LimFlow Extension Stent Graft (5.5 mm x 200 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
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.
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