal stents per implant.

The RelayPro Stent-Graft is available in the following configurations and sizes maximizing device selections available to the physician:

- Two proximal configurations: Proximal Bare Stent & Non-Bare Stent (NBS)
- Covered Lengths (Bare Stent): 100mm (± 10mm depending on graft diameter) to 250 mm
- Covered Lengths (Non-Bare Stent): 109mm (± 10mm depending on graft diameter) to 259mm
- Diameters: 24mm – 46mm in 2 mm increments
- Straight and Tapered Configurations
- Straight: Consistent diameter through the implant length
- Standard Taper: Diameter of device decreases proximal to distal (typical 4mm transition; availability from 2mm and up to 18mm transition)
- Reverse Taper: Diameter of device increases proximal to distal (availability from 2mm and up to 18mm transition)

Figure 1. RelayPro Thoracic Stent-Graft, with bare stent and with non-bare stent, illustrating stents and spiral support strut

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# Delivery System Description

The RelayPro Delivery System consists of a series of coaxially-arranged sheaths and catheters (outer introduction sheath, inner delivery sheath, through lumen), handle and apex release mechanism. The stent-graft is constrained within the inner sheath, which is further constrained within the outer sheath. The tapered tip and introducer sheath have a lubricious hydrophilic coating. The radiopaque, polymeric outer sheath is tracked over a guidewire to facilitate introduction of the device through the femoral and iliac arteries. Once the outer sheath reaches the distal end of the treatment site, the deployment grip of the delivery system is advanced to exit the inner sheath from the outer sheath. The inner sheath is advanced to the proximal landing zone in preparation for deployment. The inner sheath, which is connected to the delivery catheter and the delivery handle, can be retracted to deploy the constrained stent-graft in a controlled fashion. The apex release mechanism constrains the most proximal stent of the stent-graft. Sliding the outer control tube over the guidewire lumen after the deployment from the inner sheath controls this mechanism. This provides a controlled apposition of the stent to the vessel wall.

The delivery systems used for the RelayPro NBS and Bare Stent configurations are functionally and operationally equivalent. There are minor differences to accommodate the NBS configuration which do not change the mode of operation. Figure 2 illustrates the delivery system for the Bare Stent and NBS configuration. Item 16 in Figure 2 (support wires) are not present in the Bare Stent configuration delivery system. The two Nitinol wires, called support wires, control the expansion of the inferior portion of the stent-graft, which helps avoid asymmetrical deployment of the NBS configuration. The support wires are attached to the delivery system catheter at one end. The other end of the support wires are atraumatic teardrop-shaped and are tethered to the inferior portion of the graft with loops of suture. The support wires control the expansion of the proximal end of the stent-graft to ensure proper apposition against the anatomical inner curvature and are for NBS graft diameters 32mm to 46mm only. In addition, the design of Item 2 in both figures (apex holder) differs slightly between the configurations. The NBS delivery system introducer (outer) sheath diameter ranges up to 23Fr depending on the stent-graft diameter whereas the Bare Stent configuration ranges up to 22Fr.

The delivery system is provided in outer diameters ranging from 19 up to 22 French for the Bare Stent Configuration and from 19 up to 23 French for the NBS Configuration, depending on the corresponding stent-graft diameter, with a working length of 90 cm.

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Figure 2. RelayPro Bare and Non-Bare Stent Configuration Delivery System

1. Delivery System Tip
2. Apex Holder
3. Inner Sheath
4. Outer Sheath
5. Radiopaque Marker
6. Front Nose Cap
7 Gray Grip
8. Handle Body

9. Flush Port
10. Deployment Grip
11. Controller
12. Stainless Steel Rod
13. Apex Holder Knob
14. Guidewire Luer
15. Arrow Marker
16. Support Wire (Non-Bare Stent only)

## VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are several alternatives for the treatment of fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers in the descending thoracic aorta including medical management, open surgical repair, and endovascular repair using other endovascular grafts. 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 RelayPro is commercially available in the following regions and countries: the European Union, Chile, Colombia, Hong Kong, India, Lebanon, Singapore, South Africa, Thailand, UK and Vietnam since 2018.

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The RelayPro has not been withdrawn from the market for any reason related to its 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 the use of the device:

| Table 1. Potential Adverse Events | |
| --- | --- |
| Access Failure | Incision site complications |
| Allergic Reaction (to contrast, antiplatelet therapy, stent-graft materials) | Infection / Sepsis |
| Amputation | Intercostal pain |
| Anesthetic reactions/complications (e.g., aspiration) | Intramural Hematoma |
| Aneurysm Sac Enlargement | Ischemia (spinal cord, perfusion pathways) |
| Aneurysm / Lesion Rupture | Limb ischemia |
| Angina | Lymphocele |
| Aortic damage (perforation, dissection, bleeding, rupture) | Neuropathy |
| Arteriovenous fistula / aorto-esophageal fistula | Pain |
| Blindness | Paralysis/Paresthesia/Paraparesis/Paraplegia |
| Blood Loss | Perforation |
| Bowel complications (e.g., adynamic ileus, transient ischemia, infarction, obstruction, necrosis) | Peripheral Nerve injury |
| Cardiac events (e.g., arrhythmia, tachyarrhythmia, cardiac tamponade, congestive heart failure, myocardial infarction, hypotension, hypertension, tachycardia, bradycardia) | Post Implantation Syndrome |
| Catheter Breakage | Post-procedural bleeding |
| Cerebral vascular accident (stroke) | Pseudoaneurysm |
| Change in mental status | Pulmonary complications |
| Claudication (e.g., buttock, lower limb) | Pulmonary embolism |
| Coagulopathy | Radiation overexposure or reaction |
| Compartment Syndrome | Reaction to anesthesia |
| Contrast toxicity / anaphylaxis | Reaction/pain at catheter insertion site |
| Conversion to Open Repair | Renal failure or Complications |
| Death | Reoperation |
| Delivery system failure | Seizure |

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| Table 1. Potential Adverse Events | |
| --- | --- |
| Deployment failure (partial or inaccurate deployment) | Seroma |
| Device Dehiscence | Shock |
| Device Insertion or Removal Difficulty | Stenosis of native vessel |
| Dysphagia | Stent fracture / break |
| Edema | Stent-Graft failure (e.g., improper component placement, graft material wear or tear, suture break, dilatation, erosion, graft twisting or kinking, puncture, perigraft flow) |
| Embolism (micro and macro) with transient or permanent ischemia or infarction | Stent-Graft Infection |
| Endoleak | Stent-Graft migration |
| Fever and localized inflammation | Tissue necrosis |
| Fistulas | Transient Ischemic Attack |
| Gastrointestinal complications | Vascular Spasm |
| Genitourinary complications (e.g., ischemia, erosion, femoral-femoral artery thrombosis, fistula, incontinence, hematuria, infection) | Vascular Trauma (perforation / dissection) |
| Hematoma (surgical) | Vessel Damage |
| Hemorrhage | Vessel Dissection |
| Hepatic failure | Vessel Occlusion/Thrombosis |
| Impotence | Wound complications (dehiscence, infection, hematoma, seroma, cellulitis) |

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

# IX. SUMMARY OF NONCLINICAL STUDIES

Nonclinical studies were completed to evaluate the RelayPro 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

RelayPro 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 evaluation of the RelayPro, a subset of device components and sizes were used for each test or alternatively, the worst-case configuration /size was selected. A four-corners approach was utilized for sample selection. This sample selection represented the full size range available for RelayPro. A summary of this testing is provided in Table 2 and

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Table 3. Asterisk (*) indicates that the testing was performed at baseline and after aging (accelerated or real time to the shelf life duration).
Table 2. 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 RelayPro is MR Conditional. A person with this device can be safely scanned in an MR system meeting the following conditions: • Static magnetic field strength (B0) of 1.5 Tesla and 3 Tesla • Maximum spatial field gradient of 3,000 gauss/cm (30 T/m) • Circularly Polarized RF Excitation • Whole-body transmit coil • Maximum Whole-Body SAR of 2W/kg (Normal Operating Mode) • Maximum Head SAR of 3.2 W/Kg (Normal Operating Mode) | Pass |
| Graft Apposition Test | To determine if the stent-graft can be deployed in a tight radius of a simulated vessel | Must be deployed in a 15mm radius section of the aortic model with complete apposition up to the first proximal stent | Pass |
| Sealing | To determine if the fixation points are against the mock completely in order to address the sealing characteristics | Complete contact around the simulated vessel must be visually verified | Pass |

