Boston Scientific Corporation CRMA20914 ユーザーズマニュアル

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Accountability of PMA Cohort 
Of 330 patients enrolled in PMA study, 321 underwent an implant procedure, of whom 314 were implanted with the S-ICD 
System.  There were 293 patients still active at the time of database lock on February 14, 2012.  The mean follow-up duration 
for all patients implanted was 330 days with a range of 17 to 715 days.  Cumulative time of follow-up for all implanted 
patients was 3,410 months.  The disposition of all study participants is summarized in Figure 1 below:
Figure 1: Summary of Patient Status as of 14 February, 2012
Enrolled
n=330
Implant Attempt
n=321
Withdrawn Prior to 
Implant Procedure
n=9
Active
n=293
Discontinued
n=21
(11 Explanted, 
2 Withdrawn, 
8 Deaths)
Not Implanted
 n=7
(All 7 Withdrawn)
Implanted
n=314