OVATION ABDOMINAL STENT GRAFT SYSTEM

P120006 · Endologix, LLC · MIH · Oct 5, 2012 · Cardiovascular

Device Facts

• Record ID: P120006
• Device Name: OVATION ABDOMINAL STENT GRAFT SYSTEM
• Applicant: Endologix, LLC
• Product Code: MIH · Cardiovascular
• Decision Date: Oct 5, 2012
• Decision: APPR
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The TriVascular Ovation Abdominal Stent Graft System is indicated for treatment of patients with abdominal aortic aneurysms having vascular morphology suitable for endovascular repair, including: Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories, Non-aneurysmal proximal aortic neck: with a length of at least 7 mm proximal to the aneurysm, with an inner wall diameter of no less than 16 mm and no greater than 30 mm and with an aortic angle of ≤ 60 degrees if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is < 10 mm, Adequate 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 20 mm.

Device Story

Endovascular stent graft system for AAA repair; delivered via catheter to reline diseased vasculature and isolate aneurysm from blood flow. System includes aortic body stent graft, iliac limbs, iliac extensions, fill polymer kit, and autoinjector. Aortic body features laser-cut nitinol proximal stent with integral anchors and PTFE graft; sealing rings filled with liquid polymer via autoinjector to provide proximal seal and support. Iliac limbs/extensions use wire-formed nitinol stents encapsulated in PTFE. Used in clinic/OR by physicians. Radiopaque markers facilitate positioning. Polymer solidifies in situ to create conformable seal. Benefits include reduced rupture risk, minimally invasive access, and conformable sealing in non-uniform vessels.

Clinical Evidence

Prospective, international, single-arm, non-randomized pivotal study (n=161). Primary safety endpoint: 30-day Major Adverse Event (MAE) rate (2.5% vs 21% target). Primary effectiveness endpoint: 12-month Treatment Success (99.3% vs 80% target). Secondary endpoints included mortality, endoleaks, migration, and AAA enlargement. Imaging core lab verified endpoints. 12-month freedom from AAA rupture and surgical conversion was 100%.

Technological Characteristics

Materials: PTFE, nitinol, PEG-based polymers, FEP. Sensing/Actuation: Inflatable sealing rings filled with liquid polymer. Energy: Mechanical deployment. Connectivity: None. Sterilization: EtO (stent grafts) and E-Beam (autoinjector/polymer). Form factor: 13F-15F delivery catheters. MR Conditional.

Indications for Use

Indicated for patients ≥ 18 years with infrarenal abdominal aortic aneurysms (AAA) ≥ 5.0 cm, or increased by 0.5 cm in 6 months, or > 1.5 times adjacent non-aneurysmal aortic diameter. Suitable for elective open surgical repair candidates. Contraindicated in patients with conditions threatening graft infection or known sensitivities to PTFE, PEG-based polymers, FEP, or nitinol.

Reference Devices

• Talent enhanced Low Profile System (cited in literature/clinical trial comparison)

Submission Summary (Full Text)

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TriVascular, Inc
Ovation™ Abdominal Stent Graft System

# Summary of Safety and Effectiveness Data (SSED)

## I. GENERAL INFORMATION

| Device Generic Name: | Endovascular Graft |
| --- | --- |
| Device Trade Name: | Ovation Abdominal Stent Graft System |
| Device Procode: | MIH |
| Applicant’s Name and Address: | TriVascular, Inc.
3910 Brickway Blvd.
Santa Rosa, CA 95403 |
| Date(s) of Panel Recommendation: | None |
| Premarket Approval Application (PMA) Number: | P120006 |
| Date of FDA Notice of Approval: | October 5, 2012 |
| Expedited: | Not applicable |

## II. INDICATIONS FOR USE

The TriVascular Ovation Abdominal Stent Graft System is indicated for treatment of patients with abdominal aortic aneurysms having vascular morphology suitable for endovascular repair, including:

- Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories,
- Non-aneurysmal proximal aortic neck:
- with a length of at least 7 mm proximal to the aneurysm,
- with an inner wall diameter of no less than 16 mm and no greater than 30 mm and
- with an aortic angle of ≤ 60 degrees if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is &lt; 10 mm,
- Adequate 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 20 mm.

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## III. CONTRAINDICATIONS

The Ovation Abdominal Stent Graft System is contraindicated in:

- 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, fluorinated ethylene propylene [FEP] or nitinol)

## IV. WARNINGS AND PRECAUTIONS

The warnings and precautions can be found in the Ovation Abdominal Stent Graft System labeling (Instructions for Use).

## V. DEVICE DESCRIPTION

The TriVascular Ovation Abdominal Stent Graft System is an endovascular device delivered via catheter to treat abdominal aortic aneurysms (AAAs). The stent graft relines the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood to reduce the risk of rupture. The stent graft is comprised of an aortic body section, two iliac limbs, and iliac extensions, as required (Figure 1).

The TriVascular Ovation Abdominal Stent Graft System includes:

- An Aortic Body Stent Graft and delivery catheter
- Iliac Limb Stent Grafts and delivery catheters
- Iliac Extension Stent Grafts and delivery catheters, as required
- A Fill Polymer Kit
- An Autoinjector

Figure 1. Schematic of Deployed TriVascular Ovation Abdominal Stent Graft System

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The stent grafts are available in the sizes and configurations outlined in Tables 1-3.

Table 1. Aortic Body Stent Graft Sizes

| Stent Graft Proximal Diameter | Catheter Working Length | Delivery System Outer Profile | Covered Stent Graft Length |
| --- | --- | --- | --- |
| 20 mm | 57 cm | 14 F | 80 mm |
| 23 mm | | | |
| 26 mm | | | |
| 29 mm | | | |
| 34 mm | | 15 F | |

Table 2. Iliac Limb Sizes

| Stent Graft Proximal Diameter | Stent Graft Distal Diameter | Catheter Working Length | Delivery System Outer Profile | Covered Stent Graft Length |
| --- | --- | --- | --- | --- |
| 14 mm | 10 mm | 53 cm | 13 F | 80 mm |
| | 10 mm | | | 100 mm |
| | 10 mm | | | 120 mm |
| | 10 mm | | | 140 mm |
| | 12 mm | | | 80 mm |
| | 12 mm | | | 100 mm |
| | 12 mm | | | 120 mm |
| | 12 mm | | | 140 mm |
| | 14 mm | | | 80 mm |
| | 14 mm | | | 100 mm |
| | 14 mm | | | 120 mm |
| | 14 mm | | | 140 mm |
| | 16 mm | | 14 F | 80 mm |
| | 16 mm | | | 100 mm |
| | 16 mm | | | 120 mm |
| | 16 mm | | | 140 mm |
| | 18 mm | | | 80 mm |
| | 18 mm | | | 100 mm |
| | 18 mm | | | 120 mm |
| | 18 mm | | | 140 mm |
| | 22 mm | | 15 F | 80 mm |
| | 22 mm | | | 100 mm |
| | 22 mm | | | 120 mm |
| | 22 mm | | | 140 mm |

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Table 3. Iliac Extension Sizes

| Stent Graft Proximal and Distal Diameters | Catheter Working Length | Delivery System Outer Profile | Covered Stent Graft Length |
| --- | --- | --- | --- |
| 10 mm | 53 cm | 13 F | 45 mm |
| 12 mm | | | |
| 14 mm | | | |
| 16 mm | | 14 F | |
| 18 mm | | | |
| 22 mm | | | |

## Aortic Body Stent Graft

The aortic body is comprised of a proximal laser-cut stent for suprarenal fixation and a low-permeability polytetrafluoroethylene (PTFE) graft. The stent has integral anchors for fixation 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. The nitinol stent is radiopaque and the implant contains nitinol radiopaque markers adjacent to the proximal graft edge for positioning during implantation. To seal the proximal end of the graft and to provide support for the aortic body legs into which the iliac limbs are deployed, the graft body contains inflatable rings that are filled with a liquid polymer that solidifies during the deployment procedure. The graft has a fill port that connects the fill network of the graft to the delivery catheter.

## Iliac Limb and Iliac Extension Stent Graft

The iliac limbs and extensions are comprised of a wire-formed nitinol stent encapsulated within low-permeability PTFE. The iliac limbs are deployed into the leg section of the aortic body. Platinum radiopaque markers at the proximal and distal end of the stent graft enable visualization of the iliac limb-aortic body overlap or iliac extension-iliac limb overlap during deployment. The outward radial force of the stent provides fixation and sealing of the interface between the aortic body and each iliac limb, between the iliac limb and iliac extension, and between the iliac limb/extension and the landing zone in the iliac artery.

