EDWARDS INTUITY Elite

valve system

EDWARDS INTUITY Elite

valve system

The EDWARDS INTUITY Elite valve system represents our commitment to continued innovation for 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 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.

Evolution of a trusted design

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

Intuity goals

Built on a trusted, proven 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.

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.

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.

trusted valve platform
trusted 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.

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.

Provides rapid deployment for streamlined procedures

Streamlines implantation. Because time is precious.

Implantation of the EDWARDS INTUITY Elite valve system is streamlined to help reduce procedural steps.

Streamlines implantation. Because time is precious.

Short cross-clamp time demonstrated in isolated and concomitant AVR procedures in the prospective, multi-center TRANSFORM trial.

Streamlines implantation. Because time is precious.

Shorter cross-clamp times generally lead to reduced complications and hospital utilization rates17‡

streamlined concomitant  procedures
streamlined concomitant  procedures

Streamlines implantation. Because time is precious.

Short cross-clamp time demonstrated in isolated and concomitant AVR procedures in the prospective, multi-center TRANSFORM trial.

Streamlines implantation. Because time is precious.

Shorter cross-clamp times generally lead to reduced complications and hospital utilization rates17‡

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.

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.

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.

smaller incisions
smaller incisions

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.

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.

Excellent hemodynamic performance

The EDWARDS INTUITY valve platform has consistently delivered low mean pressure gradients at 1 year, as shown in multiple clinical studies.

Excellent hemodynamic performance

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.

* These numbers represent the patients who had a follow up visit during dicharge, 3 months, 1 year and 3 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.

References

  1. Haverich A, Wahlers TC, Borger MA, et al. Three-Year Hemodynamic Performance, Left Ventricular Mass Regression, and Prosthetic-Patient-Mismatch After Rapid Deployment Aortic Valve Replacement in 287 Patients, J Throac Cardiovasc Surg. 2014;148(6):2854-60
    **These data pertain to an earlier generation EDWARDS INTUITY system and supported the CE Mark approval for the EDWARDS INTUITY Elite valve system.
  2. Banbury MK, Cosgrove DM III, White JA, et al. Age and Valve Size Effect on the Long-term Durability of the Carpentier-Edwards Aortic Pericardial Bioprosthesis. Ann Thorac Surg. 2001;72(3):753-757. (Cohort size = 267, mean age = 65 ± 12 yrs. Number at risk for Explant for SVD at last follow-up not reported)
  3. McClure RS, Narayanasamy N, Wiegerinck E, et al. Late Outcomes for Aortic Valve Replacement with the Carpentier-Edwards Pericardial Bioprosthesis: Up to 17-year Follow-up in 1,000 Patients. Ann Thorac Surg. 2010;89(5):1410-1416. (Cohort size = 1,000, mean age = 74.1 ± 0.29 yrs. Number at risk for SVD at last follow-up not reported)
  4. Welke KF, Wu Y, Grunkemeier GL, Ahmad A, Starr A. Long-term results after Carpentier-Edwards pericardial aortic valve implantation, with attention to the impact of age. The Heart Surgery Forum. 2011;14(3):E160-165.
  5. Minakata K et al. Long-Term Outcome of the Carpentier-Edwards Pericardial Valve in the Aortic Position in Japanese Patients. Circulation Journal 2014;78:882-889. (Cohort size = 574, mean age = 71.9 yrs. Number at risk for Structural Deterioration at 15-year follow-up = 54)
  6. Jamieson WR, Germann E, Aupart MR, et al. 15-year Comparison of Supra-annular Porcine and PERIMOUNT Aortic Bioprostheses. Asian Cardiovasc Thorac Ann. 2006;14(3):200-205. (Cohort size = 1,430, mean age = 69.5 ± 10.4 yrs. Number at risk for SVD at last follow-up = 33)
  7. Grunkemeier GL, Furnary AP, Wu Y, Wang L, Starr A. Durability of pericardial versus porcine bioprosthetic heart valves. The Journal of Thoracic and Cardiovascular Surgery. 2012;144(6):1381-1386.
  8. Biglioli P, Spampinato N, Cannata A, et al. Long-term outcomes of the Carpentier-Edwards pericardial valve prosthesis in the aortic position: effect of patient age. J Heart Valve Dis. 2004;13(1):S49-51. (Cohort size = 327, mean age = 67.2 ± 10.6 yrs. Number at risk for Prosthesis Replacement at last follow-up not reported)
  9. Bergoënd E, Aupart MR, Mirza A, et al. 20 years’ durability of Carpentier-Edwards Perimount stented pericardial aortic valve. In: Yankah CA, Weng Y, Hetzer R,eds. Aortic Root Surgery The Biological Solution. Berlin: Springer; 2010:441-451. (Cohort size = 1,857, mean age = 69.8 yrs, Number at risk for Structural Valve Deterioration at last follow-up not reported)
  10. Aupart MR, Mirza A, Meurisse YA, et al. Perimount Pericardial Bioprosthesis for Aortic Calcified Stenosis: 18-year Experience with 1133 Patients. J Heart Valve Dis. 2006;15(6):768-775. (Cohort size = 1,133, mean age = 72.6 yrs. Number at risk for SVD at last follow-up = 2)
  11. Bourguignon T, et al. Very Long-Term Outcomes of the Carpentier-Edwards PERIMOUNT Valve in Aortic Position. Ann Thorac Surg. 2015 Mar;99(3):831-7. (Cohort size = 2,659, mean age = 71 ± 10.4 yrs. Number at risk for explant for Structural Valve Deterioration = 27).
  12. Forcillo J et al. Carpentier-Edwards Pericardial Valve in the Aortic Position: 25-Years Experience. Ann Thorac Surg 2013;96:486-93. (Cohort size = 2,405, mean age = 71 yrs. Number at risk for Structural Deterioration at last follow-up = 30)
  13. Clinical Communiqué. Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis 20-year Results. Data on file at Edwards Lifesciences, 2003. (Cohort size = 267, mean age = 65 ± 12 yrs. For patients ≥ 65, number at risk for explant due to SVD at last follow-up = 2)
  14. Johnston DR, Soltesz EG, Vakil N, et al. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg. 2015 Apr;99(4):1239-47. (Cohort size = 12,569, mean age = 71 ±11 yrs. Number at risk for explant for Structural Valve Deterioration at 20 year follow-up = 54).
  15. Clinical Investigation Report: Study Number; 2011-02 Report Date: 25 February 2016; TRANSFORM Database December 3, 2015.
  16. STS database for the period of July 2011 - December 2012.
  17. 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
  18. Borger MA, Dohmen P, Moustafine V, Conradi L, Knosalla C, Richter M, Merk DR, Doenst T, Hammerschmidt R, Treede H, Dohmen P, Strauch JT. Randomized Multi-Center Trial of Minimally Invasive Rapid Deployment Versus Conventional Full Sternotomy Aortic Valve Replacement (CADENCE-MIS). The Annals of Thoracic Surgery, 2014.
  19. Clinical Investigation Report. Report Date: 07 June 2016; FOUNDATION Database February 1, 2016.

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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.

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