Vesper Medical V-LBL 0003 IFU Duo Venous Stent System

Specifications

• Device Name: Duo Venous Stent System
• Sterilization: Ethylene oxide gas
• Pyrogenic: Non-pyrogenic
• Single Use: Yes
• Radiopacity: Yes

Product Usage Instructions

Overview
The Duo Venous Stent System is a self-expanding Nitinol stent designed for venous applications. It consists of different segments for optimal performance.

Precautions

• Keep the device away from sunlight and moisture.
• Do not re-sterilize or reuse the device.
• Do not use if the package is damaged.
• Consult the instructions for use for important cautionary information.

Usage Steps

1. Ensure the package is intact and sterile.
2. Identify the cranial and caudal ends of the stent with gold radiopaque markers.
3. Position the stent in the desired location using appropriate medical tools.
4. Deploy the stent carefully to ensure proper placement.
5. Confirm stent placement using imaging techniques.

Cleaning and Disposal
After use, dispose of the stent according to medical waste regulations. Do not attempt to clean or resterilize the device.

FAQ

Q: Can the Duo Venous Stent System be reused?
A: No, the Duo Venous Stent System is intended for single use only. Do not attempt to reuse or resterilize the device.

Q: How should I store the Duo Venous Stent System?
A: Store the device in a cool, dry place away from direct sunlight and moisture to maintain its integrity.

Symbols Glossary

STERILE.

The Duo Venous Stent System is provided STERILE. Sterilized with ethylene oxide gas. Non-pyrogenic. Radiopaque. For single use only. Do not re-sterilize and/or reuse the device.
These recommendations are designed to serve only as a general guideline. They are not intended to supersede institutional protocols or professional clinical judgment concerning patient care.

DEVICE NAME
Duo Venous Stent System

DESCRIPTION

The Duo Venous Stent System consists of a portfolio of self-expanding venous stent configurations mounted on disposable delivery systems for improving luminal diameter in symptomatic venous outflow obstructions. The portfolio approachincludes delivery systems with either a hybrid venous stent implant (Duo Hybrid Stent) or an extension venous stent implant(Duo Extend Stent), enabling the clinician to custom tailor treatment in the iliofemoral venous anatomy based on disease patterns and severity. The Duo Hybrid Stent is designed with varying mechanical characteristics such as radial force/crush resistance and flexibility along its length to target the variable dynamic loading conditions in the iliofemoral venous system related to the treatment of disease states including non-thrombotic iliac vein compression, May-Thurner syndrome, deepvenous thrombosis, and post-thrombotic venous occlusion. The Duo Extend Stent consists of a highly flexible region with reinforcement rings at both ends. The Duo Stent can be used independently or in conjunction with the Duo Extend Stent to personalize the treatment region.

Figure 1 below provides an overview of the Duo Venous Stent System.

The delivery catheter has an effective length of 90cm or 120cm. The Outer Braided Sheath (3), which constrains the Stent implant, is bonded proximally to the Bifurcation Luer (5) within the Transition sleeve (4). The Hemostatic Valve (7) is integrated proximally to the Bifurcation Luer. The Inner Core Shaft (8) slides within the Hemostatic Valve. A soft, tapered Distal Tip (1) is bonded to the distal end of the Inner Core Shaft for ease of advancement in the blood vessel. Constrained within the Outer Braided Sheath the self- expanding Stent implant is positioned on the Inner Core between two radiopaque(RO) Distal Inner Core Markers. A radiopaque Target Band (2) is located on the distal end of the Outer Braided Sheath.

The catheter is flushed prior to the procedure through the side port (6) of the Bifurcation Luer and the Guidewire Port (9). Stent implant positioning is achieved prior to deployment by using the RO Markers on the Stent implant (Figure 2 and Figure 3) and the Target Band on the outer sheath. During Stent implant deployment, the Hemostatic Valve is unlocked by rotating the valve counterclockwise. The Stent implant is unsheathed by pinning the Proximal Inner Core Shaft and pulling back on the outer sheath.

Figure 2 and Figure 3 below provide an overview of the Duo Venous Stent System, Duo Hybrid Stent, and Duo Extend Stent respectively.

The self-expanding Nitinol (nickel-titanium) Duo Hybrid Stent is designed with a “High Crush Resistance” segment (11) at the cranial end followed by a “Transition” segment (12) that transitions into a “Highly Flexible” segment (13). The caudal end of the Duo Hybrid Stent is designed with inflow reinforcement (14). Both the cranial and caudal ends of the Duo Hybrid Stent include four gold radiopaque markers (10), per end.
The self-expanding Nitinol (nickel-titanium) Duo Extend Stent is designed with a “Highly Flexible” (16) body with inflowreinforcement (15) on both ends. Both the cranial and caudal ends of the Duo Extend Stent include four gold radiopaque markers (10), per end.

The respective lengths of the stent segments are provided in Table 1:

Table 1. Length of Stent segments

Stent Configuration| Labeled Stent Diameter| Labeled Stent Length| Stent Segment per FIGURE 2 and FIGURE 3| Stent Segment Length

Duo Hybrid Stent

|

12mm, 14mm

| 60mm, 80mm, 100mm, 120mm, 140mm, 160mm|

“High Crush Resistance” segment (11)

|

38mm

16mm, 18mm

| 60mm, 80mm, 100mm, 120mm, 140mm, 160mm|

41mm

Duo Hybrid Stent

|

12mm, 14mm

| 60mm|

“Transition” segment (12)

| 13mm
80mm, 100mm, 120mm, 140mm,

160mm

|

17mm

16mm, 18mm

| 60mm| 13mm
80mm, 100mm, 120mm, 140mm, 160mm|

22mm

Duo Hybrid Stent

|

12mm, 14mm

| 60mm|

“Highly Flexible” segment (13)

| 0mm
80mm| 17mm
100mm| 30mm
120mm| 50mm
140mm| 73mm
160mm| 92mm

16mm, 18mm

| 60mm| 0mm
80mm| 9mm
100mm| 26mm
120mm| 50mm
140mm| 70mm
160mm| 88mm

Duo Hybrid Stent

|

12mm, 14mm

| 60mm, 80mm|

“Inflow reinforcement” (14)

| 8mm
100mm, 120mm, 140mm,

160mm

|

11mm

16mm, 18mm

| 60mm, 80mm, 100mm,

120mm, 140mm, 160mm

|

10mm

Duo Extend Stent

|

12mm, 14mm

| 40mm|

“Inflow reinforcement” (15)

| 8mm
60mm, 80mm, 100mm, 120mm, 140mm| 11mm

16mm

| 40mm, 60mm, 80mm, 100mm, 120mm, 140mm|

10mm

Duo Extend Stent

|

12mm, 14mm

| 40mm|

“Highly Flexible” segment (16)

| 20mm
60mm| 40mm
80mm| 60mm
100mm| 76mm
120mm| 93mm
140mm| 116mm

16mm

| 40mm| 21mm
60mm| 39mm
80mm| 61mm
100mm| 83mm
120mm| 100mm
140mm| 118mm

The Nitinol (nickel-titanium) stents self-expand upon deployment from the Delivery Catheter (Figure 1) into the target vessel. The self-expanding Nitinol (nickel-titanium) stents impart a radial outward force on the inner luminal surface of target vessel to establish patency.

Table 2. Duo Venous Stent System sizes

Stent Type

|

Stent Diameter

|

Stent Lengths Available

| Delivery System Size

Duo Hybrid Stent

| 12mm|

60mm, 80mm, 100mm, 120mm, 140mm, 160mm

| 9F
14mm
16mm| 10F
18mm

Duo Extend Stent

| 12mm| 40mm, 60mm, 80mm, 100mm, 120mm, 140mm| 9F
14mm
16mm| 10F

INTENDED USE
The Duo Venous Stent System is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. The Duo Hybrid Stent is intended to be used in the iliac vein at the confluence of the inferior vena cava only. The Duo Extend Stent is intended for use in the common iliac and common femoral vein.

CONTRAINDICATIONS FOR USE
The Duo Venous Stent System is contraindicated for the following:

1. Patients with a known hypersensitivity to nickel-titanium alloy (Nitinol).
2. Patients unable to receive standard medication used for interventional procedures including anticoagulants, contrast agents and antiplatelet therapy.
3. Patients who are judged to have a lesion that prevents complete inflation of a balloon dilation catheter or proper placement of the stent or the stent delivery system.
4. Tortuous vascular anatomy significant enough to prevent safe introduction and passage of the device to its intended location.
5. Duo Hybrid jugular or contralateral vascular access.

