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EDWARDS INTUITY Elite

valve system

INTUITY Elite
INTUITY Elite
INTUITY Elite
intuity elite valve
intuity elite valve
intuity elite valve

The EDWARDS INTUITY Elite valve system is designed to achieve three important goals simultaneously:

evolution diagram
evolution diagram
evolution diagram

The EDWARDS INTUITY Elite valve system represents our commitment to surgeons and patients in heart valve therapy.

We have combined our proven pericardial valve technology with our innovations in transcatheter heart valves to create a surgical valve 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 EDWARDS INTUITY Elite valve platform.

Built on a trusted, proven valve platform

Designed for durability. Created to last.

The EDWARDS INTUITY Elite valve system combines our proven pericardial valve technology with our innovations in transcatheter heart valves.

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intuity features chart
intuity features chart
intuity features chart
intuity features
intuity features
intuity features
intuity features chart
intuity features chart
intuity features chart
intuity features
intuity features
intuity features

Provides rapid deployment for streamlined procedures

Streamline implantation. Because time is precious.

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Implantation of the EDWARDS INTUITY Elite valve system is streamlined to help reduce implant time.

valve system
valve system
valve system

Shorter cross-clamp times generally lead to reduced complications and hospital utilization rates2‡

complications and utilizations
complications and utilizations
complications and utilizations
valve system
valve system
valve system
complications and utilizations
complications and utilizations
complications and utilizations

Implantation of the EDWARDS INTUITY Elite valve system is streamlined to help reduce implant time.

Shorter cross-clamp times generally lead to reduced complications and hospital utilization rates2‡

Well combined with small incision surgery

Empowering multiple approaches. Progress through access.

The EDWARDS INTUITY Elite valve system is designed to enhance the ease of implantation through small incisions using three guiding sutures.

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streamlined delivery
streamlined delivery
streamlined delivery
high use
high use
high use
streamlined delivery
streamlined delivery
streamlined delivery
high use
high use
high use

Excellent haemodynamic performance

Consistent excellent EOA and low gradients up to 5 years were observed during the TRITON study.

3 years
3 years
3 years

* These numbers represent the patients who had a follow up visit during discharge, 3 months, 1 year, 3 years and 5 years. Not the number of patients for which the EOA and the mean gradient was measured. These data pertain to an earlier generation EDWARDS INTUITY valve as part of TRITON trial.

Longer-term follow-up of patients from Edwards’ studies are ongoing. Physicians should assess the benefits and risks of the EDWARDS INTUITY Elite valve prior to implantation.

Preparation animation

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Procedure animation

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The Edwards Advantage

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.

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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 valves1,3,4. Physicians should assess the benefits and risks of the EDWARDS INTUITY Elite valve prior to implantation. See instructions for use for additional information.

References

  1. Laufer G, Haverich A, Andreas M, et al. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardiothorac Surg. 2017;52(2):281-287.
  2. Al-Sarraf N, Thalib L, Houlihan M, Tolan M, Young V, McGovern E. Cross-clamp time is an independent predictor of mortality and morbidity in low- and high-risk cardiac patients. Int J Surg 2011;9:104-109.
  3. Edwards Data on File.
  4. Romano, M., et al. Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement. 2018; 106, 685-90.
  5. Barnhart GR, Accola KD, Grossi EA, et al. TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg. 2017;153(2):241-251.e2.
Medical device for professional use

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).