Medtronic Open Pivot Instrucciones De Uso página 15

Valve Model Num-
Size ber
(mm)
26 501DA26
28 501DA28
MITRAL
16 501DM16
18 501DM18
20 501DM20
22 501DM22
24 501DM24
26 501DM26
28 501DM28
Table 4. MEDTRONIC OPEN PIVOT APex HEART VALVE SPECIFICATIONS
Valve Model Num-
Size ber
(mm)
AORTIC
16 503DA16
18 503DA18
20 503DA20
22 503DA22
24 503DA24
26 503DA26
28 503DA28
Table 5. MEDTRONIC OPEN PIVOT STANDARD HEART VALVE SPECIFICATIONS (Japan Only)
Valve Size Model
(mm) Number
AORTIC
19 500FA19
21 500FA21
23 500FA23
25 500FA25
27 500FA27
29 500FA29
31 500FA31
MITRAL
19 500DM19
21 500DM21
23 500DM23
25 500DM25
27 500DM27
29 500DM29
31 500DM31
33 500DM33
1.1. Orifice and Leaflets
Based on its history of successful use in cardiac valve prostheses, pyrolytic carbon was chosen for the leaflets
and orifice. The orifice is made of 100% pyrolytic carbon. The leaflets are made of pyrolytic carbon coated
over a graphite substrate that is impregnated with tungsten (20%) for radiopacity.
Each leaflet opens to a maximum of 85° with a maximum travel arc of 60° in all sizes.
The low profile of the prosthesis results from the bileaflet design with the pivot areas located entirely within
the orifice ring. This method of construction minimizes the overall height of the valve. Leaflet movement is
controlled by pivot guides located on the inner circumference of the orifice ring. The leaflets move smoothly
within these guides. There are no recesses or cavities in the pivot area.
The Medtronic Open Pivot Heart Valve can be rotated for optimal positioning once implanted in either the
aortic or mitral position.
The strengthening band, lock rings, and lockwire surrounding the pyrolytic carbon orifice are made of titanium
or a cobalt-chromium alloy (MP35N), for added strength and radiopacity.
1.2. Sewing Cuff
The sewing cuff of the Medtronic Open Pivot Heart Valve is made from double velour polyester that has a
history of use in cardiac valve prostheses.
Overall Inflow Pro-
Profile file Height
Height (mm)
(mm)
14.3 1.5
15.4 1.5
9.3 4.8
10.3 5.3
11.3 5.8
12.3 6.3
13.3 6.7
14.3 7.2
15.4 7.7
Overall Inflow Pro-
Profile file Height
Height (mm)
(mm)
9.3 1.5
10.3 1.5
11.3 1.5
12.3 1.5
13.3 1.5
14.3 1.5
15.4 1.5
Overall Inflow Pro-
Profile file Height
Height (mm)
(mm)
9.3 2.4
10.3 2.9
11.3 3.4
12.3 3.4
13.3 3.4
14.3 3.9
15.4 4.6
9.3 3.0
10.3 3.0
11.3 3.0
12.3 3.3
13.3 3.7
14.3 3.7
15.4 3.7
15.4 3.7
Outflow Inside
Profile Diameter
Height I.D. (mm)
(mm)
12.8 24.8
13.9 26.8
4.5 14.8
5.0 16.8
5.5 18.8
6.1 20.8
6.6 22.8
7.1 24.8
7.7 26.8
Outflow Inside
Profile Diameter
Height I.D. (mm)
(mm)
7.8 14.8
8.8 16.8
9.8 18.8
10.8 20.8
11.8 22.8
12.8 24.8
13.9 26.8
Outflow Inside
Profile Diameter
Height I.D. (mm)
(mm)
6.9 14.8
7.4 16.8
7.9 18.8
9.2 20.8
9.9 22.8
10.4 24.8
10.8 26.8
6.3 14.8
7.3 16.8
8.3 18.8
9.0 20.8
9.6 22.8
10.6 24.8
11.7 26.8
11.7 26.8
Instructions for Use
Tissue Geomet-
Annulus ric Orifice
Diameter Area
(mm)
(cm 2 )
26.2 4.59
28.2 5.35
16.2 1.55
18.2 2.02
20.2 2.56
22.2 3.17
24.2 3.84
26.2 4.59
28.2 5.35
Tissue Geomet-
Annulus ric Orifice
Diameter Area (cm
(mm)
16.2 1.55
18.2 2.02
20.2 2.56
22.2 3.17
24.2 3.84
26.2 4.59
28.2 5.35
Tissue Geometric
Annulus Orifice
Diameter Area (cm
(mm)
19.5 1.55
21.5 2.02
23.5 2.56
25.5 3.17
27.5 3.8
29.5 4.59
31.5 5.35
19.5 1.55
21.5 2.02
23.5 2.56
25.5 3.17
27.5 3.84
29.5 4.59
31.5 5.35
33.5 5.35
English
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