WARNINGS / PRECAUTIONS

1. 1. Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient.
2. It is not recommended that Stent implants be used in patients that are allergic/intolerant to contrast media and are not amenable to pretreatment with steroids and/or antihistamines.
3. The Stent implant may cause a thrombus or thrombo-embolization or may migrate from the site.
4. Before insertion of the primary dilatation catheter, it is recommended that the appropriate antiplatelet and/or anticoagulant therapy be administered.
5. Perform all device deployment under fluoroscopic guidance.
6. Use caution when moving the Duo Venous Stent System catheter through already deployed stent implants.
7. This device should only be used by physicians who have received appropriate training.
8. Post stent implant balloon dilatation is recommended. Failure to adequately size the stent implant may result in inadequate tissue apposition and risk of stent migration or occlusion.
9. Use caution (advance slowly) during advancement of post-dilatation balloon catheter through deployed Stent implants.
10. Fully deflate post-dilatation balloon prior to withdrawing balloon catheter.
11. Do not use excessive force when using this device as this could result in damage to the device, including component fracture, or venous injury.
12. Do not use the system without the guidewire extending beyond the tip of the delivery catheter.
13. Failure to pin or secure the delivery catheter’s inner core during Stent implant deployment may result in improper placement of the Stent implant.
14. Care should be taken not to kink the delivery system. If kinking occurs this could result in the inability to reach the target treatment site and to properly deploy the Stent implant.
15. Failure to tighten (lock) the hemostatic valve prior to repositioning the delivery system could result in inadvertent deployment of Stent implant.
16. If the Stent implant cannot deploy, remove the delivery catheter, and use a new device.
17. It is recommended that the Delivery System be used with a 0.035” guidewire.
18. Is recommended that the 9F and 10F Delivery Systems be used with 9F (3.0 mm) and 10F (3.3 mm) introducer sheaths, respectively.
19. Duo Venous Stent System Storage and Preparation
    • The Duo Venous Stent System is designed and intended for single use only. DO NOT re-sterilize and/or reuse the device.
    • Reuse of this product, including reprocessing and/or re-sterilization, may lead to a failure of the device to perform as intended and/or a loss of critical labeling/use information, all of which present a risk to patient safety.
    • Store in a dark, dry place.
    • Do not use if the pouch is open or damaged. If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.
    • Use prior to the “Use-by” date specified on the package.
    • If the system cannot be flushed, do not use the system.
20.  Duo Venous Stent System Handling
    • Avoid contamination of the Stent implant(s). As with any type of vascular implant, contamination may lead to infection, thrombosis, or pseudoaneurysm.
    • Do not use with Ethiodol or Lipiodol contrast media to avoid possible damage to the delivery system components.
    • Do not expose the delivery system to organic solvents (e.g., alcohol).
21. Stent Implant Placement
    • The Duo-Hybrid Stent (high crush resistance segment) is intended to be used in the common iliac vein at the confluence of the IVC only.
    • The Duo Extend Stent is intended for use in the common femoral vein and the external iliac vein.
    • Do not use with power injection systems.
    • If resistance is encountered at any time during the insertion procedure, do not force advancement of the delivery system. Forcing the delivery system through resistance may cause damage to Stent implant or vessel. Carefully withdraw the Duo Venous Stent System without deploying a Stent implant.
    • If resistance is felt when beginning deployment, do not force deployment. Carefully withdraw the Duo Venous Stent System without deploying the Stent implant.
    • The Duo Hybrid and Duo Extend Stent(s) are not designed for repositioning or recapturing.
    • Once the stent is partially or fully deployed, do not attempt to drag or reposition the Stent implant with the delivery system, as this may result in Stent or vessel damage.
    • Stenting across a major branch vessel could cause catheterization difficulties during future diagnostic or therapeutic procedures.
    • If a long lesion needs to be stented, consider using the longest available single stent rather than overlapping stents. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., Nitinol).
    • The Duo Extend Stent has not been clinically evaluated as a stand-alone device and should only be used in conjunction with the Duo Hybrid Stent.
    • The long-term outcomes following repeat dilatation of previously implanted stents are unknown.
    • The safety and effectiveness of this device for use in the arterial system have not been established.
    • In the event of symptomatic thrombosis within the Stent implant, thrombolysis/thrombectomy and balloon venoplasty should be attempted, per standard of care.
22. Stent Implant Removal
    • In the event of a complication such as infection, surgical removal of a Stent implant may be required. Standard surgical procedure is appropriate.
23. Post Implant
    • Re-crossing a Stent implant with adjunct devices should be performed with caution to avoid damage or displacement of the implanted stent.
    • Do not attempt to re-sheath the device within the deployed Stent implant treatment area as this could result in displacement.
    • Used products are considered biohazardous material and should be disposed of properly as per hospital or lab protocol.
    • In patients requiring the use of antacids and/or H2-antagonists before or immediately after Stent implant placement, oral absorption of antiplatelet agents (e.g., aspirin) may be adversely affected.

POTENTIAL COMPLICATIONS

The following complications may be associated with intravascular Stent device implantation:

• Access failure or abrupt closure
• Allergic/anaphylactoid reaction to anticoagulant and/or antithrombotic therapy or contrast medium Allergic reaction to Nitinol
• Amputation
• Aneurysm
• Angina / coronary ischemia / myocardial infarction
• Arrhythmia
• Arteriovenous fistula
• Death
• Embolism (Thromboembolism)
• Extravasation
• Fever
• Gastrointestinal bleed from anticoagulation / antiplatelet medication
• Hematoma/hemorrhage
• Hypotension / hypertension
• Incorrect positioning of the stent requiring further stenting or surgery
• Intimal Injury/dissection
• Ischemia / infarction of tissue/organ
• Infection/abscess at insertion site
• Inflammation
• Malposition of stent
• Multi-organ failure
• Open surgical repair
• Pain
• Procedure Delay
• Pulmonary Embolism
• Pseudoaneurysm
• Renal insufficiency or failure
• Respiratory distress or failure
• Restenosis
• Septicemia / bacteremia (sepsis)
• Stent implant fracture
• Stent implant migration (device moves over time)
• Trauma to adjacent structures
• Vasospasm
• Venous occlusion/thrombosis, remote from puncture site
• Venous occlusion/thrombosis, near puncture site
• Venous occlusion/restenosis of the treated vessel

INFORMATION FOR THE PATIENT
The Duo Venous Stent System Patient Implant Card (PIC) is designed for the patient to carry along with their insurance cards. This Patient Implant Card provides information pertaining to the Stent device(s) including the catalog number, lot number and location of the implanted Stent device(s), the date of the procedure. The card also provides company information and MRI Compatibility.

How Supplied
The Duo Venous Stent System is supplied sterile inside a pouch. The device is sterilized via Ethylene Oxide. The device is non-pyrogenic. The packaged device should be stored in a dry, dark place. Caution: Do not use if the package is damaged. In case of damage, contact Vesper Medical at 1-484-982-6340 or info@vespermedical.com.

INSTRUCTIONS FOR USE

Pre-Procedure

1. Pre-procedural anticoagulation and antiplatelet should be stopped if required by the institutional standards of care.
2. Antiplatelet and/or anticoagulant therapy should be administered per institutional standards of care.
3. The percutaneous placement of a Stent implant should be done in an appropriate fluoroscopic guided procedure room.
4. Appropriate diagnostic imaging (venography and/or IVUS + fluoroscopy) should be performed using the standard technique prior to, during and after Stent placement.
5. Venography should be performed to identify, evaluate, and mark the target treatment site.
6. Patient preparation and sterile precautions should be the same as for any endovascular procedure.

Select Stent Size

1. Pre-procedural anticoagulation and antiplatelet should be stopped if required by the institutional standards of care.
2. Antiplatelet and/or anticoagulant therapy should be administered per institutional standards of care.
3. The percutaneous placement of a Stent implant should be done in an appropriate fluoroscopic guided procedure room.
4. Appropriate diagnostic imaging (venography and/or IVUS + fluoroscopy) should be performed using the standard technique prior to, during and after Stent placement.
5. Venography should be performed to identify, evaluate, and mark the target treatment site.
6. Patient preparation and sterile precautions should be the same as for any endovascular procedure.

Table 3. Stent Size Selection Table

Reference Vessel Diameter| Stent Diameter| Stent Type| Foreshortening
9mm – 11mm| 12mm| Duo Hybrid/Duo Extend| <3%
11mm – 13mm| 14mm| Duo Hybrid/Duo Extend| <5%
13mm – 15mm| 16mm| Duo Hybrid/Duo Extend| <4%
15mm – 17mm| 18mm| Duo Hybrid| <6%

Procedure

1. Preparation of the Duo Venous Stent System

   • Open the outer box and pouch to reveal the backing card containing the Duo Venous Stent System.
   • Carefully inspect the backing card and device for any damage. If damage is suspected, the sterility or performance of the device has been compromised; the device should not be used.
   • Flush the delivery system with sterile saline to expel any air. A 3cc syringe is recommended (to avoid damage to the delivery system).
   1. Flush through the Bifurcation Luer side port until saline weeps from the distal catheter end.
   2. Flush through the Guidewire Port until saline flows out of the Guidewire Lumen at the distal catheter end.
   • Inspect the distal end of the catheter to ensure that the Stent implant is contained within the outer sheath. If a gap between the catheter tip and outer sheath tip exists, unlock the hemostatic valve in the counterclockwise direction and gently pull the inner core in a proximal direction of the device until the gap is closed. Lock the hemostatic valve after the adjustment by rotating the proximal end of the device in a clockwise direction.
   • Wipe the usable portion of the stent delivery catheter with saline.

2. Insertion of Introducer Sheath or Guide Catheter and Guidewire

   • Access the treatment site with the appropriate accessory equipment compatible with the 9F/10F (3.0 mm / 3.3 mm) delivery system depending upon stent size to be implanted (reference TABLE 2).
   • Place a 0.035” (0.89 mm) guidewire of sufficient length across the treatment site for Stent implantation via the introducer sheath or guide catheter.

3. Dilate Lesion

   • Predilatation of chronic lesions with a balloon dilation catheter is recommended. If performed, select a balloon catheter that matches the size of the reference vessel.
     CAUTION: During dilation, do not over-size the balloon such that dissection or perforation could occur.

   • While maintaining site access with a guidewire, remove the balloon catheter from the patient. CAUTION: Fully deflate balloon catheter prior to withdrawing.

4. Introduction of Duo Venous Stent System

   • Ensure the Hemostatic valve is locked.

   • Advance the delivery catheter over the guidewire through the hemostatic valve and sheath introducer to the treatment site.
     NOTE: If resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used. A stiffer guidewire may also be considered to facilitate device introduction and passage.
     NOTE: The Duo Hybrid Stent (high crush resistance segment) is intended to be used in the cranial portion of the iliac vein at the confluence of the IVC only.
     NOTE: The Duo Hybrid Stent is not designed for use in procedures that require jugular or contralateral access.
     CAUTION: DO NOT USE the Duo Hybrid Stent from any access other than an ipsilateral venous access.

   • CAUTION: Always use an introducer sheath for the implant procedure to protect puncture site.

5. Slack Removal

   • Advance the Duo Venous Stent System past the treatment site.
   • Pull back the Duo Venous Stent System until the radiopaque marker on the outer sheath is aligned with the cranial end of the target treatment site (just beyond the cranial aspect of the lesion).
   • Ensure the device outside the patient remains flat and straight.
     CAUTION: Slack in the catheter shaft, either outside or inside the patient, may result in deploying the Stent implant in a non-target treatment site.

