CVRx Touts Long-term Benefits For Barostim In Heart Failure Patients

  • CVRx Inc CVRX announced detailed preliminary results of the post-market phase of the BeAT-HF trial at the second annual Technology and Heart Failure (HF) Therapeutics (THT) conference.
  • The company announced the preliminary topline results of the BeAT-HF (Baroreflex Activation Therapy for Heart Failure) post-market randomized clinical trial.
  • Safety - Major Adverse Neurological or Cardiovascular (MANCE) system or procedure-related event-free rate
    • MANCE-free rate of 97%.
  • Long-term symptom improvement for Barostim Baroreflex Activation Therapy (BAT) vs. Control
    • 6 Minute Hall Walk improved by 44 meters at 12 months.
    • Quality of Life improved by 10 points on Minnesota Living with Heart Failure Questionnaire at 24 months.
    • NYHA Class improved in 27% more BAT patients at 24 months.
  • Mortality (cardiovascular death, LVAD, heart transplant) and morbidity (HF hospitalizations, ER visits) – primary endpoint
    • No statistically significant difference [Rate Ratio 0.94, (95% Confidence Interval 0.57, 1.57).
  • All-cause mortality (all-cause death, LVAD, heart transplant)
    • 34% relative reduction in BAT vs. Control [Hazard Ratio 0.66 (95% CI 0.44, 1.007); nominal p=0.054]
  • Hierarchical composite of cardiovascular death, LVAD, heart transplant, HF hospitalization, and Quality of Life using Win Ratio
    • A Win Ratio of 1.26 favored BAT vs. Control.
  • Price Action: CVRX shares are down 3.36% at $9.50 on the last check Tuesday.
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