ABBOTT PARK, Ill., Nov. 6, 2017
/PRNewswire/ -- Abbott (NYSE: ABT) today announced that
Japan's Ministry of Health, Labour
and Welfare (MHLW) has approved the company's MitraClip device for
treatment of people with mitral regurgitation (MR), a serious,
progressive heart disease in which the mitral valve does not close
properly, allowing blood to flow backward into the heart.
MR causes many life-altering symptoms, and left untreated, can
ultimately lead to heart failure and death.
i,ii,iii Most people affected are elderly as
MR incidence increases with age.iv
"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."
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.
"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."
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 MR and improving
patient quality of life. v
After obtaining CE mark approval in Europe in 2008, MitraClip was approved by the
U.S. Food & Drug Administration (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 (DMR) and functional mitral regurgitation
(FMR) heart diseases.
About the AVJ-514 Trial
The approval in Japan is based on
the results of the AVJ-514 clinical trial and extensive global
experience and clinical data available for the MitraClip System. In
the AVJ-514 study, patients with severe degenerative mitral
regurgitation or functional mitral regurgitation were treated at
six facilities in Japan. Enrolled
patients were limited to those who were not candidates for mitral
valve surgery. In a late breaking session at the 81st Annual
Scientific Meeting of the Japanese Circulation Society in
March 2017, the results of 30-day
follow-up observation after the procedure in the clinical trial
were reported: at 30 days, 86.7 percent of patients had MR ≤2+ and
96.7 percent were 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.
About Degenerative and Functional Mitral
Regurgitation
Degenerative mitral regurgitation (DMR) is
caused by abnormality of valve structures including the valve
leaflets, valve ring, and chordae tendineae. Functional mitral
regurgitation (FMR) is a disease that occurs when the left
ventricle of the heart dilates, leading to incomplete coaptation of
the mitral valve.
For U.S. important safety information on MitraClip, visit
https://mitraclip.com/#isi.
About Abbott
At Abbott, we're committed to helping people live their best
possible life through the power of health. For more than 125 years,
we've brought new products and technologies to the world -- in
nutrition, diagnostics, medical devices and branded generic
pharmaceuticals -- that create more possibilities for more people
at all stages of life. Today, 94,000 of us are working to help
people live not just longer, but better, in the more than 150
countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
________________________________
i Healthline.com. Mitral Valve Disease. 2016. Accessed
September 7, 2017 at:
http://www.healthline.com/health/mitral-valve-disease.
ii Patient Info. Mitral Regurgitation. 2017. Accessed
September 7, 2017 at:
https://patient.info/health/mitral-regurgitation-leaflet.
iii National Heart, Lung and Blood Institute. What is
Heart Valve Disease? 2015. Accessed September 7, 2017 at:
https://www.nhlbi.nih.gov/health/health-topics/topics/hvd.
iv Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott
CG, Enriquez-Sarano M. Burden of
valvular heart diseases: a population-based study. Lancet.
2006 Sep 16;368(9540):1005-11.
http://www.ncbi.nlm.nih.gov/pubmed/16980116
v
http://www.abbottvascular.com/docs/ifu/structural_heart/eIFU_MitraClip.pdf
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