Alto Abdominal Stent Graft System

P120006S031 · Endologix, LLC · MIH · Mar 13, 2020 · Cardiovascular

Device Facts

• Record ID: P120006S031
• Device Name: Alto Abdominal Stent Graft System
• Applicant: Endologix, LLC
• Product Code: MIH · Cardiovascular
• Decision Date: Mar 13, 2020
• Decision: APPR
• Device Class: Class 3
• Attributes: Therapeutic

Indications for Use

The Alto™ Abdominal Stent Graft System is indicated for treatment of patients with infrarenal abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair with the device, which includes the following: - Adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories, - A proximal aortic landing zone for the sealing ring 7mm below the inferior renal artery. - An aortic sealing zone comprised of healthy aorta defined as: - Lack of significant thrombus > 8 mm in thickness; at any point along the aortic circumference at the level of 7mm below the inferior renal artery, - Lack of significant calcification at the level of 7mm below the inferior renal artery, - Conicity < 10% as measured from the inferior renal artery to the aorta 7mm below the inferior renal artery, - An inner wall diameter of no less than 16 mm and no greater than 30 mm at 7 mm below the inferior renal artery, and - An aortic angle of ≤ 60 degrees. - A distal iliac landing zone: - With a length of at least 10 mm, and - With an inner wall diameter of no less than 8 mm and no greater than 25 mm.

Device Story

Alto™ Abdominal Stent Graft System is a modular endovascular device for infrarenal AAA repair. It consists of an aortic body, iliac limbs, and extensions delivered via low-profile catheters. The aortic body features a proximal nitinol stent for suprarenal fixation and a PTFE graft. A unique feature is the CustomSeal™ Polymer Fill Kit, which uses an Autoinjector 2 to inject a reactive monomer mixture into channels and rings within the graft, forming a solid hydrogel seal against the aortic wall. The device is used in a hospital setting by vascular surgeons. The physician uses fluoroscopy to guide delivery and deployment. The polymer fill provides a patient-specific seal, reducing rupture risk. The system includes an integrated balloon for graft opening and stability. Post-procedure, the healthcare provider monitors the patient via CT/X-ray to ensure graft integrity and detect endoleaks. The device benefits patients by providing a minimally invasive alternative to open surgery.

Clinical Evidence

Prospective, multicenter, single-arm ELEVATE study (IDE G160226) enrolled 75 patients. Primary endpoint: treatment success at 1 year (composite of technical success and freedom from AAA enlargement, migration, type I/III endoleak, rupture, conversion, or secondary intervention). Results: 95.1% (58/61 evaluable) treatment success; 100% technical success. MAE rate 10.7% at 1 year. No AAA-related deaths or ruptures. One surgical conversion (1.3%) due to device infection. Bench testing confirmed structural integrity and durability.

Technological Characteristics

Modular endovascular graft; materials: PTFE, Nitinol, Platinum-Iridium. Energy: mechanical deployment, chemical polymerization (hydrogel). Dimensions: 15Fr-16Fr delivery profile. Connectivity: none. Sterilization: Ethylene Oxide (EO). Software: None (mechanical/chemical device).

Indications for Use

Indicated for patients ≥18 years with infrarenal abdominal aortic aneurysms (AAA) ≥5.0 cm (or ≥4.0 cm if meeting specific growth/size criteria) suitable for endovascular repair. Contraindicated in patients with conditions threatening graft infection or known sensitivities to PTFE, PEG-based polymers, contrast agents, FEP, titanium, nickel, platinum, or iridium.

Predicate Devices

• Ovation Abdominal Stent Graft System (P120006)
• Ovation Prime Abdominal Stent Graft System (P120006/S001)
• Ovation iX™ Abdominal Stent Graft System (P120006/S020)

Submission Summary (Full Text)

{0}

# SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

## I. GENERAL INFORMATION

Device Generic Name: Endovascular Graft

Device Trade Name: Alto™ Abdominal Stent Graft System

Device Procode: MIH

Applicant's Name and Address: Endologix, Inc.
3910 Brickway Blvd.
Santa Rosa, CA 95403

Date(s) of Panel Recommendation: None

Premarket Approval Application (PMA) Number: P120006/S031

Date of FDA Notice of Approval: March 13, 2020

The Alto™ Abdominal Stent Graft System is Endologix’s next generation polymer-based abdominal stent graft system, based on the Ovation Abdominal Stent Graft System.

The original PMA (P120006) for the Ovation Abdominal Stent Graft System was approved on October 5, 2012 and is indicated for treatment of patients with abdominal aortic aneurysms having vascular morphology suitable for endovascular repair. Changes to the Ovation delivery system were made to enhance ease of use during deployment via a PMA real-time supplement (i.e., P120006/S001, approved December 11, 2012) and marketed under the Ovation Prime Abdominal Stent Graft System trade name. Additional changes to the Ovation Prime delivery system were made via a PMA real-time supplement (i.e., P120006/S020, approved on July 17, 2015) and marketed under the Ovation iX™ Abdominal Stent Graft System trade name. The Summary of Safety and Effectiveness Data (SSED) to support the Ovation Abdominal Stent Graft System is available on the CDRH website and is incorporated by reference here.

Ovation Abdominal Stent Graft System (Original PMA Approval): https://www.accessdata.fda.gov/cdrh_docs/pdf12/p120006b.pdf

This Panel Track PMA Supplement was submitted to obtain approval for the Alto™ Abdominal Stent Graft System, a modified device design from the Ovation iX™ Abdominal Stent Graft System, for the treatment of patients with infrarenal abdominal aortic aneurysms having the appropriate anatomy.

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 1

{1}

## II. INDICATIONS FOR USE

The Alto™ Abdominal Stent Graft System is indicated for treatment of patients with infrarenal abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair with the device, which includes the following:

- Adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories,
- A proximal aortic landing zone for the sealing ring 7mm below the inferior renal artery.
- An aortic sealing zone comprised of healthy aorta defined as:
- Lack of significant thrombus > 8 mm in thickness; at any point along the aortic circumference at the level of 7mm below the inferior renal artery,
- Lack of significant calcification at the level of 7mm below the inferior renal artery,
- Conicity < 10% as measured from the inferior renal artery to the aorta 7mm below the inferior renal artery,
- An inner wall diameter of no less than 16 mm and no greater than 30 mm at 7 mm below the inferior renal artery, and
- An aortic angle of ≤ 60 degrees.
- A distal iliac landing zone:
- With a length of at least 10 mm, and
- With an inner wall diameter of no less than 8 mm and no greater than 25 mm.

### III. CONTRAINDICATIONS

- Patients who have a condition that threatens to infect the graft.
- Patients with known sensitivities or allergies to the device materials including polytetrafluoroethylene (PTFE), polyethylene glycol (PEG)-based polymers, contrast agents, fluorinated ethylene propylene (FEP), titanium, nickel, platinum, or iridium.

### IV. WARNINGS AND PRECAUTIONS

The warnings and precautions can be found in the Alto™ Abdominal Stent Graft System Instructions for Use.

### V. DEVICE DESCRIPTION

The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high-pressure flow of blood, thereby reducing the risk of rupture. The

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 2

{2}

stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required (Figure 1).

The Alto™ Abdominal Stent Graft System includes:

- An Aortic Body Stent Graft and delivery catheter
- Ovation iX™ Iliac Limb Stent Grafts and delivery catheters
- Ovation iX™ Iliac Extension Stent Grafts and delivery catheters (as required)
- CustomSeal™ Polymer Fill Kit
- Autoinjector 2


Figure 1: Schematic of Alto™ Abdominal Stent Graft System

The Alto™ Abdominal Stent Graft System incorporates the following primary modifications to the currently approved Ovation iX™ Abdominal Stent Graft System:

- Locating Sealing Ring 7mm below renal arteries,
- Inclusion of webbing between the aortic body legs at the graft bifurcation,
- Standardization of the aortic body leg diameter,
- Lengthened contralateral leg,
- Graft laminate layer composed of fewer discrete PTFE pieces and one additional wrapped PTFE layer,
- Incorporation of an integrated balloon into the delivery system, and
- Use of a lower pressure Autoinjector 2.

The Alto™ Abdominal Stent Graft System includes a modified location of the sealing ring, with the center of the sealing ring being nominally 7mm below the graft edge and corresponding to the location of the proximal aortic landing zone where the aortic artery is 16 – 30mm in diameter. The Alto™ Abdominal Stent Graft System was also modified to include webbing between the aortic body legs at the graft bifurcation to improve leg stability during cannulation. Additionally, the Alto™ Abdominal Stent Graft System was modified to have a standardized aortic body leg diameter of 11 mm to improve ease of cannulation, a lengthened contralateral leg to enhance differentiation of the contralateral

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 3

{3}

and ipsilateral legs under fluoroscopy, and a graft laminate layer composed of fewer discrete PTFE pieces and one additional wrapped PTFE layer as compared to the previously approved Ovation Abdominal Stent Graft Systems. Additionally, the Alto™ Abdominal Stent Graft Delivery System incorporates use of an integrated balloon to ease deployment and uses a lower pressure Autoinjector 2 to inject the fill polymer.