6. Stent Implant Deployment

   • Verify that the delivery system and stent radiopaque markers are positioned cranial and caudal to the target treatment site.

   • Ensure the access sheath does not move during deployment.

   • Initiate Stent implant deployment by unlocking the hemostatic valve while holding the inner core shaft in a fixed position.
     NOTE: Failure to maintain a fixed inner core shaft position may result in undesired Stent implant placement.

   • While using fluoroscopy, maintain position of the radiopaque markers relative to the target treatment site. Watch for the Outer Sheath radiopaque marker band to move caudally as the outer sheath is retracted which indicates the stent is being exposed and deploying. The stents cranial radiopaque markers will start to radially expand during deployment. Carefully, continue to retract the outer sheath until the stents cranial radiopaque markers are fully apposed to the vessel wall. Continue to slowly unsheathe the stent until the Stent implant is fully deployed. The stent is fully deployed once the stents cranial and caudal radiopaque markers are fully apposed to the vessel wall.
     DO NOT attempt to recapture the stent.

   • If overlapping of a Duo Extend Stent inside of a Duo Hybrid Stent is required to extend the treatment region, there should be a 10-20mm overlap of the Duo Hybrid and Duo Extend Stent.

7. Stent Implant Post-dilatation

   • Carefully remove the delivery system from the body.

   • Using fluoroscopy, visualize the Stent implant to verify deployment.

   • Post Stent expansion with a balloon catheter is recommended. If performed, select a balloon catheter that matches the size of the reference vessel, but is not larger than the stent diameter itself.

   • Post-dilate the stent treated site with conventional techniques. Remove the balloon catheter from the patient following the complete deflation of the balloon prior to removal.
     CAUTION: Fully deflate balloon catheter prior to withdrawing.

   • Following stent deployment, a post intervention venogram and Intravascular Ultrasound are recommended to ensure adequate stent placement, full lesion coverage and full stent expansion.

8. Post Treatment

   • Remove the guidewire and sheath from the body.
   • Close entry wound/obtain hemostasis as appropriate.
   • Discard the delivery system, guidewire, and sheath.
     NOTE: Physician experience and discretion will determine the appropriate post-procedure drug regimen for each patient.

SUMMARY OF THE PRIMARY CLINICAL STUDY
The results of the VIVID Study investigating the safety and effectiveness of the Duo Venous Stent System for treating symptomatic iliofemoral venous outflow obstructions, are presented below.

Study Design
The VIVID study is a prospective, multi-center, single-arm, non-blinded clinical trial designed to investigate the safety and efficacy of the Duo Venous Stent System as compared to a pre-defined performance goal (PG) established from published, peer reviewed scientific literature related to stenting of iliofemoral venous outflow obstructions.

Patients were treated between November 30, 2020, and December 6, 2021. The database for this PMA reflected data collected through June 15, 2023. The study enrolled 162 subjects at 30 clinical sites in the United States and European Union.

The study enrolled subjects with nonmalignant iliofemoral venous outflow obstruction presenting with non-thrombotic (NT), acute thrombotic (AT) or chronic post-thrombotic (CPT) disease pathogenesis. Any subject that received one or more Duo Stents was followed for 30-days, 6 months, 12 months, 24 months, and 36 months.

An independent Clinical Events Committee consisting of a team of clinical experts with experience in the conduct of clinical trials was formed to review clinical events reported by the investigators that had potential to be classified as Major Adverse Events. A medical monitor was employed to provide a first review of all Adverse Events to review unanticipated adverse device effects (UADE) potential, seriousness, severity, causality, and effectiveness. Additionally, an independent board of multi-disciplinary physicians and subject matter experts was convened to serve as the Data Safety and Monitoring Board (DSMB) for the study. The DSMB served as an independent body conducting a review and oversight of all key safety events to monitor the rate of occurrence (both site-reported and CEC-adjudicated events) as part of their mission to protect the rights and safety of research subjects.

Clinical Inclusion and Exclusion Criteria
Enrollment in the VIVID study was limited to patients who met the following inclusion criteria:

General Inclusion Criteria:

1. Males or non-pregnant, non-breastfeeding females ≥18 years of age at the time of consent.

2. Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures.

3. Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to treatment and must use some form of contraception (abstinence is acceptable) throughout the time of clinical trial exit.

4. Willing and capable of complying with all required follow-up visits.

5. Estimated life expectancy ≥1 year

6. Subject is ambulatory (use of assistive walking device such as a cane or walker is acceptable) |

7. Body mass index (BMI) <45

8. Clinically significant symptomatic venous outflow obstruction in one iliofemoral venous segment (one limb) per subject, is indicated for venoplasty and stenting, and meets at least one of the following clinical indicators:
   A. CEAP score ≥3
   B. VCSS (Venous Clinical Severity Score) pain score 22
   C. Suspected deep vein thrombosis (DVT) with symptoms occurring prior to receiving a Duo Stent

9. Subject is willing and able to comply with principal investigatory (PI) recommendation for compression therapy, if required.

10. Presence of unilateral, non-malignant venous obstruction of the common femoral vein (CFV), external iliac vein (EIV, common iliac vein (CIV, or any combination thereof, defined as a 250% reduction in target vessel lumen diameter and confirmed by venographic or IVUS imaging. The cranial point of the obstruction may extend to the iliac vein confluence of the inferior vena cava (IVC) and the caudal point may be 2mm above either the inflow of the deep femoral (or profunda) or the lesser trochanter, whichever is most cranial.

11. Obstructive lesion(s) able to be treated with continuous stent coverage.

12. Adequate inflow to the target lesion(s) involving at least a patent femoral or deep femoral vein and a landing zone in the CFV free from significant disease requiring treatment.

13. Reference vessel diameter is of adequate size to accommodate the appropriate size stent as measured by IVUS.

14. All vessels from insertion site through target vessel can accommodate a 9F or 10F sheath, depending on the stent size used.

15. Ability to cross interventional devices through target lesion (s).

16. In DVT subjects, successful treatment of acute thrombus must have occurred prior to receiving any Duo Stents for an underlying obstructive lesion. Successful treatment of acute thrombus is defined as reestablishment of antegrade flow with ≤30% residual thrombus (confirmed by venogram or IVUS) and freedom from bleeding and symptomatic pulmonary embolism (confirmed by imaging). After successful treatment of thrombus is confirmed, eligible obstructive lesion(s) can be treated with a Duo Stent during the came nrocedure

17. All subjects must undergo a SARS-CoV-2 test and have a negative test result within 8 days prior to the index procedure. If a SARS-CoV-2 test is unavailable due to institution policy, a test shortage, or if there is a delay in test results, the subject must complete the COVID-19 questionnaire and must have answered NO to all questions to be eligible for enrollment. A SARS-CoV-2 test will not be required for enrollment if a subject has received a complete cycle of an authorized COVID-19 vaccine or has documented evidence of a positive COVID- 19 antibody test and is asymptomatic and has no long-lasting effects (per Pl discretion) from a prior COVID-19 infection.

18. A measured temperature less than 99.5°F (37.5°C) on the day of the index procedure and no history of fever or feeling feverish within 14 days of the index procedure.

19. No prior history, within 60 days of the index procedure of a SARS-CoV-2 positive test, or COVID-19 symptoms.
    Patients were not permitted to enroll in the VIVID study if they met any of the following exclusion criteria.

General Exclusion Criteria:

1. Target limb symptoms caused by peripheral arterial disease.
2. Presence of unresolved significant pulmonary emboli prior to use of the Duo Venous Stent System confirmed by chest computed tomography (CT). If subject has documented history of significant pulmonary embolism within the last 6 months, a chest CT is required to confirm significant pulmonary embolism is not currently present.
3. Presence of IVC obstruction or target venous obstruction that extends into the IVC.
4. Presence of acute DVT located outside target limb.
5. Contralateral venous occlusive disease of the CFV, E V, and/or CIV, with planned treatment ≤390 days after the index procedure
6. Uncontrolled or active coagulopathy or known, uncorrectable bleeding diathesis.
7. Coagulopathy causing INR >2 which is not amenable to medical treatment.
8. Platelet count <50,000 cells/mm3 or >1,000,000 cells/mm3 and/or White blood cell (WBC) <3,000 cells/mm3 or >12,500 cells/mm3
9. Uncorrected hemoglobin of ≤9 g/dL
10.  Subject is on dialysis or has an estimated glomerular filtration rate (eGFR) <30 mL/min. In subjects with diabetes mellitus, eGFR <45 mL/min.
11. History of Heparin Induced Thrombocytopenia
12. Presence of known aggressive clotting disorders such as Lupus Anticoagulant Disorder, Antiphospholipid antibody syndrome, homozygous gene Factor V Leiden or Prothrombin gene abnormalities, Protein C and S deficiency or Antithrombin deficiency
13. Known hypersensitivity or contraindication to antiplatelet therapy or anticoagulation, nickel, or titanium.
14. Contrast agent allergy that cannot be managed adequately with pre-medication.
15. Intended concurrent adjuvant procedure (except for venoplasty) such as creation of temporary arteriovenous fistula, femoral endovenectomy, or saphenous vein ablation and/or saphenous vein stripping during the index procedure.
16. Subjects who have had any prior surgical or endovascular procedures to the target vessel. Note that subjects who have had successful catheter-directed or mechanical thrombolysis in the target vessel for DVT at least 90 days prior to the index procedure may be included.
17. Planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in subjects at high risk for pulmonary embolism) within 30 days prior to or 30 days after the index procedure.
18. Planned surgical or interventional procedures for other medical conditions (i.e., not associated with the target limb) 30 days prior to or 30 days after the index procedure.
19. Previous venous stenting of the target limb, the IVC, or contralateral limb if stents extend into the IVC.
20. Iliofemoral venous segment unsuitable for treatment with available sizes of Duo Stent implants
21. Lesions with intended treatment lengths extending into the IVC.
22. No safe landing zone at or above the profunda femoral confluence
23. Participating in another investigational study in which the subject has not completed the primary endpoint(s)
24. Has other comorbidities that, in the opinion of the PI, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments.

