Abbott (NYSE:ABT) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its MitraClip transcatheter mitral valve repair device, cleared for indications of treating people with mitral regurgitation.
Currently, standard of care treatment for mitral regurgitation in Japan is limited to open-heart surgery and medication, Abbott said. Clearance of the catheter-based MitraClip system adds a minimally-invasive treatment option not previously available in the region, the company added.
The MitraClip is designed to be delivered to the heart through a blood vessel in the leg, securing portions of the leaflets of the mitral valve with a clip to allow the heart to pump blood more efficiently through the body.
“It is our mission to help people suffering from structural heart disease return to better health and quality-of-life by providing technologies and therapies that advance how people are treated. With the approval of our revolutionary MitraClip device in Japan, we can help more people live better by reducing the severity of their extremely life-altering illness in a safe and predictable way,” structural heart biz VP Michael Dale said in a press release.
Approval in Japan came based on data from the AVJ-514 clinical trial in the region, which reported an 86.7% rate of 2+ or less mitral regurgitation and classified 96.7% of patients as NYHA class I or II with no major adverse events at 30 days.
“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,” trial principal investigator Dr. Kentaro Hayashida of Tokyo’s Keio University said in a press release.
Last week, Abbott said it won’t introduce its next-generation drug-eluting stent, the Xience Sierra, to the Indian market due to price caps there.