- CVRx Inc CVRX announced the preliminary topline results of the BeAT-HF (Baroreflex Activation Therapy for Heart Failure) post-market randomized clinical trial.
- The BeAT-HF post-market trial assessed 323 patients suffering from heart failure with reduced ejection fraction.
- The patients were randomized into two groups, treatment with Barostim and guideline-directed medical therapy versus guideline-directed medical therapy alone.
- The primary endpoint was a composite of cardiovascular mortality and heart failure morbidity (specifically worsening heart failure events requiring treatment in the hospital or emergency department).
- The trial accrued 332 primary events and had a median follow-up of 3.7 years, corresponding to 1,037 patient-years.
- While the trial did not reach statistical significance on the primary endpoint, it did contain additional clinically meaningful prespecified analyses that favored Barostim, including:
- All-cause survival, free from LVAD and heart transplant,
- A hierarchical composite analysis of cardiovascular mortality, heart failure events, quality of life, and clinical stability analysis.
- In addition, the safety profile of Barostim and the symptomatic improvement at six months were durable through 24 months.
- Barostim, approved by the FDA, uses neuromodulation to improve the symptoms of patients with heart failure.
- Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery, activating the body's baroreflex, which in turn triggers an autonomic response to the heart.
- Price Action: CVRX shares are down 33.7% at $11.40 during the premarket session on the last check Tuesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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