Magna Mitral Ease valve

Carpentier-Edwards PERIMOUNT Magna Mitral Ease valve

Built upon the unique and proven PERIMOUNT valve design, the Magna Mitral Ease valve gives you and your patients:

Ultra-low profile, with reduced ventricular projection by up to 40%^‡
Exceptional long-term durability^1-8
Ease of implant

The Magna Mitral Ease valve is built upon the proven, time-tested PERIMOUNT valve design, with unique design elements including:

Mathematically modeled, bioengineered design. Intended to optimize implantability, hemodynamics and long-term durability
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

‡ As compared to the Carpentier-Edwards PERIMOUNT Theon mitral valve.

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Model 7300TFX

Ease of implant

Wide, contoured cuff with unique anterior saddle and lateral contour to mimic the shape of the native mitral anatomy

Exceptional long-term durability

Magna Mitral Ease heart valve

Model 7300TFX Nominal Specifications (mm)	Size 25	Size 27	Size 29	Size 31	Size 33
A. Stent Diameter (Wireform)	25	27	29	31	31
B. Tissue Annulus Diameter	28	29.5	31.5	33.5	33.5
C. External Sewing Ring Diameter	36	38	40	42	44
D. Anterior Effective Profile	7	7.5	8	8.5	8.5

References

Aupart MR, et al. Carpentier-Edwards pericardial valves in the mitral position: ten-year follow-up. J Thorac Cardiovasc Surg. 1997 Mar;113(3):492-8. (Freedom from structural deterioration; n = 150; mean age = 62.9 ± 11.9 yrs)
Jamieson WRE, et al. Structural Valve Deterioration in Mitral Replacement Surgery: Comparison of Carpentier-Edwards Supra-Annular Porcine and PERIMOUNT Pericardial Bioprostheses. J Thorac Cardiovasc Surg. 1999 Aug;118:297-305. (Freedom from explant due to structural valve deterioration; n = 429; mean age = 60.7 ± 11.7 yrs)
Murakami T, et al. Aortic and mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 10-year results. J Heart Valve Dis. 1996 Jan;5(1):45-9. (Freedom from structural deterioration; n = 57; mean age = 55.1 ± 13.2 yrs)
Poirier NC, et al. 15-year experience with the Carpentier-Edwards pericardial bioprosthesis. Ann Thorac Surg. 1998;66:S57-61. (Freedom from structural deterioration; n = 214; mean age = 65 ± 23 yrs)
Neville PH, et al. Carpentier-Edwards pericardial bioprosthesis in aortic or mitral position: a 12-year experience. Ann Thorac Surg. 1998;66(6 Suppl):S143-7. (Freedom from structural deterioration; n = 182; mean age = 63.9 ± 11.5 yrs)
Marchand MA, et al. Fifteen-year experience with the mitral Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. Ann Thorac Surg. 2001 May;71(5 Suppl):S236-9. (Freedom from structural valve deterioration; n = 435; mean age = 60.7 ± 11.6 yrs)
Bourguignon, T, et al. Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25 year follow-up of 450 implantations. J Thorac Cardiovasc Surg. 2014 Nov;148:2004-11. (Freedom from explant due to structural valve deterioration; n = 404; mean age = 68.0 ± 10.4 yrs)
Carpentier-Edwards PERIMOUNT pericardial bioprosthesis 16-year results. Data on file at Edwards Lifesciences, 2003. (Freedom from explant due to structural valve deterioration; n = 435; mean age = 60.7 ± 11.6 yrs)

Important safety information

Carpentier-Edwards PERIMOUNT Mitral Bioprostheses

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

Contraindications: Do not use if surgeon believes such 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, ventricular perforation by stent posts 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 (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information.