27
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
IDE G030052 Pilot
IDE G040029 Pilot
RVAD HDE PAS
All CentriMag System Clinical
Patients
FTW
Cardiogenic Shock (BVAD)
RVAD w/ LVAD
RVAD w/ HMII LVAD
(n=32)
(n=26)
(n=12)
(n=25)
(n=95)
Adverse Event
Type
Total
Number
of
Number of Subjects Total
Number
of
Number of Subjects Total
Number
of
Number of Subjects
Total
Number
of
Number of Subjects
Total
Number
of
Number of Subjects
Events
With Event
Events
With Event
Events
With Event
Events
With Event
Events
With Event
Death [While on
device support or
< 30 days post
explant]
10
10
31%
15
15
58%
5
5
42%
5
5
20%
35
35
37%
Infection
22
13
41%
39
13
50%
17
4
33%
25
15
60%
103
45
47%
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.
