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Products / Venovo® Venous Stent System
Venovo® Venous Stent System

Venovo® Venous Stent System
Venovo® Venous Stent System

Purpose-Built for the Iliofemoral Veins 

 

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Features:

  • 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
Venovo® Venous Stent System

Venovo® Venous Stent System

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
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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

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
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Videos

Dr. Nicolas Shammas Discusses the Venovo® Venous Stent’s Open-Cell Design:

Dr. Michael Dake Discusses the 24-Month Results of the Venovo® Venous Stent VERNACULAR Trial:

Charing Cross 2019 Venovo Interview

Specifications

Product Item IDProduct Item NameStent Diameter (mm)Stent Length (mm)Catheter Length (cm)GuidewireRecommended Sheath
VENUM10040VENOVO® Venous Stent System1040800.035"8F
VENUM10060VENOVO® Venous Stent System1060800.035"8F
VENUM10080VENOVO® Venous Stent System1080800.035"8F
VENUM10100VENOVO® Venous Stent System10100800.035"8F
VENUM10120VENOVO® Venous Stent System10120800.035"8F
VENUM10140VENOVO® Venous Stent System10140800.035"8F
VENUM10160VENOVO® Venous Stent System10160800.035"8F
VENUM12040VENOVO® Venous Stent System1240800.035"8F
VENUM12060VENOVO® Venous Stent System1260800.035"8F
VENUM12080VENOVO® Venous Stent System1280800.035"8F
VENUM12100VENOVO® Venous Stent System12100800.035"8F
VENUM12120VENOVO® Venous Stent System12120800.035"8F
VENUM12140VENOVO® Venous Stent System12140800.035"8F
VENUM12160VENOVO® Venous Stent System12160800.035"8F
VENUM14040VENOVO® Venous Stent System1440800.035"9F
VENUM14060VENOVO® Venous Stent System1460800.035"9F
VENUM14080VENOVO® Venous Stent System1480800.035"9F
VENUM14100VENOVO® Venous Stent System14100800.035"9F
VENUM14120VENOVO® Venous Stent System14120800.035"9F
VENUM14140VENOVO® Venous Stent System14140800.035"9F
VENUM14160VENOVO® Venous Stent System14160800.035"9F
VENUM16040VENOVO® Venous Stent System1640800.035"10F
VENUM16060VENOVO® Venous Stent System1660800.035"10F
VENUM16080VENOVO® Venous Stent System1680800.035"10F
VENUM16100VENOVO® Venous Stent System16100800.035"10F
VENUM16120VENOVO® Venous Stent System16120800.035"10F
VENUM16140VENOVO® Venous Stent System16140800.035"10F
VENUM16160VENOVO® Venous Stent System16160800.035"10F
VENUM18040VENOVO® Venous Stent System1840800.035"10F
VENUM18060VENOVO® Venous Stent System1860800.035"10F
VENUM18080VENOVO® Venous Stent System1880800.035"10F
VENUM18100VENOVO® Venous Stent System18100800.035"10F
VENUM18120VENOVO® Venous Stent System18120800.035"10F
VENUM18140VENOVO® Venous Stent System18140800.035"10F
VENUM18160VENOVO® Venous Stent System18160800.035"10F
VENUM20040VENOVO® Venous Stent System2040800.035"10F
VENUM20060VENOVO® Venous Stent System2060800.035"10F
VENUM20080VENOVO® Venous Stent System2080800.035"10F
VENUM20100VENOVO® Venous Stent System20100800.035"10F
VENUM20120VENOVO® Venous Stent System20120800.035"10F
VENUM20140VENOVO® Venous Stent System20140800.035"10F
VENUM20160VENOVO® Venous Stent System20160800.035"10F
VENUL10040VENOVO® Venous Stent System10401200.035"8F
VENUL10060VENOVO® Venous Stent System10601200.035"8F
VENUL10080VENOVO® Venous Stent System10801200.035"8F
VENUL10100VENOVO® Venous Stent System101001200.035"8F
VENUL10120VENOVO® Venous Stent System101201200.035"8F
VENUL10140VENOVO® Venous Stent System101401200.035"8F
VENUL10160VENOVO® Venous Stent System101601200.035"8F
VENUL12040VENOVO® Venous Stent System12401200.035"8F
VENUL12060VENOVO® Venous Stent System12601200.035"8F
VENUL12080VENOVO® Venous Stent System12801200.035"8F
VENUL12100VENOVO® Venous Stent System121001200.035"8F
VENUL12120VENOVO® Venous Stent System121201200.035"8F
VENUL12140VENOVO® Venous Stent System121401200.035"8F
VENUL12160VENOVO® Venous Stent System121601200.035"8F
VENUL14040VENOVO® Venous Stent System14401200.035"9F
VENUL14060VENOVO® Venous Stent System14601200.035"9F
VENUL14080VENOVO® Venous Stent System14801200.035"9F
VENUL14100VENOVO® Venous Stent System141001200.035"9F
VENUL14120VENOVO® Venous Stent System141201200.035"9F
VENUL14140VENOVO® Venous Stent System141401200.035"9F
VENUL14160VENOVO® Venous Stent System141601200.035"9F
VENUL16040VENOVO® Venous Stent System16401200.035"10F
VENUL16060VENOVO® Venous Stent System16601200.035"10F
VENUL16080VENOVO® Venous Stent System16801200.035"10F
VENUL16100VENOVO® Venous Stent System161001200.035"10F
VENUL16120VENOVO® Venous Stent System161201200.035"10F
VENUL16140VENOVO® Venous Stent System161401200.035"10F
VENUL16160VENOVO® Venous Stent System161601200.035"10F
VENUL18040VENOVO® Venous Stent System18401200.035"10F
VENUL18060VENOVO® Venous Stent System18601200.035"10F
VENUL18080VENOVO® Venous Stent System18801200.035"10F
VENUL18100VENOVO® Venous Stent System181001200.035"10F
VENUL18120VENOVO® Venous Stent System181201200.035"10F
VENUL18140VENOVO® Venous Stent System181401200.035"10F
VENUL18160VENOVO® Venous Stent System181601200.035"10F
VENUL20040VENOVO® Venous Stent System20401200.035"10F
VENUL20060VENOVO® Venous Stent System20601200.035"10F
VENUL20080VENOVO® Venous Stent System20801200.035"10F
VENUL20100VENOVO® Venous Stent System201001200.035"10F
VENUL20120VENOVO® Venous Stent System201201200.035"10F
VENUL20140VENOVO® Venous Stent System201401200.035"10F
VENUL20160VENOVO® Venous Stent System201601200.035"10F
  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.
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