ABBOTT PARK, Ill., Jan. 7, 2020
/PRNewswire/ -- Abbott (NYSE: ABT) today announced U.S. Food
and Drug Administration (FDA) approval of a new alternative
surgical technique for Abbott's HeartMate 3 heart pump that will
allow more advanced heart failure patients to avoid open heart
surgery. The new, less invasive approach is designed to provide
surgeons a choice in surgical method for patients receiving the
HeartMate 3™ Left Ventricular Assist Device (LVAD), the industry's
leading heart pump.
Approximately 615,000 people in the U.S. are living with heart
failure and nearly 40% are considered to have reached an advanced
stage where traditional therapies no longer work. Heart pumps are
small, implantable mechanical devices that pump blood through the
body in people whose heart is too weak to do so on its own. People
living with a heart pump may be waiting for a heart transplant or
may not be candidates for a transplant and will live with the
device for the rest of their life.
Historically, heart pumps have been implanted via open heart
surgery. With approval for an alternative surgical technique,
Abbott's HeartMate 3 heart pump can now be implanted via lateral
thoracotomy – a surgical approach where an incision is made between
a patient's ribs to access the heart. Physicians believe that for
many patients this technique has advantages over open heart surgery
because it can result in less bleeding and a shorter recovery time
for patients.
"This is a significant advancement for patients who can now
receive a life-saving LVAD through an alternative procedure that
can yield shorter hospital stays and a faster recovery," said heart
transplant surgeon Igor Gosev,
M.D., University of Rochester Medical Center in Rochester, New York. "Heart failure is a
crippling and costly disease so being able to offer patients the
HeartMate 3 heart pump with this less-invasive approach gives them
the opportunity to return to a better quality of life more
quickly."
The approval is based on two studies – the ELEVATE study: a
multi-center, voluntary, observational registry collecting
post-marketing data, and the LAT Feasibility study: a single arm,
prospective, multicenter study. Results of the two trials found
that bleeding (requiring surgery), infection and arrhythmias were
lower in the group implanted via the less-invasive surgical
approach than those who underwent open heart surgery.
"We continue to focus on advancing our heart failure devices and
techniques to make life better for the patients we serve," said
Robert L. Kormos, M.D., medical
director for mechanical circulatory support at Abbott. "The first
approved LVAD—HeartMate I—was approved more than 25 years ago.
Since that time, the technology has evolved immensely. Today's
HeartMate 3 device, including its design and size, allows
physicians to successfully implant it without having to perform
open heart surgery and offers survival rates, as demonstrated in
the MOMENTUM 3 clinical trial, at two-years that are comparable to
heart transplants."
The HeartMate 3 received approval from the FDA in 2017 for
patients with advanced heart failure whose hearts are unable to
circulate blood through the body, and are waiting for a transplant,
known as bridge to transplant. In 2018, HeartMate 3 was approved as
a destination therapy for those individuals who are in need of a
new heart but are not eligible for a transplant.
ABOUT ABBOTT'S HEARTMATE 3 LVAD
Abbott's HeartMate 3 LVAD is a small, implantable mechanical
circulatory support device for advanced heart failure patients who
are awaiting transplantation or are not candidates for heart
transplantation. It is the first commercially approved (CE Mark and
FDA approved) LVAD with Full MagLev™ technology,
which allows the device's rotor to be "suspended" by magnetic
forces. This design aims to reduce trauma to blood passing through
the pump and improve outcomes for patients. In the largest LVAD
trial in the world, HeartMate 3 LVAD showed a survival rate of 82.8
percent at two years.
ABOUT ABBOTT'S HEART FAILURE PORTFOLIO
Abbott is pioneering heart failure disease management with
innovative solutions like the CardioMEMS HF System, ground-breaking
quadripolar pacing technology, our first-to-market
MultiPoint™ pacing technology and, in select
European markets and the U.S, the HeartMate™ 3 left
ventricular assist system. Abbott collaborates with heart
failure specialists, clinicians and advocacy partners to provide
innovative, cost-effective solutions that help reduce
hospitalizations and improve patient quality of life for heart
failure patients around the world.
ABOUT ABBOTT
Abbott is a global healthcare 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.
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SOURCE Abbott