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PMDA
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PMDA
PMDA
QOL
In vitro In vivo
PMDA
PMDA-WEST
1.
22200BZX00939000
2.
22200BZX00940000
3. HeartMate II
Thoratec Corporation
22400BZI00017000
EVAHEART
IEC
EMC ISO
( 10 90 )
2
41 3
2 5 2 5
3 15 3
2 13
1
3 6 6
12
12 24
13
0 2
0
6 86.7%
2 41
22 32
0
2009 12 9
37 17
43
0 6
12 100%
2009 12 9
12 79.4%
24 72.2%
3 93
47
27
0
6
(
)
( )
•
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16
6
•
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•
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0 200 400 600 800 1000 1200 1400 1600 1800 2000
p=0.0165
Novacor
(n=29)
LVAS-C01
(n=18)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0 200 400 600 800 1000 1200 1400 1600 1800
LVAS-C01
(n=18)
Novacor
(n=29)p=0.0118
17
6
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DuraHeart
EU 2007 2 CE
1 1/94
1 1/94
3 5 5/94
IEC
EMC ISO
( 12 60 )
2
41 3
2010/1/15
2010/2/26
2010/8/31
4 5
4
2 16 5
4
33 6 55 28 6
13
26 76.0%
26 6 6
13
81.5%
135
96
70
26
100%
42
17
3
6
92.4%
12
10 5
1
4
2
3
1
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HeartMate II
2008 4 BTT(Bridge-to-Transplant: )
2010 1 DT(Destination Therapy: )
EU 2005 11 CE
1
72 1972
8194 16
29
SOBR
IEC
EMC ISO
( 3 30
)
2
41 3
BTT
6
194 6 6
6 6
6 66.5
75.8
41 586
460 253
6
6 100%
16 1
2 4
2012 9
13 24
EVAHEART
DuraHeart
( )
2
2
2
700
44
45
180
180
EVAHEART DuraHeart
KaplanMeier
EVAHEART 6 13/15(86.7%) 86.7%
DuraHeart
13 27/33(81.8%) 81.5%
6 76.0%
26 6/6(100%) -
HeartMateII180 147/194(75.8%) 77.7%
6 6/6(100%) -
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PMDA
PMDA
