Device typeArteriovenous endovascular stent-graft: A non-bioabsorbable, implantable tubular device intended to treat critical lower-limb ischemia by creating a communication (shunt) between an artery and a vein to produce venous arterialization in the below-knee vasculature for restoration of blood flow. It is implanted in a minimally-invasively procedure using vascular ultrasound catheters, one in an artery and one in a vein, to create a cross-bridge as a guide for positioning the stent-graft at the site of implantation, where it self-expands. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and covered by a polymer [e.g., polytetrafluoroethylene (PTFE)]. Disposable devices associated with implantation may be included.
FDA categoryStent Graft, Infrapopliteal, Venous Arterialization
Device ID00850041730110
AvailabilityPrescription
Single useYes
SterileYes
LatexNot made with natural rubber latex
MRI safetyMR Conditional