## Aortic Body Delivery System

The aortic body stent graft is preloaded into a 14F or 15F OD delivery catheter for device introduction into the access vessel (Figure 2). The aortic body delivery catheter has a lumen that allows for the use of a guidewire for delivery of the stent graft to the deployment site.

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During stent graft deployment, the device is first positioned and the sheath is retracted. The proximal stent is then deployed using stent release knobs located on the handle. The fill polymer is then delivered through the fill connector port using the autoinjector.

Figure 2. Schematic of TriVascular Ovation Abdominal Stent Graft System Aortic Body Delivery Catheter

## Iliac Limb and Iliac Extension Delivery System

The iliac limbs and iliac extensions are preloaded into delivery catheters (13F–15F OD and 13F–14F OD respectively), as illustrated in Figure 3. The contralateral and ipsilateral iliac limbs are each deployed via iliac limb delivery catheters. 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 contralateral iliac limb is advanced into position and deployed into the aortic body by retracting the catheter sheath with the catheter in the appropriate position. The contralateral delivery catheter is then withdrawn from the vasculature. After the fill polymer cures within the sealing rings, the aortic body delivery catheter is disengaged from the fill port of the graft and withdrawn from the vasculature. The ipsilateral iliac limb delivery catheter is advanced over the ipsilateral guidewire and deployed using the method described above for the contralateral limb. The ipsilateral delivery catheter is then withdrawn from the vasculature.

If an iliac extension is required, the delivery system is advanced over the guidewire and the stent graft is deployed using the method described above for contralateral and ipsilateral iliac limbs.

Figure 3. Schematic of TriVascular Ovation Abdominal Stent Graft System Iliac Limb / Iliac Extension Delivery Catheter

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## Fill Polymer and Autoinjector

The Fill Polymer Kit (Figure 4) is comprised of three materials that are mixed prior to injection. Upon mixing and injection into the graft, the components of the Fill Polymer form a radiopaque polymer that fills the sealing rings of the PTFE channels in the wall of the aortic body graft. The Fill Polymer radiopacity dissipates over time and might not be visible on fluoroscopy, X-ray, or CT beyond 1-2 months post-implant.

Prior to use, the two valves on the Fill Polymer Kit are opened and the fill polymer is mixed by alternately depressing the two syringe plungers for a minimum of 20 full strokes. Thereafter, the full syringe is disconnected from the connection tube, slipped out of the syringe support and connected to the fill polymer injection port on the catheter handle. The syringe plunger is then inserted into the autoinjector and the autoinjector is given a quarter-turn to lock it in place. The autoinjector applies controlled pressure to inject the fill polymer into the graft.

Figure 4. TriVascular Fill Polymer Kit

## VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are several alternatives for the treatment of abdominal aortic aneurysms. 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.

The alternatives include: endovascular repair using another endovascular graft system, open surgical implantation of a synthetic graft within the aneurysmal vessel, and medical management.

## VII. MARKETING HISTORY

The Ovation Abdominal Stent Graft System has been commercially available in Europe since September 2010, in the U.S. as a Humanitarian Use Device (20 mm diameter aortic body) since November 2011, in Canada through the Special Access Programme since December 2011, and commercially in New Zealand since August 2012.

The current Ovation Abdominal Stent Graft System has not been withdrawn from any market for any reason. TriVascular conducted clinical studies with a previous generation abdominal stent graft system from 2002-2004 in the U.S., Europe and

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Australia but cancelled the studies in order to pursue design changes that were incorporated into the current device. The previous generation device was not commercially available in any market.

## VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

Below is a list of the potential adverse events (e.g., complications) associated with the use of the device 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;
- Allergic reaction and/or anaphylactoid response to x-ray contrast dye, anti-platelet therapy, device materials;
- Anesthetic complications and subsequent attendant problems (aspiration);
- Aneurysm enlargement or rupture;
- 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 ileuses, obstruction, fistulas;
- 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;
- 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;
- Embolic and thrombotic events (with transient or permanent ischemia or infarction) such as deep vein thrombosis, thromboembolism, microembolism, thrombophlebitis, phlebothrombosis, air embolism;
- 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;
- Hepatic failure;
- Insertion and other vascular access site complications such as infection, dissection, transient fever, bleeding, pain, delayed healing, abscess formation, hematoma,

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dehiscence, seroma, cellulitis, nerve injury/damage, neuropathy, neuralgia, vasovagal response, pseudoaneurysm, anastomotic false aneurysm, arteriovenous fistula;

- Impotence/ sexual dysfunction;
- Lymphatic complications and subsequent attendant problems such as lymphocele, lymph fistula;
- Multi-system organ failure;
- Neoplasm;
- 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;
- Possible infection—urinary tract, systemic or localized, endograft;
- 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;
- Sepsis;
- Seroma;
- Shock;
- Spinal neurological deficit;
- 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.

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

## IX. SUMMARY OF NON-CLINICAL STUDIES

TriVascular completed comprehensive biocompatibility (Section A), *in vitro* bench and analytical testing (Section B), animal studies (Section C), and Sterility, Packaging and Shelf-Life testing (Section D) on the Ovation Abdominal Stent Graft System to support the safety and effectiveness of the device. The testing included the stent graft, iliac limbs, extensions and delivery system following recognized standards and guidance documents.

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## A. Biocompatibility

Biocompatibility testing was conducted on the Ovation Abdominal Stent Graft System to ensure that the finished device is biocompatible. Testing was performed in accordance with ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The Ovation Abdominal Stent Graft System delivery system was categorized as an external communicating device in short-term contact with circulating blood (&lt;24 hours). The stent graft and fill polymer were categorized as implant devices with permanent blood contact (&gt;30 days). The autoinjector was categorized as a non patient contacting component. All testing was performed with finished sterile devices and met the requirements as specified within the applicable standard, and is summarized in Tables 4-6.

Table 4. Biocompatibility Test Summary - Stent Graft and Fill Polymer

| Test/Study Name | Purpose | Results | Conclusion |
| --- | --- | --- | --- |
| Cytotoxicity - MEM Using L-929 Mouse Fibroblast Cells | To evaluate the ability of the test article extract to elicit a cytotoxic response in cultured mouse fibroblast cells when conducted in accordance with the test method requirements | Test article is non-toxic.
Grade 0 cytotoxicity for test and negative controls
Grade 2 for intermediate controls
Grade 4 for positive controls | PASS |
| Sensitization - LLNA Albino Swiss Mice | To assess the dermal sensitization potential of a test article using the Murine Local Lymph Node Assay (LLNA). | Not a sensitizer. Differences in test article results from the negative control were not statistically significant. | PASS |
| Irritation - Intramuscular Implant: 28 Day | To evaluate the local toxic effects of a biomaterial in direct contact with living muscular tissue of the rabbit for twenty eight (28) days. | Slight irritant - Implant tissue had an irritant ranking score of 3.2. All animals survived to the scheduled study endpoint. Gross observations were unremarkable. | PASS |
| Irritation - Intramuscular Implant: 84 Day | To evaluate the local toxic effects of a biomaterial in direct contact with living muscular tissue of the rabbit for eighty four (84) days. | Non-irritant - Implant tissue had an irritant ranking score of 2.2. All animals survived to the scheduled study endpoint. Gross observations were unremarkable. | PASS |
| 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 the rabbit. | Non-irritant - Saline and cottonseed oil extracts had an average dermal score of 0. The difference between the mean of the control and the mean of the test group was <1.0, which is acceptable. | PASS |
| Systemic Toxicity (Acute) - ISO Acute Systemic Injection | To screen test article extracts for potential toxic effects as a result of a single-dose system injection in mice. | Test article is non-toxic. No fatalities, signs of clinical toxicity or body weight loss >2 grams. | PASS |

