a new level of design excellence. - edwards...

2
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%

Upload: others

Post on 20-Jul-2020

8 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: A new level of design excellence. - Edwards …ht.edwards.com/resourcegallery/eu/magnamitral/ar01605.pdf• 800.268.3993 • 905.566.4220 Edwards Lifesciences S.A. • Ch. du Glapin

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.

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 technologyLeaflet matching

XenoLogiX tissue treatment

PERIMOUNT Magnamitral valve

PERIMOUNT Theon system

PERIMOUNT Plusmitral valve

PERIMOUNT mitral valve

...to a new level of design excellence.

999289

N= 99 80 77 73 71 65 59 49 46 36 29 20 15 8 3 1N= 188 160 153 147 143 131 120 104 98 82 72 55 37 21 10 5 2N= 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%

Page 2: A new level of design excellence. - Edwards …ht.edwards.com/resourcegallery/eu/magnamitral/ar01605.pdf• 800.268.3993 • 905.566.4220 Edwards Lifesciences S.A. • Ch. du Glapin

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.

© 2006 Edwards Lifesciences LLCAll rights reserved. AR01605

Proven hemodynamic performance

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

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

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

Surg 1997;113:492.3. 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, 2003:951986.4. 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.