Follow-up Schedule

After hospital discharge, subjects were required to return to the study center for clinical assessments on Day 30 (-2 days / +14 days), 12 months ± 30 days, 24 months ± 30 days and 36 months ± 30 days. A time and events schedule for all assessments is provided in Table 4.

Table 4. Time and Events Schedule

Assessment

| Baseline 1| ****

Index Procedure

| Post-Procedure/ Pre-Discharge 2| ****

30- day

(-2 days/+14 Days)

| ****

6

Month (±30 Days)

| ****

12

Month (± 30 Days)

| 24

Month (± 30 Days)

| 36

Month (± 30 Days)

---|---|---|---|---|---|---|---|---
Informed Consent| X

3

|  |  |  |  |  |  |
Inclusion/Exclusion Criteria| X| X|  |  |  |  |  |
SARS-CoV-2

Test/COVID-19 Questionnaire5

| X

4

|  |  | ****

X

| ****

X

| ****

X

| ****

X

| ****

X

Demographics, Medical History and Risk Factors| ****

X

|  |  |  |  |  |  |
Brief Physical Exam (Height, Weight, Temp)| X|  |  |  |  |  |  |
Serum Creatinine, eGFR, WBC, Platelet Count, Hemoglobin| ****

X

|  |  |  |  |  |  |
Prothrombin Time (PT)/ International Normalized Ratio

(INR)6

| ****

X

|  | ****

X

|  |  |  |  |
Activated Partial Thromboplastin time (aPTT)7| ****

X

|  | ****

X

|  |  |  |  |
Urine or Blood Pregnancy Test8| X|  |  |  |  |  |  |
Venous Ulcer

Assessment

| X|  |  | X| X| X| X| X
CEAP Classification| X|  |  |  | X| X| X| X
Villalta Score| X|  |  |  | X| X| X| X
VCSS Pain Score| X|  |  |  | X| X| X| X
VEINES-QOL/Sym

Questionnaire

| X|  |  |  | X| X| X| X
EQ-5D-3L

Questionnaire

| X|  |  |  | X| X| X| X
Concomitant Medications| X| X| X| X| X| X| X| X
---|---|---|---|---|---|---|---|---
Duplex Ultrasound

(DUS)9

|  |  |  | X| X| X| X| X
Venogram10|  | X|  |  |  | X11| X| X
Intravascular Ultrasound (IVUS)10|  | X|  |  |  | X11| X| X
X-ray of Implanted Stent10|  |  |  |  |  | X| X| X
Adverse Event (AE)

Assessment

|  | X| X| X| X| X| X| X

1. Assessments may be done up to 30 days prior to the index procedure, except for a pregnancy test and SARS-CoV-2 test.
2. Assessments are to be completed post-index procedure and prior to the subject being discharged from the hospital/clinic.
3. Informed Consent may be obtained up to 30 days prior to index procedure.
4. All subjects must undergo a SARS-CoV-2 test and have a negative result within 8 days of the Index Procedure to be eligible for study inclusion.
5. If a SARS-CoV-2 test is unavailable due to institution policy, a test shortage, or if there is a delay in test results, the subject must complete the COVID-19 questionnaire and answer NO to all questions to be eligible for study treatment.
6. PT/INR to be obtained only if a subject is on chronic warfarin therapy.
7. aPTT to be obtained only if a subject is on chronic heparin therapy.
8. Negative urine or blood pregnancy test is required for female subjects of childbearing potential within 7 days of the index procedure.
9. All scheduled DUS exams should be performed per the protocol established by the core laboratory. If a DUS is non-diagnostic (per the imaging protocol), the site should make every effort to obtain a repeat exam within the visit window.
10. All imaging of the target limb acquired during scheduled visits or an interventional procedure to the target limb (such as venogram, IVUS, DUS, or X- ray) should be submitted to the respective core laboratory within 3 business days.
11. Required if DUS suggests >50% stenosis or occlusion of the stented segment, or if the DUS is non-diagnostic or sub-optimal (i.e., due to obesity).

Clinical Endpoints

Primary Safety Endpoint
The primary safety endpoint was to demonstrate freedom from major adverse events (MAEs) at 30 days post index procedure, as adjudicated by the Clinical Events Committee (CEC) or Core Laboratory, including:

• Device or procedure-related death
• Device or procedure-related bleed at the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention or blood transfusion of ≥2 units
• Device or procedure-related venous injury occurring in the target vessel and /or the target lesion or at the access site requiring surgical or endovascular intervention
• Major amputation of the target limb
• Clinically significant pulmonary embolism (PE), confirmed by CT angiography
• Stent embolization outside of the target vessel
• Presence of new thrombus within the stented segment requiring surgical or endovascular intervention

Disease specific PG was calculated from the point estimates for major bleeding, pulmonary embolism and peri-procedural mortality from Razavi et al converted to freedom from estimates and application of a 10% delta. The resulting PGs were 89%,87% and 88% for the non-thrombotic, acute thrombotic and chronic post-thrombotic, respectively. Given the similarity of the disease-state specific PGs, it was determined that a disease state specific goal was not necessary. A PG of 89% was adopted for the study in both the SARS-CoV-2 negative subset and overall.

Statistical hypothesis testing was performed as follows:

• H0: Proportion of subjects with freedom from MAE (pMAE) is less than or equal to the PG) at 30 days, pMAE ≤89%
• H1: Proportion of subjects with freedom from MAE is greater than the (PG) at 30 days, pMAE >89%

The primary statistical analysis was conducted in the full-analysis set (FAS) subset for the primary safety endpoint overall and in the SARS-CoV-2 negative subset. A subject was defined as an Intent-To-Treat (ITT) patient once the subject had the Duo Venous Stent System advanced through the introducer sheath. A subject is defined as full-analysis set (FAS) if they meet the ITT definition and have data evaluable for the primary endpoints. The Per-Protocol (PP) population was defined as ITT subjects with evaluable data that met the definition for Device Success and did not have any major protocol deviations. The primary statistical method is a one-sample exact test comparing the proportion of subjects free from a MAE to the PG using a one-sided a=0.025. The exact two-sided 95% confidence interval for the proportion of subjects free from MAE was calculated.

Primary Effectiveness Endpoint
The primary effectiveness endpoint is primary patency of stented segment at 12 months defined as freedom from:

• Duplex Ultrasound (DUS) core laboratory adjudicated stenosis or occlusion >50% within the stented segment. If DUS shows >50% stenosis or occlusion, confirmation by diagnostic intravascular ultrasound (IVUS) is required.
• CEC adjudicated clinically driven target lesion reintervention (CD-TLR) defined as endovascular or surgical procedure for new, recurrent, or worsening symptoms and core lab adjudicated >50% stenosis or occlusion within the stented segment confirmed by diagnostic IVUS.

The PG for primary effectiveness was set when all enrolled subjects completed the index procedure and was based upon the proportions of ITT subjects in each of the disease states, (i.e., non-thrombotic, acute thrombotic and chronic post-thrombotic). The disease specific PGs were adopted as suggested in Razavi et al1 with, the lower 95% confidence limit minus 10%. The disease state PGs were 83%, 70% and 66% for non-thrombotic, acute thrombotic and chronic post- thrombotic subjects respectively. The PG for the VIVID study is a weighted combination of these disease state specific PGs, where the weights are the proportion of subjects in each disease state in the ITT sample. Therefore, the performance goal (PG) was defined as

PG = (0.642)0.83 + (0.099)0.70 + (0.259)*0.66. = 77.3%

Statistical hypothesis testing was performed as follows:

• H0: Proportion of subjects with primary patency (pp_pat) is less than or equal to performance goal (PG) at 12 months, pp_pat
• H1: Proportion of subjects with primary patency is greater than the performance goal at 12 months, pp_pat >PG

The study device was considered to have met the effectiveness endpoint if the one-sided p-value from hypothesis testing, comparing the proportion of subjects in the FAS with primary patency to the PG using a one-sample Z-test, was less than 0.025.

Secondary Endpoints
The following secondary endpoints were evaluated through 12 months:

• Subject symptom relief via VCSS pain score at 12 months
• Primary assisted patency at 12 months
• Defined as freedom from DUS core laboratory adjudicated occlusion or stenosis >50% within the stented segment following a clinically driven target lesion reintervention due to a >50% but <100% stenosis. If DUS shows >50% stenosis or occlusion, confirmation by diagnostic IVUS was required.
• Secondary patency at 12 months
• Defined as freedom from DUS core laboratory adjudicated occlusion or stenosis >50% within the stented segment following a clinically driven target lesion reintervention. If DUS shows >50% stenosis or occlusion, confirmation by diagnostic IVUS was required.

Observational Endpoints

• Device Success defined as:
• Successful deployment of the Duo Stents) at the intended target site, AND
• Successful withdrawal of the delivery catheter(s) from the introducer sheath, AND
• The Duo Stent remaining at the intended deployment location through completion of the index procedure as determined by the Principal Investigator (PI)
• Lesion success defined as target lesion patency of ≤50% residual diameter or area stenosis of the stented segment at the completion of the procedure*
• Procedural success defined as lesion success without the occurrence of CEC adjudicated major adverse events (MAEs) from the time start of the index procedure through discharge.
• Stent fracture via X-ray through 36 months*
• Stent migration via X-ray through 36 months*
• Stent embolization via X-ray or venogram through 36 months*
• Primary patency of the stented segment via DUS at 24 and 36 months. If DUS shows >50% stenosis or occlusion,confirmation by diagnostic IVUS may be required*
• Primary assisted patency of the stented segment via DUS at 24 and 36 months. If DUS shows >50% stenosis or occlusion, confirmation by diagnostic IVUS may be required*
• Secondary patency of the stented segment via DUS at 24 and 36 months. If DUS shows 50% stenosis or occlusion confirmation by diagnostic IVUS may be required*.
• Change in the CEAP classification through 36 months.
• Changes in the EQ-5D-3L through 36 months.
• Changes in the Villalta Score through 36 months.
• Changes in the VCSS Pain Score at 24 and 36 months.
• Changes in the VEINES QOL/Sym Score through 36 months.
• CEC adjudicated MAEs post 30 days through 36 months.
• CEC adjudicated CD-TLR through 36 months.
• CEC adjudicated CD-TVR through 36 months.
• Venous Ulcer Assessment through 36 months.

