VICI VENOUS STENT System

P180013 · Boston Scientific Corporation · QAN · May 2, 2019 · Cardiovascular

Device Facts

Record IDP180013
Device NameVICI VENOUS STENT System
ApplicantBoston Scientific Corporation
Product CodeQAN · Cardiovascular
Decision DateMay 2, 2019
DecisionAPPR
Device ClassClass 3
AttributesTherapeutic

Intended Use

The VICI VENOUS STENT System is intended for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

Device Story

The VICI VENOUS STENT System is a self-expanding, laser-cut Nitinol stent designed to improve luminal diameter in iliofemoral veins. It includes a 9F coaxial delivery system with a distal-to-proximal 'pin and pull' deployment mechanism. Used in clinical settings by physicians under fluoroscopic guidance, the device is advanced over a 0.035in guidewire to the target lesion. Upon deployment, the stent expands to appose the vessel wall, restoring venous outflow. Radiopaque tantalum markers at both ends facilitate accurate placement. The device is intended to alleviate symptoms of venous outflow obstruction, potentially improving patient quality of life. Clinical decision-making relies on pre-procedural imaging (venography) to confirm obstruction and post-procedural assessment to ensure patency.

Clinical Evidence

Prospective, global, multi-center single-arm trial (VIRTUS) of 170 subjects (127 post-thrombotic, 43 non-thrombotic). Primary effectiveness endpoint: 12-month primary patency (freedom from occlusion/re-intervention/in-stent stenosis >50%). Results: 84% patency rate (ITT), meeting the 72.1% performance goal (p<0.0001). Primary safety endpoint: freedom from Major Adverse Events (MAE) through 30 days. Results: 98.8% freedom from MAE, meeting the 94% performance goal. Secondary endpoint (VCSS improvement) was not met. Clinical data supported by core lab-adjudicated venography, DUS, and IVUS.

Technological Characteristics

Implant: Laser-cut self-expanding Nitinol stent with tantalum radiopaque markers. Delivery system: 9F coaxial, over-the-wire (0.035in guidewire compatible), 100cm length. Sterilization: 100% ethylene oxide (EO) gas. MRI compatibility: MRI Conditional (1.5T and 3.0T). Shelf life: 3 years.

Indications for Use

Indicated for patients ≥18 years with symptomatic, chronic non-malignant obstruction of the common femoral, external iliac, or common iliac veins (≥50% diameter reduction). Contraindicated in patients unable to receive intraprocedural anti-coagulation or those with lesions preventing full balloon inflation/stent placement.