### Aortic Body

The aortic body is comprised of a proximal stent for suprarenal fixation and a low-permeability polytetrafluoroethylene (PTFE) graft connected using discrete attachments and attachment coils as shown in Figure 2. The bare proximal stent is designed with 8 anchors to help fixate the device to the aortic wall. For delivery, the stent is in a compressed state within the catheter. When released from the compressed state, the stent expands to engage the vessel wall.


Figure 2: Image of Alto™ Aortic Body Stent Graft

Please reference the Alto™ Aortic Body Stent Graft Materials below in Table 1.

Table 1: Aortic Body Stent Graft Materials

| Implant Component | Material |
| --- | --- |
| Graft | Polytetrafluoroethylene (PTFE) |
| Polymer Injector Port | Polytetrafluoroethylene (PTFE) |
| Proximal Stent | Nickel-Titanium (Nitinol) Alloy |
| Discrete Attachments | Nickel-Titanium (Nitinol) Alloy with FEP |
| Radiopaque Markers (Attachment Coils) | Nickel-Titanium (Nitinol) Alloy |

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 4

{4}

The nitinol proximal stent is radiopaque, and radiopaque markers (attachment coils) are located adjacent to the graft proximal edge. These radiopaque markers aid in the placement of the device in its intended location relative to the renal arteries. The fill polymer is radiopaque and provides visualization of the polymer fill channels once the graft is filled.

### Iliac Limbs/Extensions

The iliac limbs and extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. The materials can be referenced in Table 2 below. The iliac limbs are deployed into the leg sections of the aortic body. Radiopaque markers enable the physician to visualize the appropriate iliac limb - aortic body overlap or iliac extension – iliac limb overlap during a catheter-based deployment.

Table 2: Iliac Limb/ Extension Stent Graft Materials

| Implant Component | Material |
| --- | --- |
| Graft | Polytetrafluoroethylene (PTFE) |
| Stent and Attachments | Nickel-Titanium (Nitinol) Alloy |
| Radiopaque Markers | Platinum-Iridium Alloy |

### Delivery System

To facilitate device introduction into the access vessel, the aortic body, the iliac limbs, and the iliac extensions are preloaded into delivery catheters as illustrated in Figures 3 - 4. The delivery catheters each have a lumen for use with a .035" (0.89 mm) guidewire to facilitate access and deployment. The outer sheaths are hydrophilic coated. There are two variations of the delivery system: one for the aortic body stent graft (Figure 3) and one for the iliac limbs/extensions (Figure 4). Both systems allow for the inner catheter to be withdrawn through the outer sheath, with the outer sheath and integrated hemostatic valve remaining in the vasculature to facilitate the introduction of ancillary devices.


Figure 3: Schematic of Alto™ Abdominal Stent Graft System Aortic Body Delivery Catheter

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 5

{5}


Figure 4: Schematic of Ovation iX™ Iliac Limb/ Iliac Extension Delivery Catheter

The aortic body is deployed via the aortic body delivery catheter (Figure 3), which has a working length of approximately 60cm and outer sheath diameter of 15Fr (inner diameter 13Fr). The catheter has a connection to the distal legs of the aortic body. During aortic body stent graft deployment, the device is first positioned, and the sheath is retracted. The proximal stent is deployed using stent release knobs on the handle, with an integral balloon used to facilitate graft opening. The fill polymer is then delivered through the fill connector port using the Autoinjector 2.

The contralateral and ipsilateral iliac limbs are each deployed via iliac limb delivery catheters (Figure 4). After deployment of the aortic body, a guidewire is placed from the contralateral access site into the contralateral distal leg of the aortic body; the integrated crossover lumen on the aortic body delivery system can be utilized to facilitate the process.

Please refer to the Alto™ Abdominal Stent Graft System Instructions for Use for additional description on the implants and associated delivery systems.

### Alto™ Abdominal Stent Graft System Sizing

The Alto™ Abdominal Stent Graft System is designed to accommodate various aortic anatomies, including a range of proximal and distal aortic diameters, aneurysm lengths, and common iliac artery diameters. Refer to Tables 3-5 below for product sizes and configurations.

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 6

{6}

**Table 3: Alto™ Aortic Body Stent Graft Sizes**

| Stent Graft Proximal Diameter, mm | Catheter Working Length, cm | Delivery System Outer Profile, F | Integral Sheath Inner Diameter, F | Covered Stent Graft Length, mm |
| --- | --- | --- | --- | --- |
| 20 | 60 | 15 | 13 | 80 |
| 23 | | | | |
| 26 | | | | |
| 29 | | | | |
| 34 | | | | |

**Table 4: Ovation iX™ Iliac Limb Sizes**

| Stent Graft Proximal Diameter, mm | Stent Graft Distal Diameter, mm | Catheter Working Length, cm | Delivery System Outer Profile, F | Integral Sheath Inner Diameter, F | Covered Stent Graft Length, mm |
| --- | --- | --- | --- | --- | --- |
| 14 | 10 | 60 | 12 | 10 | 80 |
| | 10 | | | | 100 |
| | 10 | | | | 120 |
| | 10 | | | | 140 |
| | 10 | | | | 160 |
| | 12 | | | | 80 |
| | 12 | | | | 100 |
| | 12 | | | | 120 |
| | 12 | | | | 140 |
| | 12 | | | | 160 |
| | 14 | | | | 80 |
| | 14 | | | | 100 |
| | 14 | | | | 120 |
| | 14 | | | | 140 |
| | 14 | | 160 | | |
| | 16 | | 13 | 11 | 80 |
| | 16 | | | | 100 |
| | 16 | | | | 120 |
| | 16 | | | | 140 |
| | 16 | | | | 160 |
| | 18 | | | | 80 |
| 18 | 100 | | | | |

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 7

{7}

| Stent Graft Proximal Diameter, mm | Stent Graft Distal Diameter, mm | Catheter Working Length, cm | Delivery System Outer Profile, F | Integral Sheath Inner Diameter, F | Covered Stent Graft Length, mm |
| --- | --- | --- | --- | --- | --- |
| | 18 | | | | 120 |
| | 18 | | | | 140 |
| | 18 | | | | 160 |
| | 22 | | 14 | 12 | 80 |
| | 22 | | | | 100 |
| | 22 | | | | 120 |
| | 22 | | | | 140 |
| | 22 | | | | 160 |
| | 28 | | 15 | 13 | 80 |
| | 28 | | | | 100 |
| | 28 | | | | 120 |
| | 28 | | | | 140 |
| | 28 | | | | 160 |

**Table 5: Ovation iX™ Iliac Extension Sizes**

| Stent Graft Proximal & Distal Diameters, mm | Catheter Working Length, cm | Delivery System Outer Profile, F | Integral Sheath Inner Diameter, F | Covered Stent Graft Length, mm |
| --- | --- | --- | --- | --- |
| 10 | 60 | 12 | 10 | 45 |
| 12 | | | | |
| 14 | | | | |
| 16 | | 13 | 11 | |
| 18 | | | | |
| 22 | | 14 | 12 | |
| 28 | | 15 | 13 | |

### ***Polymer Fill Kit (CustomSeal™ Kit) and Autoinjector 2***

The CustomSeal™ Kit is comprised of two fill syringes containing fill polymer, which is used to inflate a network of channels and rings in the aortic body (refer to **Figure 1** above) and solidifies during the deployment procedure. The fill polymer is comprised of three components that are mixed within the fill syringes prior to injection into the aortic body stent graft. The components include a buffered solution containing a contrast agent which resides in one syringe and a reactive monomer that resides in the other syringe. The third

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 8

{8}

component is a separate reactive monomer that resides within the connecting tube between syringes. The reaction between the two monomers results in the formation of a solid hydrogel within the primary sealing ring, secondary support ring, fill channels, and leg support rings in the graft material of the aortic body (refer to Figure 1) during the deployment procedure. The CustomSeal™ Kit (Figure 5) is labeled with a 14 minute detach time, meaning the aortic body delivery catheter should not be disconnected from the graft until the polymer has had 14-minutes to cure.

Upon mixing and injection into the aortic body stent graft, the polymer components form a radiopaque cross-linked polymer that fills the primary sealing ring, fill channels, and support rings in the graft material of the trunk and legs of the aortic graft. The fill polymer radiopacity dissipates over time (1-2 months) so as not to create imaging artifacts that could interfere with endoleak detection in subsequent CT imaging follow-up.


Figure 5: CustomSeal™ Kit with 14-minute Disconnection Time

### Alto™ Abdominal Stent Graft System Specific Anatomic Considerations

The specific design features of this endovascular graft impact how to assess a patient's suitability for treatment. The following diagrams indicate the specific anatomic considerations that should be considered when evaluating suitability for treatment with the device as described in the Indications for Use statement.

