Use Instructions

24
evaluation of the MANCE free rate includes all subjects in the BAT + MM arm in the
Intended Use Population that have an attempted implant.
Within the Intended Use Population supporting the Expedited Phase, there are two cohorts
of data. Data that was previously analyzed in the original PMA dated December 14, 2018,
called the Initial Cohort data, and data that had not been previously unblinded and
analyzed and also is included here, called the Second Cohort data that was collected
through April 22, 2019. See Table 1 below for a breakdown of the intended use
populations that were used for the safety and effectiveness analyses.
Table 1: Analysis Populations for the Expedited Phase - Intended Use
Description
BAT +
Medical
Management
Medical
Management
Total
Expedited Phase Population - Intended Use
130
134
264
Expedited Phase Six Month Efficacy Analysis Population -
Intended Use
120
125
245
Not in Expedited Phase Six Month Efficacy Analysis
Population - Intended Use
10
9
19
No Implant Attempt
5
N/A
5
Died / LVAD / Heart Transplant prior to 6 month visit
1
5
6
Withdrew / LTFU prior to 6 month visit
2
0
2
Missed 6 month visit
2
4
6
Expedited Phase Safety Analysis Population - Intended Use
125
N/A
125
Not in Expedited Phase Safety Analysis Population -
Intended Use
5
N/A
5
No Implant Attempt
5
N/A
5
Total Randomized - Intended Use
130
134
264
The demographics of the study Intended Use Population are typical for a reduced ejection
fraction heart failure study performed in the US and UK. Baseline demographics for
Expedited Phase Intended Use Population subjects are in Table 2 below. Demographics
between the two randomized arms were balanced. Approximately 35% had a history of
atrial fibrillation, 24% chronic kidney disease and 47% Type II diabetes. Almost all subjects
(93 to 95%) are NYHA Class III at baseline with an average LVEF of 27% for BAT +MM and
28% for MM.
Table 2: Demographics at Baseline - Intended Use
BAT + Medical Management
Medical Management
Variable
N
Mean ± SD
or N (%)
Range
N
Mean ± SD
or N (%)
Range
P-value
Race
Asian
130
3 (2.3%)
N/A
134
2 (1.5%)
N/A
0.680
Black or African American
130
24 (18.5%)
N/A
134
20 (14.9%)
N/A
0.510
White
130
97 (74.6%)
N/A
134
96 (71.6%)
N/A
0.677