Regulatory Classification

Identification

A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. GENERAL INFORMATION Device Generic Name: Stent, Iliac Vein Device Trade Name: VICI VENOUS STENT® System Device Procode: QAN Applicant’s Name and Address: Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 Date(s) of Panel Recommendation: None Premarket Approval Application (PMA) Number: P180013 Date of FDA Notice of Approval: 5/02/2019 II. INDICATIONS FOR USE The VICI VENOUS STENT System is intended for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. III. CONTRAINDICATIONS The VICI VENOUS STENT System is contraindicated for use in: - Patients who are judged to have a lesion that prevents complete inflation of a balloon dilatation catheter or proper placement of the stent or the stent delivery system. - Patients who cannot receive intraprocedural anti-coagulation therapy. IV. WARNINGS AND PRECAUTIONS The warnings and precautions can be found in the VICI VENOUS STENT System labeling. V. DEVICE DESCRIPTION The VICI VENOUS STENT System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque (RO) markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained in a 9F (maximum 3mm outside diameter) delivery system (Figure 1) available in a 100cm length. The delivery system is a coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. The delivery system is an Over-the- PMA P180013: FDA Summary of Safety and Effectiveness Data Page 1 {1} Wire system compatible with 0.035in (0.89mm) guidewires. ![img-0.jpeg](img-0.jpeg) Figure 1: VICI VENOUS STENT Delivery System The VICI VENOUS STENT is available in a variety of stent diameters and lengths. The VICI VENOUS STENT size matrix is provided in Table 1. Table 1: VICI VENOUS STENT Size Matrix | Stent Diameter | Stent Length | | | | --- | --- | --- | --- | | 12 mm | 60 mm | 90 mm | 120 mm | | 14 mm | 60 mm | 90 mm | 120 mm | | 16 mm | 60 mm | 90 mm | 120 mm | The VICI VENOUS STENT System delivers the stent in a distal-to- proximal direction with the standard "pin and pull" method. After obtaining access to the vessel, the physician prepares the System by flushing the inner lumen and outer shaft with heparinized saline. When the physician is ready to deploy a stent in a patient, the delivery system is inserted into the vasculature over an 0.035in guidewire that runs through the entire inner lumen of the delivery system. The delivery system is advanced to the location where the stent is to be deployed. The physician will determine the specific location of the vessel to land the first part of the stent. A radiopaque marker at the distal end of the delivery system aids in visibility during placement and deployment. Under fluoroscopic guidance, the physician will align the distal end of the VICI VENOUS STENT and the selected delivery system with the desired location. The physician deploys the stent by "pinning" the proximal end of the inner catheter (i.e., inner shaft hub) and "pulling" the outer shaft back. This exposes the distal end of the stent and, as the outer shaft is pulled more, the stent length is progressively uncovered until the proximal end of the VICI stent is exposed and opens in the vasculature. As the stent is exposed to body temperature, it expands to appose the vessel wall. VI. ALTERNATIVE PRACTICES AND PROCEDURES There are several alternatives for prevention or treatment of symptomatic venous outflow PMA P180013: FDA Summary of Safety and Effectiveness Data {2} obstruction including: - Preventative measures include life-style changes such as balanced diet, exercise regimen, weight loss, smoking cessation and avoiding prolonged sitting or standing. - Non-invasive treatment therapies may include compression stockings, pneumatic compression therapy and/or an oral anticoagulation regimen with Vitamin K antagonists (VKA) or direct oral anticoagulation (DOACs). - Minimally-invasive treatment options may include percutaneous transluminal angioplasty (PTA) or stenting with another stent for which there is an approved indication. Thrombolysis (systemic, catheter-directed or pharmacomechanical) may also be performed adjunctively. - Open surgical treatments are endophlebectomy, crossover vein bypass and surgical bypass with graft, all with or without A/V fistula. Each alternative has its own advantages and disadvantages. The physician should fully discuss each alternative with the patient to select the method that meets the patients' expectations and lifestyle. ## VII. MARKETING HISTORY The VICI VENOUS STENT System was first commercially available in the European Union in January 2014. The countries where the VICI VENOUS STENT System is currently commercially available are listed below. The device has not been withdrawn from marketing for any reason related to its safety or effectiveness. - Republic of Ireland - United Kingdom - France - Norway - Sweden - Denmark - The Netherlands - Belgium - Germany - Poland - Slovakia - Switzerland - Austria - Italy - Spain - Argentina - Australia - New Zealand - Hong Kong ## VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH Below is a list of the potential adverse effects (e.g. complications) which may be associated with use of the device: - Abscess - Access site complications including: bleeding, pain, tenderness, pseudoaneurysm, hematoma, nerve or vessel damage, or infection - Allergic or hypersensitivity reactions (drug, contrast, device or other) - Amputation - Aneurysm - Arteriovenous fistula formation and rupture - Back pain PMA P180013: FDA Summary of Safety and Effectiveness Data {3} - Cerebrovascular dysfunction and/or stroke - Death - Embolization - Entanglement of delivery system in deployed stent - Fever - GI bleeding - Hypotension/hypertension - Myocardial infarction, ischemia, angina, or other cardiovascular disturbance - Need for urgent intervention or surgery - Obstruction of venous tributaries - Organ failure - Pneumothorax or respiratory distress, pneumonia and/or atelectasis - Renal failure - Restenosis - Sepsis/Infection - Stent fracture - Stent migration, misplacement/jumping, or embolization - Stent occlusion - Stent thrombosis - Thrombophlebitis - Tissue ischemia/necrosis - Vasospasm - Vein thrombosis - Venous congestion - Venous occlusion - Vessel injury, examples include dissection, intimal tear, rupture or perforation For the specific adverse events that occurred in the clinical study, please see Section X below. ## IX. SUMMARY OF NON-CLINICAL STUDIES A series of non-clinical laboratory and animal studies related to the product were performed to evaluate the device. ## A. Biocompatibility Studies A series of Good Laboratory Practice (GLP) biocompatibility tests were conducted to demonstrate that the components of the VICI VENOUS STENT and the VICI VENOUS STENT Delivery System are biocompatible. All biocompatibility testing was conducted in accordance with: - Guidance for Industry and FDA Staff, Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems Guidance, Document issued on April 18, 2010 - Good Laboratory Practices Regulations (§CFR Part 58) - Guidance for Industry and Food and Drug Administration Staff, PMA P180013: FDA Summary of Safety and Effectiveness Data {4} Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," Document Issued on June 16, 2016 The tests summarized in Table 2 have been conducted in support of the VICI STENT as recommended for a permanent implantable device contacting circulating blood for $&gt;30$ days and Table 3 for the VICI VENOUS STENT Delivery System as recommended for external communicating, circulating blood contact with limited contact duration ( $&lt; 24$ hours). Table 2: Summary of Biocompatibility/Toxicity Results for the VICI VENOUS STENT | Test | Test Description | Applicable Standard | Acceptance Criteria | Results /Status | | --- | --- | --- | --- | --- | | Cytotoxicity | Colony Assay | ISO 10993-5:2009 Tests for Cytotoxicity | The test requirement is met if none of the cultures treated with the test article showed greater than mild reactivity (Grade 2). | Non-Cytotoxic/ PASS | | Sensitization | Guinea Pig Maximization Test - SC and SO Extracts | ISO 10993-10:2010 Tests for Irritation & Sensitization | The test requirement is met if the skin reaction scores received by the test group are equal or less than the scores received by the negative control group. | Non-sensitizer/ PASS | | Irritation/Intracutaneous Toxicity | Intracutaneous Study - SC and SO Extracts | ISO 10993-10:2010 Tests for Irritation & Sensitization | The test requirement is met if the difference between the test article and the control mean score is 1.0 or less (negligible or slight). | Non-irritant/ PASS | | Systemic Toxicity (Acute) | Systemic Toxicity Study - SC and SO Extracts | ISO 10993-11:2006 Tests for Systemic Toxicity | The test requirement is met if none of the animals injected with the test article extracts show a significantly greater biological reaction than the animals treated with the vehicle control. | Non-toxic/ PASS | | Material Mediated Pyrogenicity | USP Pyrogen Study - Material Mediated | ISO 10993-11:2006 Tests for Systemic Toxicity | The test requirement is met if no rabbit shows an individual rise in temperature of 0.5°C or more above baseline | Non-pyrogenic/ PASS | | Hemocompatibility: Hemolysis | ASTM Hemolysis - Direct and Indirect Contact | ISO 10993-4:2002 Tests for Hemocompatibility | The test requirement is met if the hemolytic index of test article/test article extract is 2% or less. | Non-hemolytic/ PASS | | Hemocompatibility: Complement Activation C3a | Complement Activation Assay - C3a | ISO 10993-4:2002 Tests for Hemocompatibility | The test requirement is met if the C3a concentration from the test article extract is not statistically higher than both the activated NHS | Non-activator/ PASS | PMA P180013: FDA Summary of Safety and Effectiveness Data {5} | Test | Test Description | Applicable Standard | Acceptance Criteria | Results /Status | | --- | --- | --- | --- | --- | | | | | and negative controls. | | | Hemocompatibility: Complement Activation SC5b-9 | Complement Activation Assay - SC5b-9 | ISO 10993-4:2002 Tests for Hemocompatibility | The test requirement is met if the SC5b-9 concentration from the test article extract is not statistically higher than both the activated NHS and negative controls. | Non- activator/PASS | | Genotoxicity: (Bacterial Reverse Mutation Assay) | Bacterial Reverse Mutation Assay - SC and DMSO Extracts | ISO 10993-3:2003 Tests for Genotoxicity, Carcinogenicity & Reproductive Toxicity | The test requirement is met if less than 2-fold increase in the number of mean revertants over the means obtained from the negative control for strains of TA98, TA100 and WP2uvrA, and/or less than 3-fold increase in the number of mean revertants over the means obtained from the negative control for strains TA1535 and TA 1537 are observed in the DMSO and saline extracts. | Non- mutagenic/PASS | | Genotoxicity: Chromosomal Aberration (MLA) | Mouse Lymphoma Assay - Serum-Free Culture Medium and DMSO Extracts | ISO 10993-3:2003 Tests for Genotoxicity, Carcinogenicity & Reproductive Toxicity | The test requirement is met if less than two-fold increase in the RPMI0 and DMSO test article extracts are observed in the mean mutant frequency of L5178Y/TK+/- cell line either in the presence or absence of metabolic activation. | Non- mutagenic/PASS | | Genotoxicity: (Mouse Peripheral Blood Micronucleus) | Mouse Peripheral Blood Micronucleus Assay - SC and SO Extracts | ISO 10993-3:2003 Tests for Genotoxicity, Carcinogenicity & Reproductive Toxicity | The test requirement is met if the average %MN-RETs obtained for the negative control animals was between 0.1% and 0.5% and the average %MN-RETs for the positive control animals was at least 1.0%. | No increase in mutagenic activity/PASS | | Hemocompatibility: Thrombogenicity (in vivo) | Acute and Chronic Thromboresistance - Ovine GLP Study | ISO 10993-4:2002 Tests for Hemocompatibility | The test requirement is met if no significant differences in vascular response between test article and control stents in stent-related mortality | No evidence of thrombogenicity detected/PASS | PMA P180013: FDA Summary of Safety and Effectiveness Data {6} Table 3: Summary of Biocompatibility/Toxicity Results for the VICI VENOUS STENT Delivery System | Test | Test Description | Test Methodology | Acceptance Criteria | Results /Status | | --- | --- | --- | --- | --- | | Cytotoxicity | MEM Elution | ISO 10993-5:2009 Tests for Cytotoxicity | The test article meets test requirements if none of the cultures treated with the test article show greater than Mild reactivity (Grade 2). | Non-cytotoxic/ PASS | | Sensitization | Guinea Pig Maximization Test - SC and SO Extracts | ISO 10993-10:2010 Tests for Irritation & Sensitization | The test requirement is met if the skin reaction scores received by the test group are equal or less than the scores received by the negative control group. | Non-sensitizer/ PASS | | Irritation/Intracutaneous Toxicity | Intracutaneous Study - SC and SO Extracts | ISO 10993-10:2010 Tests for Irritation & Sensitization | The test requirement is met if the difference between the test article and the control mean score is 1.0 or less (negligible or slight). | Non-irritant/ PASS | | Systemic Toxicity (Acute) | Systemic Toxicity Study - SC and SO Extracts | ISO 10993-11:2006 Tests for Systemic Toxicity | The test requirement is met if none of the animals injected with the test article extracts show a significantly greater biological reaction than the animals treated with the vehicle control. | Non-toxic/ PASS | PMA P180013: FDA Summary of Safety and Effectiveness Data {7} | Test | Test Description | Test Methodology | Acceptance Criteria | Results/Status | | --- | --- | --- | --- | --- | | Material Mediated Pyrogenicity | USP Pyrogen Study – Material Mediated | ISO 10993-11:2006 Tests for Systemic Toxicity | The test requirement is met if no rabbit shows an individual rise in temperature of 0.5°C or more above baseline. | Non-pyrogenic/PASS | | Hemocompatibility: Hemolysis | ASTM Hemolysis – Direct and Indirect Contact | ISO 10993-4:2002 Tests for Hemocompatibility | The test requirement is met if the hemolytic index of test article/test article extract is 2% or less. | Non-hemolytic/PASS | | Hemocompatibility: Complement Activation C3a | Complement Activation Assay – C3a | ISO 10993-4:2002 Tests for Hemocompatibility | The test requirement is met if the C3a concentration from the test article extract is not statistically higher than both the activated NHS and negative controls. | Non-activator/PASS | | Hemocompatibility: Complement Activation SC5b-9 | Complement Activation Assay – SC5b-9 | ISO 10993-4:2002 Tests for Hemocompatibility | The test requirement is met if the SC5b-9 concentration from the test article extract is not statistically higher than both the activated NHS and negative controls. | Low potential activator/PASS | | Hemocompatibility: Acute Thromboresistance | Acute Thromboresistance | ISO 10993-4:2002 Tests for Hemocompatibility | The test requirement is met if no significant differences in vascular response between test article and control stents in stent-related mortality or luminal thrombus. | Non-thrombogenic/PASS | | Genotoxicity | Biological Risk Assessment | ISO 10993-3:2003 Tests for Genotoxicity, Carcinogenicity & Reproductive Toxicity | n/a | Testing considered not necessary | # B. Physico-Chemical Testing Physico-chemical testing on the VICI VENOUS STENT was conducted, as applicable, in accordance with: Guidance for Industry and FDA Staff, Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems Guidance, Document issued on April 18, 2010 - Guidance for Industry and FDA Staff, Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Document issued on August 18, 2015 Physico-chemical testing on the VICI VENOUS STENT was performed, including the following tests: Nickel Ion Release Chemical Characterization $\mathrm{O}$ Exhaustive Extraction: water/hexane/ethanol Inductively Coupled Plasma (ICP)/Mass Spectroscopy (MS): water $\mathrm{O}$ Ion Chromatography (IC): water PMA P180013: FDA Summary of Safety and Effectiveness Data {8} Gas Chromatography (GC)/Mass Spectroscopy (MS): water/hexane/ethanol $\mathrm{O}$ Fourier Transform Infrared Spectroscopy (FTIR): water/hexane/ethanol $\mathrm{O}$ Ultra Performance Liquid Chromatography/Mass Spectroscopy (UPLC-MS): water/hexane/ethanol # 1. Nickel Ion Release Results In accordance with FDA Guidance Document "Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems" dated April 18, 2010, the assessment of nickel ion release from Nitinol devices is recommended. However, there is no recognized standard that specifies the maximum permissible nickel ion leaching. The acceptance criteria for this study was therefore based on a literature review. The data were analyzed based on the F.W. Sunderman 1983 article (F.W. Sunderman, Potential Toxicity from Nickel Contamination of Intravenous Fluids, Annals of Clinical and Laboratory Science, vol 13 (1), 1-4). Test articles were prepared in accordance with ISO 10993-15 "Biological Evaluation of Medical Devices - Part 15: Identification and quantification of degradation products from metals and alloys." The nickel ion release was observed at Day 1 and Day 60. Results from the nickel ion release test demonstrated that the amount of nickel released was below the $35\mu \mathrm{g}$ per day acceptance criteria recommended by Sundemann. # 2. Chemical Characterization Results The chemical characterization results are provided in Table 4. The results from these tests were all acceptable. Table 4: VICI VENOUS STENT Chemical Characterization Results | Effect | Results | | --- | --- | | Exhaustive Extraction – water | Total non-volatile residue was determined to be <0.5 mg. | | Exhaustive Extraction – ethanol | Total non-volatile residue was determined to be <0.5 mg. | | Exhaustive Extraction – hexane | Total non-volatile residue was determined to be <0.5 mg. | | FTIR – water | There were no major bands detected | | FTIR – ethanol | There were no major bands detected | | FTIR – hexane | There were no major bands detected | | ICP/MS – water | There was one element detected in the extract | | UPLC-MS – water | No compounds were observed greater than the 0.017 μg/cm2 | | UPLC-MS – hexane | No compounds were observed greater than the 0.034 μg/cm2 | | UPLC-MS – ethanol | No compounds were observed greater than the 0.017 μg/cm2 | | GC/MS – water | There were no semi-volatile organic compounds detected. | | GC/MS – hexane | There were no semi-volatile organic compounds detected. | | GC/MS – ethanol | There were no semi-volatile organic compounds detected. | # C. Functional and Engineering Testing Functional and engineering testing on the VICI VENOUS STENT and the VICI VENOUS STENT System was conducted, as applicable, in accordance with: Guidance for Industry and FDA Staff, Non-Clinical Engineering Tests PMA P180013: FDA Summary of Safety and Effectiveness Data {9} and Recommended Labeling for Intravascular Stents and Associated Delivery Systems Guidance, April 18, 2010 - Guidance for Industry and FDA Staff, Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Document issued on August 18, 2015 - ISO 25539-2:2012 Cardiovascular devices -- Part 2: Vascular Stents These studies are summarized in Tables 5-8. "Pass" denotes that the test results met product specifications and/or the recommendation in the above-referenced guidance documents. Table 5: Summary of Functional and Engineering Test Results for the VICI VENOUS STENT, T=0 | Test Name | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Stent Visual Inspections | To evaluate the stent outer diameter to ensure that the device meets the design specifications. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (10) 16mm x 120mm | Specification 12, 14 & 16mm ±1mm Acceptance Criteria 40 of 40 stents are within spec. | PASS: 40 of 40 stents were within spec | | | To evaluate the stent length to ensure that the device meets the design specifications. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (10) 16mm x 120mm | Specification 60, 90 & 120mm ± 3mm Acceptance Criteria 40 of 40 stents are within spec | PASS: 40 of 40 stents were within spec | | | To evaluate the stent to ensure that the device meets the design specifications on surface defects and contamination. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (29) 16mm x 120mm | Specification Stent must conform to specs with regard to surface defects and contamination that would render the stent unsuitable for its intended use Acceptance Criteria 59 of 59 stents have no defects | PASS: 59 of 59 stents have no defects | | Radial Strength | To characterize the force exerted by the implant as a function of implant diameter. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (10) 16mm x 120mm | Specification 12mm: RRF ≥1.6N, COF ≥0.75N 14mm: RRF ≥1.55N, COF ≥0.68N 16mm: RRF ≥1.5N, COF ≥0.6N Acceptance Criteria 12mm OD RRF: LCL≥1.6N 12mm OD COF: LCL≥0.75N 16mm OD RRF: LCL≥1.5N 16mm OD COF: LCL≥0.6N | PASS: 40 of 40 met the radial strength specification | PMA P180013: FDA Summary of Safety and Effectiveness Data Page 10 {10} | Test Name | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Crush Resistance | To evaluate the ability of the stent to resist permanent deformation and demonstrate the stent’s resistance to localized compressive loads. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (10) 16mm x 120mm | Specification Stent diameter must recover by at least 95% after a flat plate crush of 50% of the diameter Acceptance Criteria LCL≥95%, all sizes | PASS: 40 of 40 met the crush resistance specification | | Flex/Kink Resistance | To evaluate the stent’s flexibility and kink resistance following deployment. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (10) 16mm x 120mm | Specification At least 50% of stent diameter must be maintained when wrapped around a 2.00" disc Acceptance Criteria 40 of 40 units must maintain at least 50% of their original lumen diameter | PASS: 40 of 40 units maintained at least 50% of original lumen diameter | | Foreshortening | To analyze the foreshortening of the stent when loaded and after deployment. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (29) 16mm x 120mm | Specification Amount of foreshortening must be less than: - 20% for 30% oversize - 30% for 10% oversize Acceptance Criteria 10% oversize: UCL<30%, all sizes 30% oversize: UCL<20%, all sizes | PASS: 59 of 59 units had foreshortening <30% for 10% oversize 59 of 59 units had foreshortening <20% for 30% oversize | | RO Marker Pushout Force | To evaluate the RO Marker Pushout Force. | 29 RO Markers (4 -16mm x 60mm stents) | Specification RO Marker Pushout Force must be ≥ 3.6N (ID to OD direction) Acceptance Criteria 29 of 29 have Pushout Force ≥ 3.6N (ID to OD direction) | PASS: 29 of 29 RO markers had Pushout Force ≥ 3.6N (ID to OD direction) | | MRI Compatibility | To evaluate the safety and compatibility of the stent under MRI environment and ensure that stent is not affected by scanning at 1.5 and 3.0 Tesla field strengths. (Displacement Force, Rotational Force [Torque], Inductive Heating [RF] and Image Artifacts) | (1) 12mm x 60mm (7) 12mm x 90mm (2) 12mm x 120mm (7) 16mm x 120mm | The test requirements are met based on MRI Testing Laboratory assessment. | PASS: The stent was determined to be classified as “MRI Conditional” | | Finite Element Analysis | To evaluate the design of the stent with respect to | Finite Element Analysis Model: 16mm | No 16mm stent will exhibit Type 3 fractures. If any Type 1 or Type 2 fractures | PASS No fractures were shown. | PMA P180013: FDA Summary of Safety and Effectiveness Data {11} | Test Name | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | | fatigue resistance over the designated implant life. | | are seen then radial strength will be measured at that location. Stent should have a min radial strength of 1.5N at the vessel diameter | | | Fatigue Testing | To characterize the fatigue resistance of stents in an overlapped bend configuration over the implant life. | (12) 16mm x 60mm (6 pairs) | Specification No 16mm stent will exhibit Type III or IV fracture and having a radial strength of less than 1.5N at the fracture location. RO Markers remain intact and fully attached to the stent for the duration of the test Acceptance Criteria Stent must maintain structural integrity for 10 years of typical physiological movements | PASS: 12 out of 12 samples maintained structural integrity. No fractures occurred. All RO Markers stayed intact and fully attached to the stent. | | Photodynamic Corrosion Resistance (ASTM F2129-17) | To evaluate the susceptibility of the implant materials to corrosion and ensure that the implant maintains corrosion resistance following implantation. | (6) 16mm x 60mm | Specification Breakdown potential ≥ +600mV Acceptance Criteria All samples exhibit breakdown potential ≥ +600mV | PASS: All samples had breakdown potential of ≥ +600mV. | | Galvanic Corrosion Resistance (ASTM F3044-14) | To evaluate the susceptibility of the implant materials to corrosion and ensure that the implant maintains corrosion resistance following implantation. | (3) 16mm x 60mm | Specification Average current density ≤8.36x10-6A/cm2 Acceptance Criteria The average current density of all three samples ≤8.36x10-6A/cm2 | PASS: The average current density of all three samples ≤8.36x10-6A/cm2 | | Radiopacity | The evaluate the radiopacity of the stent and ensure that the stent is visible using angiographic or radiographic imaging to allow for proper stent placement. | (2) RO Nosecone (2) 16mm x 60mm (1) 16mm x 120mm | Specification Implant must be sufficiently visible with standard fluoroscopic imaging equipment to allow for assessment of position and integrity Acceptance Criteria All stents are radiopaque | PASS: The stent was visible utilizing standard fluoroscopic imaging equipment in all arms | PMA P180013: FDA Summary of Safety and Effectiveness Data {12} | Test Name | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | VICI Stent Fatigue Testing | To characterize the crush fatigue resistance of the stent over the implant life. | (6) 16mm x 60mm | Specification Stent must not migrate more than 1cm within the vein. No 16mm stent will exhibit Type 3 fractures. If any Type 1 or Type 2 fractures are seen then radial strength will be measured at that location. stent should have a min radial strength of 1.5N at the vessel diameter. Acceptance Criteria Implant must maintain structural integrity for a minimum of 10 years of physiological movements during typical respiratory cycles and Valsalva maneuvers. | PASS: 6 out of 6 samples maintained structural integrity. PASS: No fractures occurred. | | Stent Conformability | To evaluate the conformability of the stent within a simulated stenosed vein to ensure the device meets the design specifications. | (20) 12mm (20) 16mm | Average Conformability >80% | PASS: The average conformability was >80%. | | Percent Surface Area of the VICI Stent | To calculate the percent surface area for the expanded stent post-deployment and ensure that the device meets the design specifications. | All sizes | N/A | This is characterization testing and does not have acceptance criteria. | | VICI Stent Fatigue Testing | To characterize the crush fatigue resistance of the stent over the implant life. | (6) 16mm x 60mm | Specification Stent must not migrate more than 1cm within the vein. No 16mm stent will exhibit Type 3 fractures. If any Type 1 or Type 2 fractures are seen then radial strength will be measured at that location. stent should have a min radial strength of 1.5N at the vessel diameter. Acceptance Criteria Implant must maintain structural integrity for a minimum of 10 years of physiological movements during typical respiratory cycles and Valsalva maneuvers. | PASS: 6 out of 6 samples maintained structural integrity. PASS: No fractures occurred. | PMA P180013: FDA Summary of Safety and Effectiveness Data Page 13 {13} Table 6: Summary of Functional and Engineering Test Results for the VICI VENOUS STENT, T=3-year AA | Test Name | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Stent Visual Inspections | To evaluate the stent outer diameter to ensure that the device meets the design specifications. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (10) 16mm x 120mm | Specification 12, 14 & 16mm ±1mm Acceptance Criteria 40 of 40 stents are within spec. | PASS: 40 of 40 stents were within spec | PMA P180013: FDA Summary of Safety and Effectiveness Data {14} | Test Name | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | | To evaluate the stent length to ensure that the device meets the design specifications. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (10) 16mm x 120mm | Specification 60, 90 & 120mm ± 3mm Acceptance Criteria 40 of 40 stents are within spec | PASS: 40 of 40 stents were within spec | | | To evaluate the stent to ensure that the device meets the design specifications on surface defects and contamination. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (29) 16mm x 120mm | Specification Stent must conform to specs with regard to surface defects and contamination that would render the stent unsuitable for its intended use Acceptance Criteria 59 of 59 stents have no defects | PASS: 59 of 59 stents had no defects | | Radial Strength | To characterize the force exerted by the implant as a function of implant diameter. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (10) 16mm x 120mm | Specification 12mm: RRF ≥1.6N, COF ≥0.75N 14mm: RRF ≥1.55N, COF ≥0.68N 16mm: RRF ≥1.5N, COF ≥0.6N Acceptance Criteria 12mm OD RRF: LCL≥1.6N 12mm OD COF: LCL≥0.75N 16mm OD RRF: LCL≥1.5N 16mm OD COF: LCL≥0.6N | PASS: 40 of 40 met the radial strength specification | | Crush Resistance | To evaluate the ability of the stent to resist permanent deformation and demonstrate the stent’s resistance to localized compressive loads. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (10) 16mm x 120mm | Specification Stent diameter must recover by at least 95% after a flat plate crush of 50% of the diameter Acceptance Criteria LCL≥95%, all sizes | PASS: 40of 40 met the crush resistance specification | | Flex/Kink Resistance | To evaluate the stent’s flexibility and kink resistance following deployment. | (12) 16mm x 120mm | Specification At least 50% of stent diameter must be maintained when wrapped around a 2.00" disc Acceptance Criteria Stent final diameter LCL >5% of their original lumen diameter. | PASS: 12 of 12 units maintained at least 50% of original lumen diameter | | Foreshortening | To analyze the foreshortening of the stent when loaded and after deployment. | (10) 12mm x 60mm (10) 12mm x 120mm (10) 16mm x 60mm (29) 16mm x 120mm | Specification Amount of foreshortening must be less than: - 20% for 30% oversize - 30% for 10% oversize | PASS: 59 of 59 units had foreshortening <30% for 10% oversize | PMA P180013: FDA Summary of Safety and Effectiveness Data {15} Table 7: Summary of Functional Test Results for the VICI VENOUS STENT System, T=0 | Test Name | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Hemostasis | To evaluate the ability of the delivery system to maintain hemostasis during use and ensure that the delivery system performs adequately for the intended use. | (29) 16mm x 120mm | Specification Maintain hemostasis (0.7psi for 30 seconds minimum) Acceptance Criteria 29 of 29 units maintain hemostasis | PASS: 29 of 29 units maintained hemostasis | | Flush | To ensure that the lumens and Hemostasis Valve of the delivery system can be appropriately flushed with saline using standard luer fittings. | (29) 16mm x 120mm | Specification All lumens and Hemostasis Valve can be flushed with saline using standard luer fittings Acceptance Criteria 29 of 29 units are flushable | PASS: 29 of 29 units were flushable | | Placement Accuracy | To characterize the deployment accuracy of the stent system and verify that the delivery system performs adequately for the intended use with respect to deployment accuracy. | (29) 16mm x 120mm | Specification Delivery System must allow for accurate placement of stent ±2.5mm of target location Acceptance Criteria 29 of 29 stents are placed within ±2.5mm of target location | PASS: 29 of 29 stents were placed within ±2.5mm of target location | | Hypotube Travel Distance | To evaluate the final delivery system Hypotube travel distance to ensure that the device meets the design specifications. | (29) 16mm x 120mm | Specification 120mm length: 170mm ± 5mm Acceptance Criteria 29 of 29 units have Hypotube travel distance of 170 ± 5mm | PASS: 29 of 29 units had Hypotube travel distance of 170 ± 5mm | | Outer Diameter Inspection | To evaluate the final delivery system Outer Shaft outer diameter to ensure that the device