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 9

{9}


Figure A: Proximal Landing Zone and Conicity


Figure B: Proximal Landing Zone


Figure C: Sealing Zone Thrombus

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 10

{10}


Figure D: Aortic Angle

# VI. ALTERNATE PRACTICES AND PROCEDURES

There are several alternatives for the treatment of infrarenal abdominal aortic aneurysms, including medical management, open surgical repair, or endovascular repair using another endovascular graft system. 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 Alto™ Abdominal Stent Graft System 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 potential adverse effects (e.g., complications) associated with the use of the device.

Adverse events that may occur and/or require intervention include but are not limited to:

- Acute and chronic renal failure, renal microembolism, renal insufficiency, renal artery occlusion, contrast toxicity;
- Amputation;
- Anesthetic complications and subsequent attendant problems (aspiration);

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 11

{11}

- Aneurysm enlargement or rupture;
- Aortic damage (perforation, dissection, bleeding, rupture);
- Aortocaval fistulae;
- Aortoenteric fistulae;
- Blood or bleeding events such as anemia, gastrointestinal bleeding, retroperitoneal bleeding;
- Bowel events such as bowel ischemia, infarction, bowel necrosis, colon ischemia, paralytic or adynamic ileus, obstruction, fistula;
- Cardiac events and subsequent attendant problems such as congestive heart failure, volume overload, arrhythmias, myocardial infarction, chest discomfort or angina, elevations in creatinine phosphokinase (CPK), hypotension, hypertension;
- Cerebral events (local or systemic) and subsequent attendant problems such as change in mental status, cerebrovascular accident (hemorrhagic or embolic), reversible ischemic neurologic deficit, nerve injury, transient ischemic attacks, paraplegia, paraparesis, paralysis;
- Claudication;
- Contrast toxicity/anaphylaxis;
- Death;
- Device events such as deployment or device malfunction, stent fracture, loss of stent graft system component integrity, graft twisting and/or kinking, graft material wear, dilation, erosion, puncture, endograft occlusion, migration, dislodgement, endoleak;
- Edema;
- Embolic and thrombotic events (with transient or permanent ischemia or infarction) such as deep vein thrombosis, thromboembolism, microembolism, thrombophlebitis, phlebothrombosis, air embolism;
- Endoleaks (or perigraft flow);
- Fever;
- Gastrointestinal complications;
- General discomfort related to the procedure;
- Generalized inflammatory response that may be associated with elevated levels of systemic mediators of inflammation, elevated temperature;
- Genitourinary complications and subsequent attendant problems such as ischemia, erosion, fistula, incontinence, hematuria, infection;
- Hematoma (surgical);
- Hepatic failure;
- Hypersensitivity (severe allergic reaction and/or anaphylactoid response) to x-ray contrast dye, anti-platelet therapy, device materials including polytetrafluoroethylene (PTFE), polyethylene glycol (PEG)-based polymers, contrast agents, fluorinated ethylene propylene (FEP), titanium, nickel, platinum, or iridium;
- Insertion and other vascular access site complications such as infection, dissection, transient fever, bleeding, pain, delayed healing, abscess formation, hematoma, dehiscence, seroma, cellulitis, nerve injury/damage, neuropathy,

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 12

{12}

neuralgia, vasovagal response, pseudoaneurysm, anastomotic false aneurysm, arteriovenous fistula;

- Impotence/ sexual dysfunction;
- Improper stent graft placement;
- Incomplete stent graft deployment;
- Insertion and removal difficulties;
- Lymphatic complications and subsequent attendant problems such as lymphocele, lymph fistula;
- Multi-system organ failure;
- Neoplasm;
- Open surgical conversion;
- Operative and post-operative bleeding and hemorrhage, coagulopathy;
- Paralysis (temporary or permanent) such as paraplegia, monoplegia, paresis, spinal cord ischemia, hemiplegia, bowel or bladder incontinence;
- Pericarditis;
- Pneumothorax;
- Polymer leak with hypersensitivity reaction;
- Possible infection–urinary tract, systemic or localized (access site), endograft;
- Prosthesis occlusion/stenosis;
- Pseudoaneurysm;
- Pulmonary/respiratory events and subsequent attendant problems such as pulmonary insufficiency, pneumonia, respiratory depression or failure, pulmonary edema, pulmonary embolism, atelectasis, pleural effusion;
- Radiation injury, late malignancy;
- Renal failure/renal insufficiency
- Sepsis;
- Seroma;
- Shock;
- Spinal neurological deficit;
- Stenosis/occlusion of native vessel
- Surgical conversion to open repair; and/or
- Vascular spasm or vascular injury/trauma including damage to blood vessels and surrounding tissues, atherosclerotic ulcer, vessel dissection, perforation, plaque dissection, stenosis, pseudoaneurysm, vessel occlusion, embolization, ischemia, tissue loss, limb loss, gangrenous disease, worsened or new onset claudication, edema, fistula, bleeding, rupture, death.
- Wound or access site complications.

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

### IX. SUMMARY OF NONCLINICAL STUDIES

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 13

{13}

The following non-clinical studies were performed on the Alto™ Abdominal Stent Graft System:

### A. Laboratory Studies

Attributes, specifications and use conditions of the Alto™ Abdominal Stent Graft System were evaluated against bench testing previously submitted for the Ovation Abdominal Stent Graft System (P120006), the Ovation Prime Abdominal Stent Graft System (P120006/S001), the Ovation iX™ Iliac Stent Graft (P120006/S015) and the Ovation iX™ Abdominal Stent Graft System (P120006/S020).

Where applicable, additional testing was conducted to confirm the in vitro performance of the Alto™ Abdominal Stent Graft System. This testing focused on the aspects of performance that could have been impacted by the unique design characteristics of the device as compared to previous generations. It included bench testing to support compatibility and functionality of Autoinjector 2 with the Alto™ Abdominal Stent Graft System.

Bench testing was performed per Endologix's test protocols, which incorporated the requirements of ANSI/AAMI/ISO 25539-1:2003/Amendment 1:2015/(R)2009, Cardiovascular Implants – Endovascular Devices – Part 1: Endovascular Prostheses (equivalent to BS EN ISO 25539-1:2009) and Guidance for Industry and FDA Staff, Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff (April 18, 2010).

Testing was conducted on a subset of device configurations/sizes, or worst-case for each test, as appropriate, to represent the entire Alto™ Abdominal Stent Graft System range of sizes available. Test methods and results are summarized in Table 6, Table 7 and Table 8 and organized according to (1) System Level, (2) Delivery System, and (3) Stent Graft testing, respectively.

Bench testing is presented within the in vitro bench test results as part of Table 6.

All in vitro bench tests produced acceptable results.

The Alto™ Aortic Body Stent Graft System Level testing (with the Autoinjector 2) is provided in Table 6 below.

Table 6: Alto™ Aortic Body Stent Graft System Level Testing

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Simulated Use | Design validation tests to evaluate device deliverability. | The delivery system shall deploy and fill the stent graft within the simulated use model without failure to: access, deploy the stents, fill the graft, enable contralateral wire access via the integral | Pass |

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 14

{14}

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | deployment, and removal. | crossover lumen, enable ballooning of the aortic body sealing rings [requirement unique to Alto™], disconnection between fill tube and the Alto™ aortic body, or withdraw the catheter. This device must be evaluated using an *in vitro* approximation of the clinical setting for the device. | |
| Product Performance, Post Sterilization | To confirm the Alto™ stent graft system can withstand two EtO sterilization cycles without compromising performance as evaluated in simulated use. | The stent graft systems must withstand two EtO sterilization cycles without compromising performance as evaluated in simulated use. The autoinjector must withstand e-beam sterilization without compromising performance as evaluated in simulated use. | Pass |

The Alto™ Aortic Body Stent Graft Delivery System testing is provided in **Table 7** below.

**Table 7: Alto™ Aortic Body Stent Graft Delivery System Testing**

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Delivery System Placement Accuracy | To provide assurance of the ability to successfully place the stent graft in the *in vivo* environment. | The system must permit consistent and accurate deployment of the aortic body implant to within +5/-0 of the intended proximal aortic landing site. The sign convention: minus = toward heart, plus = away from heart. The system must permit consistent and accurate deployment of the implant to within ±5mm of the distal iliac landing site. | Pass |
| Delivery System Hemostasis | To confirm the ability of the device to maintain adequate hemostatic seal. | The hemostatic seals on the catheter shall not leak water at a rate greater than 7 ml/min under simulated use conditions. a) The maximum allowable delivery system leak rate (sheath seal, proximal handle assembly and guidewire lumen) is 7 ml/min for water under simulated use conditions. b) The maximum allowable introducer sheath (integral sheath seal) leak rate is 7 ml/min for water under simulated use conditions. | Pass |
| Delivery System Radiopacity | To ensure adequate visibility of the delivery system required for completion of the procedure. | The delivery system must have sufficient radiopacity as rated during simulated use and/or animal deployments under fluoroscopy to orient the implant, to confirm sheath retraction, to confirm fill tube disconnection between the Alto™ aortic body, to position the integral balloon, and confirm catheter withdrawal from the implant. | Pass |

