Heart Failure Clinical Trial Overview12-14
Healthcare Professionals
Heart Failure Trial Results
The Wold's First FDA Approved Neuromodulation Device for the Treatment of Heart Failure
FDA Approval (16 Aug 2019): Indication For Use in the United States
The BAROSTIMNEOTM System is indicated for the improvement of symptoms of heart failure – quality of life, six-minute hall walk and functional status – for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.
BeAT-HF Phase III Trial Results Published in the Journal of American College of Cardiology
BAROSTIM THERAPY is a safe and effective solution for improvement of symptoms in patients with heart failure
- BeAT-HF was a multi-center, prospective, randomized, controlled trial; subjects were randomized one-to-one to receive either baroreflex activation therapy (BAT) administered through Barostim Neo plus optimal medical management (BAT) or optimal medical management alone (Control).
- BeAT-HF patient cohort continues to be followed in the post-market study, for mortality and morbidity outcomes
- The intended use population that reflects the FDA approved instructions for use12 (enrollment criteria plus NT-proBNP < 1600 pg/ml), consisted of 245 patients followed for 6 months, 120 in BAT and 125 in control.
BAROSTIM THERAPY is Safe
View the PresentationMANCE-Free Rate
97% of patients experienced freedom from major adverse neurological cardiovascular events at 6 months
97%
Implant Success Rate*
100% of patients randomized to the device arm in BeAT-HF were successfully implanted with BAROSTIM NEO
100%
Effectiveness
Quality of Life
BAROSTIM THERAPY shows a clinically and statistically meaningful improvement in Quality of Life
Effectiveness
Exercise Capacity
BAROSTIM THERAPY shows a clinically and statistically meaningful improvement in Exercise Capacity
Effectiveness
New York Heart Class Improvement
65% of patients treated with BAROSTIM THERAPY improved by at least 1 NYHA Class after just 6 months of treated, which is a 34% improvement over the control arm
Effectiveness
NT - proBNP
BAROSTIM THERAPY shows a clinically and statistically meaningful improvement in NT – proBNP
Effectiveness
Other Serious Cardiovascular Events
- Heart failure hospitalization data from BeAT-HF remains blinded to support the on-going post-market outcome phase
- Evaluation of other serious cardiovascular events suggest a reduction between treatment arms
*events per patient-year of follow-up
Effectiveness
Patients with or without Atrial Fibrillation
BAROSTIM THERAPY is effective in the treatment of heart failure symptoms in patients with or without atrial fibrillation
Effectiveness
Phase II: HOPE4HF Shows LVEF Improvement and Hospitalization Days Reduction
Effectiveness
Phase II: HOPE4HF Shows Functional and Symptomatic Improvements
Durability of Effects
Phase II: HOPE4HF 12-Month Data Shows Significant and Sustained Benefit
Publications
CVRx is committed to the continued publication of clinical evidence supporting the benefit of BAROSTIM THERAPY for the treatment of heart failure.
BAROSTIM NEO Physician Brochure
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BAROSTIM NEO™ Brief Summary for Physicians
CAUTION: Federal law restricts this device to sale by or on the order of a physician. See System Reference Guide 900120-001 for a complete instruction for use and a description of indications, contraindications, warnings, precautions and adverse events.