Core Laboratory Adjudicated

Accountability of PMA Cohort

Of the 270 subjects consented for the VIVID study, 162 patients were enrolled and represent the Intent-to-Treat (ITT) population. The Per Protocol (PP) population includes 158 subjects and excludes three subjects that did not meet the criteria for device success and one subject that did not meet Inclusion Criteria #10. The Full-Analysis Set (FAS) is subjects who meet the ITT definition and have data evaluable for the primary endpoints. Subject accountability is also described in Table 5 below. Of the 162 enrolled subjects, 155 completed 30-day follow-up or telemedicine/phone visit and 140 completed 12-month follow-up or telemedicine/phone visit per Figure 4.

1. -270 consented subjects – 108 screen failures = 162 enrolled subjects
2. 162 enrolled subjects – 2 discontinued subjects – 5 missed follow-up visits – 5 visits conducted via telemedicine or phone call = 150 completed 30-day follow-up visits 3160 enrolled subjects still in study – 2 additional discontinued subjects – 8 missed follow-up visits – 6 visits
   conducted via telemedicine or phone call = 144 completed 6-month follow-up visits 4158 enrolled subjects still in study – 6 additional discontinued subjects – 12 missed follow-up visits – 4 visits
   conducted via telemedicine or phone call = 136 completed 12-month follow-up visits
   §Cumulative discontinued subjects prior to the 12-month follow-up visit

Figure 4. VIVID Study Subject Enrollment

Study Population Demographics and Baseline Parameters

Baseline demographics and clinical characteristics for subjects treated in the trial are summarized in Table 5. The mean age was 59.4 ± 15.8 years and males comprised 63.0% of the ITT population. CEAP clinical assessment category C3 (edema) comprised 66.0% of the subjects and an additional 20.5% were in category C4 (changes in skin and subcutaneous tissue secondary to venous disease). Most subjects reported pain rated as moderate (52.5%) or severe (25.6%) on the VCSS pain scale.

Table 5. VIVID Subject Demographics

 | Mean ± SD (N) (Min, Median, Max) or % (#/#)
ITT Subjects
SARS-CoV-2 Status at Enrollment

Positive Negative

|

8.0% (13/162)

92.0% (149/162)

Age at consent (years)| 59.4 ± 15.8 (162)

(19.0, 61.0, 90.0)

Biological Gender

Female Male

|

37.0% (60/162)

63.0% (102/162)

Ethnicity|
Hispanic or Latino| 12.3% (20/162)
Not Hispanic or Latino| 84.0% (136/162)
Unknown| 3.7% (6/162)
Race (Check all that apply)|
American Indian or Alaska Native| 0.0% (0/162)
Asian| 0.6% (1/162)
Black| 9.3% (15/162)
Native Hawaiian or Pacific Islander| 0.0% (0/162)
Caucasian| 82.7% (134/162)
Other| 1.9% (3/162)
Decline to Answer| 1.9% (3/162)
Unknown| 3.7% (6/162)
BMI| 30.1 ± 5.7 (162)

(18.4, 29.2, 43.7)

CEAP Clinical Assessment|
C0| 1.2% (2/162)
C1| 0.6% (1/162)
C2| 0.6% (1/162)
C2r| 0.0% (0/162)
C3| 66.0% (107/162)
C4| 5.6% (9/162)
C4a| 13.0% (21/162)
C4b| 1.9% (3/162)
C4c| 0.0% (0/162)
C5| 4.9% (8/162)
Table 5. VIVID Subject Demographics

 | Mean ± SD (N) (Min, Median, Max) or % (#/#)
ITT Subjects
C6

C6r

| 5.6% (9/162)

0.6% (1/162)

VCSS Pain

0 – none

1 – mild

2 – moderate

3 – severe

|

6.9% (11/160)

15.0% (24/160)

52.5% (84/160)

25.6% (41/160)

Data presented as Mean ± SD (N) (Min, Median, Max) or % (#/#)

The risk factors for developing venous disease are summarized in Table 6. The most common include hyperlipidemia (48.8%) and hypertension (44.4%).

Table 6. VIVID Subject Risk Factors|
---|---
 | % (#/#)
ITT Subjects
Smoking|
Current| 9.3% (15/162)
Former| 29.6% (48/162)
Never| 61.1% (99/162)
Diabetes Mellitus| 19.1% (31/162)
Type I| 2.5% (4/162)
Type II| 16.7% (27/162)
Hypertension| 44.4% (72/162)
Hyperlipidemia| 48.8% (79/162)
Mobility|
Able to ambulate without assistance| 90.1% (146/162)
Able to walk with walking device| 9.9% (16/162)
Not ambulatory| 0.0% (0/162)
Other| 0.0% (0/162)
Knee replacement| 9.3% (15/162)
Right| 3.1% (5/162)
Left| 3.1% (5/162)
Both| 3.1% (5/162)
Hip replacement| 4.9% (8/162)
Right| 1.2% (2/162)
Left| 2.5% (4/162)
Both| 1.2% (2/162)
Family history of venous disease|
Yes| 16.7% (27/162)
No| 34.0% (55/162)
Unknown| 49.4% (80/162)

Data presented as % (#/#)

A summary of the medical history for all subjects is provided in Table 7. As would be expected for this subject population, 66.0% and 31.5% have a history of May-Thurner Syndrome and varicosis, respectively. Previous diagnosis and resolution of DVT in the target limb was reported by 14.8% of subjects and 14.2% had a previous superficial venous ablation to the target limb.

Table 7. VIVID Subject Medical History

 | % (#/#)
ITT Subjects
Stroke| 2.5% (4/162)
Transient Ischemic Attack (TIA)| 4.3% (7/162)
Angina| 8.0% (13/162)
Myocardial Infarction| 5.6% (9/162)
Congestive Heart Failure| 6.8% (11/162)
Coronary Artery Disease| 14.2% (23/162)
Vascular Heart Disease| 4.9% (8/162)
Cardiomyopathy| 2.5% (4/162)
Venous Valve Disease| 13.0% (21/162)
Atrial Fibrillation| 10.5% (17/162)
Arrythmia (Other than atrial fibrillation)| 3.7% (6/162)
May-Thurner Syndrome| 66.0% (107/162)
Peripheral Arterial Disease| 10.5% (17/162)
Varicosis| 31.5% (51/162)
Chronic Renal Insufficiency| 3.1% (5/162)
Uremia| 0.0% (0/162)
Uncontrolled or active coagulopathy or known uncorrectable bleeding diathesis| 0.0% (0/162)
Clinically Significant Pulmonary Emboli| 3.7% (6/162)
---|---
Cancer| 14.8% (24/162)
Gastrointestinal Disease| 17.3% (28/162)
Genitourinary Disorder| 3.1% (5/162)
Respiratory Disorder| 9.3% (15/162)
Liver Disease| 1.2% (2/162)
Allergic reaction sensitivity or intolerance to nickel or titanium| 0.0% (0/162)
Allergic reaction sensitivity or intolerance to contrast media antiplatelet anticoagulant or

thrombolytic medications

|

1.9% (3/162)

Superficial venous ablation to the target limb| 14.2% (23/162)
Previously diagnosed and resolved DVT in target limb| 14.8% (24/162)
Previously diagnosed and resolved DVT in non-target limb| 5.6% (9/162)
Contralateral venous occlusive disease| 5.6% (9/162)
Onset of symptoms that led to venous stenting intervention

::14 days

14 days

|

15.4% (25/162)

84.6% (137/162)

Data presented as % (#/#)

Core laboratory reported assessments of the target lesion are summarized in Table 8. The median lesion length was 43.3 mm but ranged widely from a minimum of 6.3 mm to a maximum of 295.0 mm. As such, the overall stented length also varied widely from the median of 110.0 mm from a minimum of 26.5 mm to 274.0 mm. The median pre- and post-procedure stenosis was 74% and 1%, respectively.

Table 8. VIVID Core Laboratory Reported Target Lesion Details

 | Mean ± SD (N) Min, Median, Max

or % (#/#)

ITT Subjects
Most Cranial Lesion Location 1

IVC

Common Iliac Vein – Cranial Common Iliac Vein – Mid Common Iliac Vein – Caudal External Iliac Vein – Cranial External Iliac Vein – Mid External Iliac Vein – Caudal

Common Femoral Vein

|

2.0% (3/150)

79.3% (119/150)

6.7% (10/150)

5.3% (8/150)

6.0% (9/150)

0.0% (0/150)

0.0% (0/150)

0.7% (1/150)

Most Caudal Lesion Location 1

IVC

Common Iliac Vein – Cranial Common Iliac Vein – Mid Common Iliac Vein – Caudal External Iliac Vein – Cranial External Iliac Vein – Mid External Iliac Vein – Caudal

Common Femoral Vein

|

0.0% (0/150)

2.0% (3/150)

10.0% (15/150)

23.3% (35/150)

9.3% (14/150)

13.3% (20/150)

23.3% (35/150)

18.7% (28/150)

Reference Lumen Diameter (mm) 1| 14.0 ± 4.0 (143)

(3.6, 13.9, 28.5)

Lesion Length (mm) 1| 55.2 ± 44.6 (145)

(6.3, 43.3, 295.0)3

Pre-Intervention Stenosis (%) 2| 71.2 ± 15.0 (162)

(23.0, 74.0, 95.0)

Pre-Intervention Occlusion (%) 2| 0.0% (0/162)
Post Stent Placement Stenosis (%) 2| 6.7 ± 9.6 (162)

(0.0, 1.0, 41.0)

Overall Stented Length (mm) 1| 126.4 ± 46.9 (147)

(26.5, 110.0, 274.0)

Minimum Lumen Diameter In-Stent (mm) 1| 13.9 ± 3.7 (144)

(6.4, 13.5, 44.0)

Data presented as Mean ± SD (N) (Min, Median, Max) or % (#/#)

1. Measured by venogram
2. Measured by both IVUS and venogram. IVUS was preferred, and venogram was used only when IVUS was not available

A summary of the index procedure is provided in Table 9. The final disease state classification of the ITT subjects was primarily non-thrombotic (64.2%). Chronic post-thrombotic and acute thrombotic accounted for 25.9% and 9.9% of the subjects, respectively.