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| Test/Study Name | Purpose | Results | Conclusion |
| --- | --- | --- | --- |
| Genotoxicity - Bacterial Mutagenicity Test - AMES Assay Using Five Salmonellea Strains and Escherichia Coli | To evaluate the mutagenic potential of the test article (or its metabolites) by measuring its ability to induce back mutations at selected loci of several strains of bacteria in the presence and absence of microsomal enzymes by a method compliant with the requirements. | Non-toxic and non-mutagenic. | PASS |
| Genotoxicity - In Vitro Mouse Lymphoma Assay | To determine the ability of a test article to induce forward mutations at the thymidine kinase (TK) locus as assayed by colony growth of L5178Y mouse lymphoma cells in the presence of trifluorothymidine (TFT). | Non-toxic and non-mutagenic. | PASS |
| Genotoxicity - In Vivo Mouse Micronucleus Assay | To evaluate the mutagenic potential of the test article (or its metabolites) by measuring its ability to induce back mutations at selected loci of several strains of bacteria in the presence and absence of microsomal enzymes by a method compliant with the requirements. | Non-toxic and non-mutagenic. | PASS |
| Implantation | To evaluate the local toxic effects of a biomaterial in direct contact with living muscular tissue of the rabbit for eighty four (84) days. | Test implant sites did not demonstrate any significant difference as compared to the control implant sites. Bioreactivity Rating = 1.5 (no reaction) | PASS |
| Hemocompatibility – Hematology: Hemolysis Test, Direct Contact Method | To evaluate the hemolytic potential of test articles according to the ASTM guideline. | Values of 2% or less are considered non-hemolytic. Test article % Hemolytic Index is 0.2%. Negative and Blank control % Hemolytic Index is 0.0%. Positive control % Hemolytic Index is 11.5%. | PASS |
| Hemocompatibility – Coagulation: Partial Thromboplastin Time (PTT) | To determine the time citrated plasma exposed to medical materials takes to form a clot when exposed to a suspension of phospholipid particles and calcium chloride. | Average clotting time is comparable to negative control. At this time, there are no ranges or levels that have been established as acceptable. | N/A |
| Hemocompatibility – Coagulation: Platelet and Leukocyte Count | To determine if medical materials exposed to whole blood would adversely affect the make-up of the platelet and leukocyte components of the blood. | Leukocyte counts were decreased (88% of baseline) and platelet counts were increased (108% of baseline) after exposure to the test article when compared to the negative control (baseline) and reference material. No acceptable levels have been established at this time. | N/A |

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| Test/Study Name | Purpose | Results | Conclusion |
| --- | --- | --- | --- |
| Pyrogen – Mediated Rabbit Pyrogen | To determine if a saline extract of the test article causes a febrile response in rabbits. | Non-pyrogenic – Acceptable results are sum of temperature increase less than 3.3°C and not more than 3 rabbits with >0.5°C increase. Sum of temperature differences between 8 rabbits was 1.1°C; 1 rabbit had a >0.5°C (+0.7°C) increase. | PASS |

Table 5. Biocompatibility Test Summary - Iliac Limb Stent Graft

| Test/Study Name | Purpose | Results | Conclusion |
| --- | --- | --- | --- |
| Cytotoxicity - MEM Using L-929 Mouse Fibroblast Cells | To evaluate the ability of the test article extract to elicit a cytotoxic response in cultured mouse fibroblast cells when conducted in accordance with the test method requirements. | Test article is non-toxic. Grade 0 cytotoxicity for test and negative controls. Grade 2 for intermediate controls. Grade 4 for positive controls. | PASS |
| Sensitization – ISO Guinea Pig | To evaluate the allergic potential or sensitizing capacity of a test article. | Test article results were equivalent to the negative control. | PASS |
| Irritation - Intramuscular Implant: 26 week | To evaluate a test article for the potential to induce local toxic effects in the muscle tissue of New Zealand White rabbits for a period of 26 weeks. | Non-toxic – Test article was non-toxic (rating of 0.95 after 26 weeks, <1 is defined as non-toxic) when compared to the control article. All animals survived to the scheduled study endpoint. | PASS |
| Intracutaneous Reactivity | To determine if chemicals that may leach or be extracted from the test article were capable of causing local irritation in the dermal tissues of the rabbit. | Non-irritant - The difference between the mean of the control and the mean of the test group was <1.0, which is acceptable. | PASS |
| Systemic Toxicity (Acute) – ISO Acute Systemic Injection | To screen test article extracts for potential toxic effects as a result of a single-dose systemic injection in mice. | Test article is non-toxic. No fatalities, signs of clinical toxicity or body weight loss > 2 grams. | PASS |
| Genotoxicity - Salmonellea Typhimurium and Escherichia Coli Reverse Mutation Assay | To evaluate the potential of a test article to include histadine reversion and tryptophan reversion in the genomes of these respective organisms. | Non-mutagenic | PASS |
| Genotoxicity - Mouse Lymphoma Mutagenesis Assay | To evaluate the potential of a test article to induce an increase in the formation of homozygous thymidine kinase mutants over the background rate in a mouse lymphoma mutant of the L5178Y cell line, heterozygous at the thymidine kinase locus, in the presence and absence of a metabolic activation system. | Non-mutagenic | PASS |

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| Test/Study Name | Purpose | Results | Conclusion |
| --- | --- | --- | --- |
| Genotoxicity – Rodent Bone Marrow Micronucleus Assay | To evaluate the potential of a test article and/or its metabolites to induce micronuclei in maturing erythrocytes of mice. | Non-mutagenic | PASS |
| Implantation | To evaluate a test article (solid material) for the potential to induce local toxic effects in the muscle tissue of New Zealand White rabbits for a period of 26 weeks. | Non-toxic – Test article was non-toxic (rating of 0.95 after 26 weeks, <1 is defined as non-toxic) when compared to the control article. All animals survived to the scheduled study endpoint. | PASS |
| Hemocompatibility – Hematology: Hemolysis Test, Direct Contact Method | To evaluate the hemolytic potential of test articles according to the ASTM guideline. | Values 2% or less are considered non-hemolytic.
Test article % Hemolytic Index is 0.9%.
Negative control % Hemolytic Index is 0.1%.
Blank control % Hemolytic Index is 0.0%.
Positive control % Hemolytic Index is 11.6%. | PASS |
| Pyrogen Mediated Rabbit Pyrogen | To evaluate the test articles for the presence of materials mediated pyrogens. | Non-pyrogenic – Acceptable result is no rabbits with a temperature increase >0.5°C. None of the 3 rabbits had an increase in temperature >0.5°C. | PASS |

Table 6. Biocompatibility Test Summary - Delivery Catheter with Hydrophilic Coating

| Test/Study Name | Purpose | Results | Conclusion |
| --- | --- | --- | --- |
| Cytotoxicity – MEM Using L-929 Mouse Fibroblast Cells | To evaluate the ability of the test article extract to elicit a cytotoxic response in cultured mammalian cells when conducted in accordance with the test method requirements. | Test article is non-toxic.
Grade 0 cytotoxicity for test and negative controls.
Grade 2 for intermediate controls.
Grade 4 for positive controls. | PASS |
| Sensitization – ISO Guinea Pig Maximization Sensitization Test | To evaluate the allergenic potential or sensitizing capacity of a test article upon exposure to guinea pigs. | Test article sensitization response equivalent to the negative controls.
No abnormal clinical signs or sensitization responses were noted for any of the animals during the study. | PASS |
| Intracutaneous Reactivity | To determine if chemicals that may leach or be extracted from the test article were capable of causing local irritation in the dermal tissues of the rabbit. | Test article is a non-irritant.
The difference in the mean test and control scores of the 0.9% Normal Saline and Cottonseed Oil extract dermal observations were less than 1.0. | PASS |
| Systemic Toxicity (Acute) – ISO Acute Systemic Injection | To screen test article extracts for potential toxic effects as a result of a single-dose systemic injection in mice. | Test article is non-toxic.
No fatalities, signs of clinical toxicity, or body weight loss > 2 grams in control or test animals. | PASS |

