Help Maintain Hemodialysis Access in Dysfunctional AV Fistula and AV Graft
• Designed to help treat challenging lesions in tortuous vessel segments within the AV access.
• At 24 months, on average, patients who received the Covera™ Vascular Covered Stent went 163 additional days between interventions to maintain target lesion patency of their fistula, compared to PTA alone.1
CREATE
RESTORE
MAINTAIN
1The AVeNEW Clinical Study was a Prospective, Multi-Center, Randomized, Concurrently-Controlled Clinical Study of the Covera™
Vascular Covered Stent in the Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits. Data on file. N=280. At 6
months, treatment with the Covera™ Vascular Covered Stent resulted in a primary patency of 78.7% vs. 47.9% with PTA alone. Primary Patency was 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. At 30 days, primary safety event rate of 95.0% vs. 96.4% for PTA alone (p-value <0.0022.) Freedom from primary safety events is defined as freedom from any adverse events, localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death. Index of Patency Function (IPF) at Target Lesion (TL) is 380.40 days vs. 217.57 days with PTA alone. Index of Patency Function – Target Lesion (IPF-T) was 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.
Indication for Use: The Covera™ Contraindications: There are no known contraindications for the Covera™
Vascular Covered Stent is indicated for use in hemodialysis patients for the treatment of stenoses in the venous outflow of an arterio-venous (AV) fistula and at the venous anastomosis of an ePTFE or other synthetic AV graft. Vascular Covered Stent.
Do not use if you have uncorrectable coagulation disorders or are hypersenstivie to nickel-titanium or tantalum. Potential Complications and Adverse Events: Complications and Adverse Events associated with the use of the Covera™
Vascular Covered Stent may include the usual complications associated with endovascular stent and covered stent placement and dialysis
shunt revisions. Potential complications may include, but are not limited to: new lesions in the access circuit requiring reintervention; thrombotic occlusion; restenosis of the target lesion requiring reintervention; pseudoaneurysm; vessel rupture; dissection; extravasation; perforation; pain; infection; arm or hand edema; steal syndrome; bleeding at access site; numbness; venous spasm; and death.
Please consult product labels and instructions for use for indications, contraindications, hazards, warnings and precautions. Lutonix™
bd.com BD, Tempe, AZ, USA 1 800 321 4254
035 DCB
BD, the BD logo, Conquest, Covera, Lutonix, and WavelinQ are trademarks of Becton, Dickinson and Company or its affiliates. © 2022 BD. All rights reserved. © 2022 Illustrations by Mike Austin. BD-24160
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