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Valve
size (mm)
20
501DA20 11.3
22
501DA22 12.3
24
501DA24 13.3
26
501DA26 14.3
28
501DA28 15.4
Table 6. Medtronic Open Pivot AP heart valve specifications (mitral)
Valve
size (mm)
16
501DM16 9.3
18
501DM18 10.3
20
501DM20 11.3
22
501DM22 12.3
24
501DM24 13.3
26
501DM26 14.3
28
501DM28 15.4
Table 7. Medtronic Open Pivot standard heart valve specifications (Japan only): aortic
Valve size
(mm)
19
500FA19
21
500FA21
23
500FA23
25
500FA25
27
500FA27
29
500FA29
31
500FA31
Table 8. Medtronic Open Pivot standard heart valve specifications (Japan only): mitral
Valve size
(mm)
19
500DM19
21
500DM21
23
500DM23
25
500DM25
27
500DM27
29
500DM29
31
500DM31
33
500DM33
1.1. Orifice and leaflets
Pyrolytic carbon was chosen for the leaflets and orifice based on its history of successful use in cardiac
valve prostheses. 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.
The leaflets open to an approximate angle of 85 degrees and close to a maximum angle of approximately
25 degrees.
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.
Separate sewing cuffs are available for mitral or aortic implantation (Figure 1, Figure 2, and Figure 3). Cuff
markers are provided to assist in the uniform placement of sutures around the valve annulus.
Overall pro-
Inflow pro-
file height
file height
(mm)
(mm)
1.5
1.5
1.5
1.5
1.5
Overall pro-
Inflow pro-
file height
file height
(mm)
(mm)
4.8
5.3
5.8
6.3
6.7
7.2
7.7
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
Overall
Inflow pro-
profile
file height
height
(mm)
(mm)
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)
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)
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)
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
Outflow
Inside
profile
diameter
height
I.D. (mm)
(mm)
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
Geometric
annulus
orifice
diameter
area (cm
(mm)
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)
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
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
3.84
29.5
4.59
31.5
5.35
33.5
5.35
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