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| 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 | The RelayPro migration resistance must meet the requirements per diameter and stent-graft configuration (bare or non-bare stent):Bare Stent (minimum value):24mm – 28mm: 5.4N (1.2lbf)30mm – 28mm: 5.2N (1.2lbf)40mm – 46mm: 5.6N (1.3lbf) | Pass |
| | | Non-Bare Stent (minimum value):24mm – 28mm: 3.5N (0.79lbf)30mm – 28mm: 4.5N (1.0lbf)40mm – 46mm: 5.0N (1.1lbf) | |
| 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 | Results must meet a minimum modular pull out force of 4.0 N. | Pass |
| Compression Resistance | 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 if it recovers to its original geometry after testing. | Observations were documented as pass/fail. A force was applied until displacement of 50% occurred. The pre and post-compression outer diameters must be within 1mm of each other with no permanent deformation. | Pass |
| 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 |

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| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Radial Force (Self-Expanding Endovascular Prostheses)* | To determine the force exerted by a self-expanding implant as a function of the implant diameter | The RelayPro radial force must meet the requirements per diameter and stent-graft configuration (bare or non-bare stent):

*Bare Stent (minimum force at proximal landing zone):*
24mm – 28mm: 7.6N (1.7lbf)
30mm – 28mm: 5.4N (1.2 lbf)
40mm – 46mm: 6.0N (1.3lbf)

*Bare Stent (minimum force at middle):*
24mm – 28mm: 9.9N (2.2lbf)
30mm – 28mm: 6.9N (1.6 lbf)
40mm – 46mm: 6.0N (1.3lbf)

*Bare Stent (minimum force at proximal landing zone):*
24mm – 28mm: 9.8N (2.2lbf)
30mm – 28mm: 7.3N (1.6lbf)
40mm – 46mm: 7.4N (1.7lbf)

*Non-Bare Stent (minimum force at proximal landing zone):*
24mm – 28mm: 6.0N (1.3lbf)
30mm – 28mm: 7.0N (1.6lbf)
40mm – 46mm: 6.8N (1.5lbf)

*Non-Bare Stent (minimum force at middle):*
24mm – 28mm: 9.2N (2.1lbf)
30mm – 28mm: 7.5N (1.7lbf)
40mm – 46mm: 7.5N (1.7lbf)

*Non-Bare Stent (minimum force at distal landing zone):*
24mm – 28mm: 4.5N (1.0lbf)
30mm – 28mm: 3.6N (0.81lbf)
40mm – 46mm: 3.9N (0.88lbf) | 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 graft must conform to the “S” shape of the model while not kinking and/or permanent deformation occurring (if kinking occurs before deformation, only the kinking diameter will be recorded). Kinking is defined as approximately 25% or | Pass |

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| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | | more of the graft lumen is not patent. | |
| Integral Water Leakage | To determine the rate of water leakage through the entire stent-graft, incorporating all modular components and extension devices | Results must be comparable to the previously approved Relay device (P110038). | 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 |
| Dimensional Verification of the Endovascular Prosthesis | To determine the dimensions of the stent-grafts in the deployed state for verification to design specifications | The length of the stent-graft must be within specification | |
| | | Length = ± 2mm | Pass |
| | | Relaxed outer diameter post deployment* | |
| | | Outer diameter must be within -1mm / +2mm of the nominal diameter at the proximal, middle and distal ends. | Pass |
| Stent-Graft Integrity (post-deployment)* | To demonstrate that the stent-graft retains its physical integrity after the deployment process | The sample must not exhibit physical damage that will negatively impact the performance of the device (e.g., stent fracture, graft fabric tear, broken suture, etc.). | Pass |
| Burst / Circumferential 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. | Tensile Force: ≥ 50 lbf (222.5 N) | Pass |
| Graft Seam (Factory Anastomotic) Strength | To determine the tensile strength of the suture/fabric seam | Tensile Force: ≥16lbs/2cm (71.2 N/2cm) | Pass |
| Graft Seam (Factory Anastomotic) Durability | To evaluate the long-term durability of the fabric and seam over 380 million cycles of | The seam must not exhibit signs of wear or separation under magnification. | Pass |

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| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | pulsatile fatigue loading | | |
| 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 or bonds between the graft material and the stent/attachment system | ≥ 10 lbf (44.5 N) per apex | Pass |
| Visibility | To evaluate the ability to visualize the stent-graft 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 stent-graft (all Nitinol) metallic components | All samples display breakdown potentials equivalent or better to comparator devices. | Pass |
| Fatigue and Durability – Computational Analyses | Finite element analysis (FEA) was used to compute the maximum strains in all of the RelayPro 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 select the worst-case prosthesis oversizing for in-vitro fatigue testing. | Pass |
| 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 bloodstream2. Fabric holes larger than 0.5 mm23. Modular disjunctions4. Compromised luminal integrity due to twisting or component collapse | Pass** |
| | Dynamic Bending Testing: To evaluate the long-term durability of the stent-graft design over 380 million cycles of bending loads. | | Pass** |

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| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | | 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. | |

** The RelayPro in-vitro durability evaluation included accelerated fatigue testing (intended to represent 10 years of physiologic loading) under a variety of loading conditions. Fractures were observed in samples tested under radial pulsatile and longitudinal bending loading conditions. An evaluation of the potential impact on device performance was conducted that evaluated materials and components, manufacturing processes, anatomical data, biomechanical analysis, computational modeling, bench top performance testing of fractured test samples, and as-applied in-vitro fatigue testing displacements per test article. Additionally, available clinical stent fracture assessments were compared to accelerated fatigue testing time duration estimates until first stent fracture. There were no reported stent fractures that were found in the pivotal study out of the 88.6% of patients with adequate imaging to evaluate stent fractures at 1 year. Additionally, there have been no reported stent fractures beyond 1-year, although patient data with adequate imaging to evaluate stent fractures is limited beyond 1 year (50.5% at 2 years, 21.2% at 3 years). Results of the investigation and comparison suggest that the high rate of stent fractures reported during in-vitro testing may be attributable to test artifact. In particular, test articles subject to supraphysiological displacements at high cycle counts appear to be associated with high rates of in-vitro stent fractures

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Table 3. Non-Clinical Testing: Delivery System

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Dimensional verification of the endovascular system* | To evaluate the conformance of the RelayPro’s dimensions to their design specifications, and to evaluate the compatibility of the RelayPro with its accessory devices listed in the IFU. Also, to determine the 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. | Pass |
| | | Delivery system sheath outer diameter (OD) must meet predetermined tolerances: 19F = 0.252” ± 0.003” (6.40mm ± 0.08mm) 20F = 0.265” ± 0.003” (6.73mm ± 0.08mm) 21F = 0.278” ± 0.003” (7.06mm ± 0.08mm) 22F = 0.291” ± 0.003” (7.39mm ± 0.08mm) 23F = 0.304” ± 0.003” (7.72mm ± 0.08mm) | Pass |
| | | All test samples must meet the nominal labeled profile. | Pass |
| | | Useable length (deployed): 90 cm +2cm / -3cm | Pass |
| Simulated Use (Including Force to Deploy and Tracking)* | An overall assessment of the RelayPro was conducted during which qualitative and quantitative measurements were made. The system was prepared, deployed and the delivery system removed from an anatomical model. The anatomical model was designed to challenge both access as well as implant site requirements. Assessments included: | | |
| | • Forces required to deploy system | Deployment Force: ≤25lbs (111.3N) Advancement Force: ≤48.4lbs (215.3N) Clasp Release: ≤ 10 lbf (44.5N) | Pass |
| | • Ability to prepare system (flushing) • Ability to track system to landing zone, while ensuring direct assessment of attributes such as guidewire acceptance, kink resistance, pushability, tracking and torqueability • Ability to accurately deploy the stent-graft at the target landing zone | All qualitative assessments (pass/fail) 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 (sheath flushing required 20cc). • System must be able to track through the anatomical model and through a stent-graft. • System must be able to accept the guidewire. | Pass |

