CVRx has announced promising results from a two-year study of its Barostim device, which is designed for heart failure patients. This device uses baroreflex activation therapy to improve patient outcomes.
The recent findings, published in the Journal of the American College of Cardiology: Heart Failure, show that patients who received the Barostim implant, combined with standard medical therapy, reported significant improvements in their physical and mental well-being compared to those who only received standard therapy.
Barostim works by delivering electrical stimulation to baroreceptors located in the carotid sinus. These receptors are part of the body’s system for regulating blood pressure. By stimulating these receptors, Barostim aims to restore balance to the autonomic nervous system, which can help alleviate heart failure symptoms.
The Device Was Frst Approved by The U.S. Food And Drug
Administration (FDA) in 2019 for patients with advanced heart failure who are not candidates for other treatments. In late 2023, the FDA expanded its approval to include a broader range of heart failure patients.
According to CVRx, patients using Barostim experienced long-term benefits, such as improved ability to perform daily activities, better sleep quality, and increased participation in social activities. The device also helped reduce symptoms like shortness of breath, fatigue, and depression.
These improvements were measured using the Minnesota Living with Heart Failure (MLWHF) and EuroQual-5D (EQ-5D) questionnaires, which assess the effectiveness of treatments in cardiovascular studies.
Professor Samuel Sears, the lead author of the study, stated, “While we know Barostim plus guideline-directed medical therapy shows long-term benefits, we now have data demonstrating sustained improvements in specific symptoms and quality of life for patients receiving this therapy.”
This publication builds on earlier data from the BeAT-HF trial, which was reported in the European Journal of Heart Failure.
The trial highlighted the sustained symptomatic benefits of Barostim for heart failure patients with reduced ejection fraction.
Dr. Philip Adamson, CVRx’s chief medical officer, expressed confidence that the analysis of the long-term BeAT-HF data would aid both patients and physicians in making informed decisions about Barostim therapy.
The global market for neuromodulation devices, which includes Barostim, is projected to reach $11.4 billion by 2033, according to a report by GlobalData.
In 2023, CVRx reported revenues of $39.3 million, reflecting an increase of $16.8 million from the previous year. As of December 31, 2023, the company had 178 active implanting centers.
Key Outcomes of The Barostim Device
CVRx’s latest findings indicate that patients using Barostim, in conjunction with guideline-directed medical therapy, experienced sustained and significant symptomatic improvements over two years.
Notably, they had a 34% lower likelihood of all-cause mortality or the need for advanced heart failure interventions, such as left ventricular assist device (LVAD) implantation or heart transplantation.
An analysis presented at the recent Technology in Heart Failure Therapeutics (THT) conference revealed that patients with Barostim had a 74% reduced risk of requiring advanced heart failure interventions compared to those receiving only standard therapy.
The study also showed significant improvements in quality of life scores, including reductions in shortness of breath, fatigue, and depression, along with enhancements in self-care and mobility.
Kevin Hykes, president and CEO of CVRx, emphasized the importance of these results. “The publication of these data allows for better dissemination of the long-term benefits of Barostim therapy for heart failure patients,” he said.
Hykes also acknowledged the contributions of the BeAT-HF executive steering committee and investigators involved in the trial, expressing optimism for future research and real-world evidence from the ongoing REBALANCE post-market registry.
As CVRx continues to gather data and expand the use of Barostim, the company aims to enhance treatment options for heart failure patients and improve their quality of life.