Abbott has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved its MitraClip device for treatment of people with mitral regurgitation. Currently, the standard-of-care treatments for mitral regurgitation in Japan are limited to open-heart surgery and medication.
Surgery is not a viable option for some patients because of advanced age or other comorbidities, and medications typically only mask symptoms, instead of treating the underlying issue of the valve itself.
The MitraClip system is a catheter-based, minimally-invasive therapy that is delivered to the heart through a blood vessel in the leg. By securing a portion of the leaflets of the mitral valve with a clip, the heart can pump blood more efficiently throughout the body, thereby relieving the symptoms of severe mitral regurgitation and improving patient quality of life.
Kentaro Hayashida,Cardiovascular Internal Medicine, Keio University, Tokyo and principal investigator of the AVJ-514 clinical trial, says: “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.”
After obtaining CE mark approval in Europe in 2008, MitraClip was approved by the FDA in 2013. To date, more than 50,000 people have been treated by MitraClip in nearly 50 countries. With approval in Japan, the device will be indicated to treat both severe degenerative mitral regurgitation and functional mitral regurgitation.