The CoreValve System and Evolut R have both been approved by the Food and Drug Administration (FDA) for use in patients who are at high and extreme risk for surgical aortic valve replacement (SAVR). This means that CoreValve and Evolut R are commercially available for use in patients who are deemed high or extreme risk for SAVR by their doctor. However, CoreValve and Evolut R have not been approved by the FDA for use in patients who are at low risk for SAVR. Therefore, the CoreValve System and Evolut R System are considered "investigational devices" in this low risk patient population and research studies are required to determine if they are safe, and provide clinical benefit.
To evaluate the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in symptomatic heart failure patients who are not candidates for mitral valve surgery.