Table 9. VIVID Index Procedure Details

 | Mean ± SD (N)

Min, Median, Max or % (#/#)

ITT Subjects
Target Limb|
Left

Right

| 79.6% (129/162)

20.4% (33/162)

---|---
Index Procedure Location Ambulatory surgical center Hospital

Office base labs

|

2.5% (4/162)

59.3% (96/162)

38.3% (62/162)

Sedation Type

General

IV Sedation

|

17.3% (28/162)

82.7% (134/162)

PI Reported Pre-Intervention Stenosis (%)| 77.6 ± 15.2 (162)

(38.9, 79.2, 100.0)

Procedure Length (min)| 56.9 ± 32.2 (162)

(8.0, 50.0, 245.0)

Total Fluoroscopy Time (min)| 13.4 ± 13.9 (159)

(0.0, 9.8, 139.0)

Total amount of contrast used (mL)| 80.8 ± 53.0 (160)

(0.0, 70.0, 426.0)

Final Disease State Classification

Acute thrombotic Chronic post-thrombotic Non-thrombotic

|

9.9% (16/162)

25.9% (42/162)

64.2% (104/162)

Data presented as Mean ± SD (N) (Min, Median, Max) or % (#/#)

Stent placement details are provided in Table 10. Of the 162 patients enrolled, 112 (69.1%) received the Duo Hybrid Stent only while 50 (30.9%) received both the Duo Hybrid Stent and Duo Extend Stent to extend treatment. Overall, 166 Duo Hybrid Stents and 53 Duo Extend Stents were implanted.

Table 10. VIVID Stent Placement Details

 | Mean ± SD (N) Min, Median, Max or % (#/#)
ITT Subjects
Per Subject

Stent Treatment

Duo Hybrid Stent Alone

Duo Hybrid + Duo Extend Stent(s)

|

69.1% (112/162)

30.9% (50/162)

Number of Duo Stents per subject

1

2

3

|

67.3% (109/162)

30.2% (49/162)

2.5% (4/162)

Number of Duo Hybrid Stents per subject

1

2

3

|

97.5% (158/162)

2.5% (4/162)

0.0% (0/162)

Number of Duo Extend Stents per subject

0

1

2

|

69.1% (112/162)

29.0% (47/162)

1.9% (3/162)

Per Stent Stent Type

Duo Hybrid Duo Extend

|

75.8% (166/219)

24.2% (53/219)

Stent Length| 105.5 ± 29.8 (219)

(40.0, 100.0, 160.0)

Stent Diameter| 15.5 ± 1.5 (219)

(12.0, 16.0, 18.0)

Approach for study device introduction

Ipsilateral Antegrade

Contralateral Retrograde/Crossover

|

99.5% (218/219)

0.5% (1/219)

Access site location for study device introduction

Femoral Popliteal Jugular Other

|

63.0% (138/219)

28.8% (63/219)

0.5% (1/219)

7.8% (17/219)

Successful introduction of the device through the introducer sheath?| 100.0% (219/219)
Duo Stent deployed?| 100.0% (219/219)
Deployed at the intended target site?| 99.1% (217/219)
Withdrawal of delivery catheter from the introducer sheath?| 100.0% (219/219)
Duo Stent was post-dilated| 90.4% (198/219)
Duo Stent implant remained in position from initial deployment through

completion of procedure?

|

99.5% (218/219)

Data presented as Mean ± SD (N) (Min, Median, Max) or % (#/#)

Table 11 provides the size and lengths of all Duo Hybrid Stent and Duo Extend Stent placed. Almost all available stent diameters and lengths were utilized in the study.

Table 11. VIVID Duo Hybrid Stent and Duo Extend Stent Size and Length

Stent

Diameter (mm)

| Stent Length (mm)

40 60                      80                     100

|

120

|

140

|

160

Duo Hybrid (N=166)
12

14

16

18

|

N/A1

| —| —| —| 1| —| —
4| 1| 15| 15| —| 16
13| —| 27| 28| —| 9
—| 22| —| 15| —| —
Duo Extend (N=53)
12

14

16

| —| —| 4| —| —| —|

N/A2

4| —| 17| —| —| 12
—| —| 13| —| 1| 2

1. Duo Hybrid is not available in 40mm length.
2. Duo Extend is not available in 160mm length.

Safety and Effectiveness Results

Safety Results
The primary safety endpoint for the VIVID study is freedom from major adverse events (MAEs) at 30 days post index procedure, as adjudicated by the Clinical Events Committee (CEC) or Core Laboratory. There were only two patients who had a CEC Adjudicated MAE at 30 days, both of whom had new thrombus in the stented segment requiring surgical or endovascular intervention. Both patients were in the chronic post-thrombotic cohort. Table 12 displays the analysis of all FAS subjects. In each case the lower confidence bound was >95% which met the pre-defined performance goal (p<0.0001).

Table 12. VIVID Primary Safety Endpoint – CEC Adjudicated MAES at 30 Days

Study Group

|

Freedom from MAE at 30 Days

% (#/#) (95% CI) 1

|

Performance Goal

|

p-value 1

|

Study Endpoint

FAS – All| 98.7% (157/159)

(95.5%, 99.8%)

| 89%| <0.0001| MET

One sample exact test for one proportion, p-value is one-sided, Exact Two- Sided 95% confidence interval

Adverse Effects that occurred in the PMA clinical study
Table 13 and Table 14 present an overall summary of adverse events and serious adverse events that have been reported through 390 days by Body System Organ Class. No events were determined to be unanticipated. The types and occurrences of events that were reported are within expected rates.

Table 13. Adverse Events and Device or Procedure Related Events in Body System Organ Classes in ITT Subjects

Body System Organ Class

| Adverse Events| Device or Procedure Related Events
Any| Within 30 Days| Within 390 Days| Any| Within 30 Days| Within 390 Days
# of events| # (%) of pts| # of events| # (%) of pts| # of events| # (%) of pts| # of events| # (%) of pts| # of event s| # (%) of pts| # of events| # (%) of pts
Blood and lymphatic

system disorders

| 6| 3.1% (5/162)| 1| 0.6% (1/162)| 4| 1.9% (3/162)|  |  |  |  |  |
Cardiac disorders| 17| 7.4% (12/162)| 2| 1.2% (2/162)| 14| 6.8% (11/162)|  | |  |  |  |
Congenital, familial, and genetic disorders| 3| 1.2% (2/162)|  |  | 3| 1.2% (2/162)|  |  |  |  |  |
Ear and labyrinth disorders| 1| 0.6% (1/162)|  |  | 1| 0.6% (1/162)|  |  |  | |  |
Gastrointestinal disorders| 22| 11.7% (19/162)| 1| 0.6% (1/162)| 16| 9.3% (15/162)| 1| 0.6% (1/162)|  |  | 1| 0.6% (1/162)
General disorders and administration site conditions| 44| 19.1% (31/162)| 14| 7.4% (12/162)| 36| 15.4% (25/162)| 10| 5.6% (9/162)| 6| 3.1% (5/162)| 8| 4.3% (7/162)
Immune system

disorders

| 2| 1.2% (2/162)| 1| 0.6% (1/162)| 1| 0.6% (1/162)| 1| 0.6%

(1/162)

| 1| 0.6%

(1/162)

| 1| 0.6%

(1/162)

Infections and infestations| 51| 24.1% (39/162)| 6| 3.7% (6/162)| 41| 19.1% (31/162)| 1| 0.6% (1/162)| 1| 0.6% (1/162)| 1| 0.6% (1/162)
Injury, poisoning and procedural complications| 14| 8.0% (13/162)| 3| 1.9% (3/162)| 12| 6.8% (11/162)| 1| 0.6% (1/162)| 1| 0.6% (1/162)| 1| 0.6% (1/162)
Investigations| 2| 1.2% (2/162)|  |  | 1| 0.6% (1/162)|  |  |  |  |  |
Metabolism and nutrition disorders| 2| 1.2% (2/162)|  |  | 2| 1.2% (2/162)|  | |  |  |  |
Musculoskeletal and connective tissue disorders| 47| 19.8% (32/162)| 11| 6.2% (10/162)| 37| 17.9% (29/162)| 6| 3.1% (5/162)| 5| 2.5% (4/162)| 6| 3.1% (5/162)
Neoplasms benign, malignant, and unspecified (incl cy| 2| 1.2% (2/162)| 1| 0.6% (1/162)| 1| 0.6% (1/162)|  |  |  |  |  |
Nervous system

disorders

| 23| 9.9% (16/162)| 3| 1.9% (3/162)| 20| 9.3% (15/162)|  |  |  |  |  |

Body System Organ Class

| Adverse Events| Device or Procedure Related Events
---|---|---
Any| Within 30 Days| Within 390 Days| Any| Within 30 Days| Within 390 Days
# of events| # (%) of pts| # of events| # (%) of pts| # of events| # (%) of pts| # of events| # (%) of pts| # of event s| # (%) of pts| # of events| # (%) of pts
Pregnancy, puerperium, and perinatal conditions| 1| 0.6% (1/162)|  |  |  |  | |  |  |  |  |
Product issues| 1| 0.6% (1/162)| 1| 0.6% (1/162)| 1| 0.6% (1/162)| 1| 0.6%

(1/162)

| 1| 0.6%

(1/162)

| 1| 0.6%

(1/162)

