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.
Built on a trusted, proven platform
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Provides rapid deployment for streamlined procedures
Well combined with small incision surgery
Excellent hemodynamic performance
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 Pre-Market Studies | 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.
- Edwards Data on File.
- Romano, M., et al. Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement. 2018; 106, 685-90.
- Laufer G., et al. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardiothorac Surg 2017; 52:281-7.
References
- 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. - 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)
- 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)
- 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.
- 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)
- 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)
- 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.
- 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)
- 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)
- 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)
- 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).
- 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)
- 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)
- 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).
- Clinical Investigation Report: Study Number; 2011-02 Report Date: 25 February 2016; TRANSFORM Database December 3, 2015.
- STS database for the period of July 2011 - December 2012.
- 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
- 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.
- Clinical Investigation Report. Report Date: 07 June 2016; FOUNDATION Database February 1, 2016.
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