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Table 18. End Organ Function – FTW from CPB Pivotal Study (G030052/S21)
(BUN)
(mg/dl)
Creatinine
(mg/dl)
Total Bilirubin
(mg/dl)
Survival at six months after cessation of support with the CentriMag system was also tracked as a secondary effectiveness endpoint in
the pivotal study of the failure to wean from CPB indication for use. At six months after device removal survival was 53%, compared to
69% at 30 days after device removal, showing that recovery from the initial hemodynamic instability that required use of the CentriMag
system for circulatory support was sustained over time.
A supplemental analysis of effectiveness at the 30-day post-device removal time point was conducted for the 38 evaluable patients that
participated in the other premarket pilot studies. Each of these studies had mixed cohorts, with some percentage of FTW patients.
These supplemental effectiveness outcomes are presented in Table 19 and Table 20.
Table 19. CentriMag Effectiveness in Two Pilot Studies – Survival and Primary Endpoint
N
Clinical Study
Cardiogenic Shock
26
Trial (G030052)
22
RVAS Trial
12
(G040029)
23
Table 20. Duration of CentriMag Support in in two Pilot Studies
Indication For Use
Clinical Study
RVAS Trial (IDE
PCCS after LVAD implantation,
G040029)
90% FTW
CS (PCCS and/or post Myocardial
Cardiogenic Shock
Trial (IDE G030052)
Infarction);
Subgroup Analyses
Due to the small number of patients in the clinical studies, statistically meaningful evaluations of potential associations of preoperative
characteristics with outcomes could not be performed.
For the Pivotal FTW Clinical Study, the primary effectiveness endpoint and survival to 6 months after cessation of CentriMag system
circulatory support were analyzed with respect to device configuration as shown in the table below. Due to the small number of patients
in each group no conclusions can be drawn from the analysis.
Table 21. Six Month Survival Post-Device Removal for FTW from CPB Pivotal Study (G030052/S21)
Device
Configuration
LVAD
24
BiVAD
The Cardiogenic Shock Trial (G030052) enrolled a mixed cohort of patients in CS, at least 27% FTW subjects.
22
23
The RVAS Trial (G040029) enrolled patients in post-cardiotomy cardiogenic shock following implantation of an LVAD, over 90% FTW subjects.
24
Two CentriMag pumps, one LVAD and one RVAD
Interval
N
Day 1
30
Day 2
29
Day 3
28
Day 7
16
Day 14
10
Baseline
32
Day 1
30
Day 2
29
Day 3
28
Day 7
16
Day 14
10
Baseline
31
Day 1
26
Day 2
26
Day 3
27
Day 7
15
Day 14
10
Survival to 30 Days
Post-device
11/26 (42%)
7/12 (58%)
≥ 27% FTW
Number of Subjects
Primary Endpoint Success
7
4 (57%)
5
2 (40%)
Mean
37
40
41
30
28
1.8
1.8
1.9
1.8
1.4
1.2
1.8
3.8
5.0
5.9
5.0
5.7
Survival to Discharge
---
---
Mean Duration of Support
N
(days)
12
15.3
26
12.8
Subjects Surviving to 6 Months
3 (43%)
0 (0%)
32
Range
15 – 76
15 – 76
14 – 86
14 – 67
18 – 62
0.9 – 4.0
0.9 – 4.0
0.9 – 3.1
0.7 – 3.3
0.7 – 4.8
0.9 – 1.9
0.4 – 9.7
0.7 – 8.7
0.5 – 14.5
0.8 – 13.2
0.5 – 16.0
0.5 – 28.1
Primary Endpoint Success
Not Defined
Not Defined
Range (days)
1 - 29
1 - 60
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