Surgical aortic pericardial valves Surgical aortic pericardial valves

Carpentier-Edwards PERIMOUNT Magna Ease Aortic Valve

Built upon the Carpentier-Edwards PERIMOUNT bioprosthesis design.

Carpentier-Edwards PERIMOUNT Magna Ease Aortic Valve

The PERIMOUNT Magna Ease Aortic Valve

A first in design, with a history of demonstrated performance.

Descended from a proven family of PERIMOUNT surgical valves, the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve is the first biomechanically engineered valve designed specifically for the aortic position.

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 design

Mathematically modeled, bioengineered design

Mathematically modeled, bioengineered design

Optimized for hemodynamics, durability and implantability

Flexible cobalt-chromium alloy stent

Flexible cobalt-chromium alloy stent

Absorbs energy to reduce leaflet stress

Three independent bovine pericardial leaflets

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 performs like new.14

Clinical studies show excellent long-term durability.

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

Actuarial Freedom from Structural Valve Deterioration

20+ years
of clinical durability with the PERIMOUNT valve design

20 plus years of clinical durability with the PERIMOUNT valve design

* 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.

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

Demonstrated hemodynamic performance.

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

Mean Pressure Gradient (mmHg) Chart

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.
ModelDescriptionSizesImage
3300TFX Carpentier-Edwards PERIMOUNT Magna Ease pericardial aortic bioprosthesis with ThermaFix process‡ 19, 21, 23, 25, 27 & 29 mm Carpentier-Edwards PERIMOUNT Magna Ease pericardial aortic bioprosthesis with ThermaFix process
ModelDescriptionSizes
1133SET Sizers – Complete Set 19, 21, 23, 25, 27, and 29 mm
1133 Sizers - Individual 19, 21, 23, 25, 27, and 29 mm
TRAY1133 Accessory Tray N/A
1111 Reusable Handle N/A
1126 Longer Single-Use Handle N/A

Clinical communiqué

20 year results
Carpentier-Edwards PERIMOUNT pericardial aortic bioprosthesis.
Download now  (1.14MB)
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.
  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 = 54)
  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. The Journal of Thoracic and Cardiovascular Surgery. 2012;144(6):1381-1386.
  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 not reported)
  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 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. Wendt D, et al. The new St Jude Trifecta versus Carpentier-Edwards Magna and Magna Ease aortic bioprosthesis: Is there a hemodynamic superiority? J Thorac Cardiovasc Surg. 2014;147(5):1553-1560.

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 – Simply call 800-822-9837 or email tech_support@edwards.com anytime, day or night
  • Customer service – Call 800-424-3278 to speak to a customer service representative

Contact a sales representative

Important safety information

Important safety information

Brief summary: 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.

Warnings: Alternative therapies should be considered in the presence of conditions affecting calcium metabolism or when calcium containing chronic drug therapies are used, including children, adolescents, young adults, and patients on a high calcium diet or maintenance hemodialysis. Should be used with caution in the presence of severe systemic hypertension or when anticipated patient longevity is longer than the known longevity of the prosthesis.

Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

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