Abbott Vascular's MitraClip Approved in Japan
November 6, 2017—Abbott Vascular announced that Japan's Ministry of Health, Labor, and Welfare has approved the company's MitraClip device for treatment of patients with mitral regurgitation (MR). With approval in Japan, the device will be indicated to treat both severe degenerative MR and functional MR heart diseases.
The approval in Japan is based on the results of the AVJ-514 clinical trial and the extensive global experience and clinical data available for the MitraClip system. 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.
Data from the study were presented in March 2017 during a late-breaking session at the 81st Annual Scientific Meeting of the Japanese Circulation Society. The results of 30-day follow-up observation after the procedure demonstrated 86.7% of patients had MR = 2+ and 96.7% were New York Heart Association class I/II. There were no major adverse events (death, stroke, myocardial infarction, renal failure, nonelective cardiovascular surgery) in the study through 30 days.
Kentaro Hayashida, MD, Principal Investigator of the AVJ-514 clinical trial, commented in the company’s announcement, "MitraClip provides a new treatment option for many people with severe mitral regurgitation who cannot undergo the mitral valve surgery. The introduction of MitraClip therapy in Japan will help more people who previously had limited options return to better health faster, with dramatically reduced symptoms." The company noted that the standard-of-care treatments for MR in Japan are currently limited to open heart surgery and medication.