Surgical aortic heart valves
RESILIA tissue valves
Rapid deployment valves
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 valves
Longer-term follow-up of patient from Edwards' studies are ongoing. Physicians should assess the benefits and risks of the EDWARDS INTUITY Elite valve prior to implantation.