Prof Augusto D’Onofrio
No clinical data are available that evaluate the long‐term impact of RESILIA tissue in patients. Refer to device instructions for use for important warnings related to VFit technology. These features have not been observed in clinical studies to establish the safety and effectiveness of the model 11500A for use in valve‐in‐valve procedures. VFit technology is available on sizes 19–25 mm.
Expert opinions and advice represent contributors’ views and not necessarily those of Edwards Lifesciences.
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. Physicians should assess the benefits and risks of the EDWARDS INTUITY Elite valve prior to implantation. See instructions for use for additional information.
Medical device for professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions
for Use (consult eifu.edwards.com where applicable).
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier‐Edwards, Carpentier‐Edwards PERIMOUNT, Carpentier‐Edwards PERIMOUNT Magna Ease, EDWARDS INTUITY, EDWARDS INTUITY Elite, INSPIRIS, INSPIRIS RESILIA, Magna, Magna Ease, PERI, PERIMOUNT, PERIMOUNT Magna, RESILIA and VFit are trademarks or service marks of
Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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