Michael Barbella, Managing Editor05.23.24
CVRx Inc. is adding to its growing database of clinical support for Barostim, a device used to treat heart failure patients with reduced ejection fraction.
The company found additional support in results from the post-market phase of the BeAT-HF trial, which were published in the European Journal of Heart Failure. These data highlight long-term sustained benefits of Barostim in heart failure patients with reduced ejection fraction.
“Publication of these data from the post-market phase of BeAT-HF in this journal allows for more effective dissemination of the long-term results of this important trial and the positive symptomatic impact of Barostim on patients with heart failure,” CVRx President/CEO Kevin Hykes said. “Additionally, we are pleased at the favorable physician response to new abstracts that show a reduction in additional heart failure interventions in patients with Barostim, as well as specific patient-centered benefits at long-term follow-up.”
CVRx previously announced some of these data as part of expanded labeling granted by the U.S. Food and Drug Administration (FDA). The key benefits of Barostim contained in the European Journal of Heart Failure manuscript include the following:
CVRx developed and commercializes the Barostim System, the first medical technology approved by 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 the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the United States. It has also received the CE Mark for heart failure and resistant hypertension.
The company found additional support in results from the post-market phase of the BeAT-HF trial, which were published in the European Journal of Heart Failure. These data highlight long-term sustained benefits of Barostim in heart failure patients with reduced ejection fraction.
“Publication of these data from the post-market phase of BeAT-HF in this journal allows for more effective dissemination of the long-term results of this important trial and the positive symptomatic impact of Barostim on patients with heart failure,” CVRx President/CEO Kevin Hykes said. “Additionally, we are pleased at the favorable physician response to new abstracts that show a reduction in additional heart failure interventions in patients with Barostim, as well as specific patient-centered benefits at long-term follow-up.”
CVRx previously announced some of these data as part of expanded labeling granted by the U.S. Food and Drug Administration (FDA). The key benefits of Barostim contained in the European Journal of Heart Failure manuscript include the following:
- There was not a statistically significant difference in the primary endpoint of CV death and HF hospitalization, demonstrating the therapy's benefits do not increase the long-term risk of patient harm
- Patients receiving Barostim + guideline-directed medical therapy (GDMT) had sustained and significant symptomatic improvements (six-minute hall walk, quality of life and NYHA class) at up to two years versus those patients receiving GDMT alone
- Patients receiving Barostim + GDMT had a 34% reduced likelihood of all-cause death or the need for left ventricular assist device (LVAD) implantation or heart transplant, suggesting a favorable effect of Barostim therapy
- Patients in the trial with Barostim + GDMT had a 74% reduced risk of receiving advanced heart failure interventions (transplant, LVAD, CCM, CRT or CardioMEMS) at long-term follow-up versus patients on GDMT alone.
- Patients with Barostim + GDMT had sustained and significant improvements in quality-of-life scores (MLWHF and EQ-5D) and many subdomains of these scores (e.g., reductions in shortness of breath, fatigue, depression and improvements in self-care, mobility and pain, etc.) versus patients on GDMT alone.
CVRx developed and commercializes the Barostim System, the first medical technology approved by 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 the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the United States. It has also received the CE Mark for heart failure and resistant hypertension.