Abbott Wins Additional Indication for MitraClip

Abbott Laboratories has received an expanded indication for MitraClip. The Abbott Park, IL-based company’s new indication addresses the secondary form of mitral regurgitation and significantly increases the amount of people with MR able to be treated with MitraClip. Based on this approval, Abbott said it will now begin discussions with the Center for Medicare and Medicaid Services (CMS) and physician specialty societies to request a revision to the national coverage determination that would expand Medicare coverage to include secondary MR patients.The indication was supported by the results of the COAPT Trial. Abbott said the COAPT trial was a study of 614 patients with heart failure who had moderate-to-severe or severe secondary MR and were randomly assigned to get either continuation of their optimized medication treatment plus the MitraClip or continuation of their optimized medication treatment only. The risk of being re-hospitalized for heart failure symptoms was reduced by about 47% in the MitraClip group compared to the control group. In addition, the risk of death within two years was decreased by about 37% in the MitraClip group compared to the control group.In an earnings call last month, Miles White, Abbott’s chairman and CEO, spoke about the new indication’s potential. “The [indication]would further enhance our leadership position in this large and highly under penetrated disease area and offe...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Cardiovascular Source Type: news