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 15

{15}

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Delivery System Unsheathing Force | To determine the force to deploy the prosthesis under simulated anatomical conditions. | The unsheathing force shall not exceed the minimum tensile strength of the sheath tubing and shall not exceed an ergonomic limit of 12 lbs. | Pass |
| Delivery System Kink Resistance | Design validation test to ensure the device does not kink during simulated clinical use. | The catheter can be advanced through the tortuous flow model and does not kink in a way that compromises the deployment or damages the implant. | Pass |
| Delivery System Kink Resistance (Worst Case) | To evaluate the limits of kink resistance of the device in a bench-top model. | The catheter can resist kinking in mechanically simulated worst case clinical conditions (i.e. radius of curvature). Catheters which kink must successfully advance through the tortuous flow model, deliver the device, and be withdrawn. | Pass |
| Delivery System Length | To determine the working length of the delivery system. | The delivery system should provide an insertion length of 58 to 62 cm. | Pass |
| Delivery System Pushability | Design validation test to ensure the device provides adequate force transmission to allow for proper positioning. | The delivery system must transmit sufficient pushability to position the catheter at the correct elevation within the simulated use model for an accurate placement of the stent graft. | Pass |
| Delivery System Profile | To determine the profile of the delivery system. | The delivery system outer diameter (OD) must not exceed 15.4F for the largest aortic body. | Pass |
| Delivery System Bond Strengths | To confirm adequate tensile bond strength of the delivery system to permit access, deployment, and withdrawal from the vasculature. | Minimum Tensile Strength: Crown Support to Guidewire Lumen, Polymer Fill Tube Fitting to handle assembly, Balloon Fill Tube Fitting to handle assembly, Flushport Fitting to Flushport to Flushport body: 10 lbf | Pass |
| Delivery System Autoinjector 2 Pressure Range | To ensure adequate pressure is applied by the Autoinjector to fill the stent graft with polymer while not exceeding the burst pressure of the graft. | Must supply a pressure of 10.0 – 14.9 psi 30 seconds after insertion of syringe into autoinjector. | Pass |
| Delivery System Trackability | Design validation test to ensure the device can sufficiently track over a guidewire to the intended deployment location in a simulated use environment. | The delivery system must have sufficient trackability to position the catheter and accurately position the implant within the simulated use model. | Pass |
| Delivery System Torquability | Design validation test to ensure the delivery system provides adequate torque transmission to position and orient the device in a simulated use environment. | The Aortic Body delivery system must have sufficient torquability to position the catheter and accurately position and orient the implant within the simulated use model. When placed in simulated tortuous anatomy, the tip of the sheathed catheter must rotate 180° +/- 60° | Pass |

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 16

{16}

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | | after a maximum rotation lag of 90° when the handle and flushport are rotated 180°. | |
| Torque Strength | To confirm adequate torsional bond strength of the delivery system during delivery, deployment, and withdrawal from the vasculature. | Each device must complete rotational conditioning without a failure that compromises the ability to place and deploy the implant and withdraw the delivery catheter. The safety factor for number of rotations shall be ≥ 1 for each test sample. | Pass |
| Delivery System Graft Retention | To ensure the graft does not prematurely detach from the delivery system during normal use of the device. | The system must not allow the delivery system fill tube to disconnect from the aortic body graft at a force less than 2 lbs prior to releasing the retention fitting. The Contralateral Leg Retention Tab on the Alto™ aortic body stent graft must remain intact and attached to the delivery catheter during deployment in simulated tortuous anatomy. | Pass |
| Delivery System Crossover Lumen Strength | To confirm adequate tensile bond strength of the crossover lumen tube to the lumen spacer junction. | The tensile strength of the crossover lumen/lumen spacer junction must exceed 1.5 lbf. The crossover lumen retention must remain intact during deployment in simulated tortuous anatomy. | Pass |
| Delivery System De-Mate | To ensure the detachment and withdrawal of the delivery system does not significantly affect the integrity of the implant. | The system must permit consistent withdrawal of the delivery system without causing damage to or more than 5mm dislodgement of the implant. | Pass |
| Delivery System Sheath Insertion Force | To confirm adequate lubricity due to coating on the delivery system for the Ovation iX™ limb. | Maximum sheath insertion force must be less than 1.0 lbf. | Pass |
| Integral Balloon Inflation Time | To characterize the time required to expand the integrated balloon in the delivery system, to the maximum recommended inflation volume. | The time required to expand the balloon to the maximum recommended inflation volume will be characterized. | Characterization only |
| Integral Balloon Deflation Time | To confirm the time required to deflate the integrated balloon in the delivery system from the maximum recommended inflation volume. | The system must be able to be repositioned within 30 seconds of the start of deflation. | Pass |
| Integral Balloon Fatigue | To ensure the balloon may be inflated an adequate number of cycles without loss of function. | The balloon must withstand 10 inflation / deflation cycles to the maximum recommended inflation volume without loss of integrity. | Pass |

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 17

{17}

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Integral Balloon Diameter by Volume | To confirm balloon diameter is large enough to enable primary sealing ring apposition within the vessel wall. | The balloon diameter versus inflation volume will be characterized. The balloon diameter must meet or exceed graft bore diameter within the range of inflation volumes characterized. Balloon diameter must be large enough to enable improvement in the primary sealing ring apposition with the vessel wall. | Pass |
| Integral Balloon Burst Strength | To confirm adequate burst strength of the balloon. | The balloon burst volume must exceed the recommended inflation volume. | Pass |
| Balloon Bond Tensile Strength | To confirm adequate tensile bond strength of the balloon bonds . | The tensile strength of the balloon bonds must exceed 3.4 lbf. | Pass |
| Catheter Guidewire Compatibility | To confirm the device can track over a commonly available guidewire size in order to aid in advancing the device to the treatment site. | The guidewire lumen must accept a 0.035' guidewire with little or no resistance. | Pass |
| Catheter Luer Compatibility | To confirm the catheter is compatible with ANSI ISO luer fittings in order to interface with other accessories. | The catheter must be compatible with ANSI ISO luer fittings. | Pass |
| Introducer System Compatibility | To confirm the delivery system can fit through commercially available introducers, when required. | Delivery system must fit through at least one commercially available introducer. | Pass |
| Crossover Lumen Guidewire Compatibility | To confirm a 0.018' guidewire can pass through the crossover lumen in order to facilitate cannulation. | The crossover lumen must accept a 0.018' guidewire. | Pass |

The Alto™ Aortic Body Stent Graft testing is provided in **Table 8** below.

**Table 8: Alto™ Aortic Body Stent Graft Testing**

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Stent Graft Treatment Diameters | To confirm the stent graft can treat aortic lesions with luminal diameters within the device indications. | The implant must seal a mock aorta with luminal diameters ranging from 16mm to 30mm at the proximal sealing ring location. | Pass |
| Stent Graft Conformability to Vessel Wall | To confirm the stent graft will adequately seal in | Appropriately-sized aortic body grafts will seal in simulated 16 and 30 mm proximal vessels. | Pass |

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 18

{18}

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | vessel diameters within the device indications. | The stent graft should provide an effective treatment via sealing the aneurysm from blood pressure in diseased, non-uniform simulated vessels. | |
| Stent Graft Lumen Burst Strength | To confirm adequate burst strength of the stent graft lumen. | The aortic body graft must not burst below a pressure of 320 mmHg [6.2 psi] before or after dilatation to nominal balloon pressure with a balloon sized to the nominal graft ID. | Pass |
| Stent Graft Longitudinal Tensile Strength | To confirm adequate longitudinal tensile strength of the stent graft. | Must withstand the maximum forces exerted on the graft by either a transient systolic pressure of 320 mmHg or a pull force of 2.0 lbs. [the graft fill port safety specification]. For the 34mm size device, the 320mmHg minimum pressure load corresponds to a minimum tensile force of 7.0 lbs. | Pass |
| Stent Graft Length to Diameter Relationship (Characterization only) | To characterize the graft length to diameter relationship. | Any foreshortening (length to diameter relationship) of the aortic body during deployment must be characterized. | Characterization Only |
| 10-yr Device Integrity – Graft Stent Attachment Creep | To evaluate the long term durability of the attachment strength of the stent to the graft after the equivalent of 10 years under physiologic load. | After attachment creep testing, the graft must withstand a worst-case transient load corresponding to a physiologic pressure of 320 mmHg. The device must be capable of sustaining a clinically relevant transient hypertensive physiological pressure of 320 mmHg after the equivalent of 10 years while maintaining a load corresponding to a physiologic pressure of 110 mmHg | Pass |
| 10-yr Device Integrity – Stent Graft Creep | The confirm the continued functionality of the stent graft after 10 years of simulated graft creep under physiologic loads. | After creep testing, the graft must not burst below a pressure of 320 mmHg. Additionally, changes in either diameter or length must not alter the ability of the device to function. The device must be capable of sustaining a clinically relevant transient hypertensive physiological pressure of 320 mmHg after the equivalent of 10 years while maintaining a pressure of 110 mmHg | Pass |
| 10yr Device Integrity – Stent Graft Pulsatile Fatigue | To confirm structural integrity of the stent graft under pulsatile blood pressure for the equivalent of a 10-year life. | The modular graft system (aortic body in combination with contralateral and ipsilateral iliac limbs and extensions) should provide structural integrity under pulsatile blood pressure for the equivalent of a 10-year life. The modular stent graft must withstand cyclic internal differential pressure loading from 80 to 120 mmHg for 400 million cycles. After cycling, the graft burst strength must remain greater than or equal to 320 mmHg. | Pass |

