Japan’s Ministry of Health, Labour and Welfare(MHLW) has approved Abbott’s MitraClip device for treatment of people with mitral regurgitation (MR).
MR is a serious, progressive heart disease in which the mitral valve does not close properly, allowing blood to flow backward into the heart. It causes many life-altering symptoms, and left untreated, can ultimately lead to heart failure and death. Most people affected are elderly as MR incidence increases with age.
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.
Abbott’s system is a catheter-based therapy that sees the MitraClip device 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 MR and improving patient quality of life.
After obtaining CE mark approval in Europe in 2008, MitraClip was approved by the U.S. FDA in 2013. To date, more than 50,000 people have been treated with the device in nearly 50 countries. Japanese approval means the device will be indicated to treat both severe degenerative mitral regurgitation (DMR) and functional mitral regurgitation (FMR) heart diseases.
Approval was based on the results of the AVJ-514 clinical trial and extensive global experience and available clinical data. In the AVJ-514 study, patients with severe degenerative mitral regurgitation or functional mitral regurgitation were treated at six facilities in Japan. The results of 30-day follow-up observation after the procedure were favourable with 86.7 percent of patients showing MR =2+ and 96.7 percent NYHA class I/II. There were no major adverse events (death, stroke, myocardial infarction, renal failure, non-elective cardiovascular surgery) in the study through 30 days.
“MitraClip provides a new treatment option for many people with severe mitral regurgitation who cannot undergo the mitral valve surgery,” said Kentaro Hayashida, M.D., Cardiovascular Internal Medicine, Keio University, Tokyo and principal investigator of the AVJ-514 clinical trial. “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.”
“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,” said Michael Dale, vice president for Abbott’s structural heart business. “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.”