Use Instructions

Discussion and Conclusion

In the Intended Use Population, safety was demonstrated in the BeAT-HF trial in the 125

implanted subjects with a system- or procedure-related MANCE-free rate of 96.8%. There

were four MANCE events related to the system and/or the procedure of which all

recovered, three with no residual effect. There were no deaths in the BAT + MM

associated with either system or the procedure. There were no unanticipated adverse

events.

For the three effectiveness endpoints in the Intended Use Population, the BAT + MM arm

consistently showed significant improvement from baseline to six months, while the

Medical Management arm showed virtually no change. In the Second cohort, the

difference between the device was +50 meters (p<0.001) in 6MHW, -18 points in MLWHF

QOL (p<0.001) and -37% for NT-proBNP (p=0.01). These improvements were clinically

significant within the BAT + MM arm, as well as between the arms. These effectiveness

results were consistent across the Initial and the Second cohorts.

In the Expedited Phase Intended Use Population analysis for the PMA, the MANCE safety

endpoint and the two symptomatic endpoints (6MHW and QOL) were statistically and

clinically significant. Additionally, as reported, the blinded core lab evaluated NT-proBNP

provided objective evidence of device effect as validated by the Second Cohort’s

statistically significant results. The results of the BeAT-HF trial demonstrate compelling

evidence that the Barostim NEO is both safe and effective and is ready for commercial use

for the improvement of the symptoms of heart failure in patients who remain symptomatic

despite treatment with guideline-directed therapy, have a left ventricular ejection

fraction ≤ 35% and a NT-proBNP <1600 pg/ml, excluding patients indicated for Cardiac

Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.