Use Instructions

27
BAT + Medical
Management
Medical Management
Treatment
N
Mean ± SD
or N (%)
Range
N
Mean ± SD
or N (%)
Range
P-value
Pacemaker (non-ICD)
130
2 (1.5%)
N/A
134
1 (0.7%)
N/A
0.618
CRT
130
3 (2.3%)
N/A
134
4 (3.0%)
N/A
1.000
Other cardiac device (e.g.,
CardioMEMS)
130
6 (4.6%)
N/A
134
4 (3.0%)
N/A
0.536
Safety Results
The system or procedure related Major Adverse Neurological and Cardiovascular Events
(MANCE) endpoint includes all events that occur within 6-months post implant. The
analysis includes the BAT + MM in the Intended Use Population who had an implant
attempted (n=125).
As shown in Table 5 below, the MANCE-free rate for the Intended Use Population is 96.8%
(121/125) with a lower bound one-sided 95% confidence level of 92.8% (p value <0.001).
As the lower bound is greater than 85%, the safety endpoint has been met in the Intended
Use Population.
Table 5: System or Procedure Related MANCE-Free Rate in BAT
+ Medical Management - Intended Use
Total
Number of
Subjects
Number of
Subjects
MANCE-Free
MANCE-Free
Rate
One-Sided
95% Lower
Bound
P-
value
MANCE Event-Free
125
121
96.8%
92.8%
<.001
The four MANCE components are shown in Table 6 below. There were 2 infections
requirement explant, 1 acute decompensated heart failure event and 1 stroke.
Table 6: System or Procedure Related MANCE Events
in BAT + Medical Management - Intended Use
Implanted Subjects
(N=125)
Event
Number
of Events
Number
of
Subjects
Event
Rate
CV Death
0
0
0.0%
Stroke
1
1
0.8%
Cardiac Arrest
0
0
0.0%
Acute MI
0
0
0.0%
Acute Decompensated HF
1
1
0.8%