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 category of surgical valves designed to streamline procedures and well combined with small incisions. 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.
Important safety information:
Use of the EDWARDS INTUITY Elite valve system may be associated with new or worsened conduction disturbances, which may require a Permanent cardiac Pacemaker Implant (PPI). The rate of PPI for the EDWARDS INTUITY Elite valve is within the range reported in the literature for various rapid deployment valves, but higher than that reported for surgical aortic valves20,21,22.
Table: Permanent pacemaker implant (PPI) rates
|EDWARDS INTUITY Elite|
|Patient population||PPI rate|
|TRANSFORM (US)||All-cause PPI, all patients||12.3%21|
|All-cause PPI, all patients without baseline conduction abnormalities||6.6%21|
|TRITON (EU)||All subjects <30 days||6.9%22|
|Literature reported||Patient population||PPI rate|
|Rapid Deployment Valves||Various||1.7% – 28.6%20|
|Surgical Aortic Valves||Various||3% - 11%21|
Longer-term follow-up of patients from Edwards’ studies are ongoing. Physicians should assess the benefi ts and risks of the EDWARDS INTUITY Elite valve prior to implantation.
We are committed to providing your institution, clinicians and staff with the highest levels of customer service and support.
You are busy – We are flexible
Indicate your topics of interest and preferred communication frequency
For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse event.
Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.
Please update to a current version of your preferred browser, this site will perform effectively on the following:Unable to update your browser?
If you are on a computer, that is maintained by an admin and you cannot install a new browser, ask your admin about it. If you can't change your browser because of compatibility issues, think about installing a second browser for browsing and keep this old one for compatibility