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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 Advantage

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800-822-9837

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800-424-3278
Mitral Replacement Valves
Mitral Replacement Valves
Mitral Replacement Valves

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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. 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, et al. 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. (Cohort size = 2,168, mean age = 73.1 ± 10.8.  Number at risk at last follow-up not reported)
  5. Minakata K, Tanaka S, Okawa, Y, 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 = 2)
  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, et al. Durability of pericardial versus porcine bioprosthetic heart valves. The Journal of Thoracic and Cardiovascular Surgery. 2012;144(6):1381-1386. (Cohort size = 2,449, mean age = 72.9. Number at risk for explantation for SVD at last follow-up not reported)
  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 = 36)
  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, Bouquiaux-Stablo, A, Candolfi P, et al. Very Long-Term Outcomes of the Carpentier-Edwards PERIMOUNT Valve in Aortic Position. Ann Thorac Surg. 2015;99(3):831-7. (Cohort size = 2,659, mean age = 71 ± 10.4 yrs. Number at risk for explant for Structural Valve Deterioration = 28).
  12. Forcillo J, Pellerin M, Perrault LP, 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 ± 9 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;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. 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.

Important safety information

EDWARDS INTUITY Elite valve system

Indications: The EDWARDS INTUITY Elite valve is indicated for the replacement of diseased, damaged or malfunctioning native or prosthetic aortic valves.

Contraindications: The EDWARDS INTUITY Elite valve is contraindicated for use in patients with pure aortic insufficiency and aneurysms of the aortic root or ascending aorta.

Warnings: Use of the EDWARDS INTUITY Elite valve system may be associated with new or worsened conduction system disturbances, which may require a permanent pacemaker implant.

Complications and Side Effects: Annulus damage, dissection or tearhemolysis, cardiac arrhythmias/conduction disturbances, congestive heart failure, endocarditis, leaflet impingement (aortic or mitral), myocardial infarction (MI), neurologic events, patient-prosthesis mismatch (PPM) (due to inappropriate sizing), structural/non-structural valve dysfunction, any of which could lead to reoperation, explantation, and death.

With the use of a bioprosthetic valve with a reduced number of sutures similar to the EDWARDS INTUITY Elite valve include: valve leakage, paravalvular (perivalvular) leak, transvalvular regurgitation, valve stenosis, valve thrombosis, valve frame distortion (from chest compression or trauma), and valve malposition, instability, dislodgement or migration/embolization.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information.