A new level of design excellence. The Carpentier-Edwards PERIMOUNT Magna mitral pericardial bioprosthesis is built upon the proven design and long-term performance of PERIMOUNT valves. From durability driven by design... The pioneering design of the first PERIMOUNT mitral valve demonstrated remarkable long-term durability 1 and exceptional hemodynamic performance. 2 The Carpentier-Edwards PERIMOUNT Magna mitral valve integrates this proven platform, as well as numerous new design features and advanced proprietary processes. Low profile Saddle shape Asymetrical design Lowest ventricular projection Variable compliance Compliant sewing band New mitral handle Carpentier-Edwards ThermaFix advanced tissue process Performance-based sizing One-piece polyester band Tricentrix holder system PeriMap technology Leaflet matching XenoLogiX tissue treatment PERIMOUNT Magna mitral valve PERIMOUNT Theon system PERIMOUNT Plus mitral valve PERIMOUNT mitral valve ...to a new level of design excellence. 99 92 89 N= 99 80 77 73 71 65 59 49 46 36 29 20 15 8 3 1 N= 188 160 153 147 143 131 120 104 98 82 72 55 37 21 10 5 2 N= 278 238 228 219 212 196 183 164 157 135 123 99 66 41 25 12 4 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Years Postoperative 100% 80% 60% 40% 20% 0% 16-year Durability of the PERIMOUNT mitral valve model 6900 Cumulative incidence at 15 years for patients ≥70 years is 1.1 ± 1.1% Cumulative incidence at 16 years for patients ≥65 years is 7.6 ± 2.2% Cumulative incidence at 16 years for patients ≥60 years is 11.3 ± 2.4% 11% 8% 1%
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A new level of design excellence.
The Carpentier-Edwards PERIMOUNT Magna mitral pericardial bioprosthesis is built upon the proven design and long-term performance of PERIMOUNT valves.
From durability driven by design...
The pioneering design of the first PERIMOUNT mitral valve demonstrated remarkable long-term durability1
and exceptional hemodynamic performance.2
The Carpentier-Edwards PERIMOUNT Magna mitral valve integrates this proven platform, as well as
numerous new design features and advanced proprietary processes.
16-year Durability of the PERIMOUNT mitral valve model 6900
Cumulative incidence at 15 years for patients ≥70 years is 1.1 ± 1.1%
Cumulative incidence at 16 years for patients ≥65 years is 7.6 ± 2.2%
Cumulative incidence at 16 years for patients ≥60 years is 11.3 ± 2.4%
11%8%1%
Any quotes used in this material are taken from independent third-partypublications and are not intended to imply that such third party reviewed orendorsed any of the products of Edwards Lifesciences.
Rx only. See instructions for use for full prescribing information.
Edwards Lifesciences devices placed on the European market meeting the essentialrequirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bearthe CE marking of conformity.
Edwards, PeriMap, PERIMOUNT Theon, ThermaFix and XenoLogiX are trademarksof Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo,Carpentier-Edwards, PERIMOUNT, PERIMOUNT Magna, PERIMOUNT Plus andTricentrix are trademarks of Edwards Lifesciences Corporation and are registered inthe United States Patent and Trademark Office.
Mosaic is a registered trademark of Medtronic, Inc. SJM and SJM Biocor areregistered trademarks of St. Jude Medical.
Design excellence results in ease of use, durability and hemodynamic performance. The design of PERIMOUNT
mitral valves demonstrates excellent hemodynamics across all sizes.3
Several published clinical studies have demonstrated that PERIMOUNT valves hemodynamic performance
matches the hemodynamics of mechanical valves in the mitral position.2,8,9
“Hemodynamically, (PERIMOUNT mitral) pericardial valves provide the best solutionto flow problems. The design maximizes use of the flow area, which results inminimal flow resistance.” —Gudbjartsson et al3
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
EOA in cm2 (Follow-up interval ≥11 months post-op)
Labeled Size 25 27 29 31 33
PERIMOUNT valve2,3 2.6 2.7 2.6 3.1 NA
SJM mechanical valve 2.64 2.54 2.44 2.85 3.15
Mosaic valve6 1.6 1.7 1.8 1.7 NA
SJM Biocor valve7 0.9 n/a 1.5 1.7 1.8
References1. Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis 16-year Results. Data on file at Edwards Lifesciences, 2003.2. Aupart MR, et al. Carpentier-Edwards pericardial valves in the mitral position: ten-year follow-up. J Thorac Cardiovasc
Cardiac Surgery in the Adult. New York: McGraw-Hill, 2003:951986.4. Hasegawa M, et al. Clinical evaluation of ATS prosthetic valve by Doppler echocardiography: comparison with St. Jude
Medical (SJM) valve. Ann Thorac Cardiovasc Surg 2000;6:247.5. Chaux A, et al. An appreciation of the new St. Jude valvular prosthesis. J Thorac Cardiovasc Surg 1981;81:202.6. Mosaic Bioprosthesis product insert – Instructions for use – version 1.5. June 2000.7. St. Jude Medical Physician’s Manual SJM Biocor® valve – 681882-001B – Table 14 – Sahlgrenska University Hospital,
Gothenburg, Sweden – unpublished.8. Goetze S, et al. In vivo short-term Doppler hemodynamic profiles of 189 Carpentier-Edwards Perimount pericardial
bioprosthetic valves in the mitral position. J Am Soc Echocardiogr. 2004 Sep;17(9):981-7.9. Firstenberg MS, et al. Short-term hemodynamic performance of the mitral Carpentier-Edwards PERIMOUNT pericardial
valve. Carpentier-Edwards PERIMOUNT Investigators. Ann Thorac Surg. 2001 May;71(5 Suppl):S285-8.