Use Instructions

31
Implanted Subjects
(N=125)
Event
Number of
Events
Number of
Subjects
Event Rate
Surgical or Anesthetic Complications,
Infection at Implant Site (No Explant)
1
1
0.8%
Surgical or Anesthetic Complications,
Infection at Implant Site Requiring
Explanation
1
1
0.8%
Surgical or Anesthetic Complications, Other
Surgical Complication, prolonged intubation
1
1
0.8%
Thromboembolism, Systemic
1
1
0.8%
Total
12
9
7.2%
During the study, there were three contralateral ICD implants that had interactions with
the NEO IPG. All were noted to have been addressed by reducing the programmed therapy
settings for the NEO IPG.
ADDITIONAL SAFETY INFORMATION
Additional safety information using the data cutoff from the April 30, 2019, Executive
Summary (PMA) Report includes the analysis shown in 8 below. This table was reported in
the supplementary material of the peer reviewed Zile et al, JACC 2020 article, Appendix
Table 13: Cardiovascular Serious Events.
1
In the report the average follow-up time in the
Intended Use Population for these cardiovascular events was 14.5 months, with over 313
total years of follow-up.
8 demonstrates that BAT appears to reduce the rate of cardiovascular serious events
compared to control in the Intended Use Population
2
,
3
Table 8: Cardiovascular Serious Events in Intended Use Subjects
1
Zile et al, Appendix Table 13: Cardiovascular Serious Events, Supplemental Information to
"Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction." J
Am Coll Cardiol 76(1): 1-13, 2020.
2
Zile et al. Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection
Fraction. J Am Coll Cardiol, 2020, 76(1): 1-13.
3
Supplemental Information to "Baroreflex Activation Therapy in Patients With Heart Failure With
Reduced Ejection Fraction." J Am Coll Cardiol 2020, 76(1): 1-13.