AngioJet® Thrombectomy Systems

Indications/Contraindications

AngioJet and AngioJet Ultra peripheral indications include:  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.  Coronary indications include: removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions prior to balloon angioplasty or stent placement.  Do not use in patients: who are contraindicated for intracoronary or 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.  Before coronary AngioJet treatment, verify the presence of thrombus because routine use of AngioJet in every STEMI patient, without proper selection for thrombus, has been associated with increased mortality risk.  Do not use the system in the coronary vasculature without placing a temporary pacing catheter to support the patient through hemodynamically significant arrhythmias which may occur.

Potential Adverse Events

Potential adverse events (in alphabetical order) which may be associated with use of the system are similar to those associated with other interventional procedures and include but are not limited to the following: abrupt closure of treated vessel, acute myocardial infarction, acute renal failure, arrhythmias (including VF and VT), bleeding from access site, death, dissection, embolization (proximal or distal), emergent CABG, hematoma, hemolysis, hemorrhage requiring transfusion, hypotension/hypertension, infection at access site, myocardial ischemia, pain, pancreatitis, perforation, pseudoaneurysm, reactions to contrast medium, stroke/CVA, thrombosis/occlusion, total occlusion of treated vessel, vascular aneurysm, vascular spasm, vessel wall or valve damage.