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| Test/Study Name | Purpose | Results | Conclusion |
| --- | --- | --- | --- |
| Hemocompatibility – Hematology: Hemolysis Test, Direct Contact Method | To evaluate the hemolytic potential of test articles according to the ASTM guideline. | Corrected hemolytic index indicates test article is non-hemolytic. | PASS |
| Hemocompatibility – Coagulation: Partial Thromboplastin Time (PTT) | To determine the time citrated plasma exposed to medical materials takes to form a clot when exposed to a suspension of phospholipid particles and calcium chloride. | Average clotting time is comparable or equal to negative control.
At this time, there are no ranges or levels that have been established as acceptable. | N/A |
| Hemocompatibility – Coagulation: Platelet and Leukocyte Counts | To determine if materials exposed to whole blood would adversely affect the make-up of the platelet and leukocyte components of the blood. | Leukocyte counts were decreased (83% of baseline) and platelet counts were increased (92% of baseline) after exposure to the test article when compared to the negative control (baseline) and reference material. No acceptable levels have been established at this time. | N/A |
| Hemocompatibility – Complement Activation C3a and SC5b Assay | To measure complement activation in Normal Human Serum (NI-IS) when serum is exposed to a test article. | The percent of normalized C3a concentration produced by the test article was 3.2% of the CVF.
The percent of normalized SC5b-9 concentration produced by the test article was 0.3% of the CVF.
No acceptable levels have been established at this time. | N/A |
| Hemocompatibility – Thrombogenicity – Thromboresistance in Beagle Dogs | To evaluate a test article for four hour thromboresistance in beagle dogs. | No adverse effects or clinical signs noted. Patency and Thrombus scores for the test article were the same as for the reference material. | PASS |
| Pyrogen – Mediated Rabbit Pyrogen | To determine if a saline extract of the test material causes a febrile response when administered intravenously in rabbits using the standard USP Rabbit Pyrogen Test procedure. | Non-pyrogenic – Test material met the acceptable result of sum of temperature increase of less than 3.3°C and not more than 3 rabbits with >0.5°C. | PASS |

## B. Laboratory Studies: In Vitro Bench Testing

The testing presented in Table 7 below includes results from both baseline (T=0) and accelerated aged units. An asterisk indicates testing that was performed at the accelerated aged timepoints. The testing verified that the Ovation Abdominal Stent Graft System met product performance and design specifications.

Table 7. Ovation Abdominal Stent Graft System In Vitro Bench Test Summary

| Test | Purpose / Objectives | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Mechanical Testing: Implant | | | |
| Stent Radial Force* | For the aortic body, the purpose is to determine the radial force of the stent graft | Aortic Body Radial Force:
When the stent is compressed after being deployed to its maximum | PASS
The stent grafts met |

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| Test | Purpose / Objectives | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | components to fixate to the vessel wall and thereby prevent migration of the graft.

For the iliac limbs, the purpose is to determine the radial force of the stent graft component to seal and fixate the iliac vessel and prevent migration of the graft. | diameter, the stent will have a radial force of at least 0.4 lbf; when the stent is expanded back to its maximum vessel diameter it will have a radial force greater than 0.2 lbf.

**Iliac Limb and Iliac Extensions Radial Force:**
>0.1 lbf and <4.5 lbf for the 10mm diameter size;
>0.2 lbf and <5.8 lbf for the 12mm diameter size;
>0.2 lbf and <7.0 lbf for the 14mm diameter size;
>0.2 lbf and <8.2 lbf for the 16mm diameter size;
>0.3 lbf and <9.4 lbf for the 18mm diameter size;
>0.3 lbf and <10.6 lbf for the 22mm diameter size. | the radial force requirements. |
| Dimensional Verification (diameter and length)* | To confirm the as-built devices meet the pre-determined range adequate to treat a broad number of patients. | The implant must treat patients within the following diameter and lengths:

**Aortic Body Diameter:**
Sized to treat 15.5mm to 17.4mm diameter vessels for the 20mm nominal diameter size.
Sized to treat 17.5mm to 20.4mm diameter vessels for the 23mm nominal diameter size.
Sized to treat 20.5mm to 23.4mm diameter vessels for the 26mm nominal diameter size.
Sized to treat 23.5mm to 26.4mm diameter vessels for the 29mm nominal diameter size.
Sized to treat 26.5mm to 30.4mm diameter vessels for the 34mm nominal diameter size.

**Iliac Limb and Extensions Diameter:**
Sized to treat 7.5mm to 9.4mm diameter vessels for the 10mm nominal diameter size.
Sized to treat 9.5mm to 11.4mm diameter vessels for the 12mm nominal diameter size.
Sized to treat 11.5mm to 13.4mm diameter vessels for the 14mm nominal diameter size.
Sized to treat 13.5mm to 15.4mm diameter vessels for the 16mm nominal diameter size.
Sized to treat 15.5mm to 17.4mm diameter vessels for the 18mm nominal diameter size.
Sized to treat 17.5mm to 20.4mm diameter vessels for the 22mm nominal diameter size.

**Aortic Body Length:**
Length tolerance = +5 / -5 mm

**Iliac Limb Length:**
Length tolerance = +5 / -5 mm

**Iliac Extension Length:** | PASS

The stent grafts met the treatment diameter and length specifications. |

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| Test | Purpose / Objectives | Acceptance Criteria
Length tolerance = +3 / -3 mm | Results |
| --- | --- | --- | --- |
| Stent Graft Conformability to Vessel Wall | To confirm the stent adequately conforms to the arterial wall in diseased, non-uniform vessels. | Aortic Body:
Appropriately-sized stent grafts will seal in 16 and 30mm simulated vessels.

Iliac Limb and Extensions:
Appropriately-sized stent grafts will seal in 8 and 20mm simulated vessels. | PASS
Testing was augmented by clinical data.
The stent grafts tested created a conformable seal. |
| Stent Graft Length to Diameter Relationship | To characterize the stent graft length to diameter relationship. | To characterize any foreshortening (length to diameter relationship) of the aortic body, iliac limb and iliac extension graft during deployment. | PASS
The stent grafts tested demonstrated that the dimensional changes during deployment did not influence the final stent length (i.e. foreshortening). |
| Stent Graft Modular Joint Integrity | To confirm the stent graft junctions do not separate when subjected to a worst-case blood pressure value (320 mmHg). | The aortic body with iliac limb and iliac limb with iliac extension junctions must not separate when subjected to an internal pressure of 320 mmHg. | PASS
The various combinations of stent grafts tested demonstrated that the stent grafts do not separate at the load corresponding to the specified blood pressure. |
| Stent Graft Lumen Burst Strength | To confirm that the stent grafts do not burst when subjected to a worst-case blood pressure value (320 mmHg). | The aortic body, iliac limb, and iliac extension stent grafts must not burst below 320 mmHg. | PASS
The stent grafts tested demonstrated that the stent grafts do not burst below the specified blood pressure. |
| Stent Graft Longitudinal Tensile Strength | To confirm that the stent grafts have adequate longitudinal tensile strength for both hemodynamic loads and delivery. | Aortic Body:
The aortic body graft must have adequate longitudinal tensile strength to withstand the maximum of either hemodynamic loads resulting from a transient systolic pressure of 320 mmHg or a delivery system pull force of 2 lbf.

Iliac Limb and Extensions:
The iliac limb and extension graft must have longitudinal tensile strength for hemodynamic loads resulting from a transient systolic pressure of 320 mmHg. | PASS
The stent grafts tested demonstrated that the stent grafts have adequate longitudinal tensile strength for both hemodynamic loads and delivery. |
| 10-yr Device Integrity | The stent grafts must demonstrate 10-year equivalent device integrity. | Stent Graft Creep:
Aortic Body and Iliac Limb Graft must not burst below a pressure of 320mmHg after 10 years simulated creep testing. Changes in either diameter or length must not affect the ability of the device to function.

Aortic Body Graft Material Cyclic Loading:
Material must maintain structural integrity under cyclic loading for an | PASS
The stent graft samples satisfied all of the acceptance criteria for 10-year device integrity. |

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| Test | Purpose / Objectives | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | | equivalent of a 10 year life under simulated physiologic conditions.

**Stent Graft Pulsatile Fatigue:**
The modular graft system (aortic body and limbs) should provide structural integrity under pulsatile internal pressure for 400 million cycles.

**Aortic Body Stent Dilatation Fatigue:**
Aortic Body Graft Stents should provide structural integrity under pulsatile dilatation for 400 million cycles.

**Iliac Limb Dilatation Fatigue:**
Iliac Limb stent grafts should maintain structural integrity under pulsatile dilatation for 400 million cycles.

**Graft Stent Attachment Fatigue:**
The proximal aortic body graft - stent attachment sites must be able to transfer load from the graft to the stent for 400 million cycles of cyclical load. The following test conditions define the anticipated clinical extreme conditions:

1) Angulated Graft-Stent Attachment Fatigue: The graft-stent attachment must withstand 400 million cycles of cyclic load under worst case angulated conditions of inner radius of curvature.