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| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | ·Ability to successfully withdraw the delivery system. | ·Device must not kink prior to or during deployment. ·Device must have the ability to be pushed through the anatomical model without buckling. ·Device must successfully track to deployment site while assessing for the ability to torque the device. ·Device must deploy at designated landing zone. ·Delivery system must be withdrawn without catching on deployed stent-graft. | |
| Manual Alignment | To evaluate the ability of the system to manually align the stent-graft while still in the secondary sheath (2ndstage of deployment) | Manual rotation of 360° must be achieved with no greater than 3 full handle body rotations. | Pass |
| Tensile Bond Strength* Tubing Tensile Strength | To determine the bond strength of the joints and/or fixed connections of the RelayPro | Sub-assemblies tested must meet pre-determined pull forces depending on the bond or tubing requirements. Acceptance criteria ranged from 5lbs to 48.4lbs (22.2 N to 215.3N). | Pass |
| Torsional Bond Strength | To determine the torque required to cause failure of the bonded joints of the RelayPro | The delivery system sheath introducer must be torqued at 180 degrees without any damage to the sheath bond. | Pass |
| Hemostasis* | To evaluate the RelayPro's ability of any seals or valves to maintain adequate hemostasis for the system | Amount of water obtained through leaking in 1 minute should be ≤ 15 cc. | Pass |
| Lubricity | To determine the lubricity of the hydrophilically coated Tip and Introducer Sheath | The force must meet the current specification for acceptable lubricity tests: - Sheath: ≤30g after 15 cycles - Tip: ≤60g after 15 cycles | Pass |
| Coating Integrity / Particulate Evaluation | To determine if particles of the hydrophilic coating would be removed from | There must be no statistical difference in the particulate count for uncoated versus coated test samples. | Pass |
| | the material used for the testing. | | |
| Coating Strength | To determine if the material used for the testing is not in contact with the device | No significant difference in the particle size of the material used for the testing. | Pass |
| Coating Strength | To determine if the material used for the testing is not in contact with the device | No significant difference in the particle size of the material used for the testing. | Pass |

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| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | the delivery system during simulated testing | | |

## B. Animal Studies

An Acute in-vivo animal study was conducted on the RelayPro and a chronic animal study was leveraged from similar representative stent-grafts including the Relay (first generation device forming the basis of the RelayPlus, P110038) and Treovance (first generation device forming the basis of the TREO, P190015). This data was leveraged for the RelayPro based on design and material similarities:

- The RelayPro graft fabric is the same as the Treovance/TREO.
- The RelayPro Nitinol stents for the Bare Stent configuration are the same material and design as the Relay.

The acute study of the RelayPro consisted of 6 sheep and was focused on evaluating the intra-operative features of delivery. The test articles were 24mm × 100mm Bare Stent configuration stent-grafts in a RelayPro delivery system. The objective of the study was to perform an acute study in an ovine model to evaluate the overall performance of the RelayPro delivery system. The results of the acute study showed successful deployment of all devices in the aorta, and no device-related adverse events occurred during deployment and subsequent recovery.

The results of both the chronic studies support that the device is well-tolerated in the ovine model and does not adversely affect the general health of animals. 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.

## C. Biocompatibility

The biocompatibility assessment performed on the RelayPro 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 RelayPro 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 for the biocompatibility evaluation for the delivery system are summarized in Table 4.

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Biological testing conducted to support the Relay Thoracic stent-grafts (P110038) has been leveraged for the RelayPro Stent-Graft because they share the same stent and suture components as well as the same marker materials and same graft fabric with differing weave. Similarly, biological testing supporting the TREO Abdominal stent-grafts (P190015) was leveraged for the RelayPro Stent-Graft because they share the same graft fabric, marker and suture components. The sponsor provided a detailed discussion regarding why any difference in the subject and reference devices design and manufacturing would not impact the biocompatibility assessment.

Table 4. Biocompatibility Evaluation – 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: Less than Grade 2 (mild reactivity) | 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 | These 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: no single animal showed a temperature rise of 0.5°C or more above its baseline temperature. | Yes |
| Hemocompatibility | | | |
| • Hemolysis | To evaluate the potential of the delivery system to cause hemolysis in direct contact or by extraction | Non-hemolytic: Percent hemolyses: Direct contact – 0% Extract – 0% | Yes |

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| Biological Effect (Test) | Purpose | Results | Acceptance Criteria Met? |
| --- | --- | --- | --- |
| • 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 | Minimal activator of intrinsic coagulation pathway (the components were tested in two groups): Group 1: Plasma exposed to the test article had an overall average clotting time of 205.9 seconds (73% of the negative control). Group 2: Plasma exposed to the test article had an overall average clotting time of 234.7 seconds (83% of the negative control). | Yes |
| • Complement Activation | To determine the potential of the delivery system to activate complement | C3a - a low potential for activation of the complement system.
SC5b-9 - a low potential for activation of the complement system. | Yes |
| • In-vivo Thrombogenicity | To evaluate the potential of the test device to resist thrombus formation when placed in the vasculature | In the 3 animals that were implanted with the delivery system, at 4 hours post-implantation, the test article was judged to be thromboresistant. | Yes |

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## D. Sterilization, Packaging and Shelf Life

RelayPro 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. Testing was also successfully performed to support device and packaging integrity after exposure to extremes of environmental conditioning per ISTA 2A. All packaging and shelf life validation testing was performed as per current standards and Terumo Aortic procedures. The RelayPro 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 Table 3. Accelerated aging shelf-life product testing conducted supports a 2-year shelf-life claim.

## 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 fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers in the descending thoracic aorta with the RelayPro in the US and Japan under IDE# G040175/S085. 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 May 10, 2017 and June 24, 2019. The database for this PMA reflected data collected through December 7, 2020 and included 110 patients. There were 36 investigational sites (25 in the United States and 11 in Japan).

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

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 $20\%$, derived from the RelayPlus Pivotal Study data (P110038). The hypothesis tested for the primary safety endpoint at a one-sided alpha level of 0.05 was:

Null hypothesis $(H_O)$: $p \geq 0.20$

Alternative Hypothesis $(H_A)$: $p &lt; 0.20$

Where $p$ is the proportion of RelayPro patients with at least one major adverse event through 30-days post implant procedure.

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The primary effectiveness endpoint was defined as the proportion of patients with successful aneurysm treatment after use of the RelayPro through 1-year post implant procedure. The results will be tested against a performance goal of 80%, derived from the RelayPlus Pivotal Study data (P110038). The hypotheses that will be tested for the primary effectiveness endpoint at a one-sided level of 0.05 is:

Null hypothesis (H₀): p ≤ 0.80

Alternative Hypothesis (Hₐ): p &gt; 0.80

Where p is the proportion of RelayPro patients with successful aneurysm treatment at 12-months post-procedure.

The study sample size was driven by the primary effectiveness endpoint. Historical data from the RelayPlus Pivotal Study (P110038) estimated the rate of successful aneurysm treatment to be 92.1%. Using the Exact Binomial Test and assuming a power of 96%, a one-sided alpha of 0.05, and a performance goal of 80%, the sample size needed was 88 patients. Assuming 20% attrition, this yielded a sample size of 110 patients.

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

- Independent Imaging Core Lab: The Core Lab confirmed a patient’s anatomical requirements for enrollment, as well as reviewed post-implant and follow-up imaging. The Core Lab assessed follow-up imaging endpoints, including endoleak, migration, aneurysm sac size increase, patency, stenosis, and stent fracture.
- 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 events, as specified in the CEC Charter, as identified by the Medical Monitor from regular review of all reported adverse events 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 RelayPro Pivotal Study was limited to patients who met the following inclusion criteria:

- Age ≥18 years.

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- Any of the following conditions in the descending thoracic aorta:
- Aneurysm ≥ 5.0 cm in diameter;
- Aneurysm ≥ 4.0 cm in diameter with an increase of ≥0.5 cm within the last 6 months or ≥1.0 cm over the last 12 months;
- Aneurysm with maximum diameter exceeding two times the diameter of the non-aneurysmal, adjacent aorta;
- Saccular aneurysm;
- PAU with a depth of 10 mm or more.

- Proximal and distal aortic neck with diameter between 20 mm and 42 mm.
- Proximal landing zone distal to the left common carotid and a distal landing zone proximal to the origin of the celiac artery; the lengths of which are dependent on the diameter and type of the device.
- Proximal and distal landing zones containing a straight segment (non-tapered, non-reverse-tapered, defined by &lt;10% diameter change) with lengths equal to or greater than the required landing length for the intended device.
- Adequate iliac or femoral artery access for introduction of the Relay Delivery System. Alternative methods to gain proper access may be utilized (e.g., iliac conduit).
- Willingness to comply with the follow-up evaluation schedule.
- Informed Consent Form prior to treatment.

