CVRx’s neuromodulation device, BAROSTIM NEO, designed to trigger the body's main cardiovascular reflex to treat patients suffering from chronic heart failure. It electrically stimulates the baroreceptors of the carotid artery to reduce heart failure symptoms in advanced heart failure patients.
BAROSTIM therapy, approved by The United States Food and Drug Administration (FDA), reduces sympathetic activity and increases parasympathetic activity, ultimately restoring autonomic balance. The system monitors and adjusts the signals it delivers to achieve optimal beat-to-beat stimulation.
The BAROSTIM NEO System is intended as a treatment option for patients who have a regular heart rhythm, who have a left ventricular ejection fraction of less than or equal to 35% per cent, are not candidates for cardiac resynchronisation therapy.
The BAROSTIM NEO improves the quality of life and the exercise capacity of heart failure. The system includes a pulse generator that is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck.
A physician tests and programs the device after the device is implanted. It delivers electrical impulses to cells in the neck called baroreceptors. These receptors sense how blood is flowing through the carotid arteries and relay information to the brain.
The signals are sent to the heart and blood vessels by the brain. These signals, in turn, relax the blood vessels and restrain the production of stress-related hormones to reduce symptoms of heart failure.
Possible complications associated with the implantation or use of the device include the need for reoperation; surgical or anesthetic complications; infection; low blood pressure that may cause dizziness, fainting, and/or falls; allergic reaction; exacerbation of heart failure; nerve damage; arterial damage; stroke and death.
The patients are provided with a new treatment option for the symptoms associated with advanced heart failure. The approval for this device was based on data obtained from the company's Baroreflex Activation Therapy for Heart Failure Pivotal Trial (BeAT-HF).
The study showed that patients who received the implant witnessed improvements in the quality of life, a 6-minute hall walk test, and cardiovascular function compared to control patients.
Neuromodulation is the most common indication for the relief of chronic pain, but various forms of nerve stimulation are also used to treat Parkinson's disease, epilepsy, psychiatric disorders, and other conditions.