2) Lesser Curve Graft-Stent Attachment Fatigue: The graft-stent attachment must withstand 400 million cycles of cyclic load on the lesser curve of an angulated aorta.

3) Asymmetric Greater Curve Graft-Stent Attachment Fatigue: The graft-stent attachment must withstand 400 million cycles of cyclic load assuming a worst-case anchor engagement into the greater curve of an angulated aorta.

**Iliac Limb Asymmetric Axial Fatigue:**
Maintain structural integrity for the equivalent of a 10 year life.

**Stent Anchor Fatigue:**
The aortic body stent anchors must withstand without fracturing 400 million cycles of axial loading at physiologic conditions.

**Iliac Limb/Extension Overlap Fatigue:**
Iliac limbs with extensions in an overlap condition should maintain structural integrity without excessive wear under pulsatile radial dilatation for 400M cycles. | |

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| Test | Purpose / Objectives | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Stent Corrosion Resistance | To demonstrate that the stents and attachment rings have adequate corrosion performance. | The stents and attachment rings must have in-vitro corrosion performance that is at least equivalent to a commercialized stent-graft device. | PASS
All tested samples met the corrosion requirement. |
| Stent Graft Radiopacity | To confirm the implant is visible under fluoroscopy during the implant procedure to allow for proper placement. | The implant must be visible under fluoroscopy during the implant procedure to allow for proper placement. | PASS
All tested samples met the radiopacity specification. |
| Stent Graft Kink Resistance | To confirm the iliac limb and extension stent grafts have sufficient flexibility to conform to tortuous anatomy. | Iliac Limb and Iliac Extension will accommodate curvature not exceeding 90° with a minimum inner radius of curvature of 1 cm without kinking. | PASS
There was no observance of kinking at the specified radius of curvature in any of the stent grafts tested. |
| Stent Graft Permeability | To confirm the stent grafts maintain adequate permeability. | Aortic Body and Iliac Limb graft water entry pressure must not be less than a differential pressure of 817 mmHg. | PASS
All samples met the permeability specification. |
| 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 16psig (827mmHg). | PASS
All samples met the minimum burst pressure. |
| Durability – Stent Maximum Strain by FEA | To confirm the stent design has adequate mechanical properties for manufacturing, delivery and fatigue performance. | The peak strains should not exceed 9% in the aortic body stent during catheter loading or under in vivo conditions.
The peak strains should not exceed 9% in the iliac limb or extension stents during catheter loading or under in vivo conditions.
The fatigue safety factors computed from the maximum FEA-predicted cyclic fatigue strains under challenging in vivo conditions and nitinol material fatigue data should be >1. | PASS
All of the computed peak strains were less than the design limit.
All of the computed fatigue safety factors were >1. |
| Mechanical Testing: Fill Polymer | | | |
| Fill Polymer Degradation Resistance* | To confirm the fill polymer has adequate degradation resistance in a test representative of 10 years in vivo duration. | The fill polymer must not degrade as measured by a loss of less than 10% mass in an in vitro degradation test representative of 10 years in vivo duration inside the graft. | PASS
All samples met the fill polymer degradation resistance specification. |
| Fill Polymer Radiopacity | To ensure adequate visibility to aid in verifying the complete deployment of the implant. | The fill polymer must have adequate radiopacity at time of deployment to indicate filling of the graft with fill polymer. | PASS
All deployments met the visibility acceptance criteria. |
| Fill Polymer Dimensional Stability* | To ensure dimensional stability such that exclusion of the aneurysm and sufficient aortic bloodflow is maintained throughout the life of the implant. | The fill polymer must not shrink during cure by an amount sufficient to cause loss of seal. It also must not swell during or after cure by an amount sufficient to cause loss of graft patency or structural integrity. | PASS
All samples met the dimensional stability specifications. Testing was augmented by clinical data. |

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| Test | Purpose / Objectives | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Fill Polymer Ease of Mixing | To confirm the fill polymer mixing force is within ergonomic limits. | The maximum syringe plunger force to mix the fill polymer must not exceed 16 lbf and an average value of 11 lbf. | PASS
All samples met the mix force specification. |
| Fill Polymer Cure Time* | To confirm the fill polymer, once mixed, consistently cures (gels) within a pre-determined range. | The fill polymer kit must provide adequate mixing to the fluid as it passes from one syringe to another as verified through a fill polymer cure time of 13±2 minutes. | PASS
The fill polymer mixing was confirmed through acceptable cure time. |
| Fill Polymer Balloonability Time | To confirm that the stent graft is balloonable within 15 minutes of mixing the fill polymer. | The stent graft must be balloonable under test protocol conditions within 15 minutes after detach of the delivery system from the graft with a properly sized balloon. | PASS
Testing demonstrated that all filled grafts maintained structural integrity when ballooned after the filling process in accordance with IFU recommendations. |
| Fill Polymer Modulus* | To confirm the fill polymer provides mechanical support and seal conformability between the stent graft and the aortic wall. | The fill polymer must have mean elastic modulus (200–500 psi when cured) and storage modulus (87-109 psi [6.0-7.5X10^{5}Pa]). | PASS
All samples met the modulus criteria. |
| Mechanical Testing: Delivery System | | | |
| Delivery System Placement Accuracy of Stent Graft* | To confirm successful placement of the stent graft in the in vivo environment. | The system must permit consistent and accurate deployment of the implant to within:
+5/-0 mm of the intended proximal aortic landing site
±5 mm of the distal iliac landing site | PASS
All samples were successfully deployed within the specification requirements of the proximal deployment target. |
| Delivery System Hemostasis* | To confirm the hemostatic seals on the proximal end of the sheath and the guidewire lumen will not leak. | The hemostatic seals on the proximal end of the sheath and the guidewire lumen shall not leak water at a rate greater than 7 ml/min. | PASS
All samples satisfied the water leak rate specification limit. |
| Delivery System Radiopacity | To ensure adequate visibility to aid in the accurate placement of the implant. | The delivery system must have sufficient radiopacity as evaluated under fluoroscopy to orient the implant, to confirm sheath retraction, to confirm fill tube detach (aortic body) and to confirm catheter withdrawal from the implant. | PASS
Visibility for all deployments met the acceptance criteria. |
| Delivery System Unsheathing Force (Force to Deploy)* | To confirm the force required to retract the sheath is within appropriate ergonomic limits. | The unsheathing force shall not exceed the minimum tensile strength of the sheath tubing and shall not exceed an ergonomic limit of 12 pounds. | PASS
All stent graft samples were successfully deployed with unsheathing forces below specification. |

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| Test | Purpose / Objectives | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Delivery System Kink Resistance* | To confirm the catheter can be advanced to the implant site such that it does not kink, compromise the deployment, or damage the implant. | The catheter can be advanced through a tortuous model and does not kink in a way that compromises the deployment or damages the implant. | PASS
All devices were advanced through the tortuous flow model without kinking. No deployments were compromised by delivery system kinks, nor were any implants found to be damaged during post-simulated use inspection. |
| Delivery System Profile* | To confirm the delivery system profiles are within labeled requirements. | The delivery system outer diameters (ODs) must not exceed the labeled OD. | PASS
All delivery system samples passed the attribute profile test. |
| Delivery System Length* | To confirm the as built delivery system lengths will provide positioning of the implant to the target location within most anatomical settings. | Working Length:
Aortic Body delivery system: 52cm - 58cm
Iliac Limb / Iliac Extension delivery system: 50cm - 55cm | PASS
The delivery systems met the dimensional specifications for length. |
| Delivery System Pushability* | To confirm the delivery system transmits sufficient pushability to position the catheter to the correct target location for an accurate placement of the stent graft. | The delivery system must transmit sufficient pushability to position the catheter at the correct elevation within the model for an accurate placement of the stent graft. | PASS
All delivery system samples met the pushability specifications. |
| Delivery System Trackability* | To confirm the delivery system has sufficient trackability to position the catheter, track over the guide wire and accurately position the implant. | The delivery system must have sufficient trackability to position the catheter and accurately position the implant within the model.
When placed in a tortuous model, the delivery system can sufficiently track over the guide wire to locate the implant at the intended deployment location. | PASS
All delivery system samples met the trackability specifications. |
| Delivery System Torquability* | To confirm the aortic body delivery system has sufficient torquability to position the catheter and accurately position and orient the implant. | The Aortic Body delivery system must have sufficient torquability to position the catheter and accurately position and orient the implant within the model.
When placed in a tortuous model, the distal end of the sheathed catheter must rotate an amount to match the rotation of the handle and flushport. | PASS
All delivery system samples met the torquability specifications. |