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

- Acute or chronic aortic dissection within the ascending aorta, arch or descending thoracic aorta.
- Diffuse intramural hematoma (current or previous).
- Traumatic aortic injury or transection.
- Aortic false aneurysm.
- Ruptured aneurysm.
- Significant stenosis (&gt;50%), calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device.
- Anatomic variants which may compromise circulation to the carotid, vertebral, or innominate arteries after device placement, and are not amenable to subclavian revascularization.
- Prior endovascular or surgical repair in the descending thoracic aorta.
- The device could not be placed within any prior endovascular or surgical graft.
- Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta requiring repair.
- Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure.
- Major surgical or medical procedure within 45 days prior to the planned procedure, or is scheduled for a major surgical or medical procedure within

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45 days post implantation. This excluded any planned procedures for the prospective stent-graft placement.

- Untreatable allergy or sensitivity to contrast media or device components.
- Known or suspected connective tissue disorder.
- Blood coagulation disorder or bleeding diathesis for which the treatment cannot be suspended for one week pre- and/or post-repair.
- Coronary artery disease with unstable angina.
- Severe congestive heart failure (New York Heart Association functional class IV).
- Stroke and/or MI within 3 months of the planned treatment date.
- Pulmonary disease requiring the routine (daily or nightly) need for oxygen therapy outside the hospital setting.
- Acute renal failure or renal insufficiency with a creatinine ≥ 2.5 mg/dL, unless stable on dialysis.
- Active systemic infection and/or mycotic aneurysms.
- Morbid obesity or other condition that may compromise or prevent the necessary imaging requirements.
- Less than two-year life expectancy.
- Current or planned participation in an investigational drug or device study that has not completed primary endpoint evaluation.
- Currently pregnant or planning to become pregnant during the course of the study.
- Medical, social, or psychological issues that Investigator believed could interfere with treatment or follow-up.

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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 (± 12 weeks) and annually (± 12 weeks) through 5 years postoperatively.

Preoperatively – Each patient was required to have the following: review of medical history, verification of meeting study selection criteria, pregnancy testing for female patients of childbearing potential, physical exam and neurological assessment, CT scan with contrast and patient-reported outcomes/Quality of Life assessment.

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 an examination of the incision site.

Postoperative Follow-up Visits – Assessments during the study included CT scans with and without contrast, chest x-ray, and patient reported outcomes/Quality of Life. Adverse events and complications were recorded at all visits.

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

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

Schedule of Assessments are shown in Table 5. Schedule of Assessment below.

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Table 5. Schedule of Assessment

| Assessment | Screening/Baseline | Treatment | Discharge | 1m ± 4 weeks | 6m ± 8 weeks | 12m ± 12 weeks | 2, 3, 4, 5y ± 12 weeks | Unscheduled Visits |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Informed Consent | X | | | | | | | |
| Medical History | X | | | | | | | |
| Verify Inclusion/Exclusion Criteria | X | | | | | | | |
| Pregnancy testing for female patients of childbearing potential | X | | | | | | | |
| Physical Exam, including Neurological Assessment | X | | | | | | | |
| CT Scan with Contrast | X | | | | | | | X |
| Examination of incision site and assessment of healing | | | X | | | | | |
| CT Scan w/ & w/o Contrasta | | | | X^{a} | X^{a} | X^{a} | X^{a} | |
| Angiogram | | X | | | | | | |
| Chest X-Ray | | | | X^{b} | X^{b} | X^{b} | X^{b} | |
| Adverse Event Assessment | | X | X | X | X | X | X | X |
| Device-Related Events | | X | X | X | X | X | X | |
| Patient-Reported Outcomes | X | | | X | X | X | X | |
| Clinical Utility Measures | | X | X | | | | | |

$^a$ MRI, combined with unenhanced CT, could be performed at follow-up visits for patients unable to receive contrast
$^b$ Chest X-Ray: To assess for stent strut integrity (wireform fractures) and modular graft component overlap, which may be indicative of graft migration. All imaging submitted is used to assess device integrity and evaluated by the core lab to determine the protocol requirement for adequate imaging, at a minimum x-ray imaging to assess anterior-posterior, oblique and lateral aspects of the device are necessary.

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

3. Clinical Endpoints

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

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- Death
- Myocardial infarction
- Stroke, excluding transient ischemic attack (TIA)
- Renal failure
- Respiratory failure
- Paralysis, excluding paraparesis
- Bowel ischemia
- Procedural blood loss &gt;1,000 cc

The primary safety endpoint was compared to a Performance Goal (PG) of 20%.

With regards to effectiveness, the primary effectiveness endpoint was successful aneurysm treatment, which was a composite of the following:

- Technical success through 24 hours post-procedure, defined as:
- Successful delivery of the device through the vasculature
- Successful deployment of the device at the intended location
- Absence of Type I or III endoleak
- Patent stent-graft without significant stenosis (&gt;50%)
- Stent-graft patency through 12 months;
- Absence of aneurysm rupture through 12 months;
- Absence of Type I or III endoleak at 12 months;
- Absence of stent fractures in the attachment zone through 12 months;
- Absence of open or endovascular secondary interventions related to the device or treated pathology through 12-months;
- Absence of aneurysm expansion (&gt;5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study; and
- Absence of stent-graft migration (&gt;10 mm) through 12 months, compared to the first post-procedural CT.

The primary effectiveness endpoint was compared to a PG of 80%.

With regard to success/failure criteria, the RelayPro Pivotal Study will be considered successful if both the primary safety and effectiveness goals are met.

The following secondary analyses were completed using descriptive statistics:

- Intervention-Free Technical Success defined as:
- Successful delivery of the device through the vasculature (i.e., ability to deliver the implant to the intended location without the need for unanticipated corrective intervention related to delivery);
- Successful and accurate deployment of the device defined as:

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- deployment of the endovascular stent-graft in the planned location;
- patency of the endovascular stent-graft, absence of device deformations (e.g., kinks, stent eversion, mal-deployment, misaligned deployment) requiring unplanned placement of an additional device within the endovascular stent-graft, and;

- Successful withdrawal (i.e., successful withdrawal of the delivery system, without the need for unanticipated corrective intervention related to withdrawal)

- All-cause mortality and lesion-related mortality through 1-month, 6-months, 12-months and annual through 5 years;
- Loss of stent-graft patency through 1-month, 6-months, 12-months and annual through 5 years;
- Decreased stent-graft lumen diameter through 1-month, 6-months, 12-months and annual through 5 years;
- Aneurysm rupture through 1-month, 6-months, 12-months and annual through 5 years;
- All Endoleaks, evaluated individually, at 1 month, 6 months, 12 months and annual through 5 years;
- Stent fractures through 1-month, 6-months, 12-months and annual through 5 years;
- Incidence of open or endovascular secondary interventions related to the device or treated pathology to treat a condition involving the study device and/or the aneurysm treated with the study device through 1 month, 6 months, 12-months and annual through 5 years;
- Aneurysm expansion (&gt; 5 mm diameter increase) at 6-months, 12-months and annual through 5 years compared to the first post-procedural CT;
- Stent migration (&gt; 10 mm) at 6-months, 12-months and annual through 5 years compared to the first post-procedural CT;
- Thromboembolic events attributed to the stent-graft through 1-month, 6-months, 12 months and annual through 5 years;
- Individual outcomes of the composite safety endpoints through 6 months, 12 months and annual through 5 years;
- All adverse events through 6-months, 12-months and annual through 5 years;
- Device-related adverse events through 5 years;
- Vascular access complications at the index procedure;
- Clinical utility measures, including duration of procedure, transfusions required, length of hospital stay, and time in ICU.

B. Accountability of PMA Cohort

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At the time of database lock, of 110 patients enrolled in the PMA study, all 110 patients were implanted with the RelayPro. All but one patient (109/110, 99.1%) completed the 30-day visit (minimum of 96.4% with imaging adequate to assess endovascular graft parameters). Ninety-six patients (of 108 eligible patients) completed the 6-month visit with at least 83.3% of imaging adequate to assess endovascular graft parameters.

