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Heart Valve
1. Device description
The Medtronic Open Pivot™ heart valve (Models 500, 501, and 505) orifice and leaflets are constructed of
pyrolytic carbon. The sewing cuff is constructed of polyester fabric and titanium or cobalt chrome. The
Medtronic Open Pivot heart valve is available in the aortic and mitral configurations in several sewing cuff
styles, the Standard, AP, and AP360. The AP Series valves are supra-annular configurations of the
standard heart valve. The valves are available in the dimensions and sizes shown in Table 1
through Table 8.
Table 1. Medtronic Open Pivot standard heart valve specifications (aortic)
Valve size
(mm)
19
500FA19
21
500FA21
23
500FA23
25
500FA25
27
500FA27
29
500FA29
31
500FA31
Table 2. Medtronic Open Pivot standard heart valve specifications (mitral)
Valve size
(mm)
19
500DM19 9.3
21
500DM21 10.3
23
500DM23 11.3
25
500DM25 12.3
27
500DM27 13.3
29
500DM29 14.3
31
500DM31 15.4
33
500DM33 15.4
Table 3. Medtronic Open Pivot AP360 heart valve specifications (aortic)
Valve size
(mm)
16
505DA16
18
505DA18
20
505DA20
22
505DA22
24
505DA24
26
505DA26
28
505DA28
Table 4. Medtronic Open Pivot AP360 heart valve specifications (mitral)
Valve size
(mm)
16
505DM16
18
505DM18
20
505DM20
22
505DM22
24
505DM24
26
505DM26
28
505DM28
Table 5. Medtronic Open Pivot AP heart valve specifications (aortic)
Valve
size (mm)
16
501DA16 9.3
18
501DA18 10.3
16
Instructions for Use
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 pro-
Inflow pro-
file height
file height
(mm)
(mm)
3.0
3.0
3.0
3.3
3.7
3.7
3.7
3.7
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
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 pro-
Inflow pro-
file height
file height
(mm)
(mm)
1.5
1.5
English
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
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)
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
Tissue
Geometric
annulus
orifice
diameter
area (cm
(mm)
19.2
1.55
21.2
2.02
23.2
2.56
25.2
3.17
27.2
3.8
29.2
4.59
31.2
5.35
Tissue
Geometric
annulus
orifice
diameter
area (cm
(mm)
19.2
1.55
21.2
2.02
23.2
2.56
25.2
3.17
27.2
3.84
29.2
4.59
31.2
5.35
33.2
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)
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)
16.2
1.55
18.2
2.02
2
)
2
)
2
)
2
)
2
)
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