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| Test | Purpose / Objectives | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Delivery System Bond Strengths* | To confirm the delivery system has adequate bond tensile strengths to permit access, deployment and withdrawal of the stent graft. | Sheath to Sheath Fitting:
Minimum Tensile Strength: 15 lbf

Radiopaque Marker Band on Lumens:
Minimum Tensile Strength: 1.5 lbf

All other bonded components:
Minimum Tensile Strength: 5 lbf

Nosecone:
Minimum Torsional Strength: 5 lbf after rotational test

Sheath to Sheath Fitting:
Minimum Torsional Strength: 12.2 in-oz

Inner Catheter Proximal Band (Aortic Body only)
Minimum Torsional Strength: 12.2 in-oz | PASS
The delivery system bonds have adequate strength to reliably meet functional specifications. |
| Delivery System Detach Stop Force* | To confirm that the aortic body delivery system fill tube does not disconnect from the aortic body graft at a force below the designated specification. | The system must not allow the fill tube to detach from the aortic body graft at a force less than 2 lbs prior to releasing the stop. | PASS
All aortic body delivery systems passed the detach stop force requirement. |
| Delivery System Detach Force* | To confirm the aortic body permits consistent withdrawal of the delivery system without causing damage to or dislodgement of the implant. | The system must permit consistent withdrawal of the delivery system without causing damage to or more than 5 mm dislodgement distance of the implant. | PASS
The delivery system samples met the detach force specification: No movement of the stent-graft was observed during detach for any of the aortic body samples. |
| Simulated Use* | To confirm the delivery system can deploy and fill the stent graft within an in vitro model without failure to: access, deploy the stents, fill the graft or withdraw the catheter. | The delivery system shall deploy and fill the stent graft within the in vitro model without failure to: access, deploy the stents, fill the graft or withdraw the catheter. | PASS
In all devices tested, access, deployment, fill, and catheter withdrawal were successful. |
| Delivery System Auto-Injector Pressure Range* | To confirm the autoinjector supplies adequate force to the syringe in order to fill the stent graft with fill polymer while not exceeding the burst pressure of the stent graft inflation channels. | The autoinjector must supply a 12-16 psig soon after insertion of syringe into autoinjector. | PASS
All auto-injector samples met the specifications. |
| 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 035" guidewire with little or no resistance. | PASS
All delivery system samples met the guidewire compatibility specifications. |
| Catheter Luer Compatibility* | To confirm compatibility with a commonly available connector type for elements of the catheter which interface with other accessories. | The catheter must be compatible with standard luer fittings in order to interface with other accessories. | PASS
All delivery system samples met the luer compatibility specifications. |

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| Test | Purpose / Objectives | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Introducer System Compatibility* | To confirm that, in the event an introducer is required, delivery system can fit through commercially available introducers. | Delivery system must fit through a commercially available introducer. | PASS
All delivery system samples passed through the appropriately-sized introducer sheath. |
| Graft Magnetic Resonance Imaging Safety | To confirm the implant will not migrate or heat significantly in the presence of magnetic resonance. | The implant must pose no known hazards in an MR environment pursuant to an "MR Conditional" label status. | PASS
The implants are deemed MR Conditional. |

## C. In vivo Animal Studies

The objectives of the animal studies were to evaluate device deployment and chronic implant performance in ovine models. Preclinical *in vivo* GLP and non-GLP animal testing utilizing early and final versions of the fill material was conducted in 27 animals to meet these objectives. The stent grafts used in the animal study were prototypes of the final device design of the Ovation Abdominal Stent Graft System. Although not conducted on the final design of the stent graft, the performance of the devices used in the animal studies was considered indicative of the current system performance. The results demonstrated successful device delivery, graft patency, absence of migration or kinking, absence of abnormalities on end-organ histopathology, and/or normal healing. The results support the safety and expected performance of the Ovation Abdominal Stent Graft System. Table 8 outlines the *in vivo* animal studies conducted.

Table 8. Ovation Abdominal Stent Graft System In vivo Animal Studies

| Study Number / Study Name | GLP / Non-GLP | Type / Number of Animals | Follow-up Duration / Procedure | Objectives | Results |
| --- | --- | --- | --- | --- | --- |
| DVP-2144; Chronic GLP study of in ovine Stent Graft and Fill Polymer Vasculature utilizing a prototype delivery system to the final marketed delivery system^{#} | GLP | Ovine/ 18 | 30 day and 90 day | Evaluate the deployment of the stent grafts for the following items:
• Successful device placement
• Ease of delivery
• Deployment accuracy
• Device radiopacity
• Delivery system flexibility
Verify that the stent grafts maintain luminal patency and physiological function.
Evaluate the stent grafts for migration and kinking.
Determine the response of the host and the prosthesis in the vascular system. | The test devices were deployed successfully, maintained patency, did not migrate, kink significantly, or elicit an abnormal host response when deployed in the ovine vascular system. |
| DVP-2150; a 30-day chronic GLP safety study of Stent Graft and Fill Polymer in ovine vasculature | GLP | Ovine/ 3 | 30 day | Evaluate the deployment of the stent grafts and fill polymer.
Verify that the stent grafts maintain patency and physiological function.
Evaluate the stent grafts for migration and kinking.
Determine the response of the host and the prosthesis in the vascular system. | The study endpoints were successful delivery, graft patency, absence of migration or kinking, and normal healing. Delivery was successful in all animals treated. All endpoints of the study were satisfied. |

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| Study Number / Study Name | GLP / Non-GLP | Type / Number of Animals | Follow-up Duration / Procedure | Objectives | Results |
| --- | --- | --- | --- | --- | --- |
| DVP-2151: a 90-day chronic GLP study of Stent Graft and Fill Polymer in ovine vasculature | GLP | Ovine/3 | 90 day | Evaluate the deployment of the stent grafts and fill polymer.
Verify that the stent grafts maintain patency and physiological function.
Evaluate the stent grafts for migration and kinking.
Determine the response of the host and the prosthesis in the vascular system. | The study endpoints were successful delivery, graft patency, absence of migration or kinking, and normal healing. Delivery was successful in all animals treated. All endpoints of the study were satisfied. |
| DVP-2154: a 30-day non-GLP chronic study of Fill Polymer in ovine vasculature^{b} | Non-GLP | Ovine/3 | 30 day | Determine the outcome resulting from a bolus release of soluble fill material into the ovine vasculature during the cure process. | A bolus release of the fill polymer did not produce angiographic changes either acutely or chronically, and did not produce any abnormalities evident on end organ histopathology. There did not appear to be any adverse response of the ovine vascular system or organs to the worst-case fill polymer spill exposure. |

a The delivery system used in the animal studies was determined to be similar to the system tested in clinical investigation. Differences included the addition of lubricious coating, switch from PEBAX to ABS handle material, and the addition of a Detach prevention feature (release of one additional wire before withdrawal).

b The FDA was not obliged to accept this non-GLP study and utilized regulatory discretion and additional scrutiny in deciding whether it could be utilized. This study provided adjunctive, supporting data to the additional GLP studies. It was conducted to address a risk evaluation of a device fault condition and is not relevant to the normal/intended use of the device

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

The Ovation Abdominal Stent Graft System is sterilized by a validated ethylene oxide (EtO) or E-Beam sterilization process to achieve a minimal sterility assurance level (SAL) of 10⁻⁶. Packaging performance and stability testing (summarized in Table 9) demonstrated that the Ovation Abdominal Stent Graft System maintains functionality and packaging integrity through 3 year shelf life.

