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Covera™ Vascular Covered Stent

The covered stent Tailor-Made for AV patients

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Overview

The covered stent Tailor-Made for AV patients

The Covera™ Vascular Covered Stent has been designed to address challenging lesions within in the AV access circuit – including the terminal cephalic arch, the basilic swingpoint segments, and the vein-graft anastomosis. Flared and straight configurations allow for precise sizing and adaptation to the vessel wall, while an easy-to-use thumbwheel delivery system with two speed options provides placement control.

The Covera™ Vascular Covered Stent delivered effective results in two separate clinical trials, one for patients dialysing with AV grafts and one for patients dialysing with AV fistulas.1

Innovative Design

For radial strength and flexibility

 

 

Flexible base stent architecture designed to conform to native vessel in challenging AV anatomy. 

    Design

    covera-dual-h-full
    Straight and Flared configurations for optimised haemodynamic flow at the venous anastomosis
     
    • Straight configurations are intended for use in anatomies where the diameter of the outflow vessel is equal to or smaller than that of the inflow vessel
    • Flared configuration is intended for use in anatomies where the diameter of the outflow vessel is larger than that of the inflow vessel
    atraumatic-tip-cropped

    Atraumatic tip designed for ease of insertion and removal at the access site

    Thumbwheel Delivery

    Facilitates accurate placement control

     

    Intuitive triaxial delivery system designed for precise placement and to faciliate optimal lesion coverage

      Range of Sizes
      in both Straight and Flared Configurations

      References

      Dolmatch B, Waheed U, Balamuthusamy S, Hoggard J, Settlage R; AVeVA Trial Investigators. Prospective, Multi-Centre Clinical Study of the Covera Vascular Covered Stent in the Treatment of Stenosis at the Graft-Vein Anastomosis of Dysfunctional Hemodialysis Access Grafts. J Vasc Interv Radiol. 2022;33(5):479-488.e3. doi:10.1016/j. jvir.2022.02.008. AVeNEW Clinical Studies data on file. At 6 months in AVeVA target lesion primary patency (TLPP) was 70.3% (proportional analysis). At 6 months in AVeNEW, TLPP was 78.7% for Covera™ Vascular Covered Stent vs. 47.9% for PTA alone, P < .001. 130 of the 142 (91.5%) subjects randomised to the Covera™ Vascular Stent group and 123 of the 138 (89.1%) randomised to PTA completed their 6-month follow-up. TLPP defined as the interval following the index intervention until the next clinically-driven reintervention at or adjacent to the original treatment site or until the extremity was abandoned for permanent access. In AVeNEW, TLPP at 6 Months – Subgroup Analysis is provided as observational data without P values. In AVeNEW, patients who received the Covera™ Vascular Covered Stent had 103 reinterventions involving a new lesion compared to 72 reinterventions in the PTA only group at 24 months. At 30 days, freedom from primary safety events was 96.4% in AVeVa and 95.0% (Covera™ Vascular Covered Stent) vs. 96.4% (PTA alone) in AVeNEW (P < .0022). Freedom from primary safety events was defined as freedom from an adverse event involving the access circuit resulting in additional intervention, surgery, hospitalisation, or death.

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

      BD-23522v2

      Overview

       

      The Covera™ Vascular Covered Stent has been designed to address challenging lesions within in the AV access circuit – including the terminal cephalic arch, the basilic swingpoint segments, and the vein-graft anastomosis.

       

      The Covera™ Vascular Covered Stent delivered effective results in two separate clinical trials, one for patients dialysing with AV grafts and one for patients dialysing with AV fistulas, both of which demonstrated the benefits of the stent’s innovative design.1

       

      AVeVA
      Clinical Study

      AVeVA was a prospective, non-randomised, single arm, multi-center study of the Covera™ Vascular Covered Stent used to treat stenoses at the anastomosis of an arteriovenous graft and outflow vein. 110 patients were treated with the Covera™ Vascular Covered Stent at 14 investigational sites in the US

      The AVeVA Clinical Study demonstrated that the Covera™ Vascular Covered Stent is effective in the treatment of stenoses at the vein-graft anastomosis of patients dialysing with an AV graft.

      Study DesignProspective, Non-Randomised, Multi-Centre, Single-Arm
      ObjectiveTo assess the safety and effectiveness of the Covera™ Vascular Covered Stent for the treatment of stenotic lesions at the graft-vein anastomosis of hemodialysis patients dialysing with an AV graft
      Status24-month follow-up completed
      Number of Patients/Sites110 patients were treated with the Covera™ Vascular Covered Stent at 14 investigational sites in the US 
      Primary Effectiveness EndpointTarget Lesion Primary Patency (TLPP) - 6 months
      Primary Safety EndpointFreedom from an adverse event involving the access circuit resulting in additional intervention, surgery, hospitalisation, or death through 30 days
      Follow-Up30 & 90 days; 6, 12, 18 & 24 months

      6-Month Target Lesion Primary Patency (TLPP) After Treatment of AV Graft Anastomotic Stenoses with BD Stent Grafts

      This chart is for educational purposes only and not for comparison. Differences in study design may impact results. Reference full manuscripts for complete study design details.