meets the design specifications. | (29) 16mm x 120mm | Specification ≤0.122" (compatibility with 9F introducer) Acceptance Criteria 29 of 29 units pass through OD tool | PASS: 29 of 29 units passed through OD tool | PMA P180013: FDA Summary of Safety and Effectiveness Data {16} | Test Name | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | | To evaluate the final delivery system Nosecone outer diameter to ensure that the device meets the design specifications. | | Specification ≤0.122" (compatibility with 9F introducer) Acceptance Criteria 29 of 29 units pass through OD tool | | | Advanceability | To evaluate the final delivery system Inner Shaft lumen inner diameter to ensure that the device meets the design specifications for compatibility with a 0.035" guidewire. | (29) 16mm x 120mm | Specification >0.035" (compatibility with 0.035" guidewire) Acceptance Criteria 29 of 29 units are advanceable | PASS: 29 of 29 units were advanceable | | | To evaluate the final delivery system Nosecone inner diameter to ensure that the device meets the design specifications for compatibility with a 0.035" guidewire. | | Specification >0.035" (compatibility with 0.035" guidewire) Acceptance Criteria 29 of 29 units are advanceable | | | | To evaluate the final delivery system Inner Shaft Hub inner diameter to ensure that the device meets the design specifications for compatibility with a 0.035" guidewire. | | Specification >0.035" (compatibility with 0.035" guidewire) Acceptance Criteria 29 of 29 units are advanceable | | | Flex/Kink | To evaluate the pushability, trackability, and flexibility of the delivery system over a guidewire and ensure that the delivery system performs adequately for the intended use. | (29) 16mm x 120mm | Specification Delivery System will be sufficiently pushable and flexible to track over a 0.035" guidewire Acceptance Criteria 29 of 29 units don't kink at radius ≥10.6mm in catheter body, stent and transition sections | PASS: 29 of 29 units didn't kink at radius ≥10.6mm in catheter body, stent and transition sections | | Working Length | To evaluate the final delivery system Outer Shaft length (Working Length) to ensure that the device meets the design specifications. | (29) 16mm x 120mm | Specification 1000mm ± 10mm Acceptance Criteria 29 of 29 units have working lengths within ±10mm of 1000mm | PASS: 29 of 29 units had Working lengths within ±10mm of 1000mm | | Deployment Force | To evaluate the force required to deploy the stent from the delivery system and verify that the deployment force is adequate for the intended use. | (29) 16mm x 120mm | Specification Stent deployment requires a reasonable amount of input force from the user ≤55N Acceptance Criteria 29 of 29 units require <55N to deploy | PASS: 29 of 29 units required <55N to deploy | | | | (29) 16mm x 120mm | Specification Stent deployment requires a reasonable amount of input force from the user ≤40N | PASS: 29 of 29 units required <40N to deploy | PMA P180013: FDA Summary of Safety and Effectiveness Data Page 17 {17} Table 8: Summary of Functional Test Results for the VICI VENOUS STENT System, T=3-year AA | Test | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Hemostasis | To evaluate the ability of the delivery system to maintain hemostasis during use and ensure that the delivery system performs adequately for the intended use. | (29) 16mm x 120mm | Specification Maintain hemostasis (0.7psi for 30 seconds minimum) Acceptance Criteria 29 of 29 units maintain hemostasis | PASS: 29 of 29 units were removable | | Flush | To ensure that the lumens and Hemostasis Valve of the delivery system can be appropriately flushed with saline using standard luer fittings. | (29) 16mm x 120mm | Specification All lumens and Hemostasis Valve can be flushed with saline using standard luer fittings Acceptance Criteria 29 of 29 units are flushable | PASS: 29 of 29 units were flushable | PMA P180013: FDA Summary of Safety and Effectiveness Data {18} | Test | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | Placement Accuracy | To characterize the deployment accuracy of the stent system and verify that the delivery system performs adequately for the intended use with respect to deployment accuracy. | (29) 16mm x 120mm | Specification Delivery System must allow for accurate placement of stent ±2.5mm of target location Acceptance Criteria 29 of 29 stents are placed within ±2.5mm of target location | PASS: 29 of 29 stents were placed within ±2.5mm of target location | | Hypotube Travel Distance | To evaluate the final delivery system Hypotube travel distance to ensure that the device meets the design specifications. | (29) 16mm x 120mm | Specification 120mm length: 170mm ± 5mm Acceptance Criteria 29 of 29 units have Hypotube travel distance of 170 ± 5mm | PASS: 29 of 29 units had Hypotube travel distance of 170 ± 5mm | | Outer Diameter Inspection | To evaluate the final delivery system Outer Shaft outer diameter to ensure that the device meets the design specifications. | (29) 16mm x 120mm | Specification ≤0.122" (compatibility with 9F introducer) Acceptance Criteria 29 of 29 units pass through OD tool | PASS: 29 of 29 units passed through OD tool | | | To evaluate the final delivery system Nosecone outer diameter to ensure that the device meets the design specifications. | | Specification ≤0.122" (compatibility with 9F introducer) Acceptance Criteria 29 of 29 units pass through OD tool | | | Advanceability | To evaluate the final delivery system Inner Shaft lumen inner diameter to ensure that the device meets the design specifications for compatibility with a 0.035" guidewire. | (29) 16mm x 120mm | Specification >0.035" (compatibility with 0.035" guidewire) Acceptance Criteria 29 of 29 units are advanceable | PASS: 29 of 29 units were advanceable | | | To evaluate the final delivery system Nosecone inner diameter to ensure that the device meets the design specifications for compatibility with a 0.035" guidewire. | | Specification >0.035" (compatibility with 0.035" guidewire) Acceptance Criteria 29 of 29 units are advanceable | | | | To evaluate the final delivery system Inner Shaft Hub inner diameter to ensure that the device meets the design specifications for compatibility with a 0.035" guidewire. | | Specification >0.035" (compatibility with 0.035" guidewire) Acceptance Criteria 29 of 29 units are advanceable | | | Flex/Kink | To evaluate the pushability, trackability, and flexibility of the delivery system over a guidewire and ensure that | (29) 16mm x 120mm | Specification Delivery System will be sufficiently pushable and flexible to track over a | PASS: 29 of 29 units didn't kink at radius ≥10.6mm in | PMA P180013: FDA Summary of Safety and Effectiveness Data {19} | Test | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | | the delivery system performs adequately for the intended use. | | 0.035" guidewire Acceptance Criteria 29 of 29 units don't kink at radius ≥10.6mm in catheter body, stent and transition sections | catheter body, stent and transition sections | | Working Length | To evaluate the final delivery system Outer Shaft length (Working Length) to ensure that the device meets the design specifications. | (29) 16mm x 120mm | Specification 1000mm ± 10mm Acceptance Criteria 29 of 29 units have working lengths within ±10mm of 1000mm | PASS: 29 of 29 units had Working lengths within ±10mm of 1000mm | | Deployment Force | To evaluate the force required to deploy the stent from the delivery system and verify that the deployment force is adequate for the intended use. | (29) 16mm x 120mm (29) 16mm x 120mm | Specification Stent deployment requires a reasonable amount of input force from the user ≤55N Acceptance Criteria 29 of 29 units require <55N to deploy | PASS: 29 of 29 units required <55N to deploy | | | | | Specification Stent deployment requires a reasonable amount of input force from the user ≤40N Acceptance Criteria 29 of 29 units require <40N to deploy | PASS: 29 of 29 units required <40N to deploy | | Removability | To evaluate the removal of the delivery system from the venous anatomy and ensure that the device can be appropriately removed for the intended purpose. | (29) 16mm x 120mm | Specification Delivery System must be safely removed from typical venous anatomy Acceptance Criteria 29 of 29 units are removable | PASS: 29 of 29 units were removable | | Torque | To evaluate the resistance of the delivery system to torqueing forces and ensure that the device can withstand an appropriate number of rotations for its intended use. | (29) 16mm x 120mm | Specification The Delivery System must withstand >3 rotations Acceptance Criteria 29 of 29 units withstand >3 rotations | PASS: 29 of 29 units withstood >3 rotations | | Delivery System Bond Strength | To evaluate joint integrity of the Gen 1.5 Delivery System bonds. | (29) 16mm x 120mm | Specification The tensile and compression strength of the Gen 1.5 Delivery System must meet specifications | PASS: 29 of 29 units had joint strengths that met specification. | PMA P180013: FDA Summary of Safety and Effectiveness Data {20} | Test | Purpose/Objective | Samples Tested | Specification/Acceptance Criteria | Results | | --- | --- | --- | --- | --- | | | | | (specifications ranged from ≥10N to >55N). Acceptance Criteria 29 of 29 units meet all joint strength specifications | | ## D. Packaging Testing Packaging verification testing was performed to demonstrate that the design of the VICI VENOUS STENT System packaging can withstand the hazards of the distribution environment and that the sterility of the device is maintained throughout the labeled shelf life. Packaging verification testing included a visual assessment, bubble leak testing, and seal strength testing at both the baseline condition and for packages aged to the product's shelf life. ## E. Shelf Life Testing Functional device and packaging performance testing were conducted to demonstrate that the device and packaging performs within product specifications for a labeled shelf life of 3 years. Tables 5-8 above show which tests were performed at baseline and shelf-life aged conditions. The combination of the Packaging and Shelf Life testing supports the VICI VENOUS STENT System shelf life of 3 years. ## F. Sterilization The VICI VENOUS STENT System is terminally sterilized using 100% ethylene oxide (EO) gas. The sterilization validation for the VICI VENOUS STENT System was originally based on the guidelines for an Overkill approach sterilization cycle in accordance with ANSI/AAMI/ISO 11135-1:2007 "Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices", AAMI TIR16:2009 "Microbiological aspects of ethylene oxide sterilization", ANSI/AAMI/ISO 11135-2:2008 "Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1" and ISO 10993-7:2008 "Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals". A gap assessment has also been performed against the new requirements of ISO 11135:2014 "Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices". This