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 19

{19}

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| 10-yr Device Integrity – Graft Stent Attachment Fatigue 1) Angulated Graft-Stent Attachment Fatigue 2) Lesser Curve Graft-Stent Attachment Fatigue 3) Asymmetric Greater Curve Graft-Stent Attachment Fatigue | To evaluate the long-term durability of the aortic body stent graft and attachment for a 10-year life under 3 different clinically extreme conditions. | The aortic body graft - stent attachment sites must be able to transfer load from the graft to the stent for a 10-year life, and subsequently withstand a worst-case transient load corresponding to a physiologic pressure of 320 mmHg. The following test conditions define one of the anticipated clinical extreme conditions: 1) Angulated Graft-Stent Attachment Fatigue: The graft-stent attachment must withstand 400 million cycles of cyclic load corresponding to an 80 to 160 mmHg pressure differential, under worst case angulated conditions of 60 degree proximal neck angulation at a D/4 (i.e., diameter of aorta divided by 4) inner radius of curvature. 2) Lesser Curve Graft-Stent Attachment Fatigue: The graft-stent attachment must withstand 400 million cycles of cyclic load corresponding to a 0-80mmHg pressure gradient. These pressures simulate the relatively low (near compression) local loads observed on the lesser curve of an angulated aorta having neck angulation of 60 degrees at a D/4 (i.e., diameter of aorta divided by 4) inner radius of curvature. 3) Asymmetric Greater Curve Graft-Stent Attachment Fatigue: The graft-stent attachment must withstand 400 million cycles of cyclic load corresponding to an 80 -160mmHg pressure gradient assuming a worst-case anchor engagement of 25% of anchors engaged into the greater curve of an angulated aorta having proximal neck angulation of 60 degrees at a D/4 (i.e., diameter of aorta divided by 4) inner radius of curvature. | Pass |

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 20

{20}

| Test Name | Test Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Stent Graft Radiopacity | To ensure the stent graft is visible under fluoroscopy during implant to allow for proper placement. | The implant must be visible under fluoroscopy during the implant procedure to allow for proper placement. | Pass |
| Stent Graft Length | To ensure the stent graft length meets the defined implant length. | The aortic body graft length will be 75±5 mm on the ipsilateral side and 80±5 mm on the contralateral side. | Pass |
| Aortic Body Stent Radial Force | To measure the stent radial force ensuring adequate stent to vessel barb engagement. | The radial force of the aortic body stent should meet the following criteria: minimum radial force of 0.4 lbf when the stent is compressed by a 2% diameter contraction and 0.2 lbf when the stent is at its maximum vessel diameter. The aortic body stent must transmit sufficient radial force and/or moment to embed the anchors into the aortic wall and thereby prevent migration of the graft. | Pass |
| Stent Graft Permeability | To determine the pressure required to force water through the aortic body graft material. | Graft water entry pressure (WEP) must not be less than a differential pressure of 817mmHg. | Pass |
| Stent Graft Inflation Channel Burst Strength | To confirm the aortic body graft inflation channels will not burst during graft inflation. | The aortic body graft inflation channels must not burst at a pressure differential less than 16 psi. | Pass |
| Stent Corrosion Resistance | To demonstrate that the stents and discrete attachments have adequate in vitro corrosion performance. | The stents must have *in vitro* corrosion performance that is at least equivalent to an FDA approved stent graft device. | Pass |
| Durability – Aortic Body Stent Maximum Strain by FEA | To confirm the stent design has adequate mechanical properties for manufacturing, delivery and fatigue performance. | Peak strains associated with belting the stent and tucking the anchors must be below 9% (determined analytically), and the alternating strain amplitude produced by the *in vivo* environment below ± 0.15% (i.e. 0.3% peak-to-peak) when determined by finite element analysis. | Pass |

## **B. Animal Studies**

The Alto™ Abdominal Stent Graft System shares the same basic design, materials of construction, and similar processing as the Ovation Abdominal Stent Graft System (P120006). Additionally, an earlier prototype of the Alto™ aortic body stent graft, which also shared construction of the same base materials, with similar processing, was used in animal studies to support approval of the CustomSeal™ Kit (P120006/S010) and the Ovation iX™ Iliac Stent Graft (P120006/S015).

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 21

{21}

These approved Ovation platform devices underwent previous animal testing and demonstrated acceptable results with respect to graft patency, absence of migration or kinking, absence of abnormalities on end-organ histopathology, and/or normal healing. Additionally, these devices have shown acceptable biocompatibility. Therefore, animal studies from these approved Ovation platform devices were leveraged in support of the Alto™ Abdominal Stent Graft System.

### **C. Biocompatibility**

The biocompatibility assessment performed for the Alto™ Abdominal Stent Graft and Delivery System was based on ISO 10993-1:2009/Cor 1:2010, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The stent graft was classified as an implant device, permanent contact (> 30 days), while the delivery system was classified as an external communicating device, circulating blood, limited exposure (< 24 hours). All testing was performed by a qualified contract laboratory in accordance with FDA GLP Regulations, 21 CFR Part 58. The Autoinjector 2 was categorized as non-patient contacting. Therefore, it was determined that no biocompatibility testing was required.

Biocompatibility testing and results previously submitted for the Ovation Abdominal Stent Graft System (P120006), Ovation Prime Abdominal Stent Graft System (P120006/S001), CustomSeal™ Kit (P120006/S010) and Ovation iX™ Iliac Stent Graft (P120006/S015) were evaluated to determine their applicability to the requirements for the Alto™ Abdominal Stent Graft System. Device design, materials, construction and manufacturing / sterilization environment were taken into consideration.

Based on the assessment, previously conducted biocompatibility tests continue to be applicable to, and supportive of, the Alto™ Abdominal Stent Graft System. Any additional testing is summarized in **Table 6** and **Table 7** below.

Test methods were performed in accordance with the following, as referenced:

- ISO 10993-4: Selection of tests for interactions with blood
- ISO 10993-5: Tests for *in vitro* cytotoxicity
- ISO 10993-10 Tests for irritation and skin sensitization
- ISO 10993-11: Test for systemic toxicity
- ISO 10993-12: Sample preparation and reference materials
- American Society for Testing and Materials (ASTM) F756 – Standard Practice for Assessment of Hemolytic Properties of Materials
- Guidance for Industry and FDA Staff, *Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems*, Section C Biocompatibility, subsection 1 Nickel ion release, issued on August 18, 2015

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 22

{22}

For the Alto™ Aortic Body Stent Graft, the biocompatibility testing conducted is provided in Table 9 below.

Table 9: Alto™ Aortic Body Stent Graft –Biocompatibility Testing and Results

| Test / Study Method | Test Purpose | Results | Conclusion |
| --- | --- | --- | --- |
| Cytotoxicity – MEM Using L-929 Mouse Fibroblast Cells (FEP Aqueous Dispersion) | To evaluate the ability of the stent graft extracts to elicit a cytotoxic response in cultured mouse fibroblast cells. Stent grafts will be considered non-cytotoxic, if they score a level of 0, 1 or 2 at 24, 48 or 72±4 hours. | Non-cytotoxic Grade 0 cytotoxicity for test and negative controls Grade 4 for positive controls | Pass |
| Hemocompatibility – Hematology: ASTM (F756) Hemolysis Assay, Direct Contact and Extract Method (FEP Aqueous Dispersion) | To evaluate the hemolytic potential of stent grafts according to the ASTM guideline. Direct Contact and Extract Methods: Stent grafts will be considered non-hemolytic if the “Blank Corrected Hemolytic Index above the Negative Control %” is 0-2%. | Non-hemolytic – Stent grafts for Direct Contact and Extract Methods were shown to be non-hemolytic as the “Blank Corrected Hemolytic Index above the Negative Control %” were 0-2%. | Pass |
| In Vitro Nickel Ion Release (Nickel Elution Testing) – on Nitinol of Alto™ aortic body graft | To determine whether leachables extracted from the stent grafts would cause toxicity at Day 1, Day 7 and Day 30. | Nickel levels were below the threshold of toxicity at Day 1, Day 7 and Day 30 | Pass |

For the Alto™ Aortic Body Delivery System, the biocompatibility testing conducted is provided in Table 10 below.

