March 21, 2023 — CVRx, Inc., a commercial-stage medical device company focused on developing, manufacturing and commercializing Barostim, an innovative extravascular implantable neuromodulation device for patients with cardiovascular diseases, 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 on Tuesday, March 21, 2023. These results are being presented by Dr. Michael Zile, Professor of Cardiology at the Medical University of South Carolina (MUSC).
Highlights of the data presented by Dr. Zile include:
- Safety - Major Adverse Neurological or Cardiovascular (MANCE) system or procedure-related event-free rate
- MANCE-free rate of 97% (p<0.001)
- Long-term symptom improvement for Barostim Baroreflex Activation Therapy (BAT) vs. Control:
- 6 Minute Hall Walk improved by 44 meters at 12 months (nominal p<0.001)
- Quality of Life improved by 10 points in Minnesota Living with Heart Failure Questionnaire at 24 months (nominal p<0.001)
- NYHA Class improved in 27% more BAT patients at 24 months (nominal p<0.001)
- 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); p=0.82]
- 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
- Win Ratio of 1.26 favored BAT vs. Control [95% CI 1.02, 1.58; nominal p=0.04]
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 slides from Dr. Zile’s featured presentation, as well as key slides that will be presented as part of the CVRx-sponsored THT symposium, can be found at ir.cvrx.com.
“We are happy to see the significant long-term data that favored Barostim,” added Nadim Yared, President and CEO of CVRx. “Interest and adoption of the therapy continue to expand based on the previously-approved claims, and now we look forward to submitting this new data to the FDA to pursue expanded labeling for Barostim. We are forever grateful to the patients, investigators, nurses, and research staff involved in the study.”
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.
For more information: www.cvrx.com