gap assessment established that VICI VENOUS STENT System's original sterilization validation also meets the requirements of EN ISO 11135:2014. The test results obtained from the sterilization testing demonstrated that the product can be adequately sterilized to the desired level of sterility assurance of 10⁻⁶. PMA P180013: FDA Summary of Safety and Effectiveness Data {21} PMA P180013: FDA Summary of Safety and Effectiveness Data Page 22 # G. Animal Studies Good Laboratory Practice (GLP) in vivo animal testing was performed on the VICI VENOUS STENT and Delivery System. Table 9 provides a summary of the animal studies performed. The results support the safety and performance of the VICI VENOUS STENT and Delivery System. Table 9: Summary of Animal Studies | Study Description | Test Article/ Control | Study Summary and Results | | --- | --- | --- | | Acute GLP Thrombogenicity Study in Ovine | VICI VENOUS STENT/Wallstent | This acute thrombogenicity study was conducted in ovine to evaluate the thrombogenic potential of the VENITI VICI VENOUS STENT in comparison to a commercially available device (Boston Scientific Wallstent). Three animals were enrolled with a total of six external jugular and six external femoral/iliac veins successfully implanted with either the test or control devices (stents were placed in the external jugular veins and the delivery systems were placed in external femoral/iliac veins). Thrombus coating on one test article was observed and may be an anomalous finding. The other test articles had an equivalent thrombogenic response as the control stents. Histopathological evaluations were performed, and all were within normal limits. There was no physiologic or mechanical causative event or finding attributable to the abnormal thrombus coating on one of the test stents | | GLP Animal Study for VICI VENOUS STENT System | VICI VENOUS STENT System/Wallstent | The VICI VENOUS STENT System performance characteristics and mechanical integrity requirements were evaluated using visual inspection, fluoroscopy and intravascular ultrasound (IVUS) techniques. The animal study included three study arms (Acute, 56-Day and 180-Day) with four animals in each arm. Tissue interaction was evaluated using visual examination at gross necropsy. Chronic thromboresistance was evaluated in the 56-Day and 180-Day chronic arms. Prior to sacrifice, a venogram was performed to generally evaluate the vein and stents for presence of thrombus. Additionally, a visual inspection was performed during gross necropsy to generally evaluate the iliac vein and stent site for the presence of thrombus. The results showed VICI VENOUS STENT remained intact and in place in all chronic animals. Vessel trauma during implantation or at follow-up was not noted and the impact on the endothelium was considered minimal and expected. The VICI VENOUS STENT performed similarly to the Wallstent and no difference was seen between the two stent types. | # X. SUMMARY OF PRIMARY CLINICAL STUDY The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of the implantation of a venous stent into the iliofemoral vein with the VICI VENOUS STENT System to treat patients with post-thrombotic or non-thrombotic disease in the US, France, Germany, Ireland, Spain, and the United Kingdom under IDE G140016. The study included a feasibility cohort (the first 30 subjects enrolled) and a pivotal cohort (170 subjects). Data from the pivotal cohort of this clinical study were the basis for the PMA approval decision. A summary of the clinical study is presented below. Data from the {22} feasibility cohort were analyzed separately and are not included in this summary. ## A. Study Design Subjects were enrolled in the pivotal cohort between March 20, 2015 and November 2, 2016. The database for this PMA reflected pivotal cohort data collected through November 1, 2018. There were 22 sites in the pivotal study. The VIRTUS study was conducted as a prospective, global, multi-center single-arm trial with outcomes compared to performance goals developed from medical literature. Enrollment in the VIRTUS study was stratified according to each subject's disease etiology, i.e., post-thrombotic or non-thrombotic. A Statistical Analysis Plan (SAP) for the VIRTUS study was generated for this study protocol. The VIRTUS pivotal cohort consisted of 170 subjects. A total of 127 subjects, approximately 74% of the pivotal cohort enrollees, were to be enrolled with an iliofemoral venous segment obstruction associated with thromboembolic disease. These subjects are referred to as the post-thrombotic (PT) group in this summary. A total of 43 subjects, approximately 26% of the pivotal cohort enrollees, were to be enrolled with iliofemoral venous segment obstruction without previous thromboembolic disease and without intraluminal disease. These subjects are referred to as the non-thrombotic (NT) group in this summary. Subjects in the VIRTUS study were evaluated preoperatively and were followed through their index procedure (when they were officially enrolled) and hospital discharge. The study subjects had follow-up evaluations at Month 1, Month 6 and Month 12 post-procedure. The VIRTUS subjects will continue to be followed for a total of 5 years, as described further below. All imaging modalities (venography, duplex ultrasound (DUS), intravascular ultrasound (IVUS), X-ray) were assessed by independent core labs. Safety events were adjudicated by an independent Clinical Events Committee and an independent Data Safety Monitoring Board assessed the ongoing risk/benefit profile of the study device based on aggregate and individual study subject data. ## 1. Clinical Inclusion and Exclusion Criteria Enrollment in the VIRTUS study was limited to patients who met the following inclusion criteria: ### A. Pre-Procedural Inclusion Criteria 1. Age ≥18 years 2. Willing and capable of complying with all follow-up evaluations at the specified times 3. Able and willing to provide written informed consent prior to study specific procedures 4. Presence of unilateral, clinically significant, chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof, defined as a ≥50% reduction in target PMA P180013: FDA Summary of Safety and Effectiveness Data {23} vessel lumen diameter (to be measured by venogram during procedure, per Exclusion 25). 5. Clinically significant venous obstruction defined as meeting at least one of the following clinical indicators: - Clinical severity class of CEAP classification ≥3 (See Appendix 4 of VIRTUS protocol.) - VCSS Pain Score ≥2 (See Appendix 7 of VIRTUS protocol.) 6. Negative pregnancy test in females of child-bearing potential 7. Intention to stent the target lesion only with the VICI VENOUS STENT Patients were not permitted to enroll in the VIRTUS study if they met any of the following exclusion criteria: B. Pre-Procedural Exclusion Criteria 1. Presence or history of clinically significant pulmonary emboli within 6 months prior to enrollment 2. Venous obstruction that extends into the inferior vena cava 3. Contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof with planned treatment within 30 days after subject enrollment 4. Life expectancy &lt;12 months 5. Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study 6. A. Uncontrolled or active coagulopathy OR B. Known, uncorrectable bleeding diathesis with the following definitions: - Uncorrected INR ≥2.0 or aPTT ≥1.5 X normal local lab value - Platelet count &lt;80,000 7. Uncorrected hemoglobin of ≤9 g/dL 8. Patients with an estimated glomerular filtration rate (eGFR) &lt;30 mL/min. In patients with diabetes mellitus, eGFR &lt;45 mL/min. 9. Known hypersensitivity to nickel or titanium 10. Contrast agent allergy that cannot be managed adequately with pre-medication 11. Intended concurrent thrombolysis or thrombectomy procedure OR intended or planned (within 30 days) adjuvant procedure such as creation of temporary AV fistula, placement of IVC filter, endovenectomy or saphenous vein ablation 12. Current or recent (within 30 days) active participation in another drug or device clinical trial (Participation in observational studies is acceptable) PMA P180013: FDA Summary of Safety and Effectiveness Data Page 24 {24} 13. Patient judged to be a poor candidate by the primary investigator 14. Patients who have had any prior surgical or endovascular intervention of the target vessel Note: Patients who have had catheter-directed or mechanical thrombolysis in the target vessel for DVT at least 3 months (90 days) prior to the VIRTUS index procedure may be included in the trial C. Intra-procedural Exclusion Criteria: If patients met any of the following exclusion criteria, they were not counted in the study sample size. 1. Patients in whom the lesions cannot be traversed with a guide wire. 2. Patients where the obstruction extends into the inferior vena cava or below the level of the lesser trochanter. 3. Patients whose vein diameters are not within limits stated in current Instructions for Use as determined by venogram. 4. Patients who do not meet the venogram binary stenosis definition above, as determined by the treating physician. 2. Follow-up Schedule The VIRTUS pivotal subjects were followed in accordance with the protocol-specified visit schedule of: 1 Month Evaluation (30 days -7/+14 days), 6 Month Evaluation (180 days ± 30 days), and 12 Month Evaluation (365 days ± 60 days). Enrolled VIRTUS subjects will continue to be followed at 24 Months, 36 Months, 48 Months and 60 Months. All adverse events and complications were recorded at all visits through the 12 Month Evaluation. Serious adverse events and complications will continue to be collected through the 60 Month Evaluation. Table 10 provides the follow-up schedule and tests conducted through the 60 Month visit. PMA P180013: FDA Summary of Safety and Effectiveness Data Page 25 {25} Table 10: Summary of Procedures | Visit (window) | Description | Screening | Baseline Evaluation (30 days from implant) | Implant Procedure (Day 0) | Post-stent placement assessment | Discharge or 3 days post-procedure^{a} | 1 Month Evaluation (30 days -7/+14 days) | 6 Month Evaluation (180 ±30 days) | 12 Month Evaluation (365 ±60 days) | 24 and 36 Month Evaluation (±90 days) | 48 and 60 Month Evaluation (±90 days) | Interval Evaluation^{b} | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Assessment of Inclusion and Exclusion Criteria | Medical records | X | X | X^{c} | | | | | | | | | | Informed Consent | IC | | X^{d} | | | | | | | | | | | Assessment of baseline characteristics | H&P, labs, CEAP | | X | | | | Physical Exam Only | Physical Exam Only | Physical Exam Only | | | Physical Exam | | Duplex Ultrasound | DUS | | | | | X | | X^{e} | X | X^{i} | | X | | Venogram | VG | | | X | X | | | | X^{h} | | | X | | IVUS | IVUS | | | X | X | | | | X | | | X | | AE Assessment | | | | X | X | X | X | X | X | | | X | | SAE Assessment | | | | | | | | | | X^{j} | X^{j} | | | Anticoagulation Regimen | | | | X | | X | X | X | X | | | X | | Pregnancy Test (women of child bearing years) | | | X^{f} | | | | | | | | | | | CIVIQ-2 | | | X | | | | | X | X | | | | | VAS | | | X | | | | | X | X | | | | | VCSS | | | X | | | | | X | X | | | | | Biplane X-ray^{g} | | | | | | | | | X | | | | a: Discharge or 3 days post-procedure, whichever comes first b: Performed if patients present with symptoms of clinically significant obstruction of the target vessel. c: Evaluate intra-procedural exclusion criteria prior to implant d: Informed consent may be collected before or at the Baseline Evaluation visit. e: Required only for the feasibility patients to assess patency f: Pregnancy test in females of child-bearing age must be collected within 48 hours of implant procedure g: To assess stent integrity. h: To assess primary patency i: To assess patency j: SAE Assessment may be performed via telephone. PMA P180013: FDA Summary of Safety and Effectiveness Data {26} PMA P180013: FDA Summary of Safety and Effectiveness Data Page 27 # 3. Clinical Endpoints ## Primary Effectiveness Endpoint The primary effectiveness endpoint was the primary patency rate at 12 months post-intervention, defined as freedom from occlusion by thrombosis (assessed via venogram) and freedom from surgical or endovascular intervention on target vessel which are found to have re-stenosis or stent occlusion to maintain patency and freedom from in-stent stenosis more than 50% by venogram. Target vessel revascularization (TVR) was adjudicated by an independent Clinical Events Committee (CEC). Using literature, a single primary effectiveness performance goal was derived. The performance goal was based on both PT and NT etiologies and assumed a fixed proportion population (75% of the patients were expected to be PT and 25% were expected to be NT). The estimated patency rate from literature was 77.6% for PT subjects and 95.5% for NT subjects, respectively. The combined patency rate was 82.1% using a weighted average of the patency rates for each etiology. A 10% margin was applied to arrive at a combined, weighted primary effectiveness performance goal of 72.1%. Sample size was calculated using a one-sided significance level of α=0.025 and power of 84%. The null and alternative hypotheses can be expressed as: HO: P_Eff ≤ 72.1% HA: P_Eff &gt; 72.1% where P_Eff is the proportion of subjects with a successful outcome. ## Secondary Effectiveness Endpoint The secondary effectiveness endpoint for this study was a binary response variable based on an improvement in Venous Clinical Severity Score (VCSS) by at least 50% at 12 months post-intervention. ## Additional Effectiveness Endpoint The following additional effectiveness endpoints were evaluated: ### Estimate Primary-Assisted Patency Primary-assisted patency is defined as freedom from occlusion regardless of whether an intervention (subsequent to the index procedure) was performed. ### Estimate Secondary Patency Secondary patency is defined as freedom from "permanent" loss of patency determined through last follow-up (irrespective of the number of interventions). ### Procedural Technical Success Procedural technical success is achievement of a final residual target vessel diameter stenosis of 50% as measured on the post-procedural venogram, without skipped lesion regions, with placement of the study device alone with or without post-stenting balloon dilation as needed. {27} Lesion Success Lesion success is defined as achievement of ≤50% residual diameter stenosis of the target lesion using any percutaneous method (including the use of non-study devices). Procedural Success Procedural success is defined as procedural technical success without the occurrence of a Major Adverse Event (MAE) between the index procedure and discharge. Late Technical Success Late technical success (through 12 months) is the absence of device movement &gt;10mm related to anatomical landmarks or any migration leading to symptoms or requiring therapy; absence of stent occlusion by thrombosis or restenosis, defined as reduction in treated segment lumen more than 50% from the post-procedure vessel lumen diameter as measured by post-procedural venogram or DUS and maintenance of structural integrity, defined as the absence of pinching (focal compression), kinking (stent doubling or bending upon itself) that results in &gt;50% diameter reduction of the stent, recoil (poor radial resistive force) or absence of fractures. Change in the Quality of Life (CIVIQ-2) The area under the curve will be calculated for the CIVIQ-2. The mean and 95% confidence intervals for the study patients will be presented. Primary Safety Endpoint The primary safety endpoint for this study was a composite endpoint of any major adverse event within 30 days, as adjudicated by a Clinical Events Committee. The VIRTUS protocol-defined Major Adverse Events (MAEs) are listed below: - Device or procedure-related death; - Device or procedure-related bleeding at the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention or blood transfusion ≥2 units; - Device or procedure-related arterial or venous injury occurring in the target vessel segment and/or target lesion location or at the access site requiring surgical or endovascular intervention; - Device or procedure related acute DVT outside of the target vein segment; - Clinically significant pulmonary embolism defined as being symptomatic with chest pain, hemoptysis, dyspnea, hypoxia etc. AND be documented on CT; or - Embolization of stent. The primary safety endpoint was the proportion of subjects free of a MAE through Day 30 post-index procedure. The performance goal was 94% and was derived using literature. In the absence of controlled studies to indicate a true adverse event rate, a conservative approach was taken and 1% was used as the pre-specified safety rate. Sample size was calculated using a one-sided significance level of α=0.025 and power of 90%. The null and alternative hypotheses can be expressed as: PMA P180013: FDA Summary of Safety and Effectiveness Data Page 28 {28} HO: $P_{\text{Safe}} \leq 94\%$ HA: $P_{\text{Safe}} &gt; 94\%$ where $P_{\text{Safe}}$ is the proportion of subjects free from a MAE. ## Secondary Safety Endpoints The secondary safety endpoints for this study included adverse events, all serious adverse events and all device-related adverse events. ## B. Accountability of PMA Cohort All 170 pivotal cohort subjects had one or more VICI stents successfully implanted and were discharged from the hospital. In total, seven subjects withdrew prior to the Month 12 visit. One subject did not return for follow-up after discharge. Two subjects withdrew prior to the Month 6 visit and an additional four subjects discontinued the study prior to the Month 12 visit. None of the subjects were discontinued for safety reasons. Six additional subjects missed the Month 12 visit. A detailed breakdown of the VIRTUS pivotal subjects available at each visit and the subjects who missed each visit is presented in Figure 2. A detailed breakdown of the evaluable imaging for the VIRTUS pivotal subjects is presented in Table 11. There were data integrity issues at one US center, affecting 24 subjects. Primary patency and safety results for these subjects are included in the primary analyses; however, survey data (VCSS, CIVIQ, VAS) are not included. Primary patency was assessed via venogram by an independent core lab and as such, patency results for this center were determined to be unlikely to be affected by the data integrity issues and are included in the primary effectiveness endpoint analysis. To ensure safety events were verified and comprehensively captured, a full review of the institution's electronic medical records was completed. A detailed review of electronic medical records from surrounding institutions was also completed by sponsor and CRO personnel. Adverse event data was verified for all 24 subjects either via electronic medical record review or documented contact with the subject. Survey data was not able to be verified and is not included in the analyses. FDA performed an inspection to audit the study data and to verify the results of the medical record review. PMA P180013: FDA Summary of Safety and Effectiveness Data Page 29 {29} Figure 2: Subject Accountability - Pivotal Cohort ![img-1.jpeg](img-1.jpeg) *Six subjects missed the 12 Month follow-up visit. Table 11: Core Lab Imaging - Evaluability for Month 12 Primary Patency Analyses - Pivotal Cohort | Month 12 Imaging1 | Subject Count (N = 157) | | --- | --- | | Venogram2 | 118 | | Duplex Ultrasound (DUS) | 126 | | Intravascular Ultrasound (IVUS) | 113 | | Any Imaging (Venogram, DUS and/or IVUS) | 147 | $^{1}$ TVR status is not taken into consideration when determining evaluability of imaging $^{2}$ Pre-specified imaging modality for the Primary Effectiveness Endpoint PMA P180013: FDA Summary of Safety and Effectiveness Data {30} # C. Study Population Demographics and Baseline Parameters The demographics of the study population are typical for the type of study performed in the US and EU for this condition. The mean $\pm$ SD subject age was $54.4 \pm 16.2$ years with a range of 20 to 88 years old for the VIRTUS pivotal cohort. The majority of subjects were white, 127/170 (74.7%), and female, 96/170 (56.5%). A large majority of subjects, 145/170 (85.3%), had venous disease in their left leg and, of the remaining subjects, 24/170 (14.1%) had venous disease in their right leg and 1/170 (0.6%) had bilateral venous disease. Four subjects (4/170, 2.4%) were assessed as either CEAP Class 0, 1 or 2. The majority of subjects were assessed as either CEAP Class 3 (45/170, 26.5%) or Class 4 (78/170, 45.9%). Twenty-two subjects (22/170, 12.9%) were classified as CEAP Class 5 and 21 subjects (21/170, 12.4%) were classified as CEAP Class 6. Fifteen subjects (15/146, 10.3%) had VCSS leg pain reported as "Absent", 35/146 subjects (24.0%) had VCSS leg pain reported as "Mild", 54/146 subjects (37.0%) had VCSS leg pain reported as "Moderate" and 42/146 subjects (28.8%) had VCSS leg pain reported as "Severe". Table 12 provides a summary of the demographics and baseline characteristics for the pivotal cohort of the VIRTUS study. Table 13 provides a summary of the VIRTUS pivotal cohort's medical history. Table 12: Demographics and Baseline Characteristics - Pivotal Cohort | Subject Demographic and Baseline Characteristics | Statistic | Results | | --- | --- | --- | | Age, years | N | 170 | | | median [Q1, Q3] | 56 [41, 66] | | | mean ± SD | 54.4 ± 16.2 | | | (min, max) | (20, 88) | | Sex: | | | | Male | n/N (%) | 74/170 (43.5%) | | Female | n/N (%) | 96/170 (56.5%) | | Race: | | | | American Indian or Alaska Native | n/N (%) | 1/170 (0.6%) | | Asian | n/N (%) | 5/170 (2.9%) | | Black or African American | n/N (%) | 20/170 (11.8%) | | Native Hawaiian or Pacific Islander | n/N (%) | 1/170 (0.6%) | | White | n/N (%) | 127/170 (74.7%) | | White African | n/N (%) | 1/170 (0.6%) | | Latin