Table 10: Alto™ Stent Graft Delivery System – Biocompatibility Test Results

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 23

{23}

| Test / Study Method | Test Purpose | Results | Conclusion |
| --- | --- | --- | --- |
| Cytotoxicity – MEM Using L-929 Mouse Fibroblast Cells | To evaluate the ability of the delivery system extract to elicit a cytotoxic response in cultured mouse fibroblast cells. | Non-cytotoxic. Grade 0 cytotoxicity for test and negative controls Grade 4 for positive controls | Pass |
| Sensitization – ISO Guinea Pig Maximization Sensitization Test | To evaluate the potential of the delivery system extract to cause delayed dermal contact sensitization in a guinea pig. | No sensitization response – None of the test animals scored higher than a Grade 0 (Defined as “No visible change – No erythema or edema”) | Pass |
| Irritation or Intracutaneous Reactivity - ISO Intracutaneous Reactivity | To determine if any chemicals that may leach or be extracted from the delivery system were capable of causing local irritation in the dermal tissues of the rabbit. | Non-irritant - Difference in extract dermal observations between the mean of the control and the mean of the test group was <1.0. | Pass |
| Systemic Toxicity (Acute) – ISO Acute Systemic Injection | To screen delivery system extracts for potential toxic effects as a result of a single-dose systemic injection in mice. | Non-toxic None of the animals showed signs of clinical toxicity, lost more than 10% of body weight, or had other adverse observations. | Pass |
| Hemocompatibility: Hematology – ASTM (F756) Hemolysis Assay, Direct Contact and Extract Method | To evaluate the hemolytic potential of the delivery system according to the ASTM guideline. | Non-hemolytic – Direct Contact Method –Delivery System Hemolytic Index is 0.0% and Negative control is 0.4% Positive control % Hemolytic Index is 84.9%. Extract Method –Delivery System and Negative control % Hemolytic Index is 0.0%. Positive control % Hemolytic Index is 88.8% | Pass |
| Hemocompatibility: Coagulation/Partial Thromboplastin Time (PTT) | To determine the potential of the delivery system to cause an effect on the coagulation cascade via the intrinsic coagulation pathway. | Non-activator of the intrinsic coagulation pathway. Average delivery system clotting time was 116% of the negative control while the average clotting time of the comparison article was 108% of the negative control. | Pass |

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 24

{24}

| Test / Study Method | Test Purpose | Results | Conclusion |
| --- | --- | --- | --- |
| **Hemocompatibility: Coagulation/Platelet and Leukocyte Count** | To determine if the delivery system exposed to whole blood would adversely affect the make-up of the platelet and leukocyte components of the blood. | After exposure to delivery system, Leukocyte and Platelet counts were not statistically different between the test and comparison articles. | Pass |
| **Hemocompatibility: Complement Activation SC5b-9 Assay** | To measure complement activation in Normal Human Serum (NI-IS) when serum is exposed to a delivery system. | The percent of normalized SC5b-9 concentration produced by the delivery system was 0.1-0.3% of the Cobra Venom Factor CVF, and comparison article was 0.2-0.3% of the CVF. Results were not statistically different from the negative reference material. | Pass |
| **Pyrogen: Materials Mediated Rabbit Pyrogen** | To determine whether an extract of the delivery system induced a pyrogenic response after hour 3 following intravenous injection in rabbits. | Non-pyrogenic – None of the rabbits had a temperature rise ≥ 0.5°C. | Pass |
| **Hemocompatibility: Thrombogenicity** | The Alto™ Aortic Body Delivery Catheter was evaluated for *in vivo* thrombogenicity by using data obtained during IDE study G160226. An analysis of that data concluded that incidence rates for thrombosis potentially emanating from the delivery catheter/blood interactions were lower than the average rates when compared to commercially approved EVAR devices. | | |

#### **D. Sterilization / Packaging / Shelf Life Testing**

##### ***Alto™ Aortic Body Stent Graft and Delivery System***

The Alto™ Aortic Body Stent Graft and Delivery System is a single-use device that is provided sterile to the end user. The system is ethylene oxide (EO) sterilized and was adopted into the same validated EO sterilization process under the same contract sterilizer and built in the same manufacturing environment as the previously approved Ovation devices. The adoption test results demonstrate that the Alto™ Abdominal Stent Graft System meets AAMI TIR28:2009 requirements, including comparative resistance, EO residuals, bioburden levels and bioburden recovery efficiency, and pyrogen levels and can be adopted into the currently validated cycle. The sterilization process was validated to demonstrate a Sterility Assurance Level (SAL) of 10⁻⁶.

The Alto™ Abdominal Stent Graft System utilizes the same packaging design / materials, similar configuration / labeling and sterilization cycles as those used for other approved Ovation devices, previously submitted packaging and labeling verification testing was leveraged in support of the packaging design for the Alto™ Abdominal Stent Graft System.

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 25

{25}

Testing of the Alto™ Abdominal Stent Graft System and its packaging were conducted to verify that the integrity and performance was not compromised due to the effects of packaging stress during transit. Test results passed requirements. A shelf life of 3 years has been established for the Alto™ Abdominal Stent Graft System based on product and package shelf-life testing.

### ***Autoinjector 2***

The Autoinjector 2 is electron beam sterilized using the same processes as the original Autoinjector (approved as part of the Ovation Abdominal Stent Graft System (P120006). Due to the similarities in design, sterilization re-validation was not required.

A shelf life of 3 years has been established for the Autoinjector 2 based on product and package shelf-life testing.

## **X. SUMMARY OF PRIMARY CLINICAL STUDY**

The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of endovascular aneurysm repair with the Alto™ Abdominal Stent Graft System for the treatment of infrarenal abdominal aortic aneurysms (AAAs) in the US under IDE G160226 and known as the ELEVATE Study. Data from this clinical study were the basis for the Panel-Track PMA Supplement approval decision.

The Alto™ Abdominal Stent Graft System is Endologix’s next generation polymer-based abdominal stent graft system, based on the previously approved Ovation Abdominal Stent Graft Systems (i.e., Ovation, Ovation Prime, and Ovation iX™).

As the Alto™ Abdominal Stent Graft System is expected to perform similarly to Endologix’s previously approved Ovation Abdominal Stent Graft Systems, this clinical study was designed to confirm that the device design modifications and modified Indications for Use, did not negatively impact clinical performance as compared to the clinical study conducted for the original Ovation Abdominal Stent Graft System, under IDE G090239.

Note: Information regarding the clinical evaluation of the previously approved Ovation Abdominal Stent Graft Systems can be found in the IFU for those devices.

A summary of the clinical study is presented below.

### **A. Study Design**

Patients were treated between March 2017 and February 2018. The database for this Panel Track PMA Supplement reflected data collected through May 16, 2019 and included 75 patients. There were 13 investigational sites in the United States.

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 26

{26}

The study was a prospective, consecutively enrolling, single-arm, nonrandomized multicenter clinical study utilizing the Alto™ Aortic Abdominal Stent Graft System. The primary composite endpoint was defined as treatment success at 1 year relative to a performance goal of 80%, which represents a typical one-year performance threshold for EVAR devices. The primary effectiveness hypotheses were defined as:

$$H_0: \pi \leqslant 0.80 \text{ vs. } H_1: \pi > 0.80$$

where $\pi$ = the expected treatment success rate at 1 year. If the lower limit of the one-sided Clopper-Pearson 95% confidence interval for $\pi$ is greater than 80%, then the null hypothesis for this analysis will be rejected in favor of the alternative indicating that treatment success is statistically significant above 80%.

A sample size of 75 patients was calculated based upon the primary effectiveness endpoint of treatment success at 1 year. It was estimated that 60 subjects with evaluable data at 1 year would provide 80% statistical power to test the primary hypothesis (estimated treatment success of 92.8% at 12 months) using a one-sided 95% confidence interval (Clopper-Pearson interval). This provided a more conservative estimate than the approximate method. Statistical analyses included standard descriptive statistics and the Kaplan-Meier method, with Kaplan-Meier curves generated for outcomes through 12 months.

The clinical study utilized the following independent oversight committees:

- Clinical Events Committee to adjudicate major adverse events (MAEs) and adverse events (AEs) reported by the sites as potentially related to the device;
- Core Laboratory - an independent imaging core laboratory to analyze computed tomography scans and x-rays for key baseline characteristics and effectiveness endpoints;
- Data Safety and Monitoring Board to provide ongoing study oversight of the safety of enrolled subjects.

### 1. Patient Screening and Enrollment

The patient screening process was as follows:

- The site consented the subject per their consent process.
- The site submitted the subject's computed tomography (CT) images to Endologix.
- Once received, subject CTs were reviewed by Endologix Imaging Services. Imaging Services evaluated the anatomical metrics of the subject against the inclusion/exclusion criteria and also the general suitability for EVAR. If the subject did not pass anatomical criteria, the subject was failed.

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 27

{27}

- If the subject passed Imaging Services, the CT was then reviewed by a Case Review Board (CRB). The CRB consisted of two vascular surgeons (i.e., the national principle investigator and the chief medical officer of Endologix). At least one CRB member was required to review a case. Site investigators received standing invitations to each CRB call and summaries of CT reviews were disseminated to the Site Investigators. The CRB reviewed the subjects' screening films for overall vascular suitability, such as excessive neck thrombus and a lack of proximal aortic neck.
- If both the CRB and Imaging Services deemed it appropriate, the site was given permission to enroll the subject.