At 12-months, 93 of the 105 eligible patients (88.6%, 93/105) returned for the follow-up visit with at least 81% of imaging adequate to assess aneurysm diameter, endoleak, migration and fracture. At 2-years, 48 of the 91 eligible patients returned for the follow-up visit with 38 patients (41.87%, 38/91) still within the follow-up window. At 3-years, 4 patients of the 19 eligible patients have completed the follow-up visit. Compliance and imaging follow-up are provided in Table 6 below.

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Table 6. Summary of Compliance and Core Lab Imaging Follow-Up

| | Patient Follow-up | | | | Imaging Performedd | | Imaging Adequate to Assess the Parameter† | | | | Events Occurring Within Window‡ | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Analysis Window | Eligiblea | Follow-up donec | Pending* | Still in Window | CT Scan | X-Ray | Diameter | Endoleak | Migration | Fracture | Death | Lost to follow-up | Early Withdrawal | Otherb |
| Procedure | 110 | NA | NA | N/A | NA | NA | NA | NA | NA | NA | 0 | NA | NA | 0 |
| 30 Days | 110 | 99.1% (109) | 0.9% (1) | 0.0% (0) | 99.1% (109) | 97.3% (107) | 98.2% (108) | 96.4% (106) | 99.1% (109) | 97.3% (107) | 2 | 0 | 0 | 0 |
| 6 Months | 108 | 88.9% (96§) | 11.1% (12) | 0.0% (0) | 89.8% (97) | 85.2% (92) | 89.8% (97) | 83.3% (90) | 89.8% (97) | 89.8% (97) | 2 | 1 | 0 | 0 |
| 12 Months | 105 | 88.6% (93) | 12.4% (13) | 0.0% (0) | 87.6% (92) | 88.6% (93) | 87.6% (92) | 81.0% (85) | 87.6% (92) | 88.6% (93) | 1 | 2 | 5 | 3 |
| 2 Years | 91 | 52.7% (48) | 47.3% (43) | 41.8% (38) | 50.5% (46) | 46.2% (42) | 50.5% (46) | 45.1% (41) | 50.5% (46) | 50.5% (46) | 3 | 1 | 3 | 0 |
| 3 Years | 19 | 21.1% (4) | 78.9% (15) | 78.9% (15) | 21.1% (4) | 21.1% (4) | 21.1% (4) | 21.1% (4) | 21.1% (4) | 21.1% (4) | 0 | 0 | 0 | 17 |

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| | Patient Follow-up | | | | Imaging Performed^{d} | | Imaging Adequate to Assess the Parameter^{†} | | | | Events Occurring Within Window^{‡} | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Analysis Window | Eligible^{a} | Follow-up done^{c} | Pending^{a} | Still in Window | CT Scan | X-Ray | Diameter | Endoleak | Migration | Fracture | Death | Lost to follow-up | Early Withdrawal |
| | | | | | | | | | | | Other^{b} | Not yet due | |

NA – Not Applicable

a Eligible patients are all patients who are enrolled by snapshot date and either have a follow-up visit form or are past due for their follow-up (beyond upper limit of window on study and did not exit the study before the upper limit of the window).

b Patients choose to not reconcent to the study follow up extension.

c Patients with follow-up data according to the investigational site.

d Patients with CT scan data as determined by the Core Lab.

*Patients who did not have a visit within the window or patients who did not have a visit but have not yet reached the end of the analysis window. The number of patients eligible for the visit is used as the denominator when calculating the percentage of visits performed.

† Sac Diameter and Migration assessments use 1 month as baseline. Eligible patients require valid value at 1 month and at the specified time point.

‡ 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 or early withdrawal.

§ One patient had no site follow-up data but has CT data available; therefore, there are 96 patients with follow-up completed, and 97 patients with CT imaging available.

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# C. Study Population Demographics and Baseline Parameters

# Demographics

The demographics of the study population are typical for a thoracic endovascular graft study performed in the US and are summarized in Table 7. Summary of Patient Demographics. In the study, $62.7\%$ of patients were males (69/110) with $54.5\%$ of the cohort being $75+$ (60/110). Additionally, $39.1\%$ (43/110) of the pivotal cohort was Asian and $49.1\%$ (54/110) were white.

Regarding the Japan and US cohorts of the RelayPro Pivotal Study, the Japan cohort was older (mean 78.5 vs. 72.6) and consisted of a higher percentage of male patients $(78.6\%, 33/42$ vs. $52.9\%, 36/68)$ as compared to the US cohort. The US cohort was predominantly white $(79.4\%, 54/68)$ .

Table 7. Summary of Patient Demographics

| Characteristic | Statistics | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- | --- |
| Sex | | | | |
| Female | % (n) | 47.1% (32) | 21.4% (9) | 37.3% (41) |
| Male | % (n) | 52.9% (36) | 78.6% (33) | 62.7% (69) |
| Age (years) at Treatment | Mean ± SD | 72.6 ± 8.5 | 78.5 ± 6.6 | 74.9 ± 8.3 |
| | Median (IQR) | 73 (67 - 78.5) | 81 (73 - 83) | 76 (70 - 81) |
| | Min - Max | 45 - 92 | 65 - 94 | 45 - 94 |
| Age Group | | | | |
| 18-64 | % (n) | 14.7% (10) | 0% (0) | 9.1% (10) |
| 65-74 | % (n) | 41.2% (28) | 28.6% (12) | 36.4% (40) |
| 75+ | % (n) | 44.1% (30) | 71.4% (30) | 54.5% (60) |
| Ethnic Group | | | | |
| Hispanic/Latino | % (n) | 4.4% (3) | 0% (0) | 2.7% (3) |
| Not Hispanic/Latino | % (n) | 85.3% (58) | 100.0% (42) | 90.9% (100) |
| Not Reported | % (n) | 10.3% (7) | 0% (0) | 6.4% (7) |
| Race | | | | |
| Asian | % (n) | 1.5% (1) | 100.0% (42) | 39.1% (43) |
| Black | % (n) | 19.1% (13) | 0% (0) | 11.8% (13) |
| White | % (n) | 79.4% (54) | 0% (0) | 49.1% (54) |

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# Baseline Medical History

Baseline patient comorbidities are presented in the Table 8. The most common comorbidities observed include hypertension and/or treatment for hypertension (86.4%, 95/110), hypercholesterolemia (64.5%, 71/110), history of smoking (81.8%, 90/110), history of peripheral vascular disease (18.2%, 20/110), documented COPD (29.1%, 32/110), history of neurologic disease (20%, 22/110), diabetes mellitus (19.1%, 21/110), and renal insufficiency (19.1%, 21/110).

Regarding the US and Japan cohorts of the RelayPro Pivotal Study, a larger proportion of patients in the US cohort had history of peripheral vascular disease (26.5% vs. 4.8%), documented myocardial infarction (16.2% vs. 9.5%), documented COPD (33.8% vs. 21.4%), hypercholesterolemia (69.1% vs. 57.1%), and history of GI complications (35.3% vs. 21.4%). A larger proportion of patients in the Japan cohort had diabetes mellitus (26.2% vs. 14.7%) and renal insufficiency (21.4% vs. 17.6%).

Table 8. Summary of Patient Comorbidities

| Comorbidity | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- |
| History of Peripheral Vascular Disease | 26.5% (18) | 4.8% (2) | 18.2% (20) |
| Coronary Artery Disease | | | |
| Stable Angina | 7.4% (5) | 9.5% (4) | 8.2% (9) |
| Unstable Angina | 1.5% (1) | 0% (0) | 0.9% (1) |
| Myocardial Infarction | 16.2% (11) | 9.5% (4) | 13.6% (15) |
| Arrhythmias | 13.2% (9) | 0% (0) | 8.2% (9) |
| Congestive Heart Failure | 5.9% (4) | 2.4% (1) | 4.5% (5) |
| Other | 25.0% (17) | 2.4% (1) | 16.4% (18) |
| Chronic Obstructive Pulmonary Disease | 33.8% (23) | 21.4% (9) | 29.1% (32) |
| Routine (daily/nightly) home oxygen use | 0% (0/23) | 11.1% (1/9) | 3.1% (1/32) |
| History of Neurologic Disease | 20.6% (14) | 19.0% (8) | 20.0% (22) |
| Diabetes Mellitus | 14.7% (10) | 26.2% (11) | 19.1% (21) |
| Hypertension (HTN) and/or Treatment of HTN | 88.2% (60) | 83.3% (35) | 86.4% (95) |
| Hypercholesterolemia | 69.1% (47) | 57.1% (24) | 64.5% (71) |
| History of Smoking | 83.8% (57) | 78.6% (33) | 81.8% (90) |
| Former Smoker | 56.1% (32/57) | 97.0% (32/33) | 71.1% (64/90) |
| Current Smoker | 43.9% (25/57) | 3.0% (1/33) | 28.9% (26/90) |
| Renal Insufficiency | 17.6% (12) | 21.4% (9) | 19.1% (21) |
| Current Antiplatelet/ Anticoagulant Medication | 66.2% (45) | 40.5% (17) | 56.4% (62) |

