- Innovations designed to allow doctors to treat more
types of cases and anatomies
- MitraClip is the gold-standard minimally invasive
alternative to open-heart surgery for people needing mitral valve
repair
- Mitral regurgitation, the most common heart valve
disease, affects one in 10 adults over 75
ABBOTT PARK, Ill., July 12, 2018
/PRNewswire/ -- Abbott (NYSE: ABT) today announced it received
approval from the U.S. Food and Drug Administration (FDA) for a
next-generation version of its leading MitraClip® heart
valve repair device used to repair a leaky mitral valve without
open-heart surgery. The transcatheter clip-based therapy, now on a
third generation of product innovations, has been used to treat
more than 65,000 patients worldwide over the last ten years.
The next-generation MitraClip system provides cardiologists
with advanced steering, navigation, and positioning
capabilities for the clip, making it easier to use in difficult
anatomies. The enhanced system is designed to
allow for more precise placement during deployment, resulting in
more predictable procedures, and additionally offers a second clip
size with longer arms that expands the reach of the clip-based
device. The additional clip size is designed to help
doctors treat patients who have more complex anatomies when
repairing the mitral valve.
Abbott received CE Mark for the next-generation device earlier
this year, allowing for sale of the devices in the European Union
and other countries that recognize this regulatory designation.
"Physicians rely on MitraClip as an alternative to surgery for
patients who aren't surgical candidates and may need treatment to
relieve their symptoms or to survive," said Francesco Maisano, M.D., Prof.,
UniversitätsSpital Zürich, Switzerland, who was an early implanter of
MitraClip. "The enhanced MitraClip design allows for even more
precise navigation, accuracy, and stability during valve repairs,
which may be important when treating people with more complex or
advanced valve disease."
A leaking mitral valve, known as mitral regurgitation (MR) is a
serious, progressive heart disease in which the flaps of the mitral
valve do not close properly, allowing blood to flow backward into
the heart. Incidence of mitral regurgitation increases
with age, with nearly one in 10 people over the age of 75 having
moderate to severe disease1. Before MitraClip, people
who were not eligible for the standard-of-care surgery to treat
their MR could only manage their symptoms with medications that
don't stop the progression of the disease. Left untreated, MR leads
to a variety of life-altering symptoms and severe complications,
and may ultimately lead to heart failure and
death.1,2,3.
"Abbott engineers designed these enhancements based on feedback
from doctors to improve device delivery and to treat more types of
cases and anatomies," said Michael Dale, vice president for
Abbott's structural heart business. "We're committed to helping
people with mitral regurgitation return to living their best lives,
and these advances will enable doctors to treat even more patients
without surgery."
MitraClip treats people with degenerative mitral
regurgitation and is a therapy that is delivered via a
catheter to the heart through a blood vessel in the leg. MR
patients are often not eligible for the standard-of-care surgery
because of advanced age, frailty, multiple comorbidities or other
complicating factors and the therapy offers a minimally invasive
alternative. Treatment with MitraClip provides almost immediate
symptom relief and patients are released from the hospital on
average after two days.
Abbott recently began enrollment in the MitraClip EXPAND
clinical study, a prospective study evaluating the safety and
performance of the new MitraClip system in a contemporary
real-world setting. Saibal Kar,
M.D., director of Interventional Cardiac Research at the
Smidt Heart Institute at Cedars-Sinai in Los Angeles, Calif., treated the first
patient enrolled, and is the lead investigator of the study. EXPAND
will enroll approximately 1,000 patients in more than 50 centers
across the U.S. and Europe and
interim results from the study are expected later this year.
About MitraClip
MitraClip received
initial CE Mark approval in Europe in 2008 and was
approved by the FDA in 2013. By securing a portion of
the leaflets of the mitral valve with an implanted clip, the heart
can pump blood more efficiently throughout the body, thereby
relieving the symptoms of severe MR and improving patient quality
of life.4
For U.S. Important Safety Information on MitraClip,
visit
http://mitraclippossibilities.com/#isi-sec.
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, 99,000 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.
1 Healthline.com. Mitral Valve Disease.
2016. Accessed April 10, 2018 at:
http://www.healthline.com/health/mitral-valve-disease.
2 Patient Info. Mitral Regurgitation. 2017.
Accessed April 10, 2018 at:
https://patient.info/health/mitral-regurgitation-leaflet.
3 National Heart, Lung and Blood Institute.
What is Heart Valve Disease? 2015. Accessed April 10, 2018 at:
https://www.nhlbi.nih.gov/health/health-topics/topics/hvd.
4
http://eifu.abbottvascular.com/content/dam/av/eifu-us/EL2106481%20Rev.%20A%202016-04-28.pdf
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SOURCE Abbott