1
Edwards Lifesciences, the stylized E logo, Edwards,
Carpentier–Edwards, ThermaFix, Neutralogic, PERIMOUNT and
PERIMOUNT Magna are trademarks of Edwards Lifesciences
Corporation; Carpentier–Edwards and PERIMOUNT are
registered in the U.S. Patent and Trademark Office.
Elgiloy is a trademark of Elgiloy Limited Partnership.
Instructions for Use
1. Device Description
The Carpentier-Edwards PERIMOUNT Magna pericardial
bioprosthesis (also referred to as the Magna bioprosthesis) is a
trileaflet valve comprised of bovine pericardium that has been
preserved in a buffered glutaraldehyde solution and mounted
on a flexible frame.
The tissue is fixed using the novel Neutralogic fixation process
in which the tissue is placed in a stress-free bath of
glutaraldehyde solution.
The bioprosthesis is treated according to the Edwards ThermaFix
process, which involves heat treatment of the tissue with
glutaraldehyde and uses ethanol and polysorbate-80 (a surfactant).
The bioprosthesis is packaged and terminally sterilized in
glutaraldehyde. Glutaraldehyde is shown to both reduce the
antigenicity of tissue Xenograft valves and increase tissue stability
(Refs. 10 & 12). Glutaraldehyde alone has not been shown to affect
or reduce the calcification rate of the valve.
The frame is designed to be compliant at the orifice as well as at
the commissures. The compliance of the commissure supports
is intended to reduce the loading shock at the valve
commissures and free margin of the leaflets (Ref. 42). The
compliance of the orifice is intended to reduce the stress on the
leaflet. The compliant orifice concept is based on the physiology
and mechanics of natural heart valves and reported experience
with implantation of unstented homografts (Refs. 5 & 7).
The lightweight wireform frame is made of Elgiloy, a corrosion-
resistant alloy, chosen because of its superior spring efficiency
and fatigue resistant characteristics, and is covered with a
knitted polyester fabric.
A thin Elgiloy/polyester film laminate band surrounds the base of
the wireform frame providing structural support for the orifice.
To this frame is attached a soft, silicone-rubber suture ring that
is covered with a porous, seamless polytetrafluoroethylene cloth
to facilitate tissue ingrowth and encapsulation. The aortic sewing
ring has been scalloped to conform to the natural aortic root. The
compliant nature of the suture ring facilitates coaptation between
the valve and an often irregular or calcific tissue bed.
An integral valve holder is attached to the valve by means of
sutures to facilitate handling and suturing the valve during
implantation. The holder is easily detached by the surgeon
(see
11.2 Handling and Preparation Instructions
).
The sewing ring diameter on the Carpentier-Edwards
PERIMOUNT Magna pericardial bioprosthesis has been reduced
to facilitate implantation in patients with small aortic roots.
English
Model 3000TFX PERIMOUNT Magna Aortic
Modelo 3000TFX PERIMOUNT Magna aórtica
Modelo 3000TFX PERIMOUNT Magna Aórtico
CP1036-20
Carpentier-Edwards PERIMOUNT Magna
• Pericardial Bioprosthesis Model 3000TFX Aortic
• Bioprótesis pericárdica modelo 3000TFX aórtica
• Prótese Biológica Pericárdica Modelo 3000TFX Aórtico
DIRECTORY
English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Español . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Português . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
References / Bibliografía / Bibliografia
. . . . . .26– 27
Specifications / Especificaciones /
Especificações
. . . . . . . . . . . . . . . . . . . . . . . . . 28– 32
Figures / Figuras / Figuras
. . . . . . . . . . . . . . . 33– 34
Symbol Legend / Significado de los Símbolos /
Legenda dos Símbolos
. . . . . . . . . . . . . . . . . . . . . .35
149256001A_EN_ES_PT 16.2.2005 14:30 Uhr Seite 1
