32
Table 18. End Organ Function – FTW from CPB Pivotal Study (G030052/S21)
Interval
N
Mean
Range
(BUN)
(mg/dl)
Day 1
30
37
15 – 76
Day 2
29
40
15 – 76
Day 3
28
41
14 – 86
Day 7
16
30
14 – 67
Day 14
10
28
18 – 62
Creatinine
(mg/dl)
Baseline
32
1.8
0.9 – 4.0
Day 1
30
1.8
0.9 – 4.0
Day 2
29
1.9
0.9 – 3.1
Day 3
28
1.8
0.7 – 3.3
Day 7
16
1.4
0.7 – 4.8
Day 14
10
1.2
0.9 – 1.9
Total Bilirubin
(mg/dl)
Baseline
31
1.8
0.4 – 9.7
Day 1
26
3.8
0.7 – 8.7
Day 2
26
5.0
0.5 – 14.5
Day 3
27
5.9
0.8 – 13.2
Day 7
15
5.0
0.5 – 16.0
Day 14
10
5.7
0.5 – 28.1
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
Clinical Study
N
Survival to 30 Days
Post-device
Survival to Discharge
Primary Endpoint Success
Cardiogenic Shock
Trial (G030052)
26
11/26 (42%)
---
Not Defined
RVAS Trial
(G040029)
12
7/12 (58%)
---
Not Defined
Table 20. Duration of CentriMag Support in in two Pilot Studies
Clinical Study
Indication For Use
N
Mean Duration of Support
(days)
Range (days)
RVAS Trial (IDE
G040029)
PCCS after LVAD implantation,
90% FTW
12
15.3
1 - 29
Cardiogenic Shock
Trial (IDE G030052)
CS (PCCS and/or post Myocardial
Infarction);
≥ 27% FTW
26
12.8
1 - 60
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
Number of Subjects
Primary Endpoint Success
Subjects Surviving to 6 Months
LVAD
7
4 (57%)
3 (43%)
BiVAD
5
2 (40%)
0 (0%)
22
The Cardiogenic Shock Trial (G030052) enrolled a mixed cohort of patients in CS, at least 27% FTW subjects.
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
