Abbott Scores Japan Approval for MitraClip

Patients in Japan who previously had limited options for mitral regurgitation (MR) can potentially benefit from Abbott's MitraClip device. Japan's Ministry of Health, Labour, and Welfare (MHLW) has approved the catheter-based therapy for MR, a progressive heart disease in which the mitral valve does not close properly, allowing blood to flow backward into the heart. During Abbott's third-quarter earnings call, as transcribed by Seeking Alpha, CEO Miles White told investors that a continued global uptick of MitraClip sales led double-digit growth in the structural heart category. Now that the device has been approved in Japan, that trend is likely to continue for Abbott. Because MR gets worse with age, most people affected by the disease are elderly and cannot undergo open mitral valve surgery. The approval in Japan is based on the results of the AVJ-514 trial and extensive global experience and clinical data available for the MitraClip System, according to Abbott. In the AVJ-514 study, patients with severe degenerative MR or functional MR were treated at six facilities in Japan. Enrolled patients were limited to those who were not candidates for mitral valve surgery. In a late-breaking session at the annual scientific meeting of the Japanese Circulation Society in March, the results of 30-day follow-up observation after the procedure in the clinical trial were reported. At 30 days, 86.7% of patients had MR ≤2+ and 96.7% were NYHA class I/II. There were no major adverse ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news