       

      In the AVeVA Clinical Study, the Covera™ Vascular Covered Stent was studied in a challenging patient cohort.

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      AVeNEW
      Clinical Study

      Study DesignProspective, Multi-Centre, Randomised, Concurrently-Controlled
      ObjectiveTo assess the safety and effectiveness of the Covera™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the AV access circuit of hemodialysis patients dialysing with an AV fistula
      Status24-month follow-up completed
      Number of Patients/Sites280 randomised subjects in 24 investigational sites (US, EU, & ANZ)
      Primary Effectiveness EndpointTarget Lesion Primary Patency (TLPP) - 6 months
      Primary Safety EndpointFreedom from any serious protocol-defined safety event(s) involving the AV access circuit through 30 days
      Follow-UpAt hospital discharge, 30 & 90 days; 6, 12, 18 & 24 months

      In the AVeNEW Clinical Study, the Covera™ Vascular Covered Stent was used in the treatment of a challenging patient population with difficult lesion characteristics.

       

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      Superior
      Target Lesion
      Primary Patency1

      The Covera™ Vascular Covered Stent was superior to the PTA control at 6 & 12 months with respect to TLPP for treatment of stenoses in the venous outflow of patients dialysing with an arteriovenous fistula.

      Subgroup Analysis

      All subgroups showed benefit at 6 months

      In all target lesion location subgroups analysed, the Covera™ Vascular Covered Stent demonstrated greater target lesion primary patency compared to PTA alone, including those treated at the cephalic vein arch.

       

       

       

      • Circles_4
      • Circles_3

       

      AVeNEW clinical study additional endpoints

      Beyond the benefits in target lesion primary patency, the Covera™ Vascular Covered Stent demonstrated a high degree of Acute Technical Success and extended the average time between interventions at the target lesion compared to PTA alone.

       

       

      • covera1-650x370
      • covera2-650x370

      Stent Case Example

      In the AVeNEW clinical study, 77 patients with stenoses in the cephalic vein arch were treated with the
      Covera™ Vascular Covered Stent.

       

      This case example demonstrates the baseline angiography showing vessel narrowing and the acute technical success with restoration of the vessel and conformability of the covered stent.

      References

      * Haskal ZJ, Trerotola S, Dolmatch B, et al. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med. 2010 Feb 11;362(6):494-503.

      ** Haskal ZJ, Saad TF, Hoggard JG, et al. Prospective, randomised, concurrently-controlled study of a stent graft versus balloon angioplasty for treatment of arteriovenous access graft stenosis: 2-year results of the RENOVA study. J Vasc Interv Radiol. 2016 Aug;27(8):1105-1114.e3.

      ***In U.S. as of Nov. 2022

      Dolmatch B, Waheed U, Balamuthusamy S, Hoggard J, Settlage R; AVeVA Trial Investigators. Prospective, multicenter clinical study of the Covera Vascular Covered Stent in the treatment of stenosis at the graft-vein anastomosis of dysfunctional hemodialysis access grafts. J Vasc Interv Radiol. 2022;33(5):479-488.e3. doi:10.1016/j. jvir.2022.02.008. AVeNEW Clinical Studies data on file. At 6 months in AVeVA, target lesion primary patency (TLPP) was 70.3% (proportional analysis). At 6 months in AVeNEW, TLPP was 78.7% for Covera™ Vascular Covered Stent vs. 47.9% for PTA alone, P < .001. 130 of the 142 (91.5%) subjects randomised to the Covera™ Vascular Stent group and 123 of the 138 (89.1%) randomised to PTA completed their 6-month follow-up. TLPP defined as the interval following the index intervention until the next clinically-driven reintervention at or adjacent to the original treatment site or until the extremity was abandoned for permanent access. In AVeNEW, TLPP at 6 Months – Subgroup Analysis is provided as observational data without P values. In AVeNEW, patients who received the Covera™ Vascular Covered Stent had 103 reinterventions involving a new lesion compared to 72 reinterventions in the PTA only group at 24 months. At 30 days, freedom from primary safety events was 96.4% in AVeVa and 95.0% (Covera™ Vascular Covered Stent) vs. 96.4% (PTA alone) in AVeNEW (P < .0022). Freedom from primary safety events was defined as freedom from an adverse event involving the access circuit resulting in additional intervention, surgery, hospitalization, or death.

      2 Acute Technical Success was defined as successful deployment, based on the operator’s opinion, of the implant to the intended location assessed at the time of the index procedure.  AVeNEW Clinical Study. Data on File. Bard Peripheral Vascular Inc., Tempe, AZ. 

      3 Index of Patency Function – Target Lesion (IPF-T) is defined as the time from the index study procedure to study completion or complete access abandonment divided by the number of visits for a reintervention performed at the target lesion in order to maintain vascular access for hemodialysis. Mean IPF-T of 380.40 days with Covera™ Vascular Covered Stent vs. 217.57 days with PTA alone at 24 months. AVeNEW Clinical Study. Data on File. Bard Peripheral Vascular Inc., Tempe, AZ.

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

      BD-23522v2

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