Bard Covera Vascular Covered Stent

The Covera Vascular Covered Stent is a flexible, self-expanding ePTFE-covered nitinol stent system engineered for treating venous anastomotic stenoses in AV grafts and native AV fistulas. Designed for use in hospital interventional suites and outpatient dialysis-access centers, this stent offers exceptional conformability, hemodynamic flow optimization, and reliable patency in challenging vascular anatomies.

Overview

Utilizing a helical nitinol scaffold encapsulated in carbon-impregnated ePTFE, the Covera stent delivers both radial strength and flexibility to address lesions in areas such as the cephalic arch, basilic swing-point, and graft-vein anastomosis. Available in both straight and flared configurations, and deployable via a thumbwheel-controlled, triaxial delivery system, the stent ensures precise positioning with minimal trauma. Clinical trials (AVeVA & AVeNEW) demonstrated target lesion primary patency rates of 70–79% at 6 months.

Key Features

• Helical nitinol design provides radial strength and flexibility in tortuous anatomies
• Carbon-impregnated ePTFE covering reduces neointimal hyperplasia
• Straight & flared configurations optimize blood flow and vessel-wall apposition
• Thumbwheel delivery system with dual-speed control enables precision placement
• Atraumatic tip and triaxial sheath enhance navigation and deployment accuracy
• Radiopaque tantalum markers improve fluoroscopic visibility
• MR-conditional at 1.5T & 3T under specified conditions

Product Specifications

• Material: Nitinol scaffold with carbon-impregnated ePTFE membrane
• Configurations: Straight & flared (3 mm flare begins ~15 mm from distal end)
• Available Diameters: 6, 7, 8, 9, and 10 mm
• Available Lengths: 30–100 mm
• Delivery System: Over-the-wire, compatible with 0.035″ guidewires & 8 F/9 F sheaths; lengths 80/120 cm
• Markers: Dual radiopaque tantalum markers at ends
• Sterility: EO-sterilized, single-use only
• MRI: MR-conditional (heating <3°C at 1.5/3T, artifact ≤5.5 mm)
• Compliance: FDA-approved (PMA P170042), CE marked, ISO 13485 certified

Ideal For

• Treatment of venous outflow stenosis in AV grafts and fistulas
• Challenging vascular anatomies—cephalic arch, basilic swingpoint, graft-vein anastomosis
• Settings: hospital interventional radiology suites, outpatient dialysis-access centers
• Physicians seeking precise, flexible covered stent solutions with proven patency
• Cases requiring MR-conditional implants post-placement