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Venovo™ Venous

Stent System

Purpose-Built for the Iliofemoral Veins 

 

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Overview

Venous disease is complex, your stent choice doesn't have to be

  • Engineered to provide the optimal balance between radial force, flexibility, and compression resistance
  • Tri-axial delivery system designed to provide accurate deployment to help facilitate optimal stent placement and lesion coverage
  • 3mm flared stent ends designed to reduce the risk of stent migration and maximize wall apposition
  • Broadest size matrix of iliofemoral-indicated venous stents in the U.S.1
    • Diameters up to 20 mm
    • Stent lengths up to 160 mm

 

 

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Overview and procedure

Purpose-Built Iliofemoral Venous Stent

  • Flared ends designed to reduce stent migration and maximize wall apposition
  • Designed for use in high compression iliofemoral venous obstructions
  • Open-cell, flexible design to conform to vessel curvature while maintaining lumen diameter
  • Highest mean radial resistive force among tested iliofemoral venous stents2
  • Tantalum markers for enhanced visibility under fluoroscopy
  • Minimal foreshortening for maximum lesion coverage3

 

Placement Accuracy

 

Triaxial delivery system designed for:

  • Ease of use
  • Deployment control
  • Precise placement accuracy    
  • Operator control with an ergonomic handle and dual-speed thumbwheels

Full Range of Sizes

The Venovo™ Venous Stent offers a broad selection of 42 sizing options in both 80 cm and 120 cm catheter lengths to accommodate a variety of iliofemoral lesion sizes.

References

As of September 2022

2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. Results shown as averages measured in N/mm as follows (n=6): Venovo™ Venous Stent System (0.126), Medtronic Abre™ Venous Stent (0.1035), Cook Zilver® Vena™ (0.063) and Boston Scientific VICI VENOUS STENT® (0.054). Data on file. Bench tests may not be indicative of clinical performance. Different test methods may yield different results. 

3Foreshortening is calculated as the difference, represented as percentage, between the compressed stent length and expanded stent length at minimum/maximum oversize (1-3 mm). Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). Data on file, BD Peripheral Intervention, Tempe, AZ.

Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information.

Venovo IFU

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Products & Accessories
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Reference

Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information.

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Clinical Summary

Proven Long-Term Results Backed by 36-Month Data1

The VERNACULAR study results provide scientific evidence that the Venovo™ Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous
outflow obstruction.

 

  • Kaplan-Meier Primary Patency in Post-Thrombotic Lesions at 36 months

  • Kaplan-Meier Primary Patency in Non-Thrombotic Lesions at 36 months

  • Freedom from Target Lesion Revascularization (TLR) at 36 months

  • Stent Fractures at 36 months

VERNACULAR Clinical Study1

Study Design

Prospective, multi-center, non-randomized, single-arm; Core lab & Data Safety Monitoring Board

 


Purpose

To assess the safety and effectiveness of the Venovo™ Venous Stent
for the treatment of iliofemoral venous occlusive disease.

As Treated Population

170 subjects at 21 sites in the U.S., Europe, and Australia/New Zealand

Primary Endpoints*

  • Primary safety: Freedom from Major Adverse Events (MAE), including stent migrations, at 30 days

 

 

 

  • Primary Effectiveness: Primary Patency at 12 months
    • Weighted Primary Patency at 12-Months: 88.6%
      • Post-Thrombotic Syndrome (PTS): 81.7%
      • Non-Thrombotic Iliac Vein Lesion (NIVL): 97.1%

 

 Key Secondary Endpoints

  • Placement accuracy: 100%
  • Venous Clinical Severity Score (VCSS) through 36 months

 

36-Month Results

(Kaplan-Meier estimated Primary Patency)

Primary Patency: 84.0%

  • PTS: 74.8%
  • NIVL: 95.5%

 

* Evaluated against literature derived performance goal of 74% for efficacy (p<.0001) and 89% for safety (p=.032)

Significant Improvements

Reference

1The Venovo™ Venous Stent System was studied in the global VERNACULAR clinical trial, which was a prospective, multi-center, non-randomized, single-arm study of 170 patients. The primary effectiveness endpoint of the study was primary patency (PP) at 12 months post-index procedure, defined as: freedom from TVR and freedom from thrombus occlusion and stenosis > 50% as measured by DUS. Patients who received a Venovo™ Venous Stent had a weighted PP rate of 88.6%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%, with an 81.7% PP rate for subjects with post-thrombotic syndrome and 97.1% PP rate for subjects with non-thrombotic iliac vein lesions. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. Primary Patency by Kaplan-Meier estimates at 36 months are 84.0% for the total population (N=170), 74.8% for subjects with post-thrombotic syndrome (N=93) and 95.5% for subjects with non-thrombotic iliac vein lesions. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS – Pain score) and stent fractures. Results demonstrated 100% acute technical success, defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator at the time of the index procedure. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. The Freedom from TLR rate at 36 months was 88.1%. At the 36-month follow-up, the CIVIQ-20 assessment demonstrated a change from baseline in the total study population of -16.8 and, for the VCSS Pain score, a change from baseline in the total population of -1.8. Stents were evaluated at the 36-month follow-up for fracture analysis. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. 98 subjects’ x-rays were analyzed and no stent fractures were reported. Missing x-ray analyses were recorded as protocol deviations. Dake, Michael D, et al. “Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction.” Cardiovasc Intervent Radiol, vol. 44, no. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. Epub 2021 Sep 20

Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information.

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Related Videos
  •  At a Glance: 24-Month VERNACULAR Results

    Dr. Michael Dake, Senior VP for Health Sciences at the University of Arizona and Principal Investigator in the Venovo™ Venous Stent VERNACULAR trial shares key findings from the 24-month clinical results including primary patency rates, target lesion revascularization (TLR) and fracture rates, patient quality of life, and more.

  • Changing Clinical Practice: Venous Experts Discuss the Venovo™ Venous Stent

    Dr. Gerard O'Sullivan, FSIR, FEBIR​ of Galway University Hospitals​ in Galway, Ireland and Dr. Steven Dubenec, MBBS, FRACS, Head of Vascular Surgery at the Royal Prince Alfred Hospital in Sydney, Australia discuss important features of the Venovo™ Venous Stent and their personal experiences using the product. Recorded at the London Charing Cross Symposium in 2019.

  • <p>NEWS - MAY 4, 2020, VENOUS NEWS</p>

    NEWS - MAY 4, 2020, VENOUS NEWS

    A Deeper Dive into the Venovo™ Venous Stent System

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  • <p>PRESS RELEASE - MAR 14, 2019, PR NEWSWIRE</p>

    PRESS RELEASE - MAR 14, 2019, PR NEWSWIRE

    BD Receives U.S. FDA Approval for First Venous Stent to Treat Iliofemoral Venous Occlusive Disease

    Learn More

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  • <p>NEWS - FEB 28, 2018, VENOUS NEWS</p>

    NEWS - FEB 28, 2018, VENOUS NEWS

    One-year data from venous stent registry "promising"

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Reference

Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information.

BD - 23533v3

Resources

Reference

Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information.

BD - 23533v3

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