The EDWARDS INTUITY Elite valve system is designed to achieve three important goals simultaneously:
The EDWARDS INTUITY Elite valve system represents our commitment to continued innovation for surgeons and patients in heart valve therapy.
The surgical heart valve market is evolving. Concomitant procedures are becoming a larger percent of the surgical mix, and MIS is gaining in importance. To enable surgeons to address these trends, we have developed the EDWARDS INTUITY Elite valve system.
We have combined our proven pericardial valve technology with our innovations in transcatheter heart valves to create a new category of surgical valves designed to streamline procedures and facilitate smaller incision surgery. We believe more efficient, less invasive procedures can provide significant benefits, both during the procedure and after.
This is the next evolution of surgical aortic valves.
This is the EDWARDS INTUITY valve platform.
The EDWARDS INTUITY valve platform has consistently delivered low mean pressure gradients at 1 year, as shown in multiple clinical studies.
In a large prospective trial1, the EDWARDS INTUITY Elite valve demonstrated excellent and stable hemodynamic performance and significant LV mass regression out to 3 years.
We are committed to providing your institution, clinicians and staff with the highest levels of customer service and support to ensure seamless product implementation and ongoing use, including:
EDWARDS INTUITY Elite valve system
Aortic valve, model 8300AB & delivery system, model 8300DB
Indications: The EDWARDS INTUITY Elite valve is indicated for the replacement of diseased, damaged or malfunctioning native or prosthetic 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: The safety and effectiveness of the valve has not been studied in the following specific populations: patients who are pregnant or lactating; patients with chronic renal impairment or calcium metabolism disorders; patients with active endocarditis or myocarditis; or children or adolescents. As with any implanted device, there is potential for an immunological response. 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.
Potential adverse events: Adverse events potentially associated with the use of bioprosthetic heart valves and aortic valve replacement surgery include but are not limited to: annulus damage, dissection, or tear; hemolysis; 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); reoperation or re-intervention, structural/non-structural valve dysfunction, explantation and death.
Additional potential risks associated 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 (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
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