CVRx presents data from post-market phase of BeAT-HF trial

CVRx announced detailed preliminary results of the post-market phase of the BeAT-HF trial at the second annual Technology and Heart Failure Therapeutics conference on Tuesday, March 21, 2023. These results are being presented by Dr. Michael Zile, Professor of Cardiology at the Medical University of South Carolina. Highlights of the data presented by Dr. Zile include: Safety – Major Adverse Neurological or Cardiovascular system or procedure-related event-free rate; MANCE-free rate of 97%; Long-term symptom improvement for Barostim Baroreflex Activation Therapy vs. Control: 6 Minute Hall Walk improved by 44 meters at 12 months; Quality of Life improved by 10 points in Minnesota Living with Heart Failure Questionnaire at 24 months; NYHA Class improved in 27% more BAT patients at 24 months; Mortality – primary endpoint; No statistically significant difference; All-cause mortality; 34% relative reduction in BAT vs. Control; Hierarchical composite of cardiovascular death, LVAD, heart transplant, HF hospitalization, and Quality of Life using Win Ratio; Win Ratio of 1.26 favored BAT vs. Control. Dr. Zile’s presentation concludes that the "Totality of evidence indicates that BAT is a safe, effective and durable treatment for patients with heart failure with reduced ejection fraction." The full results of BeAT-HF, including a number of additional analyses and endpoints, will be submitted by the executive steering committee for publication in one or more peer-reviewed journals. CVRx anticipates that regulatory submission to the FDA for expanded labeling will be made in the coming months.