Use Instructions

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CLINICAL SUMMARY
The Baroreflex Activation Therapy for Heart Failure (BeAT-HF) trial was a prospective,
randomized (1:1), two-arm controlled trial to establish a reasonable assurance of safety
and effectiveness of the Barostim NEO Systems for the reduction of the symptoms of heart
failure in patients. The trial generated data from subjects who met the following key
criteria:
• Currently NYHA Class II or III heart failure. For NYHA Class II, must have been
NYHA Class III at any point in time within 3 calendar months prior to enrollment or
at time of screening.
• Left ventricular ejection fraction ≤ 35% within 45 days prior to randomization.
• Heart failure accompanied by BNP≥100 or NT-proBNP ≥ 400 within 45 days prior to
randomization, or a heart failure hospitalization in the past 12 months.
• On optimal, stable, Guideline Directed Medical Therapy (GDMT) per country
specific guidelines for the treatment of heart-failure throughout
screening/baseline evaluation and for at least 4 weeks prior to obtaining any post-
consent screening parameters.
Excluding Subjects who:
• Received cardiac resynchronization therapy (CRT) within six months of
randomization or is actively receiving CRT.
• Currently have a Class I indication for a cardiac resynchronization therapy (CRT)
device according to AHA/ACC/ESC guidelines for the treatment of congestive heart
failure.
The trial enrolled 408 randomized subjects at 92 sites, 91 in the United States (US) and 1
in the United Kingdom (UK).
It was designed as a two-phase trial. The first phase, the Expedited Phase, supports a PMA
under the FDA Breakthrough Devices Program, which is the information included in this
summary. The second phase, the Extended Phase, is ongoing and is intended to collect
post-market long-term information, including morbidity and mortality (M&M) data.
The following endpoints were evaluated at 6 months:
• Safety - Major Adverse Neurological & Cardiac Events, event free rate
• Effectiveness – 6 Minute Hall Walk (6MHW), Minnesota Living with Heart Failure
(QoL) and NT-proBNP.
Subjects were randomized in a 1:1 ratio to receive Baroreflex Activation Therapy (BAT)
with an implanted Barostim System in addition to medical management (BAT + MM) or to
receive medical management (MM) alone (no device implant). After evaluating the pre-
planned Expedited Phase initial data review in early October 2018, a large, important and
clinically relevant population was identified. This subgroup population is characterized by
having NYHA Class III or II (recent history of Class III) heart failure, left ventricular
ejection fraction ≤ 35% and baseline NT-proBNP < 1600 pg/ml at the time of baseline.
This subgroup, referred to as the Intended Use Population, is the focus of the PMA.
The Intended Use Population for the Expedited Phase analysis of the 6-month efficacy
endpoints, includes all subjects randomized with a baseline NT-proBNP<1600 that have
complete baseline and six-month data for MLWHF QOL, 6MHW and/or NT-proBNP. The