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Venovo™ Venous

Stent System

Purpose-Built for the Iliofemoral Veins 

 

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Overview
  • Designed to provide the optimal balance between radial force, flexibility, and compression resistance
  • Delivery system designed to provide accurate deployment for optimal stent placement and lesion coverage
  • Broad range of sizes
    • Diameters up to 20 mm
    • Stent lengths up to 160 mm
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Features and Benefits
Clinically proven in Post-Thrombotic and Non-Thrombotic Lesions:
Clinically proven in Post-Thrombotic and Non-Thrombotic Lesions:

In the VERNACULAR Clinical Study, the Venovo™ Venous Stent demonstrated a primary patency benefit compared to a literature-derived performance goal at 12 months, while demonstrating significant improvement in both VCSS pain scores and quality of life (CIVIQ-20) compared to baseline at 12 months1

  • 88.3% weighted primary patency at 12 months
    • 96.9% patency in non-thrombotic lesions
    • 81.3% patency in post-thrombotic lesions
  • Zero stent fractures at 12 months
  • 100% acute technical success at time of index procedure
Designed specifically for the venous anatomy

The Venovo™ Venous Stent is specifically designed and developed for the iliofemoral veins. It offers radial force, crush resistance and flexibility without compromising on delivery accuracy. In addition, the 3 mm flared stent ends are designed to reduce the risk of stent migration and maximize wall apposition.

The Venovo™ Venous Stent is indicated for the treatment of symptomatic iliofemoral venous outflow obstructions. The Venovo™ Venous Stent is available in 10 mm to 20 mm stent diameters and 40  mm to 160 mm stent lengths. Please refer to the Specifications table below for specific size options.

Optimal stent placement
Optimal stent placement

To facilitate optimal lesion coverage and placement accuracy, the Venovo™ Venous Stent System offers:

  • Triaxial delivery system for deployment accuracy
  • Ergonomic handle and dual-speed thumbwheels for operator control
  • Tantalum markers for high stent visibility under fluoroscopy
Products & Accessories
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References

1 The 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. Patients who received a Venovo™ Venous Stent had a weighted PP rate of 88.3%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%, with an 81.3% PP rate for subjects with post-thrombotic syndrome and 96.9% 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%. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity (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. In the 12-month follow-up, the CIVIQ-20 assessment demonstrated a change from baseline in the total study population of -15.7 with 95% confidence interval of -18.41 to -12.96 (P < .0001) and, for the VCSS Pain score, a change from baseline in the total population of -1.7 with a 95% confidence interval of -1.81 to -1.49 (P < .0001). Stents were evaluated at the 12-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. 137 subjects’ x-rays were analyzed and no stent fractures were reported. Missing x-ray analyses were recorded as protocol deviations. VERNACULAR Clinical Study. Data on File. Bard Peripheral Vascular Inc., Tempe, AZ.

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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Resources
References

1 The 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. Patients who received a Venovo™ Venous Stent had a weighted PP rate of 88.3%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%, with an 81.3% PP rate for subjects with post-thrombotic syndrome and 96.9% 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%. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity (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. In the 12-month follow-up, the CIVIQ-20 assessment demonstrated a change from baseline in the total study population of -15.7 with 95% confidence interval of -18.41 to -12.96 (P < .0001) and, for the VCSS Pain score, a change from baseline in the total population of -1.7 with a 95% confidence interval of -1.81 to -1.49 (P < .0001). Stents were evaluated at the 12-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. 137 subjects’ x-rays were analyzed and no stent fractures were reported. Missing x-ray analyses were recorded as protocol deviations. VERNACULAR Clinical Study. Data on File. Bard Peripheral Vascular Inc., Tempe, AZ.

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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Reference

1 The 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. Patients who received a Venovo™ Venous Stent had a weighted PP rate of 88.3%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%, with an 81.3% PP rate for subjects with post-thrombotic syndrome and 96.9% 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%. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity (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. In the 12-month follow-up, the CIVIQ-20 assessment demonstrated a change from baseline in the total study population of -15.7 with 95% confidence interval of -18.41 to -12.96 (P < .0001) and, for the VCSS Pain score, a change from baseline in the total population of -1.7 with a 95% confidence interval of -1.81 to -1.49 (P < .0001). Stents were evaluated at the 12-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. 137 subjects’ x-rays were analyzed and no stent fractures were reported. Missing x-ray analyses were recorded as protocol deviations. VERNACULAR Clinical Study. Data on File. Bard Peripheral Vascular Inc., Tempe, AZ.

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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