Barostim Benefits Backed by Published Study Data

CVRx Inc. is sharing new data proving the quality of life benefits with Barostim for heart failure patients suffering from reduced ejection fraction.

A study published in the Journal of the American College of Cardiology: Heart Failure details durable improvements out to 24-months in the individual components of the Minnesota Living with Heart Failure (MLWHF) and EuroQual-5D (EQ-5D) quality of life measures. The published data builds on information from the BeAT-HF trial published in the European Journal of Heart Failure demonstrating the long-term sustained symptomatic benefits of Barostim in heart failure patients with reduced ejection fraction.
 
“We know many heart failure patients struggle with physical symptoms despite treatment with guideline-directed medical therapy (GDMT). As a result, patients’ reduced daily activity levels often adversely impact their emotional state and quality of life,” said Samuel F. Sears, Ph.D., a psychology professor at East Carolina University and lead author of the publication. “While we know Barostim plus GDMT demonstrates long-term symptomatic benefits, we now have data demonstrating sustained improvement in specific symptoms and quality of life measures benefiting patients receiving the therapy.”
 
Patients in the trial with Barostim plus GDMT reported feeling significantly better in a variety of physical and psychosocial measures as compared to patients who received GDMT alone. This included significant improvement in their ability to work around the house, sleep, and engage in activities with friends and family. Patients receiving Barostim reported less depression and feeling they were less of a burden on friends and family. Physically, they reported less shortness of breath, less fatigue and pain, and increased mobility and ability to perform usual activities.
 
“Congratulations to Dr. Samuel Sears and colleagues for their detailed description of the ways Barostim alleviates the burden of heart failure and improves patients’ quality of life. The durable functional and psychological improvements associated with Barostim are unique to this therapy and superior to medical management alone. To see quality of life results that remain this significant in long-term data are rare,” CVRx Chief Medical Officer Dr. Philip Adamson stated. “We believe this analysis of the long-term BeAT-HF data will support the shared decision making of patients and physicians when considering Barostim therapy.”
 
CVRx is focused on the development and commercialization of the Barostim System, the first medical technology approved by the U.S. Food and Drug Administration (FDA) that uses neuromodulation to improve heart failure symptoms. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors 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 the symptoms of heart failure. Barostim received FDA Breakthrough Device designation and is approved for use in U.S. heart failure patients. It has also received the CE Mark for heart failure and resistant hypertension.