A total of 140 subjects were screened for study inclusion with 75 subjects enrolled and 65 subjects rejected from study participation. The 65 excluded subjects were rejected by either: Imaging Services, CRB, or the Site Investigator. Twenty-five subjects were excluded by Imaging Services (on quantitative anatomic assessment of the CT). The most common reasons for study exclusion by Imaging Services were failure to meet juxtarenal aortic neck angulation ≤ 60°, patent iliac or femoral arteries that allow endovascular access with the Alto™ Abdominal stent graft system, and proximal aortic landing zone with an inner wall diameter of no less than 16mm and no greater than 30 mm at 7 mm below the inferior renal artery. Nineteen subjects were excluded by the CRB. The most common reasons for these patients being excluded were as follows: juxta-renal AAA, excess thrombus in the seal zone, narrow native bifurcation (<18mm), and aneurysm size being too small. Subjects could be excluded by the site investigator at any temporal point in the study. Twenty-one subjects were excluded by the Site Investigators. The most common reasons included: Site Investigator decision regarding subject anatomy, follow-up capabilities of subject and subject withdrawing consent. There were four subjects the site investigators determined were not appropriate candidates for the study due to anatomical reasons: one subject required hypogastric occlusion for common iliac aneurysm and the subject refused internal iliac artery coil embolization; one subject required sac embolization due to large lumbar arteries noted on preoperative CT; the Preop CT scan in one subject indicated that the upper right renal artery (RRA) was dominant, however on angiogram the right kidney was supplied equally from the upper and lower RRAs therefore an alternative AAA device was considered, and in one subject the physician determined the subject to have poor follow-up capabilities.

# 2. Clinical Inclusion and Exclusion Criteria

# Inclusion Criteria

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 28

{28}

Enrollment in the ELEVATE study was limited to patients who met the following inclusion criteria:

1. Patient is ≥ 18 years of age.
2. Patients who are male or non-pregnant female (females of childbearing potential must have a negative pregnancy test prior to enrollment into the study).
3. Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form.
4. Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification. ASA category IV patients may be enrolled provided their life expectancy is greater than 1 year.
5. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:
a. Abdominal aortic aneurysm ≥5.0 cm in diameter
b. Aneurysm has increased in size by 0.5 cm in last 6 months
c. Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment*.

*As part of the study, abdominal aortic aneurysms that are less than 5 cm in diameter may be treated, if at least one of the following anatomical criteria are met:

o Aneurysm has increased in size by at least 0.5 cm in the last 6 months
o Aneurysm is no less than 4 cm in diameter and exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment, as demonstrated on the screening CTA, performed within 6 months of anticipated treatment.
6. Patient has patent iliac or femoral arteries that allow endovascular access with the Endologix, Inc. (Sponsor) Alto™ Abdominal Stent Graft System.
7. Patient has a proximal aortic landing zone with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 7 mm below the inferior renal artery.
8. Patient has an adequate distal iliac landing zone with an inner wall diameter of no less than 8 mm and no greater than 25 mm.
9. Patient has an adequate distal iliac landing zone with a length of at least 10 mm. The resultant repair should preserve patency in at least one hypogastric artery.
10. Patient meets the following anatomic criteria: the distance from the most distal renal artery to most superior internal iliac artery measurement is at least 125 mm.
11. Patient has juxtarenal aortic neck angulation ≤60° if proximal neck is ≥7 mm and ≤45 degrees if proximal neck is <7 mm.
12. Patient must be able and willing to comply with all required follow-up exams.

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 29

{29}

### *Exclusion Criteria*

Patients were not permitted to enroll in the ELEVATE study if they met any of the following exclusion criteria:

1. Significant thrombus >8 mm in thickness; at any point along the aortic circumference at the level of 7mm below the inferior renal artery.
2. Diameter of aortic bifurcation that, in the physician's opinion, would compromise flow through the iliac limbs.
3. Patient has a dissecting aneurysm.
4. Patient has an acutely ruptured aneurysm.
5. Patient has an acute vascular injury.
6. Patient has a need for emergent surgery.
7. Patient has a known thoracic aortic aneurysm or dissection.
8. Patient has a mycotic aneurysm or has an active systemic infection.
9. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina).
10. Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 months.
11. Patient has a major surgical or interventional procedure planned 30 days prior and 30 days post procedure of the AAA repair.
12. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
11. Patient has history of bleeding disorders or refuses blood transfusions.
12. Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0 mg/dl.
13. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
14. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol/ nickel.
15. Patient has a body habitus that would inhibit x-ray visualization of the aorta.
16. Patient has a limited life expectancy of less than 1 year.
17. Patient is currently participating in another investigational device or drug clinical trial.
18. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.

### 3. *Follow-up Schedule*

All patients in the study were scheduled to return for follow-up examinations at 1 month, 6 months and 1 year postoperatively. Some patients returned for unscheduled

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 30

{30}

visits, which were incorporated into the clinical data set. Adverse events and complications were recorded at all visits.

Preoperatively – Preoperative assessment included a physical exam, an ankle-brachial Index (ABI) measurement, and laboratory testing, which included renal assessment, as well as serum pregnancy for female patients of childbearing potential.

Treatment period (implant/surgical procedure) – At the time of the endovascular procedure and prior to discharge, assessments were performed and data were collected on the following: type and length of anesthesia, type of vascular access, estimated blood loss, adjunctive procedures, volume of contrast used, total fluoroscopy time during procedure, investigator assessment of AAA device performance as it relates to delivery/deployment/required interventions, evidence of endoleak, device integrity issues, procedural times, and adverse events.

Post-Treatment follow-up visits (1 month, 6 months and 1 year) – The following post-treatment assessments were executed and documented:

- Physical examination
- Laboratory testing, which included renal assessment at 1 month follow up visit
- Contrast-enhanced spiral abdominal/pelvic CT (in the event the subject was unable to tolerate a contrast-enhanced spiral CT, a duplex ultrasound and non-contrast spiral CT was completed as an alternative assessment)
- Abdominal x-ray (KUB), including AP, lateral, left oblique and right oblique views.

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

- Type I endoleak, assessed by an Independent Core Lab
- Type III endoleak, assessed by an Independent Core Lab
- Stent graft migration > 10 mm (compared to 1-month baseline), assessed by an Independent Core Lab
- AAA enlargement > 5 mm (compared to 1-month baseline)
- Loss of patency
- Stent fracture, assessed by an Independent Core Lab
- AAA rupture
- Conversion to open repair
- Secondary interventions
- AAA-related mortality
- Adverse events, including:
- Serious adverse events
- Major adverse events
- Procedure-related adverse events
- Device-related adverse events

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 31

{31}

All adverse events, regardless of seriousness or cause

Table 11: Subject Follow-up Visit Schedule

| Procedure | Baseline | Treatment | Discharge | 1 Month Follow-Up | 6 Months Follow-Up | 1 Year Follow-Up |
| --- | --- | --- | --- | --- | --- | --- |
| Medical/Surgical History | X^{2} | | | | | |
| Physical Exam | X^{2} | | X | X | X | X |
| ABI | X | | | | | |
| Spiral Contrast Enhanced CT^{5} | X^{3} | | | X | X | X |
| Laboratory Assessments (BUN, Creatinine and Serum Pregnancy)^{1} | X^{1} | | | X^{1} | X^{1} | X^{1} |
| Adverse Event Assessment | | X | X | X | X | X |
| Device/aneurysm assessment based on imaging (endoleak, migration, integrity, patency) | | X | X^{4} | X | X | X |

1 BUN, creatinine and serum pregnancy HCG required no more than 30 days prior to the implant/surgical for baseline. At every follow up time point beginning with 1 month follow up, only serum creatinine will be collected. Note: the serum pregnancy is required for females of child-bearing potential only and only at baseline. BUN is only required at baseline.
2 Baseline medical/surgical history and physical exam performed no more than 30 days prior to the implant/surgical procedure.
3 Baseline contrast enhanced CT must be obtained within 6 months of anticipated treatment date.
4 Only the device will be assessed via X-Ray at discharge as no CT is performed at that visit.
5 Note that in the event the subject is unable to tolerate a contrast-enhanced spiral CT, a duplex ultrasound and non-contrast spiral CT should be completed as an alternative assessment.

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

### 4. Clinical Endpoints

With regards to safety, the incidence rate of Major Adverse Events (MAEs) following AAA repair were evaluated at 30 days, 6 months and 1 year. MAEs were defined as death (i.e., all-cause mortality, AAA-related mortality); myocardial infarction; stroke; renal failure; respiratory failure; paralysis; bowel ischemia; procedural blood loss (> 1,000 cc). All MAEs were adjudicated by an independent clinical events committee (CEC). Other safety variables collected and analyzed comprised of adverse events,

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 32

{32}

which included serious adverse events, major adverse events, procedure-related adverse events, device-related adverse events and all other adverse events, regardless or seriousness or cause.

