Barostim is no longer classified as a purely investigational device in the United States for its primary approved indications, as it has received premarket approval from the Food and Drug Administration (FDA) and holds specific coverage policies from major commercial insurers and Medicare administrative contractors for treating heart failure. However, certain ongoing clinical evaluations, expanded label trials (such as newer heart failure sub-study cohorts), or specific regional explorations may still evaluate the technology under investigational device exemption (IDE) frameworks to gather long-term post-market safety and efficacy data.