Edwards INTUITY Elite
The Edwards Advantage
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Important safety information
EDWARDS INTUITY Elite valve system
Indications: The EDWARDS INTUITY Elite valve is indicated for the replacement of diseased, damaged or malfunctioning native or prosthetic aortic valves.
Contraindications: The EDWARDS INTUITY Elite valve is contraindicated for use in patients with pure aortic insufficiency and aneurysms of the aortic root or ascending aorta.
Warnings: Use of the EDWARDS INTUITY Elite valve system may be associated with new or worsened conduction system disturbances, which may require a permanent pacemaker implant.
Complications and Side Effects: Annulus damage, dissection or tearhemolysis, cardiac arrhythmias/conduction disturbances, congestive heart failure, endocarditis, leaflet impingement (aortic or mitral), myocardial infarction (MI), neurologic events, patient-prosthesis mismatch (PPM) (due to inappropriate sizing), structural/non-structural valve dysfunction, any of which could lead to reoperation, explantation, and death.
With the use of a bioprosthetic valve with a reduced number of sutures similar to the EDWARDS INTUITY Elite valve include: valve leakage, paravalvular (perivalvular) leak, transvalvular regurgitation, valve stenosis, valve thrombosis, valve frame distortion (from chest compression or trauma), and valve malposition, instability, dislodgement or migration/embolization.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information.