Abbott has received approval from Japan’s Ministry of Health, Labor and Welfare for the company’s MitraClip, making it the first minimally invasive device to treat people in Japan with mitral regurgitation (MR) heart disease.
"MitraClip provides a new treatment option for many people with severe mitral regurgitation who cannot undergo the mitral valve surgery," Dr. Kentaro Hayashida of Keio University in Tokyo and principal investigator of the AVJ-514 clinical trial, said in a press release. "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.”
MR can cause life-altering symptoms if left untreated and can lead to heart failure, according to the release.
"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,” Michael Dale, Abbott’s vice president for structural heart business, said in the release.
The Food and Drug Administration approved Abbott’s MitraClip in 2013. Over 50,000 people have been treated with the device in almost 50 countries.