Abbott's Minimally Invasive MitraClip® System for Mitral Regurgitation
Demonstrates Positive Clinical and Quality-of-Life Results for Patients Too
High Risk for Surgery
SAN FRANCISCO, March 10, 2013
SAN FRANCISCO, March 10, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair
STudy) High Surgical Risk cohort evaluating the company's first-in-class
catheter-based MitraClip ^® System for the treatment of mitral regurgitation
(MR). Findings were presented today at the 62nd Annual Scientific Session of
the American College of Cardiology in San Francisco.
Abbott's MitraClip system, an investigational device in the United States,
received CE Mark in 2008 and is commercially available in approximately 30
countries, with more than 8,000 patients treated to date. 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 the leaflets of the mitral
valve to allow the heart to more efficiently pump blood.
The EVEREST II High Surgical Risk cohort included data from patients enrolled
in the multi-center EVEREST II High Risk and REALISM continued access studies.
Findings from 351 symptomatic U.S. patients deemed too high risk for open
mitral valve surgery demonstrated:
*A 30-day mortality rate significantly lower than expected for surgery (4.8
percent for patients treated with the MitraClip system versus 18.2 percent
predicted surgical mortality, p<0.0001);
*A low rate of adverse events, despite the high surgical risk profile of
*An implant success rate of 96 percent;
*Acute reduction in MR to 2+ or less achieved in 86 percent of patients
treated with the MitraClip device;
*Clinically significant improvement in left ventricular size, significant
improvements in NYHA Functional Class and SF-36 Quality of Life scores,
and significantly reduced rates of hospitalization for heart failure (48
percent reduction from one year post-discharge compared to the year prior
to treatment, p<0.0001).
"Patients with mitral regurgitation who are not candidates for mitral valve
surgery due to risk of mortality have an unmet need for a treatment option
that will reduce symptoms and improve the quality of their lives," said D.
Scott Lim, M.D., associate professor of Cardiovascular Medicine at the
University of Virginia Health System in Charlottesville, Va. "The findings of
the EVEREST II High Surgical Risk cohort suggest that treatment with the
MitraClip device represents a new option that could allow these high-risk
patients to return to activities they enjoy, and results in a reduction in
hospitalizations for heart failure."
"These results add to the large and growing body of data that show that the
first-in-class percutaneous MitraClip therapy can have positive results 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 look forward to the March 20 FDA Advisory Committee
meeting to discuss the MitraClip system as a treatment option for this patient
group in the United States."
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, its main pumping chamber. 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 System Abbott's MitraClip device 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 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
approximately 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 system 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 heart disease.
About Abbott Abbott 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.
Contact: Media, Jonathon Hamilton, +1-408-624-0314, or Steve Kelly,
+1-408-444-3018, or Financial, Brian Yoor, +1-847-937-6343, or Tina Ventura,
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