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| Comorbidity | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- |
| History of Limb Ischemia | 7.4% (5) | 7.1% (3) | 7.3% (8) |
| History of Vascular Intervention | 23.5% (16) | 28.6% (12) | 25.5% (28) |
| History of Gastrointestinal Complications | 35.3% (24) | 21.4% (9) | 30.0% (33) |
| Cholecystitis | 4.4% (3) | 0% (0) | 2.7% (3) |
| Ischemic Colitis | 1.5% (1) | 0% (0) | 0.9% (1) |
| GI Bleed | 2.9% (2) | 2.4% (1) | 2.7% (3) |
| Small Bowel Ischemia | 0% (0) | 0% (0) | 0% (0) |
| History of Impotence (males only) | 16.7% (6/36) | 3.0% (1/33) | 10.1% (7/69) |
| All values expressed as % (n). Site reported data. | | | |

## Baseline Vessel Measurements

Baseline aneurysm and anatomical measurements, as well as access vessel characteristics of the study population, were reported by both the Core Lab and the site. The clinical sites and Core Lab evaluated 100% (110/110) of the baseline contrast CT scans. Baseline aneurysm characteristics are summarized in Table 9.

All patients enrolled in this study met the inclusion criteria based on site-reported CT measurements. Patient eligibility was confirmed by the Core Lab prior to enrollment. There were minor differences observed between the Core Lab and the site measurements. See the IFU for a detailed discussion.

There were no substantial differences between the US cohort and the Japan cohort related to the baseline aneurysm and anatomical measurements. See the IFU for a detailed discussion.

Of the 110 patients enrolled in the study with aneurysms, 76 were fusiform aneurysms (45 US and 31 Japanese patients) and 34 were saccular aneurysms or PAUs per the site reported assessment.

Table 9. Core Laboratory – Reported Baseline CT Measurements

| Characteristic | Statistics | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- | --- |
| Slice Thickness | Mean ± SD | 1.5 ± 0.7 | 1.7 ± 0.8 | 1.6 ± 0.8 |
| | Median (IQR) | 1.3 (1.0 - 2.0) | 1.5 (1.0 - 2.0) | 1.3 (1.0 - 2.0) |
| | Min - Max | 0.5 - 3.0 | 0.5 - 3.0 | 0.5 - 3.0 |
| Aortic Diameter at LCC (mm) | Mean ± SD | 31.8 ± 4.1 | 34.9 ± 4.7 | 33.0 ± 4.6 |
| | Median (IQR) | 31.5 (29.4 - 33.9) | 34.4 (32.0 - 37.1) | 32.5 (30.2 - 35.1) |
| | Min - Max | 24.1 - 46.9 | 27.5 - 49.9 | 24.1 - 49.9 |

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| Characteristic | Statistics | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- | --- |
| Aortic Diameter at LSA (mm) | Mean ± SD | 30.5 ± 3.7 | 33.6 ± 4.8 | 31.7 ± 4.4 |
| | Median (IQR) | 30.4 (27.4 - 32.6) | 33.6 (30.3 - 36.3) | 31.3 (28.7 - 34.6) |
| | Min - Max | 20.6 - 39.8 | 25.5 - 47.2 | 20.6 - 47.2 |
| Aortic Diameter at Distal End of Proximal Neck (mm) | Mean ± SD | 33.8 ± 4.6 | 35.3 ± 5.0 | 34.4 ± 4.8 |
| | Median (IQR) | 34.4 (29.9 - 36.8) | 36.5 (31.7 - 39.0) | 34.7 (30.9 - 37.7) |
| | Min - Max | 23.2 - 44.3 | 24.7 - 43.8 | 23.2 - 44.3 |
| Aortic Diameter at Proximal End of Distal Neck (mm) | Mean ± SD | 32.2 ± 4.5 | 31.9 ± 4.4 | 32.1 ± 4.4 |
| | Median (IQR) | 32.2 (28.5 - 34.9) | 31.0 (28.2 - 34.8) | 31.9 (28.3 - 34.8) |
| | Min - Max | 22.4 - 42.1 | 25.1 - 44.3 | 22.4 - 44.3 |
| Length from LCC to Proximal End of Proximal Neck (mm) | Mean ± SD | 19.4 ± 17.3 | 37.0 ± 42.0 | 26.1 ± 30.3 |
| | Median (IQR) | 19.3 (0.0 - 28.4) | 17.9 (14.4 - 50.2) | 18.4 (11.0 - 32.0) |
| | Min - Max | 0.0 - 82.8 | 0.0 - 156.0 | 0.0 - 156.0 |
| Proximal Neck Length – Centerline (mm) | Mean ± SD | 64.9 ± 36.3 | 75.0 ± 36.8 | 68.8 ± 36.7 |
| Centerline distance from the proximal edge of the landing zone to the proximal edge of the aneurysm/lesion | Median (IQR) | 54.4 (35.7 - 83.0) | 70.3 (42.3 - 106.0) | 57.8 (38.6 - 94.0) |
| | Min - Max | 22.6 - 186.0 | 25.8 - 150.0 | 22.6 - 186.0 |
| Proximal Neck Length – Inner Curve (mm) | Mean ± SD | 47.8 ± 31.4 | 56.3 ± 30.6 | 51.0 ± 31.2 |
| Inner curve distance from the proximal edge of the landing zone to the proximal edge of the aneurysm/lesion | Median (IQR) | 37.9 (23.3 - 62.4) | 46.7 (29.3 - 81.0) | 40.9 (25.3 - 74.0) |
| | Min - Max | 13.9 - 158.0 | 20.0 - 125.0 | 13.9 - 158.0 |
| Distal Neck Length – Centerline (mm) | Mean ± SD | 77.4 ± 47.2 | 80.7 ± 54.9 | 78.7 ± 50.1 |
| Centerline distance from the distal edge of the aneurysm/lesion to the proximal edge of the celiac trunk | Median (IQR) | 63.0 (40.2 - 95.4) | 60.3 (36.3 - 108.0) | 63.0 (38.3 - 100.0) |
| | Min - Max | 25.1 - 219.0 | 25.8 - 204.0 | 25.1 - 219.0 |