American | n/N (%) | 1/170 (0.6%) | | Not Answered | n/N (%) | 14/170 (8.2%) | | Ethnicity:* | | | | Hispanic or Latino | n/N (%) | 13/154 (8.4%) | | Not Hispanic or Latino | n/N (%) | 141/154 (91.6%) | | Chronic non-malignant obstruction present in: | | | | Left Leg | n/N (%) | 145/170 (85.3%) | | Right Leg | n/N (%) | 24/170 (14.1%) | PMA P180013: FDA Summary of Safety and Effectiveness Data {31} PMA P180013: FDA Summary of Safety and Effectiveness Data Page 32 | Subject Demographic and Baseline Characteristics | Statistic | Results | | --- | --- | --- | | Both Legs | n/N (%) | 1/170 (0.6%) | | CEAP Assessment: | | | | 0 (No visible or palpable signs of venous disease, only symptoms) | n/N (%) | 2/170 (1.2%) | | 1 (Telangiectasia or reticular veins) | n/N (%) | 0/170 (-) | | 2 (Varicose Veins) | n/N (%) | 2/170 (1.2%) | | 3 (Edema) | n/N (%) | 45/170 (26.5%) | | 4 (Skin changes ascribed to venous disease (e.g. pigmentation, venous eczema, lipodermatosclerosis)) | n/N (%) | 78/170 (45.9%) | | 5 (Skin changes as defined above with healed ulceration) | n/N (%) | 22/170 (12.9%) | | 6 (Skin changes as defined above with active ulceration) | n/N (%) | 21/170 (12.4%) | | VCSS Leg Pain (Target Limb):† | | | | Absent | n/N (%) | 15/146 (10.3%) | | Mild | n/N (%) | 35/146 (24.0%) | | Moderate | n/N (%) | 54/146 (37.0%) | | Severe | n/N (%) | 42/146 (28.8%) | * Sixteen subjects from Sites 40 and 41 did not provide their ethnicity per the policy at each site. † Results for 24 subjects from a single US center are not included. Please refer to section B for more details. Table 13: Medical History – Pivotal Cohort | Medical History | Subject Count n/N (%) | | --- | --- | | Diabetic | 29/170 (17.1%) | | Smoking History: | | | Current Smoker | 21/170 (12.4%) | | Former Smoker | 41/170 (24.1%) | | Non-Smoker | 108/170 (63.5%) | | History of: | | | Thromboembolic Disease | 130/170 (76.5%) | | Pulmonary Embolism | 28/130 (21.5%) | | Deep Vein Thrombosis | 119/130 (91.5%) | | CAD | 14/170 (8.2%) | | MI within past 5 years | 1/170 (0.60%) | | CABG | 4/170 (2.4%) | | PTCA/Stent | 4/170 (2.4%) | | CHF | 4/170 (2.4%) | | HTN | 68/170 (40.0%) | | Hepatic Disease | 5/170 (2.9%) | | Renal Disease | 8/170 (4.7%) | | PVD | 29/170 (17.1%) | | Coagulation Disorder | 23/170 (13.5%) | | CVA | 10/170 (5.9%) | | Cancer | 18/170 (10.6%) | | Recent Trauma | 3/170 (1.78%) | | Allergies | 60/170 (35.3%) | {32} # D. Procedural Parameters The VICI stent was successfully implanted in all 170 VIRTUS pivotal cohort subjects. Table 14 summarizes the VICI stent implant procedure parameters. The VICI stent implant procedure was performed using intravenous sedation for the majority of subjects, 109/170 (64.1%), and general anesthesia for the remaining subjects. Nearly all procedures, 166/170 (97.6%), were performed using an ipsilateral anterograde approach with access obtained using the femoral vein in 148/170 (87.1%). Pre-dilatation was performed in 109/170 (64.1%) of the cases and post-dilatation was performed in 154/170 (90.6%) of the cases. One VICI stent was placed in 85/170 (50%) of the cases, two VICI stents were placed in 62/170 (36.5%) of the cases, three VICI stents were placed in 20/170 (11.8%) of the cases and four VICI stents were placed in 3/170 (1.8%) of the cases. Table 14: Implant Procedure Parameters - Pivotal Cohort | Parameter | Category | n/N (%) | | --- | --- | --- | | Sedation Type | IV Sedation | 109/170 (64.1%) | | | General | 61/170 (35.9%) | | Puncture Type | Ipsilateral Anterograde | 166/170 (97.6%) | | | Contralateral Retrograde/Crossover | 4/170 (2.4%) | | Access Approach | Femoral | 148/170 (87.1%) | | | Popliteal | 15/170 (8.8%) | | | Jugular | 4/170 (2.4%) | | | Both | 3/170 (1.8%) | | Dilatation | Pre-Implant | 109/170 (64.1%) | | | Post-Implant | 154/170 (90.6%) | | Number of VICI Stents Placed Per Subject | 1 stent | 85/170 (50%) | | | 2 stents | 62/170 (36.5%) | | | 3 stents | 20/170 (11.8%) | | | 4 stents | 3/170 (1.8%) | Table 15 provides a summary of the VICI stent sizes that were implanted per subject and the sizes of the VICI stents implanted for the pivotal cohort of the VIRTUS study. A total of 281 VICI stents were implanted in 170 subjects in the VIRTUS pivotal cohort. Table 15: VICI Stent Sizes Utilized - Pivotal Cohort | Diameter | Length | | | | --- | --- | --- | --- | | | 60mm | 90mm | 120mm | | 12mm | 3 | 2 | 4 | | 14mm | 10 | 26 | 44 | | 16mm | 29 | 43 | 120 | # E. Safety and Effectiveness Results # 1. Safety Results The analysis of the primary safety endpoint for this study was based on a composite endpoint of any Major Adverse Event within 30 days, as adjudicated by a Clinical Events Committee (CEC), including the following: Device or procedure-related death; PMA P180013: FDA Summary of Safety and Effectiveness Data {33} - Device or procedure-related bleeding at the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention or blood transfusion ≥2 units; - Device or procedure-related arterial or venous injury occurring in the target vessel segment and/or target lesion location or at the access site requiring surgical or endovascular intervention; - Device or procedure related acute DVT outside of the target vein segment; - Clinically significant pulmonary embolism defined as being symptomatic with chest pain, hemoptysis, dyspnea, hypoxia etc. AND be documented on CT; or - Embolization of stent. Safety data through 30 days post-procedure were available for 169/170 of the VIRTUS pivotal subjects. One subject never returned for follow-up after discharge. The status of the safety events was determined by adjudication of the VIRTUS CEC. There were 2 adjudicated MAEs for the pivotal cohort within 30 days. Table 16 provides the MAE criteria and provides the proportion of pivotal cohort subjects that failed each defined criterion. Both of the MAEs observed (arteriovenous fistulas at the access site) failed the criterion of an arterial or venous injury requiring surgical or endovascular intervention. There were no failures for any other MAE criterion. The estimated rate free from MAE in this study was 167/169 (98.8%) with a 95% two-sided exact confidence limit of 95.8% to 99.9%. Since the lower confidence limit lies above the safety performance goal of 94%, the primary safety endpoint has been successfully demonstrated for the primary safety objective of the study. Table 16: Summary of Major Adverse Events – Pivotal Cohort | MAE Criteria | Failures n/N (%) [95% CI] | | --- | --- | | Major adverse events (MAE) within 30 days* | 2/169 (1.2%) [95.8%, 99.9%] | | Device or procedure-relate death | 0/169 (0%) | | Device or procedure-related bleeding requiring surgical or endovascular intervention or blood transfusion ≥ 2 units | 0/169 (0%) | | Device or procedure-related arterial or venous injury requiring surgical or endovascular intervention | 2/169 (1.2%) | | Device or procedure-related acute DVT outside the target vein segment | 0/169 (0%) | | Clinically significant pulmonary embolism | 0/169 (0%) | | Embolization within stent | 0/169 (0%) | *Safety data through 30 days post-procedure were available for 169/170 of the VIRTUS pivotal subjects as one subject never returned for follow-up after discharge. There were no deaths or CEC-adjudicated UADEs reported in the VIRTUS study through the Month 12 follow-up. PMA P180013: FDA Summary of Safety and Effectiveness Data Page 34 {34} Access Site Related Adverse Events: In the VIRTUS study, there were 13 adverse events in 12 subjects that were related to the access site, either during the index procedure or for a follow-up procedure. The overall access site-related adverse event rate was $7\%$ (12/170). The type of reported access site events was within expectation, with hematoma with and without pseudoaneurysm being the most common access site event. The site reported Serious Adverse Events (SAEs) from the VIRTUS pivotal cohort are summarized in Table 17 by MedDRA System Organ Class (SOC) and Preferred Term. The site reported Adverse Events (AEs) that are device or procedure related are summarized in Table 18. Table 17: Rates of Site-Reported Serious Adverse Events to 425 Days Intent-to-Treat, All Subjects (N=170) | MedDRA System Organ Classification | Rate of Subjects with Event n (%) [95% CI] | | --- | --- | | SOC: Blood and lymphatic system disorders (Events=5) | 4 (2.4%) [0.6%;5.9%] | | Anaemia (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Sickle cell anaemia with crisis (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Thrombocytopenia (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Haemorrhagic anaemia (Events=1) | 1 (0.6%) [0.0%;3.2%] | | White blood cell disorder (Events=1) | 1 (0.6%) [0.0%;3.2%] | | SOC: Cardiac disorders (Events=9) | 7 (4.1%) [1.7%;8.3%] | | Acute myocardial infarction (Events=2) | 2 (1.2%) [0.1%;4.2%] | | Bradycardia (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Cardiac failure congestive (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Pericardial effusion (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Ventricular tachycardia (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Atrial fibrillation (Events=3) | 1 (0.6%) [0.0%;3.2%] | | SOC: Gastrointestinal disorders (Events=4) | 3 (1.8%) [0.4%;5.1%] | | Gastric perforation (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Ileus (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Melaena (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Rectal haemorrhage (Events=1) | 1 (0.6%) [0.0%;3.2%] | | SOC: General disorders and administration site conditions (Events=24) | 18 (10.6%) [6.4%;16.2%] | | Vascular stent thrombosis (Events=13) | 9 (5.3%) [2.4%;9.8%] | | Vascular stent restenosis (Events=3) | 3 (1.8%) [0.4%;5.1%] | | Vascular stent occlusion (Events=2) | 2 (1.2%) [0.1%;4.2%] | | Vascular stent stenosis (Events=2) | 2 (1.2%) [0.1%;4.2%] | | Oedema peripheral (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Peripheral swelling (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Puncture site haemorrhage (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Stenosis (Events=1) | 1 (0.6%) [0.0%;3.2%] | | SOC: Infections and infestations (Events=6) | 5 (2.9%) [1.0%;6.7%] | | Sepsis (Events=3) | 3 (1.8%) [0.4%;5.1%] | PMA P180013: FDA Summary of Safety and Effectiveness Data {35} | MedDRA System Organ Classification | Rate of Subjects with Event n (%) [95% CI] | | --- | --- | | Cellulitis (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Parotitis (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Urinary tract infection (Events=1) | 1 (0.6%) [0.0%;3.2%] | | SOC: Injury, poisoning and procedural complications (Events=4) | 4 (2.4%) [0.6%;5.9%] | | Hip fracture (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Wound (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Post procedural haematoma (Events=1) | 1 (0.6%) [0.0%;3.2%] | | Delayed haemolytic transfusion reaction (Even…
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