With regards to effectiveness, the primary composite endpoint was defined as treatment success at 12 months, which included technical success (i.e., a composite endpoint of successful delivery, successful and accurate deployment, and successful withdrawal) and freedom from AAA enlargement, stent graft migration, type I or III endoleak, AAA rupture or surgical conversion, stent graft stenosis, occlusion or kink requiring a secondary intervention, any thromboembolic event attributable to stent graft requiring secondary intervention, and stent fracture requiring secondary intervention.

With regard to success/failure criteria, the study would be considered successful if the performance goal of 80% for treatment success at 12 months for the primary composite endpoint was met.

### **B. Accountability of PMA Cohort**

At the conclusion of the study, of the 75 patients enrolled, all 75 were available at 1 month follow-up (1 died, 2 withdrew consent after 1 month follow-up but before the 6 month follow-up); 72 patients were eligible at 6 month follow-up (2 died, 1 withdrew consent, and 1 was converted to open repair after the 6-month follow-up but before the 12 month follow-up) and 68 subjects were eligible at 12 months. Sixty seven (67) subjects completed a 1-year follow-up visit and, of these 61 were evaluable for the primary composite endpoint.

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 33

{33}

**Table 12: Subject and Imaging Accountability Through 12 Month Follow- Up Visit (Alto™ Treatment Group – All Subjects)**

| Visit | Eligible for follow-up* | Subjects with follow-up | Overdue (Past) † | Missed Visit‡ | In window, follow-up pending§ | Not due for next visit¶ | Site Performed¶ | Corelab Reviewed¶ | Imaging compliance | | | | X-ray | | | Events occurring before next interval | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | | | Adequate imaging to assess the parameter n (% of eligible) § | | | | Corelab Reviewed | Fracture | Other Stent Finding | LTF or WD | Died | Conversion | Conversion + Died |
| | | | | | | | | | Size Increase (Per Corelab) | Endoleak (Per Corelab) | Migration (Per Corelab) | Patency (Per Site) | | | | | | | |
| Operative | 75 | 75 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | 68 (90.7%) | 68 (90.7%) | 68 (90.7%) | 0 | 0 | 0 | 0 |
| 1 Month | 75 | 75 (100.0%) | 0 | 0 | 0 | 0 | 74 (98.7%) | 74 (100.0%) | 74 (98.7%) | 73 (97.3%) | 74 (98.7%) | 74 (98.7%) | 70 (93.3%) | 70 (93.3%) | 70 (93.3%) | 2 | 1 | 0 | 0 |
| 6 Month | 72 | 72 (100.0%) | 0 | 0 | 0 | 0 | 72 (100.0%) | 72 (100.0%) | 72 (100.0%) | 70 (97.2%) | 72 (100.0%) | 72 (100.0%) | 69 (95.8%) | 69 (95.8%) | 69 (95.8%) | 1 | 2 | 1 | 0 |
| 1 Year | 68 | 67 (98.5%) | 1** | 0 | 0 | 0 | 63 (92.6%) | 65 (103.2%)¶ | 64 (94.1%) | 61 (89.7%) | 64 (94.1%) | 64 (94.1%) | 61 (89.7%) | 61 (89.7%) | 61 (89.7%) | 0 | 0 | 0 | 0 |

*Eligible for follow-up = Subjects with follow-up + Overdue + Missed visit. Does not include those with follow-up pending, not yet due for the visit, previous deaths, conversions, and those lost to follow-up (LTF) or withdrawn (WD).

†Subjects without a follow-up visit but not yet in next window

‡Subjects without a follow-up visit and currently in next window

§Subjects currently in window, but data not yet available

¶Subjects not yet in the window

§These counts reflect the number of subjects with adequate imaging as determined by Core Lab.

**This single subject was classified as overdue because the exit was on post-op day 455 and was therefore considered enrolled during the duration of the 1-year follow-up period. As there were no follow-up windows available beyond one year, the status is not classified as a missed visit.

¶Within each visit window, the “Site Performed” and 4 variables under “Adequate Imaging” all use the number of “Eligible” subjects as the denominator. On occasion the number of subjects with adequate imaging for a specific variable may be higher or lower than the “Site Performed” frequency, as the latter only counted images of the required type (Contrast CT or Non-Contrast CT + Duplex Ultrasound). As an example a site may not obtain a CT but still perform an ultrasound. This was not considered a compliant imaging visit for the site and thus it was not counted in the “Site Performed” column. Yet there still may be sufficient information for specific variables such as sac size, so the image was counted in those columns where evaluable information was gathered.

¶The “Corelab reviewed” column represents the number of CTs/US reviewed by the corelab, and uses the number of adequate images within the “Site Performed” column as the denominator. On occasion more images were reviewed by the corelab than compliant images obtained by the site.

¶One subject was recorded as only having an ultrasound and no CT at 1 year (the corelab reviewed the Ultrasound). Another subject did not have a contrast CT recorded by the site in the dataset, though the Corelab evaluated a non-contrast CT. The percentage was greater than 100% for the 1 year visit because two subjects did not have the required imaging type, but were captured under corelab reviewed

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 34

{34}

# C. Study Population Demographics and Baseline Parameters

# 1. Demographics

The demographics of the patient population are typical for an endovascular stent graft study performed in the US and are summarized in Table 13 below. Most subjects enrolled in the study were male (93%), elderly (mean age: approximately 73 yr.), and white/not Hispanic or Latino (77%).

Table 13: Subject Demographics

| Variable | Statistic | Alto™ Treatment Group |
| --- | --- | --- |
| | N | 75 |
| Age (years) | Mean ± std | 73 ± 7 |
| Calculated Body Mass Index (BMI), (kg/m²) | Mean ± std | 30 ± 7 |
| Gender | | |
| Male | % (n/N) | 93% (70/75) |
| Female | % (n/N) | 7% (5/75) |
| Race/Ethnicity | | |
| White / Not Hispanic or Latino | % (n/N) | 77% (58/75) |
| White / Hispanic or Latino | % (n/N) | 1% (1/75) |
| Black or African American / Not Hispanic or Latino | % (n/N) | 1% (1/75) |
| Unknown / Not Hispanic or Latino | % (n/N) | 15% (11/75) |
| Unknown / Hispanic or Latino | % (n/N) | 1% (1/75) |
| Unknown / Unknown | % (n/N) | 4% (3/75) |

# 2. Subject Medical History

Baseline data regarding subject medical history is summarized in Table 14 below. Subjects presented with typical comorbidities observed in AAA patients, most commonly hypertension 83% (62/75), hyperlipidemia 76% (57/75), and smoking history 75% (56/75). Subjects were risk-classified using the American Society of Anesthesiology (ASA) criteria with most presenting as ASA class III and IV 93% (70/75).

Table 14: Subject Medical History

| Variable | Alto™ Treatment Group % (n/N) |
| --- | --- |
| ASA Grade | |
| 1/2 | 5 (7%) |
| 3/4 | 70 (93%) |

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 35

{35}

| Variable | Alto™ Treatment Group % (n/N) |
| --- | --- |
| Cardiovascular History | 72/75 (96%) |
| Coronary artery disease | 35/75 (47%) |
| Valvular heart disease | 11/75 (15%) |
| Angina pectoris or chest discomfort | 5/75 (7%) |
| Cardiomyopathy | 3/75 (4%) |
| Congestive heart failure | 6/75 (8%) |
| Myocardial infarction | 11/75 (15%) |
| Arrhythmia | 17/75 (23%) |
| Hypertension | 62/75 (83%) |
| Hypotension | 0 (0%) |
| Hyperlipidemia | 57/75 (76%) |
| Peripheral Vascular, Stroke, and Aneurysm History | 75/75 (100%) |
| Peripheral vascular disease | 13/75 (17%) |
| Carotid artery disease | 6/75 (8%) |
| Transient Ischemic Attack (TIA) | 4/75 (5%) |
| Stroke | 0 (0%) |
| Family history of aneurysms | 9/75 (12%) |
| Pulmonary History | 71/75 (95%) |
| Tobacco use (Current) | 15/75 (20%) |
| Tobacco use (Former) | 56/75 (75%) |
| COPD | 27/75 (36%) |
| Gastrointestinal, Genitourinary, Reproductive History | 49/75 (65%) |
| Renal insufficiency | 5/75 (7%) |
| Endocrine | 31/75 (41%) |
| Diabetes (Type II) | 22/75 (29%) |
| Hematological | 9/75 (12%) |
| Anemia | 5/75 (7%) |
| Psychosocial | 11/75 (15%) |
| Depression | 7/75 (9%) |
| Alcohol | 3/75 (4%) |
| Other significant medical history | 26/75 (35%) |

### 3. Subject Vascular Characteristics

Baseline data regarding subject vascular characteristics is summarized in Table 15 below. Baseline Vascular characteristics were reported by Endologix Imaging Services

PMA P120006/S031: FDA Summary of Safety and Effectiveness Data

Page 36

{36}

exclusively. All subjects enrolled in this study met the inclusion criteria based on Imaging Services CT measurements. Mean AAA diameter was 51.7 mm, with a mean proximal neck length of 27.9 mm. External…