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| Characteristic | Statistics | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- | --- |
| Distal Neck Length –Inner Curve (mm) | Mean ± SD | 71.7 ± 45.3 | 74.7 ± 51.3 | 72.8 ± 47.5 |
| Inner curve distance from the distal edge of the aneurysm/lesion to the proximal edge of the celiac trunk | Median (IQR) | 57.2 (37.0 - 92.0) | 56.8 (34.0 - 107.0) | 57.2 (35.4 - 93.3) |
| | Min - Max | 20.0 - 219.0 | 21.4 - 194.0 | 20.0 - 219.0 |
| Aneurysm Length (mm) | Mean ± SD | 104.4 ± 59.0 | 85.0 ± 40.3 | 97.0 ± 53.3 |
| | Median (IQR) | 92.0 (54.7 - 142.5) | 84.0 (53.1 - 107.0) | 89.4 (53.6 - 127.0) |
| | Min - Max | 19.6 - 236.0 | 18.8 - 172.0 | 18.8 - 236.0 |
| Right Iliac Tortuosity Index | Mean ± SD | 1.3 ± 0.2 | 1.4 ± 0.2 | 1.4 ± 0.2 |
| | Median (IQR) | 1.3 (1.2 - 1.5) | 1.3 (1.2 - 1.5) | 1.3 (1.2 - 1.5) |
| | Min - Max | 1.1 - 1.8 | 1.1 - 2.2 | 1.1 - 2.2 |
| Left Iliac Tortuosity Index | Mean ± SD | 1.3 ± 0.2 | 1.4 ± 0.2 | 1.3 ± 0.2 |
| | Median (IQR) | 1.3 (1.2 - 1.4) | 1.3 (1.2 - 1.5) | 1.3 (1.2 - 1.5) |
| | Min - Max | 1.1 - 1.8 | 1.1 - 2.0 | 1.1 - 2.0 |
| Proximal Neck Thrombus Max Thickness (mm) | Mean ± SD | 0.9 ± 1.6 | 1.0 ± 2.0 | 0.9 ± 1.8 |
| | Median (IQR) | 0.0 (0.0 - 0.9) | 0.0 (0.0 - 0.0) | 0.0 (0.0 - 0.0) |
| | Min - Max | 0.0 - 5.4 | 0.0 - 8.3 | 0.0 - 8.3 |
| Proximal Neck Thrombus Degrees >2mm in Thickness (mm) | Mean ± SD | 20.1 ± 47.4 | 19.2 ± 41.7 | 19.7 ± 45.1 |
| | Median (IQR) | 0.0 (0.0 - 0.0) | 0.0 (0.0 - 0.0) | 0.0 (0.0 - 0.0) |
| | Min - Max | 0.0 - 200.0 | 0.0 - 151.0 | 0.0 - 200.0 |
| Proximal Neck Calcium Max Thickness (mm) | Mean ± SD | 1.2 ± 1.3 | 2.1 ± 1.7 | 1.5 ± 1.5 |
| | Median (IQR) | 0.0 (0.0 - 2.2) | 2.3 (0.0 - 2.9) | 1.8 (0.0 - 2.6) |
| | Min - Max | 0.0 - 4.5 | 0.0 - 6.0 | 0.0 - 6.0 |
| Proximal Neck Calcium Degrees | Mean ± SD | 24.2 ± 38.3 | 34.6 ± 38.6 | 28.2 ± 38.6 |
| | Median (IQR) | 0.0 (0.0 - 35.0) | 25.0 (0.0 - 45.0) | 13.5 (0.0 - 41.0) |
| | Min - Max | 0.0 - 169.0 | 0.0 - 152.0 | 0.0 - 169.0 |
| Distal Neck Thrombus Max Thickness (mm) | Mean ± SD | 1.5 ± 2.8 | 1.3 ± 2.1 | 1.5 ± 2.5 |
| | Median (IQR) | 0.0 (0.0 - 2.9) | 0.0 (0.0 - 2.9) | 0.0 (0.0 - 2.9) |

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| Characteristic | Statistics | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- | --- |
| | Min - Max | 0.0 - 15.5 | 0.0 - 7.2 | 0.0 - 15.5 |
| Distal Neck Thrombus Degrees >2mm in Thickness (mm) | Mean ± SD | 27.8 ± 48.5 | 28.6 ± 51.4 | 28.1 ± 49.4 |
| | Median (IQR) | 0.0 (0.0 - 54.0) | 0.0 (0.0 - 50.0) | 0.0 (0.0 - 51.0) |
| | Min - Max | 0.0 - 211.0 | 0.0 - 200.0 | 0.0 - 211.0 |
| Distal Neck Calcium Max Thickness (mm) | Mean ± SD | 0.9 ± 1.2 | 1.4 ± 1.3 | 1.1 ± 1.3 |
| | Median (IQR) | 0.0 (0.0 - 1.9) | 1.6 (0.0 - 2.5) | 0.0 (0.0 - 2.0) |
| | Min - Max | 0.0 - 4.1 | 0.0 - 4.5 | 0.0 - 4.5 |
| Distal Neck Calcium Degrees | Mean ± SD | 14.4 ± 29.5 | 16.0 ± 23.7 | 15.0 ± 27.3 |
| | Median (IQR) | 0.0 (0.0 - 15.5) | 11.0 (0.0 - 23.0) | 0.0 (0.0 - 19.7) |
| | Min - Max | 0.0 - 173.0 | 0.0 - 122.0 | 0.0 - 173.0 |
| Max TAA Diameter (mm) | Mean ± SD | 54.6 ± 10.6 | 58.6 ± 8.0 | 56.1 ± 9.9 |
| | Median (IQR) | 55.2 (48.2 - 61.6) | 57.7 (55.6 - 61.0) | 56.9 (50.7 - 61.1) |
| | Min - Max | 33.0 - 80.8 | 34.7 - 81.3 | 33.0 - 81.3 |
| PAU: Depth (mm) | Mean ± SD (N) | 11.0 ± 1.3 (9) | 19.7 ± NA (1) | 11.8 ± 3.0 (10) |
| | Median (IQR) | 10.2 (10.0 - 11.8) | 19.7 (19.7 - 19.7) | 10.4 (10.0 - 13.0) |
| | Min - Max | 10.0 - 13.2 | 19.7 - 19.7 | 10.0 - 19.7 |
| PAU: Diameter (mm) | Mean ± SD (N) | 27.6 ± 7.7 (9) | 27.8 ± NA (1) | 27.6 ± 7.2 (10) |
| | Median (IQR) | 26.0 (24.0 - 35.6) | 27.8 (27.8 - 27.8) | 26.9 (24.0 - 35.6) |
| | Min - Max | 14.5 - 36.3 | 27.8 - 27.8 | 14.5 - 36.3 |
| Total Treatment Length - Outer Curve (mm) | Mean ± SD (N) | 289.6 ± 59.5 (67) | 277.1 ± 71.7 (42) | 284.8 ± 64.5 (109) |
| Outer curve distance from the proximal end of the proximal neck to the distal end of the distal neck. | Median (IQR) | 293.0 (262.0 - 327.0) | 293.5 (242.0 - 320.0) | 293.0 (258.0 - 326.0) |
| | Min - Max | 40.6 - 408.0 | 60.5 - 378.0 | 40.6 - 408.0 |
| Tortuosity Index | Mean ± SD (N) | 1.5 ± 0.2 (64) | 1.6 ± 0.2 (42) | 1.5 ± 0.2 (106) |
| | Median (IQR) | 1.5 (1.4 - 1.6) | 1.6 (1.5 - 1.6) | 1.5 (1.4 - 1.6) |
| | Min - Max | 1.2 - 2.0 | 1.2 - 2.4 | 1.2 - 2.4 |
| Minimum Right Common Iliac Diameter (mm) | Mean ± SD (N) | 9.5 ± 2.5 (66) | 9.3 ± 2.7 (42) | 9.4 ± 2.5 (108) |
| | Median (IQR) | 9.5 (7.7 - 11.1) | 9.0 (7.9 - 10.5) | 9.3 (7.8 - 11.0) |

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| Characteristic | Statistics | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- | --- |
| | Min - Max | 4.6 - 15.9 | 4.1 - 18.3 | 4.1 - 18.3 |
| Minimum Right External Iliac Diameter (mm) | Mean ± SD (N) | 6.9 ± 1.8 (66) | 7.4 ± 1.3 (42) | 7.1 ± 1.6 (108) |
| | Median (IQR) | 6.9 (5.5 - 8.2) | 7.4 (6.6 - 8.3) | 7.2 (5.9 - 8.2) |
| | Min - Max | 3.7 - 11.3 | 4.5 - 10.9 | 3.7 - 11.3 |
| Minimum Right Common Femoral Diameter (mm) | Mean ± SD (N) | 7.5 ± 1.8 (66) | 8.3 ± 1.3 (42) | 7.8 ± 1.7 (108) |
| | Median (IQR) | 7.3 (6.2 - 9.0) | 8.2 (7.2 - 9.2) | 7.6 (6.8 - 9.1) |
| | Min - Max | 4.1 - 12.3 | 6.0 - 11.3 | 4.1 - 12.3 |
| Minimum Left Common Iliac Diameter (mm) | Mean ± SD (N) | 9.4 ± 2.8 (67) | 9.2 ± 2.6 (42) | 9.3 ± 2.7 (109) |
| | Median (IQR) | 9.2 (7.0 - 10.8) | 8.9 (7.7 - 10.2) | 9.2 (7.4 - 10.8) |
| | Min - Max | 3.4 - 18.6 | 4.7 - 17.5 | 3.4 - 18.6 |
| Minimum Left External Iliac Diameter (mm) | Mean ± SD (N) | 6.7 ± 1.8 (67) | 7.4 ± 1.2 (42) | 7.0 ± 1.7 (109) |
| | Median (IQR) | 6.8 (5.5 - 8.1) | 7.3 (6.6 - 8.0) | 6.9 (5.9 - 8.0) |
| | Min - Max | 2.6 - 10.5 | 5.2 - 10.6 | 2.6 - 10.6 |
| Minimum Left Common Femoral Diameter (mm) | Mean ± SD (N) | 7.5 ± 1.7 (66) | 8.0 ± 1.3 (42) | 7.7 ± 1.6 (108) |
| | Median (IQR) | 7.4 (6.2 - 8.6) | 7.8 (7.2 - 8.7) | 7.7 (6.5 - 8.7) |
| | Min - Max | 3.8 - 11.6 | 5.3 - 11.7 | 3.8 - 11.7 |
| Arch Type | | | | |
| Type I | % (n) | 8.8% (6) | 14.3% (6) | 10.9% (12) |
| Type II | % (n) | 42.6% (29) | 19.0% (8) | 33.6% (37) |
| Type III | % (n) | 48.5% (33) | 66.7% (28) | 55.5% (61) |
| Arch Type (Normal/Bovine) | | | | |
| Bovine | % (n) | 25.0% (17) | 0% (0) | 15.5% (17) |
| Normal | % (n) | 75.0% (51) | 100.0% (42) | 84.5% (93) |
| Indication | | | | |
| Aneurysm | % (n) | 86.8% (59) | 97.6% (41) | 90.9% (100) |
| PAU | % (n) | 13.2% (9) | 2.4% (1) | 9.1% (10) |

