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.

Heart Failure Clinical Trial Overview12-14

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

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MANCE-Free Rate

97% of patients experienced freedom from major adverse neurological cardiovascular events at 6 months

97%
*Data on file at CVRx

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 treatment, 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.

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BAROSTIM NEO Physician Brochure

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BAROSTIM NEO Physician Brochure

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.