FDA Advisory Committee Votes Favorably on Abbott's Minimally Invasive
MitraClip® Device for Patients with Significant Mitral Regurgitation Who Are
Too High Risk for Surgery
ABBOTT PARK, Illinois, March 21, 2013
ABBOTT PARK, Illinois, March 21, 2013 /PRNewswire/ --Abbott (NYSE: ABT) today
announced that the U.S. Food and Drug Administration (FDA) Circulatory System
Devices Panel of the Medical Devices Advisory Committee has voted by majority
(Yes: 5, No: 3) that the benefits of treatment with the MitraClip® device
outweigh its risks in patients with significant symptomatic mitral
regurgitation (MR) who have been determined by a cardiac surgeon to be too
high risk for open mitral valve surgery and in whom existing co-morbidities
would not preclude the expected benefit from correction of the MR.
Abbott's MitraClip device, which received CE Mark in 2008 and is commercially
available in Europe and other international markets, is an investigational
device in the United States. The device is delivered to the heart through the
femoral vein, a blood vessel in the leg, and is designed to reduce MR by
clipping together a portion of the leaflets of the mitral valve to allow the
heart to more efficiently pump blood.
"We appreciate the FDA's dedication of time and resources to convene this
advisory panel for MitraClip and for its review of this new and novel
technology for high surgical risk patients suffering from the debilitating
symptoms of significant mitral regurgitation," said Charles A. Simonton, M.D.,
FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical
officer, Abbott Vascular. "We are pleased with the outcome of today's panel,
and we look forward to continuing discussions with the agency regarding the
On the separate question of whether there is reasonable assurance the device
is safe, the panel voted Yes: 8, No: 0. On the question of whether there is
reasonable assurance of efficacy, the panel voted Yes: 4, No: 5. The FDA will
take into account the panel's advice in making its decision on whether to
approve the MitraClip for the treatment of significant MR in the United
States. The company expects a decision later this year.
The committee's recommendation followed a review of data from a large and
growing body of clinical evidence (EVEREST II, EVEREST II High Risk and
REALISM) in which the MitraClip therapy demonstrated positive and consistent
results for high surgical risk patients suffering from the debilitating
symptoms of significant MR, including a safe procedure, reduction in MR,
reverse left ventricular remodeling, improvement in heart failure symptoms,
improvements in quality of life, and reduced rates of re-hospitalization.
About Mitral Regurgitation
Mitral regurgitation (MR) is the most common type of heart valve
insufficiency, ^ affecting approximately one in 10 people aged 75 years and
older. The condition occurs when the leaflets of the mitral valve do not close
completely, causing blood to flow backward and leak into the left atrium of
the heart during the cardiac cycle. To maintain an adequate forward flow of
blood throughout the body, the heart compensates by increasing the size of the
left ventricle, the main pumping chamber of the heart. This requires the heart
to work harder, and may ultimately lead to irregular heartbeats, stroke, heart
attack or death. MR may also lead to heart failure, a potentially deadly
condition that occurs when the heart is unable to pump sufficiently to
distribute blood flow to meet the needs of the body.
About the MitraClip® Device
Abbott's MitraClip therapy is designed to reduce MR and provide clinical and
quality-of-life benefits for patients suffering from the debilitating symptoms
of significant MR by clipping together a portion of the leaflets of the mitral
valve. The device is delivered to the heart through the femoral vein, a blood
vessel in the leg. The heart beats normally during the procedure, and a
heart-lung bypass machine is not required. By reducing MR, the therapy may
allow the heart to recover from overwork and improve function, potentially
halting the progression of heart failure and enabling patients to live a
higher quality life.
The device received CE Mark in 2008 and is commercially available in 30
countries, with more than 8,000 patients treated to date. The European Society
of Cardiology (ESC) 2012 heart failure guidelines and the ESC/European
Association for Cardio-Thoracic Surgery 2012 guidelines for the management of
valvular heart disease specify the MitraClip as a treatment option for high
surgical risk patients with MR.
About Abbott Vascular
Abbott Vascular is the world's leader in drug eluting stents. Abbott Vascular
has an industry-leading pipeline and a comprehensive portfolio of
market-leading products for cardiac and vascular care, including products for
coronary artery disease, vessel closure, endovascular disease and structural
Abbott ( NYSE: ABT ) is a global healthcare company devoted to improving life
through the development of products and technologies that span the breadth of
healthcare. With a portfolio of leading, science-based offerings in
diagnostics, medical devices, nutritionals and branded generic
pharmaceuticals, Abbott serves people in more than 150 countries and employs
approximately 70,000 people.
Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.
^ 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.
CAUTION: Investigational device. Limited by Federal (or United States) law
to investigational use.
Contact: Media, Jonathon Hamilton, +1-408-845-3491; or Financial, Tina
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