## RelayPro Devices Implanted

A total of 168 device components were implanted in the Pivotal Study. The number of devices implanted in the initial procedure are shown in Table 10. One RelayPro device was implanted in 51.8% (57/110) of the cohort (43 NBS and 14 Proximal Bare Stent), and

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two RelayPro devices were implanted in 43.6% (48/110) of the cohort (33 NBS only, 5 Proximal Bare Stent only and 10 received both). Three RelayPro devices were implanted in 5 patients (4.5%, 5/110) of the cohort (1 NBS only and 4 received both).

Table 10. Number of RelayPro Devices Implanted During the Initial Procedure

| Number of Devices Implanted | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- |
| 1 | 57.4% (39) | 42.9% (18) | 51.8% (57) |
| 2 | 36.8% (25) | 54.8% (23) | 43.6% (48) |
| 3 | 5.9% (4) | 2.4% (1) | 4.5% (5) |
| *Denominator includes all patients who received the test device. Site reported data | | | |

Table 11. Number of Devices Implanted During the Initial Procedure – Bare Stent

| Number of Devices Implanted | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- |
| 1 | 11.8% (8) | 14.3% (6) | 12.7% (14) |
| 2 | 13.2% (9) | 14.3% (6) | 13.6% (15) |
| 3 | 5.9% (4) | 0% (0) | 3.6% (4) |
| *Denominator includes all patients who received the test device. Site reported data | | | |

Table 12. Number of Devices Implanted During the Initial Procedure - NBS

| Number of Devices Implanted | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- |
| 1 | 45.6% (31) | 28.6% (12) | 39.1% (43) |
| 2 | 30.9% (21) | 52.4% (22) | 39.1% (43) |
| 3 | 5.9% (4) | 2.4% (1) | 4.5% (5) |
| *Denominator includes all patients who received the RelayPro device. Site reported data. | | | |

The diameters of the devices implanted in the Pivotal Study are shown in

Table 13. The most commonly implanted NBS devices were the 34 mm (19.1%, 21/110), 36 mm (21.8%, 24/110), 38 mm (28.2%, 31/110), and 40 mm (13.6%, 15/110) proximal diameters. The most commonly implanted proximal bare stent configurations were the 36 mm (7.3%, 8/110), 38 mm (10.9%, 12/110), and 40 mm (6.4%, 7/110) proximal diameters.

Table 13. Diameters of RelayPro Devices Implanted During the Initial Procedure

| Diameters (mm) | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- |
| Proximal (NBS) | | | |

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| Diameters (mm) | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- |
| 26 | 0% (0) | 4.8% (2) | 1.8% (2) |
| 28 | 1.5% (1) | 0% (0) | 0.9% (1) |
| 30 | 4.4% (3) | 11.9% (5) | 7.3% (8) |
| 32 | 11.8% (8) | 7.1% (3) | 10.0% (11) |
| 34 | 19.1% (13) | 19.0% (8) | 19.1% (21) |
| 36 | 22.1% (15) | 21.4% (9) | 21.8% (24) |
| 38 | 30.9% (21) | 21.4% (9) | 27.3% (30) |
| 40 | 11.8% (8) | 16.7% (7) | 13.6% (15) |
| 42 | 5.9% (4) | 16.7% (7) | 10.0% (11) |
| 44 | 1.5% (1) | 9.5% (4) | 4.5% (5) |
| 46 | 4.4% (3) | 0% (0) | 2.7% (3) |
| Proximal (bare stent) | | | |
| 26 | 0% (0) | 0% (0) | 0% (0) |
| 28 | 0% (0) | 0% (0) | 0% (0) |
| 30 | 5.9% (4) | 4.8% (2) | 5.5% (6) |
| 32 | 4.4% (3) | 2.4% (1) | 3.6% (4) |
| 34 | 5.9% (4) | 4.8% (2) | 5.5% (6) |
| 36 | 8.8% (6) | 4.8% (2) | 7.3% (8) |
| 38 | 13.2% (9) | 7.1% (3) | 10.9% (12) |
| 40 | 5.9% (4) | 7.1% (3) | 6.4% (7) |
| 42 | 2.9% (2) | 2.4% (1) | 2.7% (3) |
| 44 | 1.5% (1) | 2.4% (1) | 1.8% (2) |
| 46 | 2.9% (2) | 0% (0) | 1.8% (2) |
| Distal | | | |
| 26 | 1.5% (1) | 4.8% (2) | 2.7% (3) |
| 28 | 5.9% (4) | 2.4% (1) | 4.5% (5) |
| 30 | 5.9% (4) | 19.0% (8) | 10.9% (12) |
| 32 | 17.6% (12) | 14.3% (6) | 16.4% (18) |
| 34 | 36.8% (25) | 31.0% (13) | 34.5% (38) |
| 36 | 25.0% (17) | 26.2% (11) | 25.5% (28) |
| 38 | 23.5% (16) | 11.9% (5) | 19.1% (21) |
| 40 | 11.8% (8) | 19.0% (8) | 14.5% (16) |
| 42 | 5.9% (4) | 16.7% (7) | 10.0% (11) |
| 44 | 1.5% (1) | 2.4% (1) | 1.8% (2) |
| 46 | 2.9% (2) | 0% (0) | 1.8% (2) |
| *Denominator includes all patients who received the test device. Site reported data. | | | |

Procedural Data

PMA P200045: FDA Summary of Safety and Effectiveness Data

{38}

Detailed information and observations regarding the index procedure were documented by the physician on case report forms. Table 14 summarizes the information from the index procedure, including clinical utility endpoints. The majority of patients had general anesthesia (93.6%, 103/110). Right femoral access (73.6%, 81/110) was the predominant access location. Mean duration of the procedure was $113.6 \pm 79.6$ min and the mean implantation duration was $20 \pm 16$ min.

Vascular access method was different between the US and Japan cohorts, with the Japan cohort using $100\%$ surgical cutdown (42/42) compared to $73.5\%$ of patients (50/68) in the US cohort having the percutaneous access. In the US cohort, the duration of ICU time was lengthier compared to the Japanese cohort $(61.4 \pm 57.9$ hours vs. $21.6 \pm 19.4$ hours), while the duration of hospital stay was lengthier in the Japananese cohort $(9.9 \pm 6.8$ days vs. $4.8 \pm 3.8$ days).

Table 14. Details of the Initial Procedure

| Characteristic | Statistics | US Cohort (N=68) | Japan Cohort (N=42) | Pivotal (N=110) |
| --- | --- | --- | --- | --- |
| Type of Anesthesia | | | | |
| General | % (n) | 98.5% (67) | 85.7% (36) | 93.6% (103) |
| Local | % (n) | 1.5% (1) | 14.3% (6) | 6.4% (7) |
| Vascular Access | | | | |
| Left Femoral | % (n) | 25.0% (17) | 26.2% (11) | 25.5% (28) |
| Right Femoral | % (n) | 73.5% (50) |…