Table 9. Ovation Abdominal Stent Graft System Sterility, Packaging, and Shelf-Life

| Test | Requirement | Results | Analysis Type |
| --- | --- | --- | --- |
| Sterilization Aortic Body, Iliac Limbs, Iliac Extensions | 100% EtO sterilization process is used. It is considered an overkill sterilization cycle in accordance with ISO 11135-1:2007 Annex B. Validation of the sterilization cycle demonstrates that the devices achieve a sterility assurance level of 10⁻⁶. Sterilization validation was performed by identifying the worst case or challenge location on the product. | PASS | Biological indicators were placed in the challenge location in 60 full test units (20 units/cycle x 3 half cycles). |

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| Test | Requirement | Results | Analysis Type |
| --- | --- | --- | --- |
| Sterilization Fill Polymer Kit and Autoinjector | E-Beam radiation sterilization process is used on the Autoinjector and Fill Polymer Kit. Both products are validated in accordance with the VDmax method detailed in AAMI TIR33:2005 and allowed per ISO 11137-2:2006. Validation of the sterilization cycle demonstrates that the devices achieve a sterility assurance level of 10^{-6}. Sterilization validation was performed by demonstrating product sterility at a fraction of the routine sterilization dose based on the average product bioburden level. | PASS | Thirty (30) full products were tested for bioburden levels. The verification dose was determined using AAMI TIR33:2005 from the average product bioburden results. Ten (10) full products were tested for sterility after the products were subjected to the verification dose. |
| Packaging Performance and Stability | The packaging designs of the Ovation Abdominal Stent Graft System must be sufficient to adequately protect the device and maintain the integrity of the Ovation Abdominal Stent Graft System package throughout its shelf life claim of up to three years. | PASS | Attribute |

## X. SUMMARY OF PRIMARY CLINICAL STUDIES

The applicant performed a prospective, international, single-arm, nonrandomized pivotal clinical study to establish a reasonable assurance of safety and effectiveness of endovascular aneurysm repair with the Ovation Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). The study was conducted in the U.S. (under IDE G090239), Germany, and Chile under an identical treatment and follow-up protocol. Information from a feasibility study of a previous generation device was also considered in evaluating the longer-term safety of the unique device characteristic (i.e., polymer stability). The feasibility study and the Ovation Abdominal Stent Graft System Pivotal Clinical Study are summarized in Table 10.

Table 10. Clinical Use of the Ovation Abdominal Stent Graft System

| Clinical Study | Device Design | Study Design | Objective | Number of Sites | Number of Patients |
| --- | --- | --- | --- | --- | --- |
| Ovation Abdominal Stent Graft System Pivotal Clinical Study | Ovation Abdominal Stent Graft System | Prospective, consecutively enrolling, single-arm, non-randomized multi center, international clinical study | Evaluate safety and effectiveness | 28 (US)
8 (OUS) | 111 (US)
50 (OUS) |
| Feasibility | ENOVUS Abdominal Stent Graft System | Prospective, consecutively enrolling, non-randomized multi center international feasibility study | Evaluate the preliminary safety of the first generation device | 7 (US)
7 (OUS) | 43 (US)
36 (OUS) |

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Data from the pivotal clinical study to support the PMA approval decision are summarized in below.

## A. Study Design

Patients were treated between November 2009 and March 2011. The database for this PMA reflected data collected through June 6, 2012 and included 161 patients (111 in the United States, 30 in Germany and 20 in Chile). There were 36 investigational sites.

The sample size of the study was calculated using the normal approximation with nQuery Advisor 6.02 (Statistical Solutions, Saugus, MA) and was based upon the primary safety evaluation. It was estimated that 150 patients with evaluable data at 30 days would provide 96% statistical power to test the primary safety hypothesis (major adverse event [MAE] incidence of 11%) at the one-sided 0.05 level. A 15% attrition rate was anticipated through 12 months, which would yield approximately 128 patients available to assess the primary effectiveness endpoint at 12 months. Should the rate for the primary effectiveness composite endpoint equal 88.2%, then 128 patients would provide 80% power to test the primary effectiveness hypothesis at the one-sided 0.05 alpha level. Therefore, the sample size of n=161 provides adequate statistical power for the evaluation of safety and effectiveness.

The analysis included endpoints that were consistent with current literature on endovascular stent grafts. The primary safety hypothesis was tested by comparing the 30-day major adverse event (MAE) incidence in patients treated with the Ovation device to a target performance goal of 21%¹, which was established based upon the 30 day MAE rate published in the literature for a recently-approved FDA device. The primary effectiveness hypothesis was tested by comparing the 12-month composite treatment success rate in patients treated with the Ovation device to a target performance goal of 80%. For effectiveness endpoint evaluation, an independent core lab reviewed CT scans and abdominal x-rays to assess aneurysm changes, device position and integrity, and endoleaks. The statistical analyses included standard descriptive statistics and the Kaplan-Meier method, with Kaplan-Meier curves generated for outcomes through 12 months.

The following external evaluation groups were used for the study:

- Core Laboratory: In order to provide independent verification of imaging findings, images required by protocol were sent by the study sites to a central imaging core laboratory with processes and systems that are GMP/GCP, HIPAA, and 21 CFR Part 11 compliant. The imaging core laboratory is housed in an ISO 13485 certified facility, which adheres to all applicable federal regulations.
- Clinical Events Committee (CEC): An independent CEC adjudicated all MAEs, SAEs, device-related AEs, and deaths for event type and device and procedure relatedness. Members included physicians with relevant endovascular AAA experience who were

¹ Turnbull IC, Criado FJ, Sanchez L, et al. Five-year results for the Talent enhanced Low Profile System abdominal stent graft pivotal trial including early and long-term safety and efficacy. J Vasc Surg. Mar 2010;51(3):537-544

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not directly involved in the conduct of the study and who had no conflicts of interest related to the study sponsor or the study investigators.

- **Data Safety and Monitoring Board (DSMB)**: An independent DSMB reviewed the progress of the study at intervals during enrollment. Based on the safety data, the DSMB could have recommended that TriVascular continue, modify, or stop the study in accordance to previously agreed parameters. The committee was composed of physicians with relevant endovascular AAA experience and one biostatistician who were not directly involved in the conduct of the study and who had no conflicts of interest related to the study sponsor or the study investigators.

## 1. Inclusion and Exclusion Criteria

Enrollment in the TriVascular Ovation Abdominal Stent Graft System study was limited to patients who meet the inclusion criteria as outlined in Table 11.

### Table 11. Inclusion Criteria

| Inclusion Criteria |
| --- |
| Patient is ≥ 18 years of age. |
| Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study). |
| Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form. |
| 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. |
| Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:
• Abdominal aortic aneurysm ≥ 5.0 cm in diameter
• Aneurysm has increased in size by 0.5 cm in last 6 months.
• Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment |
| Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation Abdominal Stent Graft System. |
| Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium. |
| Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥10 mm. The resultant repair should preserve patency in at least one hypogastric artery. |
| Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm. |
| Patient has suitable non-aneurysmal distal iliac luminal diameters between 8 and 20 mm. |
| Patient meets the following anatomic criteria: the distance from the most distal renal artery to most superior internal iliac artery measurement is at least 13 cm. |
| Patient has juxtarenal aortic neck angulation ≤ 60° if proximal neck is ≥10 mm and ≤ 45° if proximal neck is <10 mm. |

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| Inclusion Criteria |
| --- |
| Patient must be willing to comply with all required follow-up exams. |

Patients were not permitted to enroll in the TriVascular Ovation Abdominal Stent Graft System study if they met any of the exclusion criteria outlined in Table 12.

Table 12. Exclusion Criteria

| Exclusion Criteria |
| --- |
| Patient has a dissecting aneurysm. |
| Patient has an acutely ruptured aneurysm. |
| Patient has an acute vascular injury. |
| Patient has a need for emergent surgery. |
| Patient has a known thoracic aortic aneurysm or dissection. |
| Patient has a mycotic aneurysm or has an active systemic infection. |
| Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset or nocturnal angina, or onset of prolonged angina). |
| Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 months. |
| Patient has a major surgical or interventional procedure planned ≤30 days of the AAA repair. |
| Patient has history of connective tissue disease (e.g., Marfan’s or Ehler’s–Danlos syndrome). |
| Patient has history of bleeding disorders or refuses blood transfusions. |
| Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0 mg/dl. |
| Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment. |
| Patient has a known allergy or intolerance to polytetrafluorethylene (PTFE), PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol. |
| Patient has a body habitus that would inhibit X–ray visualization of the aorta. |
| Patient has a limited life expectancy of less than 1 year. |
| Patient is currently participating in another investigational device or drug clinical trial. |
| 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. |

## 2. Follow-up Schedule

The study follow-up schedule for patients consisted of imaging and clinical assessments (described below) at post-procedure (pre-discharge), 1 month, 6 months and 1 year, and yearly thereafter through 5 years. Patients who returned for unscheduled visits were incorporated into the clinical data set.

