ABBOTT PARK, Ill., Sept. 17, 2019
/PRNewswire/ -- Abbott (NYSE: ABT) today announced approvals in
Europe for two of its life-saving
pediatric devices. The Masters HP™ 15mm rotatable mechanical heart
valve and the Amplatzer Piccolo™ Occluder have received CE Mark and
are now available in Europe and
other countries that recognize CE Mark. The new treatments, already
available in the U.S., offer young pediatric patients and their
families hope when no other suitable treatment option may
exist.
Congenital heart defects (CHD) affect approximately 36,000
births in the European Union each year.i The Masters
valve is the world's smallest mechanical heart valve and allows
doctors to treat babies and toddlers in need of a mitral or aortic
heart valve replacement. The Amplatzer Piccolo is smaller than a
pea and is the world's first medical device that can be implanted
in the tiniest babies (weighing as little as under one kilogram) to
treat patent ductus arteriosus, or PDA, a potentially
life-threatening opening in the heart. These life-saving devices
for certain congenital heart defects are the first and only devices
of their kind.
"Devices like these are among the best examples of our promise
at Abbott to help people live their fullest lives – in this case,
young babies and children for whom these treatments are nothing
short of miraculous," said Michael Dale, vice president of
Abbott's structural heart business. "While the children who benefit
from these therapies represent a very small segment of the total
population with structural heart disease, these advanced
technologies enable physicians to treat vulnerable pediatric
patients who otherwise have limited options."
About the Masters HP 15mm Rotatable Mechanical Heart
Valve
Smaller than a 1c euro, at just 15mm the Masters valve is the
first and only pediatric mechanical heart valve developed for
newborns and infants and is now available in the European Union.
The valve is a rotatable, bileaflet mechanical heart valve designed
for implantation in the mitral or aortic position and is part of
the Masters Series line, which now includes seven valves with
diameter sizes ranging from 15 to 27mm.
When the tissues of the heart valve have a significant
malformation or are too damaged and cannot be repaired to function
properly, it may be necessary to replace the valve with a
mechanical valve. A mechanical heart valve mimics a healthy
heart valve, opening and closing with each heartbeat, permitting
proper blood flow through the heart.
Until Abbott's device, surgeons could only use a range of
larger-sized valves to replace a pediatric heart valve that could
not be repaired, which could result in improper fit and
complications. The Masters pediatric valve was approved in
the United States in March 2018 and in Canada in October
2018.
About the Amplatzer Piccolo Occluder
One of the most common congenital heart defects occurring in
premature babies, PDA, is a potentially life-threatening opening
between two blood vessels which lead from the heart. This channel,
which is present in normally developing fetuses, is important prior
to birth to allow oxygen-rich blood from the mother to circulate
throughout the fetus' body. For most infants, the pathway, or duct,
seals itself shortly after birth. In some cases, primarily in
babies born prematurely, the PDA fails to spontaneously close,
which can make it difficult for babies to breathe normally due to
increased blood flow to the lungs. PDA accounts for up to 10% of
all congenital heart disease.ii
The Amplatzer Piccolo, approved in the U.S. in January 2019, is a self-expanding, wire mesh
device that is inserted through a small incision in the leg and
guided through vessels to the heart, where it is placed to seal the
opening in the heart. Many of the premature babies who are
critically ill in the neonatal intensive care unit are able to be
weaned from artificial respirator support soon after the minimally
invasive procedure. With the approval of the Amplatzer Piccolo in
Europe and other countries that
recognize CE Mark, Abbott offers hope to premature infants and
newborns who need corrective treatment, and who may be
non-responsive to medical management and high risk to undergo
corrective surgery.
The Amplatzer Piccolo device builds on more than 20 years of
clinical success for Abbott's family of Amplatzer Occluder
therapies, including the Amplatzer™ Duct Occluder family of
products (ADO, ADOII and ADOIIAS), already approved for use in
Europe and countries around the
world to treat PDA in larger size pediatric patients.
"Seeing the youngest patients fight for their lives is
harrowing, and finally having solutions that can offer a dependable
treatment option to get these little ones out of the NICU and sent
home with their families is a huge advance in our field," said Dr.
Mario Carminati, Director of
Pediatric and Adult Congenital Cardiology at IRCCS Policlinico San
Donato, Milan.
For U.S. Important Safety Information on the Masters HP Series,
visit http://abbo.tt/2taeyVL.
For U.S. Important Safety Information about the Amplatzer
Piccolo Occluder, visit
https://www.structuralheartsolutions.com/us/piccolo-ISI.
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.
i Dolk, Helen et al. "Congenital heart defects in
Europe: prevalence and perinatal
mortality, 2000 to 2005." Circulation 123 8 (2011):
841-9.
ii Schneider, D. J., & Moore, J. W. (2006). Patent
ductus arteriosus. Circulation, 114(17), 1873-18.
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SOURCE Abbott