AngioJet and AngioJet Ultra Systems are indicated for breaking up and removing thrombus from infra-inguinal peripheral arteries, upper and lower extremity peripheral arteries, upper extremity peripheral veins, ileofemoral and lower extremity veins, A-V access conduits, and for use with the AngioJet Ultra Power Pulse® Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. Do not use in patients: who are contraindicated for endovascular procedures, who cannot tolerate contrast media, and in whom the lesion cannot be accessed with the wire guide.
Warnings and Precautions
The system has not been evaluated for treatment of pulmonary embolism or for use in the carotid or cerebral vasculature. Some AngioJet devices have not been evaluated for use in coronary vasculature. Operation of the catheter may cause embolization of some thrombus and/or thrombotic particulate debris. Cardiac arrhythmias may occur and cardiac rhythm should be monitored during catheter use and appropriate management employed, if needed. Systemic heparinization is advisable to avoid pericatheterization thrombus and acute rethrombosis. Operation of the system causes transient hemolysis. Large thrombus burdens may result in significant hemoglobinemia which should be monitored. Consider hydration, as appropriate.
Potential Adverse Events
Potential adverse events (in alphabetical order) which may be associated with use of the system include, but are not limited to, the following: abrupt closure of treated vessel, acute myocardial infarction, acute renal failure, bleeding from access site, cerebrovascular accident, death, dissection, embolization (proximal or distal), hematoma, hemolysis, hemorrhage requiring transfusion, hypotension/hypertension, infection at access site, pain, pancreatitis, perforation, pseudoaneurysm, reactions to contrast medium, thrombosis/occlusion, total occlusion of treated vessel, vascular aneurysm, vascular spasm, and vessel wall or valve damage.
Refer to product labeling for device-specific indications, contraindications, warnings/precautions, and adverse events. Rx only.
PER – October 2010