Preoperatively, patient demographics, medical/surgical history, physical exam, Ankle-Brachial Index (ABI) measurement, and laboratory testing, which included renal and coagulation assessment, as well as serum pregnancy for female patients of childbearing

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potential, were collected for each patient. Postoperatively, the objective parameters measured during the study included the following assessments and testing, prior to discharge:

- Physical exam
- Ankle-Brachial Index (ABI) measurement
- Laboratory testing, which includes renal and optional coagulation assessment
- Length of hospital stay
- Abdominal X-ray (KUB), including AP, lateral, left oblique and right oblique views. This X-ray served as the baseline for all future evaluations of device integrity.
- Concomitant medications (anticoagulants, antiplatelets and antibiotics only)
- Adverse events
- Other relevant data as indicated on the CRF, including optional wound assessment.

The following objective parameters were measured at the 1 month, 6 month, and yearly follow-up visits:

- Physical exam
- Laboratory testing, which includes renal and optional coagulation assessment
- Contrast Enhanced Spiral Abdominal/Pelvic CT
- Abdominal X-ray (KUB), including AP, lateral, left oblique and right oblique views
- Device/aneurysm assessment based on imaging (endoleak, migration, integrity, patency, AAA dimensions)
- Concomitant medications (anticoagulants, antiplatelets and antibiotics only)
- Adverse events
- Other relevant data as indicated on the CRF including optional wound assessment.

As noted above, adverse events and complications were recorded at all visits.

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

## 3. Clinical Endpoints

The primary safety endpoint for this study was the proportion of patients who experienced a Major Adverse Event (MAE) within 30 days of the initial procedure compared to a target performance goal. Other secondary endpoints and analyses included mortality rates at 30 days and 12 months; AAA-related mortality at 30 days and 12 months; AAA rupture through 12 months; and conversion to open repair through 12 months. All MAEs were adjudicated by an independent clinical events committee (CEC).

The primary effectiveness endpoint for this study was the proportion of patients that achieved Treatment Success. Treatment Success is a composite endpoint of technical success (defined as successful delivery and deployment of one aortic body and two iliac limbs) and freedom from the following assessed at 12 months: Type I and III endoleaks,

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stent graft migration, AAA enlargement, and AAA rupture and conversion to open repair. Other secondary endpoints and analyses included evaluation of technical success and through 12 months, freedom from: Type I and III endoleaks, stent graft migration, AAA enlargement, and loss of device integrity.

Study success was defined as meeting the primary safety and effectiveness endpoints. The Ovation pivotal study was considered successful if the null hypotheses for the test of primary safety (≥ 21%) and effectiveness (≤ 80%) were rejected.

## B. Accountability of PMA Cohort

At the time of database lock, of 161 patients enrolled in the PMA study, 152 (94%) were evaluable for primary endpoint analysis at the 12-month follow-up visit. Detailed patient accountability and follow-up are presented in Table 13. The numbers found in Table 13, as well as subsequent sections, represent those patients that had data available to assess the relevant parameters.

Table 13. Patient and Imaging Accountability Through 12-Month Follow-up Visit

| Interval (Analysis Window) | Patient follow-up | | | Patients with imaging performed (Core Lab) | | Patients with adequate imaging to assess the parameter (Core Lab) | | | | Patient events occurring before next visit | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Eligible | Clinical Follow-up | Imaging Follow-up | CT Imaging | KUB Imaging | Aneurysm size increase | Endoleak | Migration | Stent Integrity | No implant | Conversion to surgery | Death | Withdrawal | Loss to follow-up |
| Originally Enrolled | 161 | | | | | | | | | 0 | | | | |
| Events after implant but before a 1 Month visit | | | | | | | | | | | | 1 | | |
| 1 Month (Day 1 - 90) | 160 | 160 (100%) | 161 (101%)^{1} | 160 (100%) | 157 (98%) | | 153 (96%) | | 157 (98%) | | | | | |
| Events after 1 Month visit but before a 6 Month visit | | | | | | | | | | | | 1 | 1 | 1 |
| 6 Month (Day 91 - 304) | 157 | 156 (99%) | 155 (99%) | 154 (98%) | 150 (96%) | 154 (98%) | 150 (96%) | 154 (98%) | 150 (96%) | | | | | |

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| Interval
(Analysis Window) | Patient follow-up | | | Patients with imaging performed
(Core Lab) | | Patients with adequate imaging to assess the parameter.
(Core Lab) | | | | Patient events occurring before next visit | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Eligible | Clinical Follow-up | Imaging Follow-up | CT Imaging | KUB Imaging | Aneurysm size Increase | Endoleak | Migration | Stent Integrity | No Implant | Conversion to surgery | Death | Withdrawal |
| Events after 6 Month visit but before a 12 Month visit | | | | | | | | | | | 2 | 3 | |
| 12 Month (Day 305 - 547) | 152 | 152 (100%) | 152 (100%) | 150 (99%) | 146 (96%) | 150 (99%) | 143 (94%) | 150 (99%) | 146 (96%) | | | | |

Data analysis sample size varies for each of the timepoints above and in the following tables. This variability is due to patient availability for follow-up as well as quantity and quality of images available from specific timepoints for evaluation. For example, the number and quality of images available for evaluation of endoleak at 6 months is different than the number and quality of images available at 12 months due to variation in the number of image exams performed, the number of images provided from the clinical site to the Core Lab, and or the number of images with acceptable evaluation quality.

One patient expired before hospital discharge and is not eligible for 1 month visit, but has imaging follow-up in 1-90 days time period post procedure.

## C. Study Population Demographics and Baseline Parameters

The demographics of the study population are typical for an endovascular stent graft study. Baseline data regarding patient demographics, medical history and baseline aortoiliac aneurysm characteristics are summarized in Tables 14-16.

### Table 14. Patient Demographics

| Variable | Statistics | Ovation Treatment Group |
| --- | --- | --- |
| | N | 161 |
| Age (yr) | Mean ± std | 73 ± 8 |
| | Median | 73 |
| | Min, Max | 54, 95 |
| Gender | | |
| - Male | % (n/N) | 87.6% (141/161) |
| - Female | % (n/N) | 12.4% (20/161) |
| Race | | |
| - White | % (n/N) | 92.5% (149/161) |
| - Black | % (n/N) | 2.5% (4/161) |
| - Asian | % (n/N) | 0.0% (0/161) |
| - American Indian or Alaska Native | % (n/N) | 0.0% (0/161) |
| - Native Hawaiian or Other Pacific Islander | % (n/N) | 0.0% (0/161) |

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| Variable | Statistics | Ovation Treatment Group |
| --- | --- | --- |
| - Unknown/Other | % (n/N) | 5.0% (8/161) |
| Ethnicity | | |
| - Hispanic or Latino | % (n/N) | 9.3% (15/161) |
| - Not Hispanic or Latino | % (n/N) | 89.4% (144/161) |
| - Unknown | % (n/N) | 1.2% (2/161) |

Table 15. Patient Medical History

| Variable | Ovation Treatment Group % (n/N) |
| --- | --- |
| ASA Grade | |
| - I | 5.6% (9/161) |
| - II | 28.0% (45/161) |
| - III | 59.6% (96/161) |
| - IV | 6.8% (11/161) |
| Cardiovascular Disease | |
| - Coronary artery disease | 44.7% (72/161) |
| - Valvular heart disease | 11.8% (19/161) |
| - Angina | 6.8% (11/161) |
| - Cardiomyopathy | 6.8% (11/161) |
| - Congestive Heart Failure | 7.5% (12/161) |
| - Myocardial infarction | 20.5% (33/161) |
| - Arrhythmia | 21.7% (35/161) |
| - Hypertension | 84.5% (136/161) |
| - Hypotension | 0.6% (1/161) |
| - Hyperlipidemia | 70.2% (113/161) |
| Peripheral Vascular Disease, Stroke and Aneurysm History | |
| - Peripheral vascular disease | 23.6% (38/161) |
| - Carotid artery disease | 13.0% (21/161) |
| - Transient ischemic attack (TIA) | 5.0% (8/161) |
| - Stroke (CVA) | 8.1% (13/161) |
| - Family History of aneurysms | 6.2% (10/161) |
| Pulmonary History | |
| - Smoking | 70.2% (113/161) |
| - Chronic obstructive pulmonary disease (COPD) | 27.3% (44/161) |
| Gastrointestinal, Genitourinary, Reproductive History | |
| - R…