Psychiatric disorders| 2| 1.2% (2/162)|  |  | 2| 1.2% (2/162)|  |  |  |  |  |
Renal and urinary disorders| 5| 2.5% (4/162)|  |  | 3| 1.2% (2/162)|  |  |  | |  |
Reproductive system and breast disorders| 5| 2.5% (4/162)| 1| 0.6% (1/162)| 5| 2.5% (4/162)|  |  |  |  |  |
Respiratory, thoracic, and mediastinal disorders| 17| 8.0% (13/162)| 2| 1.2% (2/162)| 15| 8.0% (13/162)| 1| 0.6% (1/162)|  |  | 1| 0.6% (1/162)
Skin and subcutaneous tissue

disorders

| 14| 6.2% (10/162)| 5| 1.9% (3/162)| 11| 4.3% (7/162)| 2| 0.6% (1/162)| 2| 0.6% (1/162)| 2| 0.6% (1/162)
Surgical and medical procedures| 4| 1.9% (3/162)| 1| 0.6% (1/162)| 3| 1.2% (2/162)|  |  |  |  |  |
Vascular disorders| 33| 16.7% (27/162)| 3| 1.9% (3/162)| 27| 14.2% (23/162)| 10| 6.2% (10/162)| 2| 1.2% (2/162)| 10| 6.2% (10/162)
Not Coded| 7| 3.7% (6/162)|  |  | 1| 0.6% (1/162)|  |  |  |  |  |
Total| 325| 63.0%

(102/162)

| 56| 23.5%

(38/162)

| 257| 55.6%

(90/162)

| 34| 18.5%

(30/162)

| 19| 9.9%

(16/162)

| 32| 17.3%

(28/162)

Table 14. Serious Adverse Events and Serious Device or Procedure Related Events in Body System Organ Classes in ITT Subjects

Body System Organ Class

| Serious Adverse Events| Serious Device or Procedure Related Events
Any| Within 30 Days| Within 390 Days| Any| Within 30 Days| Within 390 Days

of events| # (%) of pts| # of events| # (%) of pts| # of events|

# (%) of pts| # of events| # (%) of pts| # of events| # (%)

of pts

| # of events| # (%) of pts
Blood and lymphatic system

disorders

| 1| 0.6% (1/162)| 1| 0.6% (1/162)| 1| 0.6% (1/162)|  |  |  |  |  |
Cardiac disorders| 6| 3.1% (5/162)|  |  | 4| 2.5% (4/162)|  |  |  |  |  |
Congenital, familial, and genetic disorders| 1| 0.6% (1/162)|  |  | 1| 0.6% (1/162)|  |  |  |  |  |
Gastrointestinal disorders| 5| 3.1% (5/162)| 1| 0.6% (1/162)| 4| 2.5% (4/162)| |  |  |  |  |
General disorders and administration site

conditions

| 7| 4.3% (7/162)| 2| 1.2% (2/162)| 4| 2.5% (4/162)| 5| 3.1% (5/162)| 1| 0.6% (1/162)| 3| 1.9% (3/162)
Infections and infestations| 9| 4.9% (8/162)| 1| 0.6% (1/162)| 7| 3.7% (6/162)| 1| 0.6% (1/162)| 1| 0.6% (1/162)| 1| 0.6% (1/162)
Injury, poisoning and procedural complications| 4| 2.5% (4/162)|  |  | 2| 1.2% (2/162)|  |  |  |  |  |
Metabolism and nutrition disorders| 1| 0.6% (1/162)|  |  | 1| 0.6% (1/162)|  | |  |  |  |
Musculoskeletal and connective

tissue disorders

| 2| 0.6% (1/162)|  |  | 2| 0.6% (1/162)|  |  |  |  |  |
Nervous system disorders| 5| 1.9% (3/162)| 2| 1.2% (2/162)| 5| 1.9% (3/162)| |  |  |  |  |
Pregnancy, puerperium, and perinatal conditions| 1| 0.6% (1/162)|  |  |  |  | |  |  |  |  |
Product issues| 1| 0.6%

(1/162)

| 1| 0.6%

(1/162)

| 1| 0.6%

(1/162)

| 1| 0.6%

(1/162)

| 1| 0.6%

(1/162)

| 1| 0.6%

(1/162)

Psychiatric

disorders

| 1| 0.6%

(1/162)

|  |  | 1| 0.6%

(1/162)

|  |  |  |  |  |
Renal and urinary disorders| 1| 0.6% (1/162)|  |  |  |  |  |  |  |  |  |
Reproductive system and breast disorders| 4| 1.9% (3/162)| 1| 0.6% (1/162)| 4| 1.9% (3/162)|  |  |  |  |  |
Respiratory, thoracic, and

mediastinal disorders

| 3| 1.9% (3/162)| 1| 0.6% (1/162)| 3| 1.9% (3/162)| 1| 0.6% (1/162)|  |  | 1| 0.6% (1/162)
Skin and

subcutaneous tissue disorders

| 1| 0.6% (1/162)|  |  | 1| 0.6% (1/162)|  |  |  |  |  |
Surgical and medical

procedures

| 3| 1.2% (2/162)| 1| 0.6% (1/162)| 3| 1.2% (2/162)|  |  |  |  |  |
Vascular disorders| 11| 5.6% (9/162)| 2| 1.2% (2/162)| 8| 4.3% (7/162)| 5| 3.1% (5/162)| 1| 0.6% (1/162)| 5| 3.1% (5/162)
Total| 67| 28.4% (46/162)| 13| 7.4% (12/162)| 52| 22.2% (36/162)| 13| 8.0% (13/162)| 4| 2.5% (4/162)| 11| 6.8% (11/162)

Effectiveness Results

The primary effectiveness endpoint was primary patency of the stented segment at 12 months defined as freedom from:

• Duplex Ultrasound (DUS) core laboratory adjudicated stenosis or occlusion >50% within the stented segment. If DUS showed >50% stenosis or occlusion, confirmation by diagnostic intravascular ultrasound (IVUS) is required.
• CEC adjudicated clinically driven target lesion reintervention (CD-TLR) defined as endovascular or surgical procedure for new, recurrent, or worsening symptoms and core lab adjudicated >50% stenosis or occlusion within the stented segment confirmed by diagnostic IVUS.

In the FAS group, 132/162 patients were evaluable for the 12M primary effectiveness endpoint. The primary endpoint was met by 90.2% of subjects with a lower confidence bound of 87.2% thus meeting the target performance goal (p=0.0002). in the PP group, 115/162 patients were evaluable for 12M primary for the 12M primary effectiveness endpoint. The primary endpoint was met by 89.8% of subjects with a lower confidence bound of 82.7% thus meeting the target performance goal
(p=0.0003).

Table 15. Primary Effectiveness Endpoint – Primary Patency at 12 Months in FAS and PP Subjects

Analysis Group| % (#/#) (95% CI) 1| Target Performance Goal| p- value 1| Study Endpoint
FAS| 90.2% (119/132)|  | 0.0002| MET
(87.2%, 93.2%)| 77.3%
PP| 89.8% (115/128)| 0.0003| MET
(82.7%, 97.0%)|

One sample Z-test for a proportion, p-value is one-sided, Two-Sided 95% confidence interval. The variation in the proportion is estimated under the null (see statistical plan).

Table 16 summarizes additional analyses conducted in FAS subjects by baseline disease state. Primary patency by disease state in the FAS cohort was 86.7% in the acute thrombotic cohort, 95.2% in the non-thrombotic cohort, and 79.4% in the chronic post-thrombotic cohort.

Table 16. Primary Effectiveness Endpoint at 12 Months in FAS Subjects Overall and by Disease State

 |

FAS Subjects

| Disease State

Acute Thrombotic

|

Non- Thrombotic

| Chronic Post Thrombotic
Primary Patency at 12M| 90.2% (119/132)| 86.7% (13/15)| 95.2% (79/83)| 79.4% (27/34)
• CD-TLR

• Not patent finding in the absence of CD-TLR

| 7

6

| 0

2

| 3

1

| 4

3

Data shown as % (n/N)

Secondary Endpoints

Secondary endpoints are summarized in Table 17 – Table 21. As seen in Table 18 below, there was a sustained decrease in Venous Clinical Severity Score (VCSS) – Pain Score from baseline to 12 months.

Table 17. VCSS Pain Score and Changes in VCSS from Baseline in ITT Patients

Parameter| Baseline| 6 months| 12 months
VCSS Pain Score|  |  |
At Follow-up| 2.0 ± 0.8 (160)| 0.5 ± 0.8 (149)| 0.5 ± 0.8 (138)
(0.0, 2.0, 3.0)| (0.0, 0.0, 3.0)| (0.0, 0.0, 3.0)
 | —| -1.4 ± 1.1 (148)| -1.4 ± 1.1 (137)
Change from Baseline| (-3.0, -2.0, 3.0)| (-3.0, -2.0, 2.0)

Data shown as ± SD (N) (min, median, max)

Primary assisted patency was defined as freedom from DUS core laboratory adjudicated occlusion or stenosis > 50% within the stented segment following a clinically driven target lesion reintervention (CD-TLR) due to a > 50% but < 100% stenosis at 12 months while secondary patency was defined as freedom from DUS core laboratory adjudicated occlusion or stenosis > 50% within the stented segment following a clinically driven target lesion reintervention at 12 months due to greater than 50% stenosis or occlusion within the stented segment. For both endpoints, if site reported or core laboratory adjudicated DUS showed > 50% stenosis or occlusion, confirmation by diagnostic IVUS was required. As with the primary patency endpoint, DUS, IVUS and venogram imaging were used to evaluate the endpoint. As shown in Table 18, primary assisted patency and secondary patency at 12M were 94.7% (124/131) and 95.4% (125/131), respectively.

Table 18. Primary Assisted Patency and Secondary Patency at 12 Months in ITT Subjects

Parameter| Patency at 12M
Primary Assisted Patency at 12M| 94.7% (124/131)

(89.4, 97.4)

•  CD-TLR for 100% occlusion| 1
•  Not patent finding in the absence of CD-TLR for 100% occlusion| 6
Secondary Patency at 12M| 95.4% (125/131)

(90.4%, 97.9%)

1 Data shown as %(n/N) (Wilson’s 95% CI)

Observational Endpoints

Device, lesion, and procedural success were evaluated using the following definitions:

• Device success is defined as successful deployment at the intended target site and successful withdrawal of the delivery catheter from the introducer sheath. The following must be met to be considered a Device Success:
• Successful deployment of the Duo Stents) at the intended target site, AND
• Successful withdrawal of the delivery catheter(s) from the introducer sheath, AND
• The Duo Stent remaining at the intended deployment location through completion of the index procedure as determined by the Principal Investigator (PI)
• Lesion success is defined as target lesion patency of ≤50% residual diameter or area stenosis of the stented segment at the completion of the procedure (core laboratory adjudicated).
• Procedural success is defined as lesion success without the occurrence of major adverse events from the time of treatment to discharge (CEC and/or core laboratory adjudicated).
  As summarized in Table 19, all subjects met the criteria for lesion and procedural success and 159/162 (98.1%) met the criteria for device success. Of the three subjects that did not meet the criteria for device success, two subjects did not have successful deployment at the target site and one subject did not have the stent remaining at the intended target location through the index procedure. No adverse events were associated with these failures.

