Abbott CentriMag Reference Manual page 26

Safety and Effectiveness and Results
Safety Results
The analysis of safety was based on all 95 patients enrolled in the four clinical studies of the CentriMag system described above, thereby providing a more conservative estimate of the safety profile inclusive
of all study (mixed) cohorts, not just FTW subjects. Safety was evaluated on the basis of adverse events and device malfunctions.
Adverse Events that occurred in all CentriMag Clinical Studies
Adverse events observed during the four studies are summarized in the table below. The clinical studies were not powered for a specific analysis of adverse events. The adverse event rates observed during
the clinical studies were not unexpected in this critically ill patient population, being typical for patients recovering from open heart surgery and supported by a mechanical circulatory support device, as
reported in the literature. The risk of bleeding, infection and respiratory failure is high in this patient population, although the number of these events which were reported as directly attributable to the
device was relatively low. There were no unanticipated adverse events reported in any of the four clinical studies. Adverse event definitions were similar but not identical across the studies so direct
comparisons are not possible. However, the table shows that general trends in types and incidence of adverse events were similar across all four studies.
Table 13. Summary of Adverse Events, All CentriMag System Clinical Studies
IDE G030052 Pivotal
FTW 15
(n=32)
Adverse Event Total Number of Subjects Total
Type Number
of
Events With Event
Death [While on 10 10
device support or
< 30 days post
explant]
Infection 22 13
14
Pivotal trial AE's are during device use only, all other studies include adverse events both during device use and during follow-up after explant.
15
Pivotal FTW Trial enrolled 100% (32/32) FTW subjects.
16
The Cardiogenic Shock Trial (G030052) enrolled a mixed cohort of patients in CS, at least 27% FTW subjects.
17
The RVAS Trial (G040029) enrolled patients in post-cardiotomy cardiogenic shock following implantation of an LVAD, over 90% FTW subjects.
18
The RVAS HDE Post Approval Study enrolled no identified FTW subjects.
14
IDE G030052 Pilot
Cardiogenic Shock (BVAD) 16
(n=26)
Number of Subjects
Number
of
Events With Event
31% 15 15 58%
41% 39 13 50%
IDE G040029 Pilot RVAD HDE PAS
RVAD w/ LVAD 17 RVAD w/ HMII LVAD
(n=12) (n=25)
Total Number of Subjects Total
Number Number
of of
Events With Event Events
5 5 42% 5
17 4 33% 25
27
All CentriMag System Clinical
Patients
18
(n=95)
Number of Subjects Total Number of Subjects
Number
of
With Event Events With Event
5 20% 35 35
15 60% 103 45
37%
47%