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Surgical aortic pericardial valves

Aortic pericardial
Aortic pericardial
Aortic pericardial
Aortic Pericardial
Aortic Pericardial
Aortic Pericardial

Carpentier-Edwards PERIMOUNT Magna Ease aortic valve

Built upon the Carpentier-Edwards PERIMOUNT bioprosthesis design.

carpentier-edwards perimount
carpentier-edwards perimount
carpentier-edwards perimount

A first in design, with a history of demonstrated performance

The Carpentier-Edwards PERIMOUNT Magna Ease aortic valve is part of the proven family of PERIMOUNT surgical valves.

Backed by over 20 years of published clinical studies for proven longevity and demonstrated hemodynamic stability, the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve combines a tested design with the benefits of pericardial tissue to deliver the potential for on-going durability.

Proven PERIMOUNT valve design

perimount
perimount
perimount

Mathematically modeled, bioengineered design

Optimized for hemodynamics, durability and implantability

flexible cobalt
flexible cobalt
flexible cobalt

Flexible cobalt-chromium alloy stent

Absorbs energy to reduce leaflet stress

bovine pericardial leaflet
bovine pericardial leaflet
bovine pericardial leaflet

Three independent bovine pericardial leaflets

Matched for thickness and elasticity to optimize stress distribution

After more than 1 billion cycles, the Magna Ease valve still performed like new14

The Magna Ease valves demonstrated excellent durability after the equivalent of 25 years in simulated in vitro wear, with hydrodynamic performance similar to that of a new valve.

Clinical studies show excellent long-term durability

More long-term clinical study publications than any other bioprosthetic aortic valve.

Aortic pericardial 20 years
Aortic pericardial 20 years
Aortic pericardial 20 years

Actuarial freedom from structural valve deterioration

20 years chart
20 years chart
20 years chart

* Freedom from explant/prosthesis replacement/reoperation due to SVD

Ease of implant

The PERIMOUNT Magna Ease valve offers many key design features that enhance the valve’s ease of implant.

magna ease features
magna ease features
magna ease features

*No clinical data are available that evaluate the long-term impact of the Carpentier-Edwards ThermaFix issue process in patients

Demonstrated hemodynamic performance

Excellent EOAs and low gradients based on the proven PERIMOUNT valve design.15

hemodynamic performance chart
hemodynamic performance chart
hemodynamic performance chart

Specifications

Indications

The Carpentier-Edwards PERIMOUNT Magna Ease pericardial bioprosthesis is intended for use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis.

Materials List

  • Valve leaflets: Bovine pericardium
  • Stent: Cobalt-chromium alloy
  • Fabric covering stent: Polyester cloth
  • Valve sewing ring: Silicone rubber

Tissue Treatment

  • Model 3300TFX features the Carpentier-Edwards ThermaFix process, which confronts both major calcium binding sites: residual glutaraldehydes and phospholipids*

General Product Information

  • Storage temperature: 10°C to 25°C (50-77°F)
  • Storage: Glutaraldehyde
  • Rinse procedure: 500 ml (sterile physiological saline solution) x 60 seconds. Repeat once using new saline solution.

*No clinical data are available that evaluate the long-term impact of the Carpentier-Edwards ThermaFix issue process in patients

Clinical communiqué

20 year results Carpentier- Edwards PERIMOUNT pericardial aortic bioprosthesis.

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, including:

24/7 Technical support

800-822-9837

For product information and orders

800-424-3278
Magna ease
Magna ease
Magna ease

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References

  1. 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)
  2. 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)
  3. 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. (Cohort size = 2,168, mean age = 73.1 ± 10.8. Number at risk at last follow up not reported)
  4. 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 = 2)
  5. 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)
  6. Grunkemeier GL, Furnary AP, Wu Y, Wang L, Starr A. Durability of pericardial versus porcine bioprosthetic heart valves. J Thorac Cardiovasc Surg. 2012;144(6):1381-1386. (Cohort size = 2,449, mean age = 72.9 yrs. Number at risk for explantation for SVD at last follow-up not reported)
  7. 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)
  8. 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 reported = 36)
  9. 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)
  10. Bourguignon T, et al. Very Long-Term Outcomes of the Carpentier-Edwards PERIMOUNT Valve in Aortic Position. Ann Thorac Surg. 2015Mar;99(3):831-7. (Cohort size = 2,659, mean age = 71 ± 10.4 yrs. Number at risk for explant for Structural Valve Deterioration = 28).
  11. 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 ± 9 yrs. Number at risk for Structural Deterioration at last follow-up = 30)
  12. 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)
  13. Johnston DR, Soltesz EG,Vakil N, et al. Long term durability of bioprosthetic aortic valves: implications from12,569 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).
  14. Raghav V, et al. Long-term durability of Carpentier-Edwards Magna Ease valve: A one billion cycle in-vitro study. Ann Thorac Surg 2016;101:1759-67.
  15. Banbury, M, et al. Hemodynamic Stability During 17 Years of the Carpentier-Edwards Aortic Pericardial Bioprosthesis. Ann Thorac Surg 2002;73:1460 –5.

Important safety information

Carpentier-Edwards PERIMOUNT Aortic Bioprostheses

Indications: For use in patients whose aortic valvular disease warrants replacement of their natural or previously placed prosthetic valve.

Contraindications: Do not use if surgeon believes it would be contrary to the patient’s best interests.

Complications and side effects: Stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, angina, any of which could lead to reoperation, explantation, permanent disability, and death.

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.