ABBOTT PARK, Ill., Jan. 13, 2020
/PRNewswire/ -- Abbott (NYSE: ABT) today announced that the
U.S. Food and Drug Administration (FDA) has approved a
first-of-its-kind clinical trial that will compare the
effectiveness of Abbott's minimally invasive MitraClip™ device –
which has now treated 100,000 patients worldwide – to open heart
mitral valve surgical repair in people with primary mitral
regurgitation (MR) who are eligible for open-heart surgery. If
successful, the trial has the potential to expand treatment options
for patients who are suffering from leaking mitral valves and whose
current options are limited to open-heart surgery.
The prospective, randomized REPAIR MR clinical trial will enroll
approximately 500 patients at 60 sites in the U.S., Canada and Europe to evaluate the effectiveness of the
MitraClip device in moderate-surgical-risk patients with severe
primary MR who are candidates for open-heart surgery, which is the
current standard of care today. The trial's design addresses the
issue that, despite symptoms and increased mortality for people
suffering from MR, patients are often undertreated by open-heart
mitral valve surgery. Currently, only an estimated 15% of patients
who are eligible for the standard-of-care surgery for their primary
MR receive surgical treatment. In some cases, this may be because
the MR goes undiagnosed, but in others, patients may forgo surgery
due to prolonged recovery time or fear of possible surgical
complications.1 2
"The REPAIR MR trial seeks to evaluate the MitraClip device in
treating a new patient population who currently undergo the
standard surgical treatment, but are at moderate surgical risk,"
said Patrick McCarthy, M.D., chief
of cardiac surgery, Northwestern Medicine, executive director,
Bluhm Cardiovascular Institute and co-principal investigator of the
REPAIR MR trial. "This is an important question since approximately
70% of people diagnosed with primary mitral regurgitation aren't
treated with open-heart mitral valve surgery today yet are in need
of treatment and symptom relief." The trial will also be led by
co-principal investigator Saibal
Kar, M.D., director of structural heart disease and
research, Los Robles Hospital and Medical Center.
Mitral regurgitation (MR) is a debilitating, progressive and
life-threatening disease in which the heart's mitral valve does not
close completely, causing blood to flow backward and leak into the
atrium of the heart. The condition is the most common valve disease
worldwide and can lead to reduced quality of life, recurrent
hospitalizations and decreased survival.
Abbott's MitraClip system has been commercially available in the
U.S. since 2013 and in Europe since 2008 and has shown
significant impact for patients with both primary and secondary MR
who are at high risk for open-heart surgery. The MitraClip therapy
– now on a fourth generation of innovation – has shown improved
clinical outcomes and quality of life through a minimally invasive
option that reduces MR's debilitating symptoms.
"Abbott is leading the way in the structural heart space. We're
pushing the field forward by making clinical investments to examine
whether new, minimally invasive treatment options are suitable, or
even preferable, to what has been the standard of care," said
Neil Moat, M.D., chief medical
officer of Abbott's structural heart business. "Devices that can be
delivered through a minimally invasive method to close or repair a
significant structural issue in the heart are in high demand, and
we are committed to continuing our efforts to bring the benefits of
these devices to patients who need them."
For more information on MitraClip,
visit:www.structuralheartsolutions.com.
For U.S. Important Safety Information about MitraClip, visit:
https://www.structuralheartsolutions.com/us/mitraclip-isi.
About Abbott:
Abbott is the global leader that helps
people live more fully at all stages of life. Our portfolio of
life-changing technologies spans the spectrum of healthcare, with
leading businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 103,000 colleagues
serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
1 Mirabel et al. European Heart Journal
2007;28(11):1358-1365; Dziadzko et al. Lancet 2018; 391:960-69
2 Hendrix, et al. Annals of Thoracic Surgery 2019;
107:747-53
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SOURCE Abbott