News | Heart Failure | March 21, 2023

Totality of Evidence from BeAT-HF Study Shows CVRx’s Barostim Provides Long-term Benefits for Patients with Heart Failure

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

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

Related content:

CVRx Reports Preliminary Results of the BeAT-HF Post-Market Randomized Clinical Trial

Allegheny Health Network Cardiovascular Institute First in Pittsburgh to Implant Groundbreaking Neuromodulation Device as Alternative Therapy for Heart Failure Patients

Device Technologies to Reduce Heart Failure Readmissions 

Heart Rhythm Society 2019 Late-Breaking Clinical Trials 


Related Content

News | Heart Failure

September 15, 2023 — A team of interventional cardiologists from Henry Ford Health’s Center for Structural Heart Disease ...

Home September 15, 2023
Home
News | Heart Failure

September 13, 2023 — Socioeconomic status (education, income, employment status and health insurance) appears to be an ...

Home September 13, 2023
Home
News | Heart Failure

September 8, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of ...

Home September 08, 2023
Home
News | Heart Failure

September 5, 2023 — Cedars-Sinai investigators are leaders in the innovation and use of transcatheter aortic valve ...

Home September 05, 2023
Home
News | Heart Failure

August 30, 2023 — “Joining forces to protect the heart – this was our mission for this year’s ESC Congress,” said ...

Home August 30, 2023
Home
News | Heart Failure

August 29, 2023 — The European Society of Cardiology (ESC) Guidelines on acute coronary syndromes are published online ...

Home August 29, 2023
Home
News | Heart Failure

August 28, 2023 — Ferric carboxymaltose(FCM) did not improve a hierarchical outcome of death, heart failure ...

Home August 28, 2023
Home
News | Heart Failure

July 28, 2023 — The Society of Thoracic Surgeons has launched its next-generation Operative Risk Calculator to assess ...

Home July 28, 2023
Home
News | Heart Failure

July 19, 2023 — The U.S. Food and Drug Administration (FDA) is recommending health care providers, laboratory personnel ...

Home July 19, 2023
Home
News | Heart Failure

July 18, 2023 — The U.S. Food and Drug Administration (FDA) has issued a Class I recall on Quidel Cardiovascular is ...

Home July 18, 2023
Home
Subscribe Now