Carpentier-Edwards PERIMOUNT Magna Ease Aortic Valve
Built upon the Carpentier-Edwards PERIMOUNT bioprosthesis design.
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
Optimized for hemodynamics, durability and implantability
Flexible cobalt-chromium alloy stent
Absorbs energy to reduce leaflet stress
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
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
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.
- Valve leaflets: Bovine pericardium
- Stent: Cobalt-chromium alloy
- Fabric covering stent: Polyester cloth
- Valve sewing ring: Silicone rubber
- 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.
|3300TFX||Carpentier-Edwards PERIMOUNT Magna Ease pericardial aortic bioprosthesis with ThermaFix process‡||19, 21, 23, 25, 27 & 29 mm|
|1133SET||Sizers – Complete Set||19, 21, 23, 25, 27, and 29 mm|
|1133||Sizers - Individual||19, 21, 23, 25, 27, and 29 mm|
|1126||Longer Single-Use Handle||N/A|
- 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. 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).
- 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 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).
- 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.
- 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.
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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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