Carpentier-Edwards PERIMOUNT MAGNA MITRAL

Pericardial Bioprosthesis

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Excellence in durability

• Built on the proven performance of PERIMOUNT valves,

with up to 20 years of durability.2,3

• Biomechanically engineered to avoid the variability

inherent in the natural aortic pig tissue used in mitral

porcine valves.4

• Long-term performance without lifelong anticoagulation.†

† For patients who do not require warfarin for other risk factors and after the usual 3-monthpostoperative period.5

A new level of exc

Advanced tisCarpentier-Edwatissue process ecalcium binding

Proven designBiomechanically engineered fromselected and proven materials: notjust an aortic valve upside-down

The Carpentier-Edwards PERIMOUNT Magna mitral valve

is position-specific and is based on the same advanced

biomechanical design that produced exceptional

performance in the Magna aortic valve. It is not, however,

just the same valve turned upside-down.

Edwards Lifesciences’ 40 years experience with the

development of mitral prostheses led to a valve that

addresses every specific challenge of the mitral position in

terms of long-term reliability, hemodynamic performance,

and ease of implantation.

Variable compliancePatented variable compliance ofthe sewing band offers moreflexibility where needed most1

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Excellence during implantation

• Low profile to ease insertion through small incisions or in small ventricles.

• Wide cuff covers mitral annulus irregularities and offers ample room for suturing.

• Performance-based sizing provides optimal hemodynamics in every size.

Excellence in design

• Designed to endure the stressful closing pressures

of the mitral position.

• Low profile and asymmetrical design facilitates proper

orientation and positions the valve for optimal flow.6

• Low ventricular projection will not interfere with the subvalvular

apparatus or the blood flow.6

cellence.

Now made for mitral.

Anatomical saddle shapeUnique anterior saddle shapemimics the native anatomy

Low projectionShort and slim struts provide avery low ventricular projection

ssue processingards ThermaFixextracts both major

sites*

Specifically designed for mitral valves—the new mitralhandle helps surgeons reachdifficult exposures.

Sizer lip mimics thesewing band forprecise sizing withany technique.

Edwards Tricentrixholder system easesimplantation.

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References1. Arounlangsy P, et al. Histopathogenesis of early-stage mitral annular calcification. J Med Dent Sci 2004 Mar;51(1):35-44. 2. Marchand MA, et al. Fifteen-year experience with the Mitral Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis.

Ann Thorac Surg 2001;71:S236-9. Carpentier-Edwards PERIMOUNT Mitral Pericardial Bioprosthesis 16-year Results. Data on file at Edwards Lifesciences, 2003.

3. Frater RW, et al. Long-term durability and patient functional status of the Carpentier-Edwards Perimount pericardialbioprosthesis in the aortic position. J Heart Valve Dis 1998;7(1):48-53. Carpentier-Edwards PERIMOUNT Aortic PericardialBioprosthesis 20-year Results. Data on file at Edwards Lifesciences, 2003.

4. Liao K, et al. Bovine Pericardium Versus Porcine Aortic Valve: Comparison of Tissue Biological Properties As ProstheticValves; Artificial Organs 1992;16(4):361-365.

5. Bonow, et al. AHA/ACC Guidelines. J Am Coll Cardiol 2006;48:el-148.6. Gudbjartsson T, Aranki S, Cohn LH. Mechanical/bioprosthetic mitral valve replacement. In: Cohn LH, Edmunds LH Jr.,

eds. Cardiac Surgery in the Adult. New York; McGraw-Hill 2003:951986.

Edwards Lifesciences LLC • One Edwards Way • Irvine, CA 92614 USA • 949.250.2500 • 800.424.3278 • www.edwards.comEdwards Lifesciences (Canada) • 1290 Central Parkway West, Suite 300 • Mississauga, Ontario • Canada L5C 4R3 • 800.268.3993 • 905.566.4220

Edwards Lifesciences S.A. • Ch. du Glapin 6 • 1162 Saint-Prex • Switzerland • 41.21.823.4300

Rx only. See instructions for use for full prescribing information.

Edwards Lifesciences devices placed on the European marketmeeting the essential requirements referred to in Article 3 ofthe Medical Device Directive 93/42/EEC bear the CE marking ofconformity.

Edwards, Magna, and ThermaFix are trademarks of EdwardsLifesciences Corporation. Edwards Lifesciences, the stylized Elogo, Carpentier-Edwards, PERIMOUNT, PERIMOUNT Magna,and Tricentrix are trademarks of Edwards LifesciencesCorporation and are registered in the United States Patent andTrademark Office

© 2006 Edwards Lifesciences LLCAll rights reserved. AR01603

Carpentier-Edwards PERIMOUNT Magna Mitral Pericardial Bioprosthesis

Model 7000/7000TFX Nominal Specifications (mm)

Size 25 mm 27 mm 29 mm 31 mm 33 mm

A. Stent Diameter (Wireform—Inner Diameter ID) 25 27 29 31 31

B. External Stent Post Diameter (Base)† 28.0 29.5 31.5 33.5 33.5

C. External Stent Post Diameter (Tip) 29 31 34 35 35

D. External Sewing Ring Diameter 36 38 40 42 44

E. Ventricular Projection (anterior) 7 7.5 8 8.5 8.5

F. Ventricular Projection (posterior) 10 10.5 11 11.5 11.5

G. Total Profile Height 16 17 18 19 19

Accessories

• Sizer model 1177HP available in sizes 25-33 mm

• Flexible mitral handle model 1117

• Sterilization tray model TRAY1177HP for 1 sizer set and 3 handles

*No clinical data are available which evaluate the long-term impact of the Edwards Lifesciences tissue treatment in patients.

† Tissue annulus diameter

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