Table 19. Device, Lesion, and Procedural Success in ITT Subjects

 | % (#/#) (95% CI) 1,2
ITT Subjects
Device Success per stent introduced| 98.6% (216/219)

(97.1%, 100.2%)1

Device Success per subject| 98.1% (159/162)

(94.7%, 99.4%)2

Lesion Success per subject| 100.0% (162/162)

(97.7%, 100.0%)2

Procedural Success per subject| 100.0% (162/162)

(97.7%, 100.0%)2

Data shown as %(n/N) (Wilson’s 95% CI)

1. Generalized estimating equations.
2. Wilson’s 95% confidence interval.

Stent fracture and migration were evaluated via X-ray through 36 months and stent embolization via X-ray or venogram through 36 months. There were no instances of stent fracture, migration, or embolization through 12 months.
Several quality-of-life measures were also included as observational endpoints. The clinical CEAP score, all EQ-5D-3L categories, Vilalta score, VEINES-QOL and VEINES-Sym scores all improved from baseline to 12 months as summarized in Table 20.

Table 20. Quality of Life Measures at Baseline and Follow-up in ITT Subjects

Clinical Measure| Time Point|  |
Baseline| 6M| 12M
Clinical CEAP Score|
C0| 1.2% (2/162)| 30.9% (46/149)| 31.2% (43/138)
C1| 0.6% (1/162)| 8.7% (13/149)| 8.0% (11/138)
C2| 0.6% (1/162)| 8.1% (12/149)| 5.8% (8/138)
C2r| 0.0% (0/162)| 0.0% (0/149)| 2.2% (3/138)
C3| 66.0% (107/162)| 32.2% (48/149)| 31.2% (43/138)
C4| 5.6% (9/162)| 2.7% (4/149)| 2.9% (4/138)
C4a| 13.0% (21/162)| 6.0% (9/149)| 7.2% (10/138)
C4b| 1.9% (3/162)| 2.0% (3/149)| 2.2% (3/138)
C5| 4.9% (8/162)| 6.0% (9/149)| 8.7% (12/138)
C6| 5.6% (9/162)| 2.7% (4/149)| 0.7% (1/138)
C6r| 0.6% (1/162)| 0.7% (1/149)| 0.0% (0/138)
EQ-5D-3L Questionnaire| Baseline| 6M| 12M
EQ-5D-3L Mobility Score|  |  |
1 – No problems| 47.8% (76/159)| 66.4% (93/140)| 64.9% (85/131)
2 – Some problems| 51.6% (82/159)| 33.6% (47/140)| 35.1% (46/131)
3 – Extreme problems| 0.6% (1/159)| 0.0% (0/140)| 0.0% (0/131)
EQ-5D-3L Self-Care Score|  |  |
1 – No problems| 83.0% (132/159)| 91.4% (128/140)| 93.1% (122/131)
2 – Some problems| 15.7% (25/159)| 8.6% (12/140)| 6.9% (9/131)
3 – Extreme problems| 1.3% (2/159)| 0.0% (0/140)| 0.0% (0/131)
EQ-5D-3L Usual Activity Score|  |  |
---|---|---|---
1 – No problems| 49.1% (78/159)| 67.1% (94/140)| 75.4% (98/130)
2 – Some problems| 45.9% (73/159)| 30.7% (43/140)| 23.8% (31/130)
3 – Extreme problems| 5.0% (8/159)| 2.1% (3/140)| 0.8% (1/130)
EQ-5D-3L Pain/Discomfort Score|  |  |
1 – No problems| 25.2% (40/159)| 52.1% (73/140)| 50.4% (66/131)
2 – Some problems| 59.7% (95/159)| 45.7% (64/140)| 47.3% (62/131)
3 – Extreme problems| 15.1% (24/159)| 2.1% (3/140)| 2.3% (3/131)
EQ-5D-3L Anxiety/Depression Score|  |  |
1 – No problems| 54.1% (86/159)| 70.7% (99/140)| 76.3% (100/131)
2 – Some problems| 39.0% (62/159)| 25.0% (35/140)| 21.4% (28/131)
3 – Extreme problems| 6.9% (11/159)| 4.3% (6/140)| 2.3% (3/131)
EQ-VAS Score (0 = worst imaginable health state and 100 = best imaginable health state)|  |  |
At follow-up| 67.7 ± 23.6 (158)| 77.7 ± 18.1 (140)| 79.7 ± 16.7 (130)
Change from Baseline| —| 8.6 ± 23.2 (137)| 10.6 ± 22.1 (127)
Villalta Score| Baseline| 6M| 12M
At follow-up| 10.4 ± 4.8 (159)| 3.4 ± 4.1 (149)| 3.3 ± 3.9 (138)
Change from Baseline| —| -6.7 ± 5.5 (146)| -6.9 ± 5.7 (135)
VEINES-QOL/Sym Score| Baseline| 6M| 12M
VEINES – Sym|  |  |
At follow-up| 52.6 ± 24.9 (157)| 75.9 ± 22.7 (139)| 76.9 ± 21.9 (132)
Change from Baseline| —| 22.6 ± 23.8 (135)| 23.4 ± 25.8 (128)
VEINES – QOL|  |  |
At follow-up| 51.4 ± 23.8 (157)| 75.0 ± 22.7 (139)| 75.9 ± 23.6 (132)
Change from Baseline| —| 23.6 ± 24.7 (135)| 24.3 ± 25.8 (128)

Data presented as Mean ± SD (N) or % (#/#)

Subgroup Analysis

Table 21 displays the results of the primary analysis by the pre-determined subgroups of FAS subjects: Gender, geography (US vs OUS), age ( 61 vs > 61), race, and ethnicity. In general, there were no differences in the primary effectiveness endpoint between any of the pre-defined sub-groups, with the exception of US vs OUS. The OUS sample size was only 8.5% of the total FAS subject population, so the differences may be due to the small numbers of OUS subjects.

Table 21. Subgroup Analyses of Primary Patency at 12M in FAS Subjects

Subgroup

| Primary Patency at 12M

% (#/#)

FAS|

Acute Thrombotic

|

Non- Thrombotic

| Chronic Post Thrombotic
Gender|  |  |  |
Male| 87.8% (43/49)| 83.3% (5/6)| 100.0% (26/26)| 70.6% (12/17)
Female| 91.6% (76/83)| 88.9% (8/9)| 93.0% (53/57)| 88.2% (15/17)
Geography|  |  |  |
Inside United States (US)| 93.3% (112/120)| 92.9% (13/14)| 95.1% (77/81)| 88.0% (22/25)
Outside United States (OUS)| 58.3% (7/12)| 0.0% (0/1)| 100.0% (2/2)| 55.6% (5/9)
Age|  |  |  |
:: Median Age=61| 88.6% (62/70)| 88.9% (8/9)| 97.6% (40/41)| 70.0% (14/20)

Median Age=61| 91.9% (57/62)| 83.3% (5/6)| 92.9% (39/42)| 92.9% (13/14)
Race|  |  |  |
White| 89.2% (99/111)| 90.9% (10/11)| 94.1% (64/68)| 78.1% (25/32)
Black| 90.9% (10/11)| 75.0% (3/4)| 100.0% (7/7)| 0
Other/Decline/Unknown| 100.0% (10/10)| 0| 100.0% (8/8)| 100.0% (2/2)
Ethnicity|  |  |  |
Not Hispanic or Latino| 89.3% (100/112)| 83.3% (10/12)| 94.4% (68/72)| 78.6% (22/28)
Hispanic or Latino| 93.3% (14/15)| 100.0% (2/2)| 100.0% (7/7)| 83.3% (5/6)
Unknown| 100.0% (5/5)| 100.0% (1/1)| 100.0% (4/4)| 0

Given that COVID-19 has been associated with a hypercoagulable state, which has the potential to increase MAE occurrence and decrease patency, the study included a test of both the primary safety and effectiveness hypotheses in both the SARS-CoV-2 negative subset and all subjects (regardless of SARS-CoV-2 status). The performance goals for both primary safety and primary effectiveness were met for both cohorts. COVID-19 status did not affect primary outcomes in this study.

Pediatric Extrapolation
In this premarket application, existing clinical data was not leveraged to support approval of a pediatric patient population.

MRI Safety Information

Non-clinical testing has demonstrated that the Duo Venous Stent is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

• Static magnetic field of 1.5 T or 3 T, only
• Maximum spatial field gradient of 4,000-gauss/cm (40-T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg (Normal Operating Mode)
• Circularly polarized (quadrature-driven) coil only

Under the scan conditions defined, an implant from the Duo Venous Stent System is expected to produce a maximum temperature rise of less than 2.0°C after 15-minutes of continuous scanning (i.e., per pulse sequence).

In non-clinical testing, the image artifact caused by an implant from the Duo Venous Stent System extends approximately 5-mm from this device when imaged with a gradient echo pulse sequence and a 3-T MR system. The lumen of this stent could be visualized on the T1-weighted, spin echo and gradient echo MR images.

Additional Information
The heating effect in the MRI environment for fractured stents is unknown. The presence of other implants or the health state of the patient may require reduction of the MRI limits listed above.
Vesper Medical recommends that patients register the conditions under which this Stent implant can be MRI scanned safely with the MedicAlert Foundation (www.medicalert.org) or equivalent organization.

References

• MedicAlert Foundation

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