CVRx’s Barostim Neuromodulation Device for Heart Failure Patients Evaluated in Long-Term BeAT-HF Data

March 21, 2023—CVRx, Inc., developer of the Barostim extravascular implantable neuromodulation device for patients with cardiovascular diseases, announced preliminary results of the postmarket phase of the BeAT-HF trial.

According to the company, the Barostim device uses neuromodulation to improve the symptoms of patients with heart failure (HF). Barostim delivers electrical pulses to baroreceptors located in the wall of the carotid artery that activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce HF symptoms.

Michael Zile, MD, presented the BeAT-HF data at THT 2023, the second annual Technology and Heart Failure Therapeutics conference held March 20-23 in Boston, Massachusetts. Dr. Zile is Professor of Cardiology at the Medical University of South Carolina in Charleston, South Carolina.

CVRx outlined the highlights of Dr. Zile’s presentation comparing Barostim baroreflex activation therapy (BAT) versus control as follows:

• Safety of BAT demonstrated by a major adverse neurological or cardiovascular (MANCE) system or procedure-related event-free rate of 97% (P < .001)
• Long-term symptom improvements with BAT versus control included 6-minute hall walk improvement of 44 meters at 12 months (nominal P < .001), Minnesota Living with Heart Failure Questionnaire quality-of-life improvement of 10 points at 24 months (nominal P < .001), and New York Heart Association class improvement in 27% more BAT patients versus control at 24 months (nominal P < .001).
• In the trial’s primary endpoint of mortality (cardiovascular death, left ventricular assist device [LVAD], heart transplant) and morbidity (HF hospitalizations, emergency room visits), there was no statistically significant difference (rate ratio, 0.94; 95% CI, 0.57-1.57; P = .82).
• In all-cause mortality (all-cause death, LVAD, heart transplant), there was a 34% relative reduction in BAT versus control (hazard ratio, 0.66; 95% CI, 0.44-1.007; nominal P = .054).
• In a hierarchical composite of cardiovascular death, LVAD, heart transplant, HF hospitalization, and quality of life, the Win Ratio of 1.26 favored BAT versus control (95% CI, 1.02-1.58; nominal P = .04).

As noted in the press release, Dr. Zile’s presentation concluded, “Totality of evidence indicates that BAT is a safe, effective, and durable treatment for patients with HF with reduced ejection fraction.”

The company advised that the slides from Dr. Zile’s featured presentation, as well as key slides presented as part of a CVRx-sponsored symposium at THT, are available at ir.cvrx.com. The full results of BeAT-HF, including 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.

Barostim received FDA Breakthrough Device designation and is FDA approved for use in HF patients in the United States. Additionally, Barostim received CE Mark approval for HF and resistant hypertension in the European Economic Area.