{"AlternateComparison":false,"RelatedProducts":false,"Specification":true,"FeatureBenefit":true}
Covera™ Vascular stent grafts Covera™ Vascular Covered Stent

Covera™ Vascular Covered Stent

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Overview

The covered stent Tailor-Made for AV patients

The Covera™ Vascular Covered Stent builds upon proven technologies from the category leader in AV access. This covered stent platform is designed to balance the flexibility and strength required to address challenging lesions from the terminal cephalic arch, to the basilic swingpoint segments, to the AV graft venous 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 dialyzing with AV grafts and one for patients dialyzing with AV fistulas.1

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Features and Benefits
Promotional Story
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References

1 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 randomized to the Covera™ Vascular Stent group and 123 of the 138 (89.1%) randomized 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.

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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Specification

GTIN - Each

00801741106613

1


Catheter Length

80 cm

Configuration

Flared

Diameter

10 mm

Length

100 mm

Sheath Size

9 F

GTIN

GTIN - Each 00801741106613 1

Product Basic Specification

Catheter Length 80 cm
Configuration Flared
Diameter 10 mm
Length 100 mm
Sheath Size 9 F
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