The results of 264 randomized patients in the BeAT-HF trial were recently published in the Journal of the American College of Cardiology. These results were used to obtain Premarket Approval from the U.S. Food and Drug Administration (FDA) to market its BAROSTIM NEO device for improvement of symptoms in patients with HF in the United States.
Enrollment in the post-market phase of the BeAT-HF trial, which continued in the background after FDA approval, is now complete. Outcome data, as planned, will continue to be collected until the completion of the trial.
CVRx has now turned its focus to enrolling patients in the BAROSTIM THERAPY in Heart Failure with Reduced Ejection Fraction Registry, which will collect individual patient data related to safety of the system, health care utilization, patient-centered symptomatic endpoints and other clinical data. Up to 5,000 patients will be enrolled across the United States.
The first patient enrolled in this HF registry was at Physician's Regional Medical Center in Naples, Fla. Dr. Ken Plunkitt, the patient's referring physician and co-surgeon said, "We are extremely excited to offer this most promising therapy to the patients of southwest Florida. Our first patient is responding well to BAROSTIM THERAPY and is extremely happy with the process and results."
BAROSTIM NEO uses CVRx-patented technology, designed to send electrical pulses to baroreceptors located in the wall of the carotid artery, to deliver BAROSTIM THERAPY. The therapy is designed to restore balance to the autonomic nervous system and thereby improve the symptoms of HF. The BAROSTIM NEO is approved by FDA for heart failure in the United States and has received the CE Marking for HF and resistant hypertension in the European Economic Area.