CVRx has announced positive two-year data demonstrating durable improvements in heart failure patients treated with its Barostim device. The study, published in the Journal of the American College of Cardiology: Heart Failure, reveals significant enhancements in patients' physical and psychosocial well-being.
Barostim Device and Baroreflex Activation Therapy
Barostim employs baroreflex activation therapy, delivering electrical stimulation to baroreceptors in the carotid sinus. This stimulation activates the body’s baroreflex, a crucial homeostatic mechanism for maintaining blood pressure. The therapy aims to rebalance the autonomic nervous system, alleviating heart failure symptoms. The device received FDA approval in 2019 for advanced heart failure patients ineligible for other devices and expanded its label in late 2023 for a wider range of patients.
Key Findings from the Study
Patients treated with Barostim, in conjunction with guideline-directed medical therapy (GDMT), exhibited notable long-term improvements. These included enhanced ability to perform normal activities such as household tasks, improved sleep quality, and increased engagement in social activities. Furthermore, patients reported less shortness of breath, reduced fatigue and pain, and fewer instances of depression.
Impact on Quality of Life
The improvements were assessed using the Minnesota Living with Heart Failure (MLWHF) and EuroQual-5D (EQ-5D) questionnaires, standard tools in cardiovascular studies for evaluating treatment efficacy. Professor Samuel Sears, the study's lead author, emphasized, "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."
Building on Previous Data
This latest publication reinforces data from the BeAT-HF trial (NCT02627196), previously published in the European Journal of Heart Failure, which highlighted the sustained symptomatic benefits of Barostim in heart failure patients with reduced ejection fraction. CVRx’s 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."
Market Context
The global neuromodulation device market is projected to reach $11.4 billion by 2033, according to a GlobalData report. CVRx reported revenue of $39.3 million in 2023, a $16.8 million increase from the previous year, with 178 active implanting centers as of December 31, 2023.
