Barostim Neo Neuromodulation Device for Heart Failure Wins FDA Approval
CVRx, a Minneapolis, Minnesota company, won FDA approval for the first neuromodulation device designed to address heart failure. Intended as a treatment option for patients with an ejection fraction ≤35% and New York Heart Failure Classification of III or II (with recent history of Class III), the device stimulates the carotid artery and in turn the baroreceptors that control cardiovascular activity.
The system monitors and adjusts the signals it delivers to achieve optimal beat-to-beat stimulation. It has been approved in Europe for a number of years (see flashbacks below).
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