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The AortaSTAT Occulsion Device is indicated for temporary vessel occlusion in the suprarenal and infrarenal aorta in applications for perioperative occlusion and emergency control of hemorrhage

The RenalPro Medical AortaSTAT Occlusion device allows continued distal perfusion of the aorta while occluding the entrance into the target side branch arteries. The RenalPro Medical AortaSTAT Occlusion Device is comprised of a polymeric thin film membrane covering a self-expanding Nitinol scaffold connected to a stainless-steel central lumen, contained within a stainlesssteel braid-reinforced, Pebax outer shaft lined with PTFE for lubricity. The outer shaft and central lumen are attached to a deployment handle. The AortaSTAT Occlusion Device is provided sterile and non- pyrogenic and is for single patient use only. The AortaSTAT device is delivered to the targeted vasculature location under fluoroscopy using standard endovascular techniques over a commercially available 0.018″ Guidewire. Once the device is positioned, the covered scaffold is deployed by actuating the handle to slide the outer shaft back, allowing the scaffold to expand and providing radial occlusion of the target vessel. The AortaSTAT has a radiopaque marker near the distal ends of the nitinol scaffold, and another marker encapsulated at the distal end of the outer shaft to enable visualization under fluoroscopy. The AortaSTAT device is 8 Fr compatible in four diameters of occluding scaffolds: 19mm, 22mm, 25mm, and 28mm. The device has a 55 ± 5mm occlusive length and a 65cm working length.