For patients and physicians grappling with challenging vascular stenosis and complex lesions in dialysis access, a new solution promises to maintain vital lifelines with unprecedented reliability.

Innovation Against Complexity: The Covera™ Difference

The BD Covera™ covered vascular stent represents a significant advancement in treating complex vascular pathologies. Engineered with global AV access expertise, its innovative design addresses anatomical challenges including terminal cephalic arch, cephalic vein turn segments, and venous anastomotic sites.

Key technological features include:

• A flexible base stent architecture conforming to native vasculature
• Precision-contoured edges optimizing wall apposition and laminar flow
• Carbon-impregnated luminal surface enhancing biocompatibility
• Spiral struts and angular bridges providing exceptional kink resistance
• Dual-layer ePTFE membrane encapsulation preventing neointimal hyperplasia

Physician-Centric Design for Precision Placement

The stent system offers two configurations - flared and straight - accommodating diverse anatomical requirements. Its intuitive delivery mechanism features:

• Dual-speed thumbwheel control for micro-adjustments
• Triaxial delivery system enhancing placement accuracy
• Ergonomic handle enabling single-handed deployment
• Stable sheath design ensuring smooth navigation

Clinical Validation: Superior Outcomes Demonstrated

Two pivotal studies substantiate Covera™'s clinical performance:

AVeVA Study (AV-Shunt Patients)

Demonstrated 70.3% target lesion primary patency at 6 months (proportional analysis) with 96.4% 30-day major safety event-free rate.

AVeNEW Study (AV-Fistula Patients)

Showed statistically superior outcomes versus PTA alone:

• 78.7% vs 47.9% target lesion primary patency at 6 months (p<0.001)
• Significantly fewer reinterventions through 24-month follow-up
• Comparable safety profile (95.0% vs 96.4% event-free rate)

Safety Considerations and Appropriate Use

Indicated for venous drainage stenosis in AV fistulae and venous anastomotic stenosis in synthetic AV shunts, the device requires:

• Experienced operator use
• Adequate pre-dilation of lesions
• Appropriate sizing covering healthy vessel segments

Contraindications include active infections, uncorrected coagulopathies, material allergies, and recently created accesses (<30 days). The system cannot be repositioned after partial deployment and requires fluoroscopic guidance throughout the procedure.

Post-deployment balloon dilation should not exceed the stent's maximum labeled diameter. The device cannot withstand temperatures above 260°C and must not be resterilized.