Heart Failure Clinical Trial Overview12-14

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.
97% of patients experienced freedom from major adverse neurological cardiovascular events at 6 months
100% of patients randomized to the device arm in BeAT-HF were successfully implanted with BAROSTIM NEO
Quality of Life
BAROSTIM THERAPY shows a clinically and statistically meaningful improvement in Quality of Life
Exercise Capacity
BAROSTIM THERAPY shows a clinically and statistically meaningful improvement in Exercise Capacity
New York Heart Class Improvement
65% of patients treated with BAROSTIM THERAPY improved by at least 1 NYHA Class after just 6 months of treatment, which is a 34% improvement over the control arm
NT - proBNP
BAROSTIM THERAPY shows a clinically and statistically meaningful improvement in NT – proBNP
Other Serious Cardiovascular Events
*events per patient-year of follow-up
Patients with or without Atrial Fibrillation
BAROSTIM THERAPY is effective in the treatment of heart failure symptoms in patients with or without atrial fibrillation
Phase II: HOPE4HF Shows LVEF Improvement and Hospitalization Days Reduction
Phase II: HOPE4HF Shows Functional and Symptomatic Improvements
Phase II: HOPE4HF 12-Month Data Shows Significant and Sustained Benefit
CVRx is committed to the continued publication of clinical evidence supporting the benefit of BAROSTIM THERAPY for the treatment of heart failure.
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.